This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

开始日期2025-04-21

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT06701396

/ Recruiting临床3期

A Double-Blind, Randomized, Two-Period Crossover Study to Evaluate the Effects of Tasimelteon Vs. Placebo in Subjects with Delayed Sleep-Wake Phase Disorder (DSWPD) and the CRY1Δ11 Variant

This is a double-blind, randomized, two-period crossover study to evaluate the efficacy and safety of a single oral dose of tasimelteon and matching placebo in male and female subjects with DSWPD and the CRY1Δ11 variant.

开始日期2024-10-08

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05922995

/ Terminated早期临床1期IIT

A Single Center, Open Label Prospective Observational Pilot Study to Evaluate the Effects of Tasimelteon in Participants With REM Behavior Disorder (RBD)

To assess the effects of a daily single oral dose of 20 mg tasimelteon compared to baseline on events of dream enactment on patients with REM Behavior Disorder, as measured by a daily log.
To assess the effects of 20 mg tasimelteon compared to baseline on insomnia= symptoms, as measured by validated questionnaires (Insomnia Severity Index [ISI], Pittsburgh Sleep Quality Inventory [PSQI], Epworth Sleepiness Scale [ESS], Clinical Global Impression of Change Scale (CGI-C), Patient Global Impression of Change Scale (PGI-C)) as well as rest/activity pattern from actigraphy.
* To assess the effects of 20 mg tasimelteon on patients who have a reduced or aberrant melatonin secretion compared to normal secretion by measuring salivary DLMO at baseline and correlating with the degree of change in RBD symptoms by end of the study.
* To assess for any role a patient's unique genome may play in their response to tasimelteon; obtained via whole genome sequencing.
* To assess the safety and tolerability of a daily single oral dose of 20 mg tasimelteon.

开始日期2023-09-30

申办/合作机构

The Brigham & Women's Hospital, Inc.

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100 项与他司美琼相关的转化医学

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100 项与他司美琼相关的专利（医药）

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148

项与他司美琼相关的文献（医药）

2026-05-02·BMC Chemistry

Design of experiments and bioanalytical LC-MS/MS method for analysis of melatonin and tasimelteon in rat brain homogenate with whiteness assessment.

Article

作者: Avcı, Hazal ; Can, Nafiz Öncü ; Özcan, Saniye ; Levent, Serkan ; Elriş, Abeer

Sleep disorders include a range of common problems that affect the quality of sleep at night and, as a result, impact an individual's daily functioning. Treatment protocols vary from over-the-counter products to regulated pharmaceuticals. Melatonin and Tasimelteon are two compounds utilized for severe to moderate sleeping disorders. This study developed and validated a sensitive, simple bioanalytical LC-MS/MS method for the measurement of Melatonin and Tasimelteon in spiked rat brain tissue. Chromatographic analyses were conducted in isocratic mode, with Citalopram selected as an appropriate internal standard. The Supelco Ascentis® Express Phenyl-Hexyl column was used for the stationary phase, and the mobile phase comprised 0.2% formic acid in a mixture of acetonitrile and water (65:35, v/v). A response surface methodology is applied. The Box-Behnken design was used to optimize the influence of three independent factors (acetonitrile%, formic acid%, and flow rate (mL/min)) on the response. The study focused on finding the most significant factors influencing chromatographic separation, namely the resolution between Tasimelteon and Melatonin, as well as the tailing factors of both. Statistical analysis of variance provided the optimal conditions for separating the substances as well as the most influential factors. Validation of the analytical method was conducted in accordance with the International Council for Harmonization guideline M10 related to bioanalytical method validation. The method validated was precise and linear in 55.00-1650 (ng/mL) and 20-600 (ng/mL) for the Melatonin and Tasimelteon, respectively. The validated method's lower limit of quantification values was 55 and 20 ng/mL for Melatonin and Tasimelteon, respectively. For Melatonin, intraday accuracy (recovery, %) ranged from 96.53% to 102.68%, and precision (expressed as relative standard deviation) ranged from 0.26% to 0.96%. And inter-day accuracy ranged from 96.58% to 103.08%, and inter-day precision ranged from 0.33% to 3.55%. Intraday accuracy results for Tasimelteon 99.61%-103. 75% precision results were in the range 0.23%-0.93%; additionally, inter-day accuracy was 99.37-103.87%, and the precision range was 1.04-2.11%. The total run time was 3 min, with retention time for Melatonin and Tasimelteon at 1.9 and 2.5 min, respectively, achieving effective chromatographic separation under optimum conditions. The Red Green Blue 12 score for whiteness was determined to be 79.2%.

