A Phase 3, Randomized, Double-Blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Once Daily Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP compared with placebo on exercise capacity in adults with PAH.

开始日期2026-04-17

申办/合作机构

Insmed, Inc.

NCT07234032

/ Not yet recruiting临床3期

A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated With Interstitial Lung Disease

The primary objective of this study is to evaluate the safety and tolerability of the long-term use of TPIP in participants with PH-ILD from Study INS1009-311 (NCT07179380).

开始日期2026-04-01

申办/合作机构

Insmed, Inc.

NCT07179380

/ Recruiting临床3期

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease

The primary objective of this study is to evaluate the effect of 24-weeks of once daily treatment with TPIP versus placebo on exercise capacity in adults with PH-ILD.

开始日期2026-01-07

申办/合作机构

Insmed, Inc.

100 项与曲前列尼尔棕榈酸酯相关的临床结果

登录后查看更多信息

100 项与曲前列尼尔棕榈酸酯相关的转化医学

登录后查看更多信息

100 项与曲前列尼尔棕榈酸酯相关的专利（医药）

登录后查看更多信息

项与曲前列尼尔棕榈酸酯相关的文献（医药）

2026-04-03·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Tubulin polymerization inhibitors in early clinical studies as cancer therapeutics

Review

作者: Shaik, Rahaman ; Yakkalaa, Prasanna Anjaneyulu ; Kamal, Ahmed

INTRODUCTION:

Microtubules are essential to cancer therapy as key cytoskeletal components that regulate cell division, intracellular transport, and mitotic spindle formation. Tubulin polymerization inhibition is a critical target in anticancer drug development. This review evaluates tubulin polymerization inhibitors (TPIs) in early clinical stages. Using pertinent keywords on tubulin polymerization inhibitors and related trials, literature from January 2018 to January 2026 was obtained from PubMed, Scopus, Embase, Web of Science, ClinicalTrials.gov, and Google Scholar.

AREA COVERED:

TPIs are classified by their tubulin binding sites into colchicine, vinca alkaloid, and taxane categories. Preclinical data demonstrate strong antiproliferative activity, tumor regression in models, and synergism with DNA-damaging agents, targeted therapies, and immunotherapy. Clinical investigations assess efficacy, identify dose-limiting toxicities, and guide biomarker-based patient selection. Challenges such as drug resistance and pharmacokinetics are addressed through nanoparticle delivery and combination strategies.

EXPERT OPINION:

TPIs are evolving from traditional cytotoxic agents to precision medicines that exploit molecular differences between cancerous and normal tissues. Advances such as βIII-tubulin as a predictive biomarker enable personalized therapy. Despite challenges, integrating nanotechnology and immunotherapy offers transformative potential. TPIs are emerging as potent agents in precision oncology with enhanced efficacy and reduced toxicity, marking a pivotal shift in targeted cancer treatment.

2025-06-25·JOURNAL OF AGRICULTURAL AND FOOD CHEMISTRY

Molecular Basis of Pseudomonas syringae pv actinidiae Levansucrase Inhibition by a Multivalent Iminosugar

Article

作者: Luti, Simone ; Cardona, Francesca ; Paoli, Paolo ; Ferraroni, Marta ; Pazzagli, Luigia ; Clemente, Francesca ; Cicchi, Costanza ; Canovai, Alberto ; Pavone, Sara ; Marchi, Guido ; Matassini, Camilla ; Campigli, Sara

Levansucrases are a class of polysaccharide-processing enzymes widely distributed among plant pathogenic bacteria, such as Pseudomonas syringae and Erwinia amylovora. Therefore, the modulation of levansucrase activity could represent a new strategy to reduce the microbial survival of such bacteria. Herein, we identified a tetravalent pyrrolidine iminosugar (TPIS) as the first levansucrase inhibitor described to date. TPIS reversibly inhibits sucrose hydrolysis and levan polymerization of levansucrase derived from different bacterial genotypes of P. syringae, showing competitive behavior and an inhibition constant (K_i) in the micromolar range. Interestingly, the monovalent pyrrolidine iminosugar (PIS) analogue shows negligible inhibition, suggesting that multivalency plays a pivotal role in the interaction with levansucrase. To gain insight into the binding mechanism, the X-ray crystal structures of the beta levansucrase isoform from P. syringae pv actinidiae (Psa) in its native form and in complex with TPIS were solved, confirming TPIS as a competitive inhibitor of levansucrases. Only a portion of TPIS, corresponding to one chain of the tetravalent iminosugar derivative, was visible in the electron density maps. Nevertheless, our structural data provided an adequate comprehension of the inhibitor/enzyme interactions, sufficient to exclude some of the possible inhibition mechanisms justifying a multivalent effect and pave the way for the development of new, more potent inhibitors.

2025-05-04·Sar and Qsar in Environmental Research

Discovery of novel 1,3,4-oxadiazole derivatives as anticancer agents targeting thymidine phosphorylase: pharmacophore modelling, virtual screening, molecular docking, ADMET and DFT analysis

Article

作者: Murmu, A. ; Roy, P.P. ; Singh, J. ; Banjare, P. ; Matore, B.W.

Thymidine phosphorylase (TP) is a key enzyme involved in angiogenesis, tumour growth and closely linked to cancer progression and metastasis. This study represents the first comprehensive 3D-QSAR pharmacophore-based approach to identifying potential 1,3,4-oxadiazole derivatives as targeted TPIs for anticancer therapy. A dataset of 76 analogues with an experimental IC₅₀ values was used to develop pharmacophore models. The BEST conformation method identified an optimal model (Hypo 2), featuring HBA, HBD and RA as key activity determinants with strong statistical validation (r² = 0.69, ΔCost = 77.41, Q² = 0.68 and MAE = 0.23). A virtual screening of 12,353 drug-like 1,3,4-oxadiazole compounds from PubChem and ChEMBL yielded 329 potential TPIs (IC₅₀ < 10 μM). MD Docking using CDOCKER (PDB ID: 1UOU) identified the top hits interacting with critical TP residues (Thr151, Gly152, Lys221, Ser217, Thr118). ADMET analysis confirmed their drug-likeness with no significant toxicity. ChEMBL2058305 exhibited the highest binding stability (-85.508 kcal/mol), the lowest HOMO-LUMO gap (0.066 ha), and superior TP affinity, highlighting its potential as a promising TP inhibitor for anticancer therapy. This first report with integration of pharmacophore modelling, virtual screening, MD Docking, ADMET, MMGBSA and DFT will be beneficial for the discovery of novel TPIs.