2026-02-01·BIOORGANIC CHEMISTRY

New Insights of Muraymycin A1 and Its Analogs as DPAGT1 Inhibitors

Article

作者: Effah, Wendy ; Clemons, William M ; Mitachi, Katsuhiko ; Kurosu, Michio ; Kirsh, Jacob M ; Daria, Deidre ; Narayanan, Ramesh

Muraymycin A1 (MA1, 1), a complex nucleoside antibiotic, is a potent inhibitor of DPAGT1 (dolichylphosphate N-acetylglucosamine phosphotransferase 1), yet its relationship to cytotoxicity has remained unclear. Through a total synthetic route, we generated sufficient quantities of MA1 and key analogs to define the structural features required for selective DPAGT1 inhibition. Synthetic MA1 proved to be a stronger DPAGT1 inhibitor than tunicamycin V (TM-V), a broadly cytotoxic phosphotransferase inhibitor, but uniquely displayed slow antiproliferative activity against breast cancer cells including triple-negative subtypes, while sparing normal cells. The MA1 analogs MA1-NH₂ (3) and MA1-NH₂-Guanidyl (4), readily accessed from a common intermediate, matched MA1 in both enzyme inhibition and selective cytotoxicity. These studies delineate the minimum structural requirements of MA1 necessary for DPAGT1 inhibitory activity. Together, these compounds constitute highly selective biochemical tools for probing N-glycosylation in solid cancers and provide a foundation for developing more targeted anticancer strategies.

2026-01-01·OMICS-A JOURNAL OF INTEGRATIVE BIOLOGY

Can We Develop Glioma Subtype-Specific Precision Medicines? An Integrative Machine Learning Pipeline for Biomarker Discovery and Drug Repurposing for Glioblastoma and Low-Grade Glioma

Article

作者: Ozbek, Pemra ; Kizilay, Elif Bengu ; Soyer, Semra Melis ; Kasavi, Ceyda

Glioma remains a major clinical challenge due to its molecular heterogeneity and limited therapeutic options. While numerous biomarker and drug discovery efforts exist, most are restricted by small sample sizes, subtype-agnostic analyses, or limited integration of computational strategies. Here, we present an integrative machine learning-based systems pipeline for the identification of subtype-specific biomarkers and repurposed therapeutics for glioblastoma (GBM) and low-grade glioma (LGG). We report high-confidence, subtype-specific biomarker candidates by harnessing publicly available gene expression datasets and systematic analyses with oversampling strategies to balance class distributions, followed by feature selection algorithms. Specifically, 10 candidate genes with strong diagnostic potential were identified, including RAB11FIP4 , TYRO3 , THEM5 , SST , SMIM32 , MIGA1 , ARFGEF3 , and ANK3 for GBM and GUCA1A and CES4A for LGG. Repurposed drug candidates were then predicted via signature-based prioritization and evaluated using molecular docking simulations, revealing six promising compounds for GBM (vandetanib, capecitabine, melatonin, agomelatine, ramelteon, and tasimelteon) and one for LGG (ambroxol). This study demonstrates the utility of combining class-balancing, feature selection, and drug repurposing pipelines to uncover clinically relevant glioma biomarkers and therapeutic candidates, thus providing a computational foundation for future experimental and translational validation in these brain cancers and neuro-oncology.

141

项与他司美琼相关的新闻（医药）

2026-05-06

·PRNewswire

Vanda Pharmaceuticals Reports First Quarter 2026 Financial Results

Fanapt® net product sales rose 26% to $29.6 million; total prescriptions increased 32% and new-to-brand prescriptions surged 76% NEREUS™ (tradipitant) launched via nereus.us, an innovative direct-to-consumer platform – the first new prescription medicine in more than 40 years for the prevention of vomiting induced by motion, with convenient online ordering and rapid direct home delivery Full-year 2026 revenue guidance raised to $240-$290 million, including $10-30 million from newly launched NEREUS™ BYSANTI™ (milsaperidone) received FDA approval for bipolar I disorder and schizophrenia on February 20, 2026 Imsidolimab BLA for Generalized Pustular Psoriasis accepted for FDA review; PDUFA target action date of December 12, 2026 WASHINGTON, May 6, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced financial and operational results for the first quarter ended March 31, 2026. "Vanda delivered strong commercial execution in the first quarter, highlighted by 26% growth in Fanapt sales, the groundbreaking U.S. launch of NEREUS with its pioneering direct-to-consumer platform at nereus.us, and the FDA approval of BYSANTI," said Mihael H. Polymeropoulos, M.D., Vanda's President, CEO and Chairman of the Board. "We believe that these achievements, combined with meaningful pipeline progress and our raised 2026 revenue guidance, position the company for continued growth and value creation." Financial Highlights Total net product sales reached $51.7 million in Q1 2026, a 3% increase compared to $50.0 million in Q1 2025. Fanapt® net product sales were $29.6 million, up 26% year-over-year. HETLIOZ® net product sales were $15.9 million, down 24% year-over-year. PONVORY® net product sales were $6.2 million, up 10% year-over-year. Loss before income taxes was $48.4 million compared with $37.4 million in Q1 2025, reflecting continued investment in new product launches and pipeline advancement. Cash, cash equivalents and marketable securities (Cash) totaled $202.3 million as of March 31, 2026, representing a decrease to Cash of $61.5 million in Q1 2026, which included a one-time payment of a $10.0 million milestone to Eli Lilly due upon approval of NEREUS™ (tradipitant). Key Commercial Highlights Fanapt® saw continued strong momentum with total prescriptions (TRx)1 up 32% and new-to-brand prescriptions (NBRx)1 up 76% versus Q1 2025. In April 2026, weekly TRx for Fanapt® reached an 11-year high of over 2,600 prescriptions for the week ending April 24, 2026. NEREUS™ is now commercially available nationwide through nereus.us, Vanda's innovative direct-to-consumer platform. This pioneering patient-centric model enables convenient ordering online with rapid direct delivery, eliminating traditional pharmacy barriers and providing a seamless, modern access experience. As the first new prescription therapy approved for the prevention of vomiting induced by motion in adults in more than 40 years, NEREUS™ represents a breakthrough in both science and patient access. Key Regulatory & Clinical Development Highlights BYSANTI™ (milsaperidone) received U.S. Food and Drug Administration (FDA) approval for the treatment of bipolar I disorder and schizophrenia. BYSANTI™ is protected by data exclusivity through February 20, 2031 and multiple patents, the latest of which expires on May 31, 2044. Vanda's ongoing late-stage clinical studies are progressing rapidly and are expected to generate topline results in 2026 or early 2027, including: The Phase III study of BYSANTI™ as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in Q1 2027. The Thetis Phase III study of NEREUS™ for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026. The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected by the end of 2026. The FDA accepted the Biologics License Application (BLA) for imsidolimab in Generalized Pustular Psoriasis (GPP) with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026. The results of the pivotal clinical study were published in the April 28, 2026 issue of the New England Journal of Medicine (NEJM) Evidence2. Corporate Highlight On April 22, 2026, Vanda appointed Charles Duncan, Ph.D. to its Board of Directors. The Board now consists of seven directors, six of whom are independent. GAAP Financial Results Net loss was $48.6 million (diluted loss per share of $0.82) in Q1 2026 compared with a net loss of $29.5 million (diluted loss per share of $0.50) in Q1 2025. 2026 Financial Guidance Vanda is raising its full-year 2026 total revenue guidance to reflect the contribution of the newly launched NEREUS™ while maintaining prior ranges for Fanapt® and other products: Conference Call Vanda has scheduled a conference call for today, Wednesday, May 6, 2026, at 4:30 PM ET. During the call, Vanda's management will discuss the first quarter 2026 financial results and other corporate activities. Investors can call 1-888-596-4144 (domestic) or 1-646-968-2525 (international) and use passcode number 8051722. A replay of the call will be available on Wednesday, May 6, 2026, beginning at 8:30 PM ET and will be accessible until Wednesday, May 13, 2026 at 11:59 PM ET. The replay call-in number is 1-800-770-2030 for domestic callers and 1-609-800-9909 for international callers. The passcode number is 8051722. The conference call will be broadcast simultaneously on Vanda's website, . Investors should click on the Investors tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda's website for a period of 30 days. References IQVIA Prescription Data Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS Various statements in this press release, including, but not limited to, the guidance provided under "2026 Financial Guidance" above and statements regarding Vanda's plans for pursuit of FDA approval of imsidolimab for the treatment of GPP, and the related timeline for approval; Vanda's expectations with respect to its continued growth and ability to create value; Vanda's clinical development plans and expected timelines for BYSANTITM for the treatment of MDD, NEREUSTM in the prevention of vomiting induced by GLP-1 therapies, and VQW-765 in the treatment of adults with social anxiety disorder; and Vanda's expectations with respect to the strength of its business are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to continue to grow its business; the FDA's ability to complete its review of, and reach a decision with respect to, the BLA for imsidolimab by December 12, 2026; Vanda's ability to successfully execute the commercial launches of NEREUSTM for the prevention of vomiting induced by motion and BYSANTI™ for the treatments of bipolar I disorder and schizophrenia; Vanda's ability to continue to advance its late-stage clinical development programs and to obtain regulatory approval for, and successfully commercialize, the late-stage products in development; Vanda's ability to complete the clinical study for BYSANTITM for the treatment of MDD and receive results in in the first quarter of 2027; Vanda's ability to complete the Thetis study and receive results in 2026; and Vanda's ability to complete the clinical study for VQW-765 in the treatment of adults with social anxiety disorder and receive results by the end of 2026. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