项与曲前列尼尔棕榈酸酯相关的新闻（医药）

2026-05-04

·PRNewswire

Insmed to Present Data Across Its Respiratory Portfolio, Including Late-Breaking ARIKAYCE® Results from Phase 3b ENCORE Study, at the American Thoracic Society International Conference 2026

—New Data in Non-Cystic Fibrosis Bronchiectasis Further Define Impact of BRINSUPRI® on Respiratory Symptoms— —Findings from a Pharmacokinetic Study Continue to Support Further Evaluation of Treprostinil Palmitil Inhalation Powder Phase 3 Development Program— —Additionally, Insmed Provides Independent Research Grant to the American Thoracic Society for a Landmark Quality Initiative to Improve Diagnosis of Bronchiectasis across the U.S.— BRIDGEWATER, N.J., May 4, 2026 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that it will present six abstracts from across its respiratory portfolio and pipeline at the American Thoracic Society International Conference 2026 (ATS 2026), taking place May 17–20 in Orlando, Florida. Notably, data will be presented from the Phase 3b ENCORE study evaluating ARIKAYCE® (amikacin liposome inhalation suspension) with multidrug therapy (azithromycin 250 mg + ethambutol 15 mg/kg) once-daily versus placebo with multidrug therapy once-daily in diagnosed adult patients with a new occurrence of Mycobacterium avium complex (MAC) lung infection who had not received antibiotics. Additional presentations include a post-hoc analysis from the Phase 3 ASPEN trial of BRINSUPRI® (brensocatib), real-world experience data in patients with non-cystic fibrosis bronchiectasis (NCFB), a pharmacokinetic analysis of investigational treprostinil palmitil inhalation powder (TPIP), and data highlighting disease burden in pulmonary hypertension associated with interstitial lung disease (PH-ILD). "At Insmed, our work in respiratory disease is guided by the experiences of people living with serious and rare pulmonary conditions, where meaningful treatment advances are still urgently needed," said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. "The research we're presenting at ATS 2026 reflects the strength of Insmed's respiratory portfolio and pipeline, and our unwavering commitment to patients. Additionally, we're honored to present the Phase 3b ENCORE study findings as a late breaker, which will highlight compelling evidence of ARIKAYCE's potential use earlier in the treatment journey for patients living with Mycobacterium avium complex lung disease." Presentations: Late Breaking Science A71, Sunday, May 17, 11:30 AM – 1:15 PM EDT Amikacin Liposome Inhalation Suspension for Newly Diagnosed Mycobacterium Avium Complex Lung Disease: Efficacy and Safety From a Phase 3b Study (ENCORE) Poster Session B45, Monday, May 18, 11:30 AM – 1:15 PM EDT Effect of Brensocatib on Patient-Reported Symptoms in Patients with Non-Cystic Fibrosis Bronchiectasis: A Post Hoc Analysis of QOL-B RSS Individual Items from the ASPEN Phase 3 Trial Poster Session B106, Monday, May 18, 2:15 – 4:15 PM EDT Population Pharmacokinetics Analysis of Treprostinil Using Data From Phase 1 and 2 Studies of Treprostinil Palmitil Inhalation Powder Poster Session B107, Monday, May 18, 2:15 – 4:15 PM EDT Patient and Caregiver Survey of Burden of Bronchiectasis in the US and Europe Poster Session C58, Tuesday, May 19, 11:30 AM – 1:15 PM EDT Long-term Hospitalizations, Comorbidities, and Survival in Patients with Pulmonary Hypertension Associated With Interstitial Lung Disease in Real-World Settings Using the NorstellaLinQ Claims Database Mini Symposium D92, Wednesday, May 20, 11:00 AM – 1:00 PM EDT Exposure-response Relationships of Brensocatib in Adult and Adolescent Patients With Non-Cystic Fibrosis Bronchiectasis In addition to its scientific presentations, Insmed will also host a Medical Affairs exhibit booth (location #937) at the ATS conference. American Thoracic Society (ATS) Bronchiectasis Diagnosis Quality Initiative As announced by the ATS, Insmed is supporting the organization with an independent research grant for a landmark quality improvement initiative aimed at addressing the widespread underdiagnosis of bronchiectasis across the United States. Working with seven academic medical systems, the ATS will independently conduct a large-scale electronic health record study to identify patients misdiagnosed with asthma or COPD, pilot scalable diagnostic interventions, and disseminate findings nationally, with the goal of ensuring patients receive timely, accurate diagnoses and guideline-directed care. About ARIKAYCE ARIKAYCE® is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI). About BRINSUPRI BRINSUPRI® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). BRINSUPRI (brensocatib 10 mg and 25 mg tablets) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. In the European Union, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. About TPIP Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction. Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate. Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate. Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate. Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate. Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures. Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE. Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE. Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions. Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus. Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside. Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%). Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol. Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. U.S. INDICATION LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients. This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitation of Use : ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease. Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED. Please see Full Prescribing Information . BRINSUPRI ® (brensocatib) U.S. INDICATION AND IMPORTANT SAFETY INFORMATION Indication in the U.S. BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. Important Safety Information in the U.S. WARNINGS AND PRECAUTIONS Dermatologic Adverse Reactions Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings. Gingival and Periodontal Adverse Reactions Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene. Live Attenuated Vaccines It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI. ADVERSE REACTIONS The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions. Less Common Adverse Reactions Liver Function Test Elevations In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. Skin Cancers In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients. Alopecia In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients. USE IN SPECIFIC POPULATIONS Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women. Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition. Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age. Please see full US Prescribing Information . About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inﬂammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit to learn more or follow us on LinkedIn, Instagram, YouTube, and X. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; our inability to obtain full approval of ARIKAYCE from the FDA or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside the U.S., Europe or Japan, including separate regulatory approval for Lamira® in each market and for each usage, or for brensocatib in NCFB in Japan; and failure to successfully commercialize our marketed products and product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for our marketed products and product candidates, if approved. The Company may not actually achieve the results, plans, intentions, or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC). The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors: Bryan Dunn Vice President, Investor Relations (646) 812-4030 [email protected] Media: Claire Mulhearn Vice President, Corporate Communications (862) 842-6819 [email protected] SOURCE Insmed Incorporated 21% more press release views with Request a Demo