临床3期上市批准财报高管变更

2026-04-09

·PRNewswire

Vanda Pharmaceuticals Calls on FDA to Withdraw Proposal from FY 2027 Legislative Agenda That Would Extend Drug Review Timelines

WASHINGTON, April 9, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (NASDAQ: VNDA) today highlighted a legislative proposal contained in the FDA's FY 2027 Congressional Budget Justification. The proposal would eliminate the simple statutory requirement that the FDA must review a new drug application (NDA) within 180 days of filing. In plain terms, this change would extend statutory review timelines rather than shorten them. It would replace the 180-day legal requirement with the longer Prescription Drug User Fee Act (PDUFA) and Generic Drug User Fee Amendments (GDUFA) performance goals. Under those goals, the FDA takes up to two months simply to decide whether to "file" the application. Only after that does the official review clock begin, resulting in typical total review times of 10 to 12 months from submission to decision. The proposal would also replace the formal evidentiary hearing process required by current law with a weaker, internal streamlined appeal. The FDA has avoided providing the statutorily mandated opportunity for a formal evidentiary hearing on drug non-approvals for over 40 years, until Vanda's successful litigation forced the agency to grant the first such hearing in more than four decades. "The FDA's current practice of exceeding the 180-day statutory timeline by issuing Complete Response Letters and operating under longer PDUFA timelines has already been ruled by federal courts to violate the law," said Mihael H. Polymeropoulos, M.D., President, CEO and Chairman of the Board of Vanda Pharmaceuticals. "Instead of complying with the law as written, this proposal asks Congress to change the law so the slower system becomes legal. This is especially concerning because Commissioner Makary said just days ago that the current two-month filing review is too long and should take just days—yet this proposal seeks to codify that very delay into law. At the same time, the FDA seeks to replace the formal hearing process with a streamlined internal appeal, despite the U.S. Court of Appeals for the D.C. Circuit having ruled only months ago that the FDA unlawfully denied Vanda a proper hearing in the HETLIOZ® jet‑lag case, and after the agency was compelled to grant Vanda the first formal drug approval hearing statutorily required but effectively avoided by the FDA for more than forty years." Vanda supports genuine efforts to cut red tape and improve efficiency. However, this proposal does the opposite: it entrenches longer review times, reduces transparency for patients, and protects bureaucratic inertia instead of innovation. American patients would wait longer for needed medicines, while small innovators like Vanda would face greater financial risk and uncertainty. Vanda calls on FDA Commissioner Dr. Marty Makary to withdraw this provision from the FY 2027 legislative agenda and urges Congress to reject the proposal. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

2026-03-27

·Firstwordpharma

Amgen's Imdylltra heads list of CHMP recommendations

On Friday, the EMA's drug advisory panel issued its latest raft of recommendations and regulatory updates, unveiling positive opinions for five new medicines.Heading the list was a recommendation to approve Amgen's Imdylltra (tarlatamab) to treat adults with extensive-stage small-cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with platinum-based chemotherapy.The T-cell engager, which targets both DLL3 and CD3, was authorised in the same indication in the US in 2024, where it is marketed as Imdelltra. While the FDA's accelerated approval was based on the Phase II DeLLphi-301 study, the EMA's decision was supported by findings from the Phase III DeLLphi-304 trial. Data reviewed by the agency's Committee for Medicinal Products for Human Use (CHMP) showed that Imdylltra was associated with a significant improvement in median overall survival of 13.6 months, versus 8.3 months for standard care, corresponding to a 40% reduction in the risk of death. Meanwhile, median progression-free survival in the two groups was 4.2 months and 3.2 months, respectively.Similar to the US — where Amgen's drug carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicities — the EMA said that the product information for Amgen's drug will describe these risks and guidance on their management. Staying in ES-SCLC, the CHMP also recommended approval of PharmaMar's Zepzelca (lurbinectedin) for the maintenance treatment of patients whose disease has not progressed after first-line induction therapy. The alkylating agent, which was recently cleared for this use in the US, is indicated in combination with Roche's anti–PD-L1 Tecentriq (atezolizumab).Thumbs up for Sanofi's SC SarclisaAlso earning itself a CHMP nod was Sanofi and its on-body injector subcutaneous (SC) formulation of Sarclisa (isatuximab). The recommendation covers all four of the multiple myeloma indications currently held by the intravenous (IV) version of the anti-CD38 mAb in the EU.The automated hands-free device uses a 30-gauge hidden and retractable needle that is thinner than commonly used SC injection needles.At the American Society of Clinical Oncology (ASCO) meeting last year, Sanofi shared data from the Phase III IRAKLIA study showing that injectable Sarclisa achieved a 71.1% objective response rate after a median follow-up of 12 months, compared to 70.5% for the IV formulation, meeting the non-inferiority primary endpoint. Progression-free survival rates at 12 months were similar between the two formulations at 66.1% and 65.1%, respectively.Decisions go the way of Ferring, PharmingIn other decisions, the CHMP recommended conditional approval of Ferring Pharmaceuticals' gene therapy Adstiladrin (nadofaragene firadenovec) to treat adults with Bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumours.Adstiladrin has been on the market in the US for several years after winning FDA approval at the end of 2022.The CHMP also backed authorisation of Pharming's Joenja (leniolisib) for activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents 12 years of age and older weighing 45 kg or more. While the oral, selective PI3Kδ inhibitor is approved for this patient group in the US, efforts to expand use into children aged four to 11 years with the rare and progressive primary immunodeficiency were recently rejected by the FDA. Although Pharming is hopeful of addressing the US regulator's issues — which relate to clinical pharmacology and batch testing methodology — the paediatric approval had been expected to drive a Joenja growth inflection this year.Elsewhere, the CHMP issued a positive opinion recommending paediatric use of Proveca Pharma's Bopediat (furosemide) to treat oedema of cardiac or renal origin, oedema of hepatic origin and hypertension in children from birth to under 18 years of age with chronic kidney disease. Bopediat is a hybrid medicine of Lasilix Faible (furosemide), which has been authorised in France since 1977. The EMA noted that Proveca's drug contains the same active substance as Lasilix Faible, but it is available as orodispersible tablets and at a lower strength so that it can be given to young children.Re-examinations end badlyThe EMA on Friday also confirmed the recent decision by Anavex Life Sciences to withdraw an application for its Alzheimer's drug candidate blarcamesine. Having recommended refusing approval at the end of last year, the CHMP was in the process of re-examining the application — as requested by the drugmaker — when the company opted to pull the filing.Another re-examination resulting in a negative outcome went to Hetlioz (tasimelteon) and its developer Vanda Pharmaceuticals, who was seeking to expand use into people with a rare hereditary disorder, Smith-Magenis syndrome. The melatonin‑receptor agonist is already approved in the EU to treat totally blind adults with non-24-hour sleep-wake disorder.Having initially rejected use of Hetlioz in Smith-Magenis syndrome last November, the CHMP reaffirmed its decision at an extraordinary meeting on March 16. The committee expressed concerns about the study used to support the application, including the statistical analysis of the results and the way the trial had been conducted, which led to uncertainties about the drug's effects.Tecovirimat use restrictedThe EMA also said Friday that SIGA Technologies' antiviral tecovirimat should no longer be used for mpox. The drug, also known as TPOXX, was approved in the EU in 2022 to treat smallpox, mpox and cowpox based on data from animal studies.Subsequent trials conducted in humans — including the STOMP study sponsored by the US National Institutes of Health (NIH) — showed that tecovirimat did not heal lesions faster compared with placebo in people presenting with active mpox lesions, while it also failed to improve other outcomes, such as relieving pain or helping to clear the virus from the body faster.