临床3期上市批准临床结果加速审批

2026-03-19

·动脉网

呼吸百亿美元赛道，长风药业吸入IND接连落地，能否走出中国版Insmed？

当呼吸成为一种奢求，医学的使命，便是令其回归日常。 2026年早春，港股“吸入制剂第一股”长风药业连发两则公告，在呼吸赛道激起涟漪。公司于调入港股通后，相继宣布其自主研发的治疗肺纤维化吸入粉雾剂ICF004（化药1类）、以及治疗肺动脉高压（PAH）及间质性肺病相关肺动脉高压（PH-ILD）的吸入粉雾剂ICF001（化药2.1类改良型新药），其新药临床试验申请（IND）已获国家药品监督管理局（NMPA）正式受理。两项IND，指向同一目标——以更优的吸入技术，帮助重症呼吸疾病患者延长生存时间，也提升生活质量。对标国际顶流，可以看得出来呼吸赛道的价值重估与平台逻辑。目前，海外资本市场对呼吸疾病创新疗法的商业化潜力，已给出了极高的定价。2025年6月，美国药企Insmed凭借其治疗PAH的吸入药物TPIP在2b期临床中取得积极数据，单日股价飙升28%，目前市值已站上300亿美元量级。与此同时，默沙东斥资约100亿美元收购Verona Pharma，而深耕吸入制剂的United Therapeutics（UT）市值也突破了200亿美元。海外巨头的估值跃升不断叩问国内市场：“吸入疗法的价值”早已不是问题，真正的核心壁垒在于谁能打造出具备长期管理能力的下一代吸入平台。具备复杂制剂与精准吸入递送底层布局的长风药业，正日益展现出成长为“中国版Insmed”的潜质。更准确地说，市场正在重新思考：长风是否开始具备被放到“呼吸创新平台”框架下观察的条件。 01 ICF001：突破耐受性瓶颈，剑指同类最佳（BIC）肺动脉高压（PAH）患者面临极高的临床未满足需求，五年生存率仅在50%左右；而PH-ILD患者的预后更严峻，中位生存期仅1.5到3年，且国内尚无针对性特效药获批。在此背景下，与传统口服或注射药物相比，吸入疗法的临床价值已被验证。吸入制剂可将药物直接递送至肺部病灶，提升局部浓度，同时降低全身副作用。United Therapeutics 的 Tyvaso 以销售数据清晰描绘出市场真实需求：2022年销售额8.7亿美元，2025年增至18.8亿美元，短短三年翻倍。然而，现有产品远未臻完美。第一代吸入药物以Tyvaso为代表，虽实现肺部靶向，但每日四次给药，患者依从性面临考验。第二代产品以Insmed的TPIP为代表，以前药技术实现每日一次，成为显著进步。2025年6月，Insmed宣布其吸入粉雾剂TPIP（曲前列环素棕榈醇吸入粉剂）治疗肺动脉高压的2b期临床数据：与安慰剂相比，患者肺血管阻力（PVR）较基线下降约35%。Insmed计划于2026年启动针对PAH、PH-ILD、特发性肺纤维化（IPF）及进行性肺纤维化（PPF）等适应症的三期临床研究。但TPIP的数据也揭示了长效吸入前列环素面临的技术挑战。2b期研究中，TPIP组咳嗽发生率40.6%（安慰剂21.2%），头痛发生率31.9%（安慰剂15.2%）。这些不良反应并非TPIP独有，而是此类药物共同面临的难题：如何在实现长效的同时，控制单次吸入的粉末负荷、减少局部刺激。这正是步入这一赛道的BIC角逐者必须回答的问题。患者真正需要的，究竟是“最长效”，还是“最舒适的疗效”？当“患者愿意并能够坚持使用的药，才是好药”成为临床共识，在罕见病与重症呼吸疾病领域，能够通过技术改良显著提升依从性的产品，其商业价值并不亚于全新分子。这一趋势正获得临床研究与资本市场的双重验证。以此为出发点，长风药业的ICF001确立了三大设计目标： ● 控制峰值暴露，改善全身耐受性。现有药物吸入后血药浓度快速升高，易致头痛、面部潮红。ICF001采用前药设计，药物在肺部缓慢转化，实现“削峰填谷”——降低峰浓度以改善耐受，同时维持平稳谷浓度。临床前研究显示，ICF001峰浓度较活性药物显著降低。 ● 优化局部耐受，降低气道刺激。吸入疗法的咳嗽问题常被笼统归因于“药物刺激”。但研发团队发现，咳嗽至少可分为两类：吸入瞬间的机械性咳嗽，与药物沉积后的药理性咳嗽。ICF001对粉末负荷与前药理化物性进行优化，刺激性与咳嗽反射评分较对照产品显著下降。 ● 保留滴定灵活，适配临床实际。肺动脉高压治疗需剂量爬坡。ICF001设计为临床医生提供灵活调整空间，使患者能逐步适应药物，而非被迫接受“全或无”方案。若后续临床能验证上述优势——峰浓度显著降低、咳嗽发生率低于TPIP的40.6%、平稳谷浓度覆盖——则ICF001不仅有望在便利性上比肩TPIP，也可能在耐受性与安全性上展现进一步优势。全球PAH+PH-ILD市场规模超50亿美元，若未来成功进入更广适应症并取得可观份额，其峰值销售潜力值得期待。尤其是针对国内仍属空白的PH-ILD适应症，该产品有望填补治疗空白，除专利保护外，还可享有孤儿药不超过7年的市场独占期。全球范围内，能通过类似技术路径推进产品开发的企业屈指可数。对标Insmed候选化合物，ICF001作为下一代吸入Tyvaso的潜在改良BIC新药，具备一药多适应症（肺高压与肺纤维化）的临床应用场景。若未来国际化战略成功落地，临床数据得以验证，其峰值销售额有望达数十亿美元，并成长为吸入制剂领域的重磅潜力资产。 02 肺纤维化：从肺部更深处求解如果说ICF001是在已验证通路上优化，那么ICF004则代表了长风药业在更前沿创新方向上的探索。ICF004聚焦肺纤维化——这一长期未被充分满足的重症呼吸领域。IPF是一种病因不明、进行性加重的致命性肺部疾病，以肺组织逐渐瘢痕化、肺功能不可逆丧失为特征。公开资料显示，全球IPF患病率约为每1万人中0.33至4.51例，患者确诊后中位生存期仅2.8年，5年生存率不足40%。目前全球IPF治疗药物主要集中在两款口服药——吡非尼酮与尼达尼布。二者可在一定程度上延缓疾病进展，故需患者长期规范使用，但普遍难以逆转已形成的纤维化。与此同时，长期用药的副作用成为临床治疗的重要挑战。尼达尼布最常见的不良反应为胃肠道症状，部分患者出现肝酶升高，严重时甚至可能引发药物性肝损伤或胰腺炎。