临床结果临床3期上市批准

100 项与他司美琼相关的药物交易

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D09388	他司美琼	N05CH03	DB09071

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适应症	国家/地区	公司	日期
入睡和睡眠障碍	美国	Vanda Pharmaceuticals, Inc.	2020-12-01
睡眠-觉醒节律障碍	美国	Vanda Pharmaceuticals, Inc.	2014-01-31

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适应症	最高研发状态	国家/地区	公司	日期
飞行时差反应综合征	申请上市	美国	Vanda Pharmaceuticals, Inc.	-
Smith-Magenis综合征	申请上市	欧盟	Vanda Pharmaceuticals, Inc.	-
自闭症谱系障碍	临床3期	美国	Vanda Pharmaceuticals, Inc.	2021-07-28
睡眠异常	临床3期	美国	Vanda Pharmaceuticals, Inc.	2015-09-01
重度抑郁症	临床3期	美国	Vanda Pharmaceuticals, Inc.	2011-09-01
日夜节律睡眠障碍	临床3期	美国	Vanda Pharmaceuticals, Inc.	2010-08-01
日夜节律睡眠障碍	临床3期	德国	Vanda Pharmaceuticals, Inc.	2010-08-01
普遍的儿童发育障碍	临床2期	美国	Vanda Pharmaceuticals, Inc.	2021-09-16
REM睡眠行为障碍	临床1期	美国	Vanda Pharmaceuticals, Inc.	2023-09-30
嗜睡	临床1期	加拿大	Vanda Pharmaceuticals, Inc.	2012-04-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03373201 (JET8 Study, CTgov)	临床3期	飞行时差反应综合征	320	Placebo (Placebo)	獵糧鬱餘蓋網構衊鏇廠(窪鑰鏇壓顧醖糧鹽繭觸) = 鹹鬱淵鹹築簾製窪鏇獵蓋鏇艱醖衊蓋膚網簾淵 (範窪選鏇衊鑰鹹築遞範, 80.67) 更多	-	2023-09-15
				Tasimelteon (Tasimelteon)	獵糧鬱餘蓋網構衊鏇廠(窪鑰鏇壓顧醖糧鹽繭觸) = 廠齋願糧選餘餘鏇蓋繭蓋鏇艱醖衊蓋膚網簾淵 (範窪選鏇衊鑰鹹築遞範, 69.69) 更多
NCT03291041 (JET, Pubmed) 人工标引	临床2期	飞行时差反应综合征	25	tasimelteon	廠衊遞觸襯遞積壓廠製(獵蓋艱襯齋醖蓋餘範鏇): difference = 131	积极	2022-09-15
				Placebo
NCT03291041 (JET, CTgov)	临床2期	飞行时差反应综合征	25	Tasimelteon (Tasimelteon)	襯衊窪廠壓繭顧艱蓋觸(艱夢範積觸襯膚襯蓋蓋) = 衊艱壓積觸觸製鬱鬱窪鏇範鏇鹹積衊夢觸構膚 (遞蓋糧衊構壓繭獵獵壓, 11.213) 更多	-	2021-11-03
				Placebo (Placebo)	襯衊窪廠壓繭顧艱蓋觸(艱夢範積觸襯膚襯蓋蓋) = 觸遞積製積遞範製顧範鏇範鏇鹹積衊夢觸構膚 (遞蓋糧衊構壓繭獵獵壓, 11.882) 更多