吡非尼酮同样存在明显不良反应，除恶心、食欲下降等胃肠道反应外，还可能引起光敏反应，患者日晒后易出现皮疹或瘙痒，同时亦有肝功能异常风险。在真实世界治疗中，因副作用累积，不少患者后期往往需减量甚至中断用药，一定程度上影响长期疗效与生活质量。正因如此，行业持续探索新的治疗路径。若能将药物直接递送至肺部病灶，在降低全身暴露的同时维持疗效，便有望改变肺纤维化长期治疗的用药体验。这一逻辑正被临床验证。2026年3月，《新英格兰医学杂志》公布了Tyvaso（曲前列环素吸入溶液）在IPF中的III期TETON-2研究完整结果。该研究纳入593例IPF患者，随机接受雾化Tyvaso或安慰剂治疗，其中75.4%的患者同时接受背景抗纤维化治疗（尼达尼布或吡非尼酮）。结果显示，治疗52周后，Tyvaso组绝对用力肺活量（FVC）较安慰剂组改善95.6毫升，临床恶化事件风险降低29%。 United Therapeutics 亦表示，TETON-1研究已完成患者入组，预计2026年下半年公布结果，并计划于同期向FDA提交补充新药申请，将IPF纳入雾化Tyvaso适应症标签。商业层面，吸入制剂赛道的空间亦已充分验证。以United Therapeutics 的 Tyvaso 为例，其近年销售表现构成典型的重磅药物成长曲线。 2022年，Tyvaso销售额约8.73亿美元；2023年增至约12.34亿美元；2024年达16.20亿美元，同比增长约31%；2025年进一步增至18.78亿美元，同比增长16%。短短数年，Tyvaso年销售额从不足10亿美元跃升至接近20亿美元。 United Therapeutics 在财报中指出，随着Tyvaso DPI的推出，产品使用量进一步提升，显示患者依从性改善对商业放量的直接推动。这进一步表明，在呼吸疾病领域，能够提升依从性的给药方式本身便具备重塑市场规模的能力。 ICF004正是基于这一判断展开的探索。作为一款定位全球创新药的吸入粉雾剂，ICF004尝试通过吸入给药直接递送药物至肺部病灶，在降低全身暴露的同时维持疗效，从而改变肺纤维化长期治疗的用药体验。 ICF004围绕纤维化相关病理过程——包括炎症、氧化应激及成纤维活化等环节——进行机制探索。这并非简单“换剂型”，而是从疾病通路出发设计分子，试图解决现有口服药“疗效有限、副作用重”的核心矛盾。临床前研究观察到，ICF004吸入给药后呈现显著的肺部组织暴露与全身血药暴露之间的差异化分布特征。药物在肺部与血液之间暴露水平差异明显，意味着其可能在肺部达到有效治疗浓度，同时大幅降低全身副作用。若后续临床顺利推进，ICF004有望成为全球吸入抗纤维化方向中极具稀缺性的创新资产之一。 ICF004的意义不止于单品。它验证了长风药业将复杂制剂、递送系统、装置工程与临床未满足需求结合的能力。而这种能力，正是ICF001得以诞生的土壤。若ICF001与ICF004均能在各自适应症中取得积极临床数据，市场将有理由相信，长风的吸入创新药平台能够持续孵化出具备全球竞争力的资产。 03 复杂制剂护城河，长风药业手握组合牌 ICF001与ICF004的IND突破并非偶然，而是源于长风在吸入制剂领域多年的技术积累。吸入制剂被公认为制剂技术壁垒最高的领域之一。从药物粒径控制、肺部沉积效率，到吸入装置设计与生产工艺，每一环节均需长期技术沉淀。此类平台往往需十年以上持续研发投入方能成型。正因如此，即使在中国创新药产业快速发展的背景下，真正能够进入吸入创新药赛道的企业仍然极为有限。长风药业目前已完成覆盖研发、生产及全球注册的完整吸入制剂平台建设，同时具备粉雾剂、气雾剂、鼻喷剂、软雾剂、小核酸、脂质体吸入递送等多种技术路径的研发与生产能力。这种平台化能力在国内外医药行业可谓稀缺。这意味着，长风可根据不同药物分子特性与临床需求，选择最优递送路径，而非“手里有锤子，看什么都像钉子”。更值得关注的是，该平台未来还可支持更前沿的药物形式。例如近年备受关注的小核酸药物，目前全球绝大多数小核酸药物仍采用注射给药，能将其开发为吸入制剂的企业极为稀缺。若能通过吸入方式实现肺部精准递送，小核酸药物有望实现“一次吸入、长期有效”的治疗模式，从而彻底改变部分呼吸疾病的治疗方式。若长风未来在小核酸吸入项目上取得突破，将成为全球小核酸“风口”赛道上一道独特风景。此外，根据长风A1资料，公司还布局了脂质体递送平台。从小核酸到脂质体递送，若再加入抗体靶向，这一研发深层布局所指向的未来空间，同样值得期待。对资本市场而言，长风药业当前最值得关注的，不止是两项IND获受理，而是其正逐步展现一种稀缺能力：依托复杂吸入制剂平台，将高壁垒递送技术转化为真正具备全球竞争潜力的创新资产。 04 故事的起点医学史上，每一次治疗方式的进步，最终都回归同一命题：它是否让患者的生活变得更好？对肺动脉高压患者而言，更好的药物不止是数字上更低的肺血管阻力，更是能轻松吸入、不引发剧烈咳嗽、可长期坚持的治疗体验。对肺纤维化患者而言，更好的药物是在延缓疾病进展的同时，不必忍受每日恶心腹泻的煎熬。 ICF001与ICF004已踏上临床之旅，它们所代表的思考方向，已值得记录：当一款药物不仅追问“是否有效”，还追问“全球患者是否愿意长期使用”，它便朝真正的全球创新迈出了关键一步。这或许是中国呼吸创新药走向世界的起点。需要指出的是，目前两项资产仍处于IND受理阶段，后续一期安全性/PK、二期差异化临床信号及全球化开发路径，将决定其创新逻辑能否真正转化为资本市场重估。目前，长风在港股市值约100亿港元。与已被全球资本按“呼吸创新平台”定价的海外公司相比，长风当前市值更多反映其复杂制剂与现有业务基础，而对其吸入创新平台能力及两项早期创新资产的潜在价值计入仍然有限。这也意味着，随着ICF001与ICF004逐步进入实质性临床阶段，长风药业在呼吸大品类赛道中的长期配置价值，正迎来被市场重新评估的重要窗口。 *封面图片来源：123rf 如果您认同文章中的观点、信息，或想进一步讨论，请与我们联系；也可加入动脉网行业社群，结交更多志同道合的好友。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。文中如果涉及企业信息和数据，均由受访者向分析师提供并确认。动脉网，未来医疗服务平台

2026-02-19

·PRNewswire

Insmed Reports Fourth-Quarter and Full-Year 2025 Financial Results and Provides Business Update

—Company Expects Full-Year 2026 BRINSUPRI® (brensocatib) Revenues to Be at Least $1 Billion; Reiterates Full-Year 2026 ARIKAYCE® (amikacin liposome inhalation suspension) Revenue Guidance of $450 Million to $470 Million— —Total Company Revenues of $606.4 Million for Full-Year 2025— —BRINSUPRI Total Revenues of $144.6 Million for Fourth-Quarter and $172.7 Million for Full-Year 2025— —ARIKAYCE Total Revenues of $119.2 Million for Fourth-Quarter and $433.8 Million for Full-Year 2025, Representing 19% Annual Growth and Exceeding the Upper End of Full-Year 2025 Guidance— —Topline Data Readouts from Phase 3 ENCORE and Phase 2b CEDAR Studies Remain on Track— —FDA grants Orphan Drug Designation to Treprostinil Palmitil for Treatment of PAH— —Company Ends 2025 with Approximately $1.4 Billion of Cash, Cash Equivalents, and Marketable Securities— BRIDGEWATER, N.J., Feb. 19, 2026 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update. "As we close out 2025 and begin an exciting new year at Insmed, I am energized by the significant opportunities ahead to serve patients with serious diseases," said Will Lewis, Chair and Chief Executive Officer of Insmed. "Our U.S. commercial launch of BRINSUPRI continues to exceed our expectations, and we are proud to provide this medicine to patients who previously had no approved treatment for their disease. Throughout 2026, we will continue to bring BRINSUPRI to patients with bronchiectasis, expand our Phase 3 clinical programs for TPIP, and advance our early-stage pipeline, fueling the research engine that we hope will power the next wave of potentially life-transforming therapies for patients." Progress and Anticipated Milestones by Therapeutic Area: Respiratory BRINSUPRI Insmed anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion. In November 2025, the European Commission approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Insmed anticipates regulatory decisions for brensocatib for the treatment of NCFB in the United Kingdom (UK) and Japan in 2026. Insmed continues to evaluate the potential effect of evolving U.S. policies which will then impact the timing for future potential international commercial launches. ARIKAYCE Insmed continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million. ARIKAYCE global revenue grew 19% in 2025 compared to 2024, reflecting year-over-year growth across all geographic regions and exceeding the upper end of 2025 guidance of $420 to $430 million. In March or April of 2026, the Company anticipates the topline readout of the Phase 3 ENCORE trial in patients with newly diagnosed or recurrent Mycobacterium avium complex (MAC) lung disease who have not started antibiotics. Pending positive topline data from the ENCORE trial, Insmed plans to submit a supplementary new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for ARIKAYCE in all patients with MAC lung disease in the second half of 2026. Similarly, Insmed plans to review the data with the Pharmaceuticals and Medical Devices Agency (PMDA) in the second half of 2026 to support potential label expansion in Japan. TPIP In January 2026, the Office of Orphan Products Development of the FDA granted orphan drug designation (ODD) to treprostinil palmitil for the treatment of patients with pulmonary arterial hypertension (PAH). Insmed plans to initiate a Phase 3 study of TPIP (treprostinil palmitil inhalation powder) in patients with PAH in the first half of 2026. Insmed is actively enrolling patients in the PALM-ILD trial, a Phase 3 study of TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). In January 2026, Insmed presented four abstracts from across its TPIP program at the Pulmonary Vascular Research Institute (PVRI) 2026 congress in Dublin. The Company expects to report data from the open-label extension (OLE) of its Phase 2b study of TPIP in PAH in the second half of 2026. The Company anticipates initiating additional Phase 3 studies of TPIP in patients with progressive pulmonary fibrosis (PPF) and idiopathic pulmonary fibrosis (IPF) in the second half of 2026. INS1148 In December 2025, Insmed acquired INS1148, a Phase 2-ready monoclonal antibody targeting a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248). The Company plans to advance Phase 2 development programs for INS1148 initially in interstitial lung disease (ILD) and moderate to severe asthma. Immunology & Inflammation Brensocatib In October 2025, Insmed completed enrollment in the Phase 2b CEDAR study of brensocatib in patients with hidradenitis suppurativa (HS). Insmed anticipates reporting topline data from CEDAR in the second quarter of 2026. INS1033 Insmed's second dipeptidyl peptidase 1 (DPP1) inhibitor, INS1033, is currently advancing toward the clinic in rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), with an initial IND filing expected in 2026. Neuro & Other Rare INS1201 Insmed continues to enroll the Phase 1 ASCEND clinical study of INS1201, an intrathecally delivered gene therapy for patients with Duchenne muscular dystrophy (DMD). INS1202 In January 2026, the Company dosed the first patient in the Phase 1 ARMOR study of INS1202, an intrathecally delivered gene therapy for patients with amyotrophic lateral sclerosis (ALS). INS1203 Insmed's third gene therapy candidate, INS1203, targeting Stargardt disease, is currently advancing toward the clinic, with an IND filing expected in 2026. Fourth-Quarter and Full-Year 2025 Financial Results The following table summarizes fourth-quarter and full-year 2025 and 2024 revenues and revenue growth for BRINSUPRI and ARIKAYCE across all commercial regions: Cost of product revenues (excluding amortization of intangibles) was $44.2 million for the fourth quarter of 2025, compared to $26.2 million for the fourth quarter of 2024. For full-year 2025, cost of product revenues (excluding amortization of intangibles) was $122.9 million compared to $85.7 million for full-year 2024. The increase in cost of product revenues in the fourth quarter of 2025 and full-year 2025 primarily reflects the increase in total product revenues for ARIKAYCE and BRINSUPRI, following BRINSUPRI's U.S. commercial launch in August 2025. Cost of product revenues as a percentage of revenues decreased in the fourth quarter of 2025 and full-year 2025 due to sales of BRINSUPRI, which has a lower manufacturing cost than ARIKAYCE. Research and development (R&D) expenses were $254.9 million for the fourth quarter of 2025, compared to $179.7 million for the fourth quarter of 2024. For full-year 2025, R&D expenses were $771.1 million compared to $598.4 million for full-year 2024. The increase in R&D expenses for fourth quarter of 2025 and full-year 2025 was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, increases in manufacturing expense, and the acquisition of INS1148. Selling, general and administrative (SG&A) expenses for the fourth quarter of 2025 were $212.5 million, compared to $142.5 million for the fourth quarter of 2024. For full-year 2025, SG&A expenses were $701.2 million, compared to $461.1 million for full-year 2024. The increase in SG&A expenses for the fourth quarter of 2025 and full-year 2025 was primarily related to increases in compensation and benefit-related expenses, as well as stock-based compensation, and an increase in professional fees and other external expenses, both driven by commercial and commercial readiness activities for BRINSUPRI. For the fourth quarter of 2025, Insmed reported a net loss of $328.5 million, or $1.54 per share, compared to a net loss of $235.5 million, or $1.32 per share, for the fourth quarter of 2024. For full-year 2025, Insmed reported a net loss of $1,276.8 million, or $6.42 per share, compared to a net loss of $913.8 million, or $5.57 per share, for full-year 2024. Balance Sheet, Financial Guidance, and Planned Investments As of December 31, 2025, Insmed had cash, cash equivalents, and marketable securities totaling approximately $1.4 billion. The Company anticipates full-year 2026 BRINSUPRI revenues of at least $1 billion. Insmed continues to anticipate full-year 2026 ARIKAYCE revenues in the range of $450 million to $470 million. The Company anticipates submitting an average of one to two INDs per year from its pre-clinical research programs. Insmed continues to anticipate that the totality of its pre-clinical research programs will comprise less than 20% of overall expenditures. The Company plans to continue to invest in the following key activities in 2026: Conference Call Insmed will host a conference call beginning today, February 19, 2026, at 8:00 AM Eastern Time. Shareholders and other interested parties may participate in the conference call by dialing (888) 210-2654 (U.S. and international) and referencing access code 7862189. The call will also be webcast live on the Company's website at . A replay of the conference call will be accessible approximately 1 hour after its completion through February 26, 2026, by dialing (800) 770-2030 (U.S. and international) and referencing access code 7862189. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at . About ARIKAYCE ARIKAYCE® is approved in the United States as ARIKAYCE (amikacin liposome inhalation suspension), in Europe as ARIKAYCE Liposomal 590 mg Nebuliser Dispersion, and in Japan as ARIKAYCE inhalation 590 mg (amikacin sulfate inhalation drug product). Current international treatment guidelines recommend the use of ARIKAYCE for appropriate patients. ARIKAYCE is a novel, inhaled, once-daily formulation of amikacin, an established antibiotic that was historically administered intravenously and associated with severe toxicity to hearing, balance, and kidney function. Insmed's proprietary PULMOVANCE™ liposomal technology enables the delivery of amikacin directly to the lungs, where liposomal amikacin is taken up by lung macrophages where the infection resides, while limiting systemic exposure. ARIKAYCE is administered once daily using the Lamira® Nebulizer System manufactured by PARI Pharma GmbH (PARI). About PARI Pharma and the Lamira® Nebulizer System ARIKAYCE is delivered by a novel inhalation device, the Lamira® Nebulizer System, developed by PARI. Lamira® is a quiet, portable nebulizer that enables efficient aerosolization of ARIKAYCE via a vibrating, perforated membrane. Based on PARI's 100-year history working with aerosols, PARI is dedicated to advancing inhalation therapies by developing innovative delivery platforms to improve patient care. About BRINSUPRI BRINSUPRI® (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). BRINSUPRI (brensocatib 10 mg and 25 mg tablets) is indicated in the United States for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. In the European Union, BRINSUPRI (brensocatib 25 mg tablets) is approved for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12 months. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. Brensocatib is also being evaluated for its potential role in hidradenitis suppurativa, another neutrophil-mediated disease. About TPIP Treprostinil palmitil inhalation powder (TPIP) is an investigational dry powder formulation of treprostinil palmitil, a treprostinil prodrug consisting of treprostinil linked by an ester bond to a 16-carbon chain. Developed entirely in Insmed's laboratories, TPIP is a potentially highly differentiated prostanoid being evaluated as once-daily therapy for the treatment of patients with pulmonary arterial hypertension (PAH), pulmonary hypertension associated with interstitial lung disease (PH-ILD), and other rare and serious pulmonary disorders. TPIP is administered in a capsule-based inhalation device. TPIP is an investigational drug product that has not been approved for any indication in any jurisdiction. About INS1148 INS1148 is an investigational monoclonal antibody that Insmed is developing as a potential first-in-class therapy to address respiratory and immunological and inflammatory diseases with high unmet need. Through its novel mechanism of action, INS1148 preferentially targets a specific isoform of Stem Cell Factor, called Stem Cell Factor 248 (SCF248). Binding to SCF248 induces clearance of this SCF isoform and interrupts only the inflammatory cascade downstream of c-Kit signaling, while leaving its homeostatic and tissue healing pathways intact. INS1148 is an investigational drug product that has not been approved for any indication in any jurisdiction. About INS1201 INS1201 is an investigational micro-dystrophin adeno-associated virus (AAV9) gene therapy that Insmed is developing as a potential treatment for patients with Duchenne muscular dystrophy (DMD). Administered intrathecally, this approach has the potential to target both skeletal and cardiac muscles as a one-time fixed (non-weight-based) dose. INS1201 is an investigational drug product that has not been approved for any indication in any jurisdiction. About INS1202 INS1202 is an investigational adeno-associated virus (AAV9) short hairpin RNA (shRNA) construct targeting the human superoxide dismutase type 1 (SOD1) gene. Insmed is developing INS1202 as a potential treatment for patients with amyotrophic lateral sclerosis (ALS) who carry SOD1 mutations and those who do not have SOD1 mutations. INS1202 is administered intrathecally as a one-time fixed (non-weight-based) dose. INS1202 is an investigational drug product that has not been approved for any indication in any jurisdiction. IMPORTANT SAFETY INFORMATION AND BOXED WARNING FOR ARIKAYCE IN THE U.S. Hypersensitivity Pneumonitis has been reported with the use of ARIKAYCE in the clinical trials. Hypersensitivity pneumonitis (reported as allergic alveolitis, pneumonitis, interstitial lung disease, allergic reaction to ARIKAYCE) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (3.1%) compared to patients treated with a background regimen alone (0%). Most patients with hypersensitivity pneumonitis discontinued treatment with ARIKAYCE and received treatment with corticosteroids. If hypersensitivity pneumonitis occurs, discontinue ARIKAYCE and manage patients as medically appropriate. Hemoptysis has been reported with the use of ARIKAYCE in the clinical trials. Hemoptysis was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (17.9%) compared to patients treated with a background regimen alone (12.5%). If hemoptysis occurs, manage patients as medically appropriate. Bronchospasm has been reported with the use of ARIKAYCE in the clinical trials. Bronchospasm (reported as asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea exertional, prolonged expiration, throat tightness, wheezing) was reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (28.7%) compared to patients treated with a background regimen alone (10.7%). If bronchospasm occurs during the use of ARIKAYCE, treat patients as medically appropriate. Exacerbations of underlying pulmonary disease has been reported with the use of ARIKAYCE in the clinical trials. Exacerbations of underlying pulmonary disease (reported as chronic obstructive pulmonary disease (COPD), infective exacerbation of COPD, infective exacerbation of bronchiectasis) have been reported at a higher frequency in patients treated with ARIKAYCE plus background regimen (14.8%) compared to patients treated with background regimen alone (9.8%). If exacerbations of underlying pulmonary disease occur during the use of ARIKAYCE, treat patients as medically appropriate. Anaphylaxis and Hypersensitivity Reactions: Serious and potentially life-threatening hypersensitivity reactions, including anaphylaxis, have been reported in patients taking ARIKAYCE. Signs and symptoms include acute onset of skin and mucosal tissue hypersensitivity reactions (hives, itching, flushing, swollen lips/tongue/uvula), respiratory difficulty (shortness of breath, wheezing, stridor, cough), gastrointestinal symptoms (nausea, vomiting, diarrhea, crampy abdominal pain), and cardiovascular signs and symptoms of anaphylaxis (tachycardia, low blood pressure, syncope, incontinence, dizziness). Before therapy with ARIKAYCE is instituted, evaluate for previous hypersensitivity reactions to aminoglycosides. If anaphylaxis or a hypersensitivity reaction occurs, discontinue ARIKAYCE and institute appropriate supportive measures. Ototoxicity has been reported with the use of ARIKAYCE in the clinical trials. Ototoxicity (including deafness, dizziness, presyncope, tinnitus, and vertigo) were reported with a higher frequency in patients treated with ARIKAYCE plus background regimen (17%) compared to patients treated with background regimen alone (9.8%). This was primarily driven by tinnitus (7.6% in ARIKAYCE plus background regimen vs 0.9% in the background regimen alone arm) and dizziness (6.3% in ARIKAYCE plus background regimen vs 2.7% in the background regimen alone arm). Closely monitor patients with known or suspected auditory or vestibular dysfunction during treatment with ARIKAYCE. If ototoxicity occurs, manage patients as medically appropriate, including potentially discontinuing ARIKAYCE. Nephrotoxicity was observed during the clinical trials of ARIKAYCE in patients with MAC lung disease but not at a higher frequency than background regimen alone. Nephrotoxicity has been associated with the aminoglycosides. Close monitoring of patients with known or suspected renal dysfunction may be needed when prescribing ARIKAYCE. Neuromuscular Blockade: Patients with neuromuscular disorders were not enrolled in ARIKAYCE clinical trials. Patients with known or suspected neuromuscular disorders, such as myasthenia gravis, should be closely monitored since aminoglycosides may aggravate muscle weakness by blocking the release of acetylcholine at neuromuscular junctions. Embryo-Fetal Toxicity: Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides, including ARIKAYCE, may be associated with total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. Patients who use ARIKAYCE during pregnancy, or become pregnant while taking ARIKAYCE should be apprised of the potential hazard to the fetus. Contraindications: ARIKAYCE is contraindicated in patients with known hypersensitivity to any aminoglycoside. Most Common Adverse Reactions: The most common adverse reactions in Trial 1 at an incidence ≥5% for patients using ARIKAYCE plus background regimen compared to patients treated with background regimen alone were dysphonia (47% vs 1%), cough (39% vs 17%), bronchospasm (29% vs 11%), hemoptysis (18% vs 13%), ototoxicity (17% vs 10%), upper airway irritation (17% vs 2%), musculoskeletal pain (17% vs 8%), fatigue and asthenia (16% vs 10%), exacerbation of underlying pulmonary disease (15% vs 10%), diarrhea (13% vs 5%), nausea (12% vs 4%), pneumonia (10% vs 8%), headache (10% vs 5%), pyrexia (7% vs 5%), vomiting (7% vs 4%), rash (6% vs 2%), decreased weight (6% vs 1%), change in sputum (5% vs 1%), and chest discomfort (5% vs 3%). Drug Interactions: Avoid concomitant use of ARIKAYCE with medications associated with neurotoxicity, nephrotoxicity, and ototoxicity. Some diuretics can enhance aminoglycoside toxicity by altering aminoglycoside concentrations in serum and tissue. Avoid concomitant use of ARIKAYCE with ethacrynic acid, furosemide, urea, or