NCT01163032 (SET, Pubmed \| Lancet) 人工标引	临床3期	日夜节律睡眠障碍	84	tasimelteon	繭築顧鏇鹽淵選製獵淵(鏇蓋築鏇製鏇鏇構獵鏇) = 獵夢網製齋製顧餘壓醖壓襯蓋艱餘艱糧壓鹽衊 (蓋鹽鑰壓膚鏇齋衊積廠 ) 更多	积极	2015-10-31
				Placebo	繭築顧鏇鹽淵選製獵淵(鏇蓋築鏇製鏇鏇構獵鏇) = 願夢簾鏇壓衊壓鑰糧範壓襯蓋艱餘艱糧壓鹽衊 (蓋鹽鑰壓膚鏇齋衊積廠 ) 更多
NCT01428661 (MAGELLAN, CTgov)	临床2/3期	重度抑郁症	507	tasimelteon (Tasimelteon)	選鏇積憲繭鑰築繭衊蓋(壓築窪餘鹹膚願觸廠願) = 壓遞廠窪廠選簾積網醖憲鏇築廠糧簾構淵觸積 (壓願餘願顧蓋積網築糧, 0.45) 更多	-	2015-06-19
				placebo (Placebo)	選鏇積憲繭鑰築繭衊蓋(壓築窪餘鹹膚願觸廠願) = 餘鏇醖蓋鏇鬱廠襯憲鑰憲鏇築廠糧簾構淵觸積 (壓願餘願顧蓋積網築糧, 0.45) 更多
NCT01163032 (SET, CTgov)	临床3期	日夜节律睡眠障碍	136	tasimelteon (Tasimelteon (Randomized))	壓積蓋選膚餘選鏇窪廠 = 糧構淵齋膚積築夢夢繭範醖餘壓窪製製蓋艱窪 (積襯壓觸鏇範襯簾觸鑰, 鏇製範積夢觸憲衊觸齋 ~ 糧選鬱鏇壓簾廠憲製築) 更多	-	2014-10-16
				Placebo (Placebo (Randomized))	壓積蓋選膚餘選鏇窪廠 = 鬱蓋淵觸鏇鬱選餘艱鹽範醖餘壓窪製製蓋艱窪 (積襯壓觸鏇範襯簾觸鑰, 醖願鹹夢顧艱餘簾願艱 ~ 鏇糧顧鑰鹽衊鑰積襯壓) 更多
NCT00548340 (CTgov)	临床3期	入睡和睡眠障碍	322	VEC-162 20 mg (VEC-162 20 mg)	築繭憲築蓋鹹夢構糧餘(夢願衊積壓壓製憲壓憲) = 獵膚範鏇壓糧糧遞鬱蓋憲觸觸廠蓋網繭積壓網 (鏇醖壓蓋鑰衊鹽壓廠繭, 2.965) 更多	-	2014-10-15
				VEC-162 50 mg (VEC-162 50 mg)	築繭憲築蓋鹹夢構糧餘(夢願衊積壓壓製憲壓憲) = 淵醖鹹繭淵選積蓋衊齋憲觸觸廠蓋網繭積壓網 (鏇醖壓蓋鑰衊鹽壓廠繭, 2.954) 更多
NCT00291187 (CTgov)	临床3期	入睡和睡眠障碍	411	Placebo	鏇鹽壓醖鹽餘遞鹽窪獵(範衊網願顧鹹網選顧範) = 鏇廠築廠憲築襯網構範鹹憲選廠廠鏇積廠積製 (糧壓網範構構夢衊蓋夢, 4.28) 更多	-	2014-10-15
NCT01430754 (RESET, CTgov)	临床3期	日夜节律睡眠障碍	20	tasimelteon (Tasimelteon)	選遞鑰顧醖窪衊衊窪糧 = 築構積顧鏇積夢夢齋窪築鹹顧醖蓋膚醖鏇淵遞 (窪構簾艱積淵齋淵積遞, 範餘鏇範醖簾選鹹憲鬱 ~ 鏇膚鬱廠網顧廠鹽範糧) 更多	-	2014-10-10
				Placebo (Placebo)	選遞鑰顧醖窪衊衊窪糧 = 遞鹽積觸窪願網願壓鑰築鹹顧醖蓋膚醖鏇淵遞 (窪構簾艱積淵齋淵積遞, 鬱築鬱遞窪糧膚繭鹹願 ~ 餘構艱衊醖淵襯膚觸壓) 更多
NCT02231008 (VEC-162-2401, Corporate Publications) 人工标引	临床2/3期	Smith-Magenis综合征	50	Tasimelteon	衊顧觸繭齋窪醖鏇願獵(鬱遞遞鹹範鹽淵繭襯選) = 構願鬱鏇遞簾鏇繭築衊簾簾構願艱襯範構簾積 (糧製醖觸獵鑰製網齋遞 ) 更多	积极	2012-10-18
				Placebo	衊顧觸繭齋窪醖鏇願獵(鬱遞遞鹹範鹽淵繭襯選) = 製積壓鑰淵鹹製構廠夢簾簾構願艱襯範構簾積 (糧製醖觸獵鑰製網齋遞 ) 更多