intravenous mannitol. Overdosage: Adverse reactions specifically associated with overdose of ARIKAYCE have not been identified. Acute toxicity should be treated with immediate withdrawal of ARIKAYCE, and baseline tests of renal function should be undertaken. Hemodialysis may be helpful in removing amikacin from the body. In all cases of suspected overdosage, physicians should contact the Regional Poison Control Center for information about effective treatment. U.S. INDICATION LIMITED POPULATION: ARIKAYCE® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. As only limited clinical safety and effectiveness data for ARIKAYCE are currently available, reserve ARIKAYCE for use in adults who have limited or no alternative treatment options. This drug is indicated for use in a limited and specific population of patients. This indication is approved under accelerated approval based on achieving sputum culture conversion (defined as 3 consecutive negative monthly sputum cultures) by Month 6. Clinical benefit has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitation of Use : ARIKAYCE has only been studied in patients with refractory MAC lung disease defined as patients who did not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy. The use of ARIKAYCE is not recommended for patients with non-refractory MAC lung disease. Patients are encouraged to report negative side effects of prescription drugs to the FDA. Visit , or call 1‑800‑FDA‑1088. You can also call the Company at 1-844-4-INSMED. Please see  Full Prescribing Information . BRINSUPRI® (brensocatib) U.S. INDICATION AND IMPORTANT SAFETY INFORMATION Indication in the U.S. BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. Important Safety Information in the U.S. WARNINGS AND PRECAUTIONS Dermatologic Adverse Reactions Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings. Gingival and Periodontal Adverse Reactions Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene. Live Attenuated Vaccines It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI. ADVERSE REACTIONS The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions. Less Common Adverse Reactions Liver Function Test Elevations In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. Skin Cancers In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients. Alopecia In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients. USE IN SPECIFIC POPULATIONS Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women. Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition. Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age. Please see full US Prescribing Information . About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inﬂammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending five consecutive years as the No. 1 Science Top Employer. Visit  to learn more or follow us on LinkedIn, Instagram, YouTube, and X. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to continue to successfully commercialize ARIKAYCE in the U.S., Europe or Japan or failure to successfully commercialize BRINSUPRI in the U.S. or Europe, or to maintain U.S., European or Japanese approval for ARIKAYCE or U.S. or E.U. approval for BRINSUPRI; our inability to obtain full approval of ARIKAYCE from the FDA, including the risk that we will not successfully or in a timely manner complete the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE, or our failure to obtain regulatory approval to expand ARIKAYCE's indication to a broader patient population; failure to obtain, or delays in obtaining, regulatory approvals for our product candidates in the U.S., Europe or Japan, for ARIKAYCE outside of the U.S., Europe and Japan, including separate regulatory approval for the Lamira® Nebulizer System in each market and for each usage, or for BRINSUPRI outside of the U.S. and the E.U.; failure to successfully commercialize our product candidates, if approved by applicable regulatory authorities, or to maintain applicable regulatory approvals for such product candidates, if approved; uncertainties or changes in the degree of market acceptance of our marketed products or, if approved, our product candidates, by physicians, patients, third-party payors and others in the healthcare community; our inability to obtain and maintain adequate reimbursement from government or third-party payors for our marketed products or, if approved, our product candidates, or acceptable prices for our marketed products or, if approved, our product candidates; inaccuracies in our estimates of the size of the potential markets for our marketed products and our product candidates or in data we have used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; failure of third parties on which we are dependent to manufacture sufficient quantities of our marketed products and our product candidates for commercial or clinical needs, as applicable, to conduct our clinical trials, or to comply with our agreements or laws and regulations that impact our business; risks and uncertainties associated with, and the perceived benefits of, our senior secured loan with certain funds managed by Pharmakon Advisors, LP and our royalty financing with OrbiMed Royalty & Credit Opportunities IV, LP, including our ability to maintain compliance with the covenants in the agreements for the senior secured loan and royalty financing and the impact of the restrictions on our operations under these agreements; our inability to create or maintain an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of our marketed products or any of our product candidates that are approved in the future; failure to successfully conduct future clinical trials for our marketed products or our product candidates and our potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval of our product candidates or to permit the use of ARIKAYCE in the broader population of patients with MAC lung disease, among other things; development of unexpected safety or efficacy concerns related to our marketed products or our product candidates; risks that our clinical studies will be delayed, that serious side effects will be identified during drug development, or that any protocol amendments submitted will be rejected; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; risk that interim, topline or preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or may be interpreted differently if additional data are disclosed, or that blinded data will not be predictive of unblinded data; risk that our competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product we are developing for a particular indication; our inability to attract and retain key personnel or to effectively manage our growth; our inability to successfully integrate our acquisitions and appropriately manage the amount of management's time and attention devoted to integration activities; risks that our acquired technologies, products and product candidates will not be commercially successful; inability to adapt to our highly competitive and changing environment; inability to access, upgrade or expand our technology systems or difficulties in updating our existing technology or developing or implementing new technology; risk that we are unable to maintain our significant customers; risk that healthcare legislation or other government action materially adversely affects our business; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; risk that our current and potential future use of AI and machine learning may not be successful; deterioration in general economic conditions in the U.S., Europe, Japan and globally, including the effect of prolonged periods of inflation, affecting us, our suppliers, third-party service providers and potential partners; risk that we could become involved in costly intellectual property disputes, be unable to adequately protect our intellectual property rights or prevent disclosure of our trade secrets and other proprietary information, and incur costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on us by agreements related to our marketed products or our product candidates, including our license agreements with PARI and AstraZeneca AB, and failure to comply with our obligations under such agreements; the cost and potential reputational damage resulting from litigation to which we are or may become a party, including product liability claims; risk that our operations are subject to a material disruption in the event of a cybersecurity attack or issue; changes in laws and regulations applicable to our business, including any pricing reform and laws that impact our ability to utilize certain third parties in the research, development or manufacture of our product candidates, and failure to comply with such laws and regulations; our history of operating losses, and the possibility that we never achieve or maintain profitability; goodwill impairment charges affecting our results of operations and financial condition; inability to repay our existing indebtedness and uncertainties with respect to our ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans. The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, "Risk Factors," in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and any subsequent Company filings with the Securities and Exchange Commission (SEC). The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors: Bryan Dunn Vice President, Investor Relations (646) 812-4030 [email protected] Media: Claire Mulhearn Vice President, Corporate Communications (862) 842-6819 [email protected] SOURCE Insmed Incorporated 21% more press release views with Request a Demo

临床3期上市批准临床1期临床2期孤儿药

100 项与曲前列尼尔棕榈酸酯相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
家族性肺动脉高压	临床3期	-	Insmed, Inc.	2026-04-17
与结缔组织病相关的肺动脉高压	临床3期	-	Insmed, Inc.	2026-04-17
间质性肺疾病	临床3期	-	Insmed, Inc.	2026-04-01
外源性变应性肺泡炎	临床3期	美国	Insmed, Inc.	2026-01-07
外源性变应性肺泡炎	临床3期	日本	Insmed, Inc.	2026-01-07
外源性变应性肺泡炎	临床3期	阿根廷	Insmed, Inc.	2026-01-07
外源性变应性肺泡炎	临床3期	澳大利亚	Insmed, Inc.	2026-01-07
外源性变应性肺泡炎	临床3期	奥地利	Insmed, Inc.	2026-01-07
外源性变应性肺泡炎	临床3期	比利时	Insmed, Inc.	2026-01-07
外源性变应性肺泡炎	临床3期	捷克	Insmed, Inc.	2026-01-07

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NEWS 人工标引	N/A	高血压	120	treprostinil palmitil	齋獵構簾簾積積築醖憲(壓範憲繭壓艱憲鹹醖襯) = 膚網齋遞範窪鏇選製艱選廠鹹蓋積齋淵襯鹹蓋 (簾餘觸觸糧構選廠壓遞 ) 更多	积极	2025-06-11
				placebo	-
NCT04791514 (CTgov)	临床2期	与结缔组织病相关的肺动脉高压 \| 肺动脉高压	1	Treprostinil Palmitil Inhalation Powder (TPIP)	蓋衊鬱網願鏇鏇積構廠(齋築齋膚窪糧構窪窪鹹) = 齋壓鬱窪築膚糧簾窪鏇製製壓壓積醖築繭蓋鑰 (艱築憲鬱廠範繭鏇齋範, 構簾艱製積網遞膚淵餘 ~ 網餘顧繭餘糧範製艱繭) 更多	-	2023-09-22
Pubmed	临床1期	肺性高血压	42	Treprostinil Palmitil Inhalation Powder	壓鬱簾積淵餘餘膚鹽築(醖憲襯艱顧選鏇壓鬱觸) = 鬱範願顧憲糧製衊壓獵夢遞廠壓糧艱齋鏇獵鹹 (鑰餘夢繭範餘鹹鹹鹹憲 ) 更多	-	2022-09-07
				Placebo	鑰襯獵鏇築艱淵淵鹽選(壓醖蓋選顧鑰遞鹽築鬱) = 鹹衊願壓遞餘鬱膚選淵廠鹹鏇選觸鬱窪簾壓窪 (願鏇積窪壓網顧壓簾獵 )
ESC2021	临床1期	-	42	TPIP 112.5 μg	築壓夢築觸壓淵窪廠製(鑰糧膚顧壓淵鬱鹹顧憲) = 鬱憲鹽構遞築衊壓蓋齋網膚襯鬱襯構淵鹽積廠 (鹹衊鹹願製鏇積窪壓積 )	-	2021-08-30
				TPIP 225 μg QD for 7 days	築壓夢築觸壓淵窪廠製(鑰糧膚顧壓淵鬱鹹顧憲) = 齋膚構網襯壓網鹽網製網膚襯鬱襯構淵鹽積廠 (鹹衊鹹願製鏇積窪壓積 )