A Global, Phase 3, Open-Label, Single Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 11.25 mg (Triptorelin Mesylate Injection, 11.25 mg) in Patients With Advanced Prostate Cancer (KATANA E3M)

This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 26 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 11.25 mg formulation will be given to the patients by separate SC injections 12 weeks apart in an unblinded manner. The first dose of FP-014, 11.25 mg, will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 11.25 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 84 (Visit 13/Week 12) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 12-week observation period (Day 168/Week 24/ Visit 22).
Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 11.25 mg administration, immediately thereafter and at specified time points through Day 168 (Week 24) to determine pharmacokinetic (PK) (triptorelin) and pharmacodynamic (PD) (testosterone, PSA, and LH) profiles.

开始日期2025-07-01

申办/合作机构

逸达生物科技股份有限公司

[+1]

NCT06795191

/ Withdrawn临床3期

A Global, Phase 3, Open-Label, Single Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg (Triptorelin Mesylate Injection, 22.5 mg) in Patients With Advanced Prostate Cancer (KATANA E6M)

This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 48 weeks.
Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 22.5 mg formulation will be given to the patients by separate SC injections 24 weeks apart in an unblinded manner. The first dose of FP-014, 22.5 mg will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 22.5 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 168 (Visit 14/Week 24) to achieve castrate levels of serum testosterone concentrations (< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 24-week observation period (Day 336/Week 48/ Visit 24) Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 22.5 mg administration, immediately thereafter and at specified time points through Day 336 (Week 48) to determine PK (triptorelin) and pharmacodynamics (PD) (testosterone, PSA, and LH) profiles.

开始日期2025-06-01

申办/合作机构

逸达生物科技股份有限公司

[+1]

NCT06763926

/ Not yet recruiting临床4期IIT

Intranasal Nafarelin Compared to Subcutaneous Triptorelin for Triggering Final Oocyte Maturation in Ovarian Stimulation: a Non-inferiority Randomised Controlled Clinical Trial

This is a non-inferiority randomised, controlled clinical trial comparing subcutaneous triptorelin to intranasal nafarelin for the final maturation of oocytes in oocyte donors undergoing ovarian stimulation.

开始日期2025-03-15

申办/合作机构-

100 项与双羟萘酸曲普瑞林相关的临床结果

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100 项与双羟萘酸曲普瑞林相关的转化医学

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100 项与双羟萘酸曲普瑞林相关的专利（医药）

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1,801

项与双羟萘酸曲普瑞林相关的文献（医药）

2025-05-24·Cureus Journal of Medical Science

Uterine Inflammatory Myofibroblastic Tumor Mimicking Myoma Treated With Gonadotropin-Releasing Hormone Therapy: A Case Report

Article

作者: Nakatani, Kimiko ; Hirano, Koki ; Yorita, Kenji

Inflammatory myofibroblastic tumors (IMTs) of the uterus are a rare entity that can be challenging to distinguish from leiomyomas, both radiologically and pathologically. No previous reports have documented the response of uterine IMT to gonadotropin-releasing hormone (GnRH) therapy. A 47-year-old Japanese woman presented to our hospital with excessive menstruation and uterine prolapse. Magnetic resonance imaging (MRI) revealed four well-demarcated uterine masses, with the largest measuring 81 mm. Myomas were suspected. Oral GnRH therapy was initiated to relieve the symptoms and reduce the preoperative volume. After four months, follow-up MRI showed a reduction in the largest mass to 62 mm and increased hyperintense areas on T2-weighted images. At six months, the patient underwent laparoscopic hysterectomy and colporrhaphy. Histopathological examination revealed that the largest tumor was an IMT with abundant myxoid matrix, positive for anaplastic lymphoma kinase (ALK), and ALK gene rearrangement. The remaining three masses were diagnosed as usual-type leiomyomas. This is the first reported case of uterine IMT treated with GnRH therapy, which resulted in notable tumor shrinkage. This case highlights both the potential therapeutic approach for uterine IMT and the diagnostic difficulty in distinguishing it from leiomyomas preoperatively.

2025-03-04·Brain Communications

Enduring differential patterns of neuronal loss and myelination along 6-month pulsatile gonadotropin-releasing hormone therapy in individuals with Down syndrome

Article

作者: di Domenicantonio, Giulia ; Sebbah, Raphael ; Draganski, Bogdan ; Vionnet, Nathalie ; Lutti, Antoine ; Adamo, Michela ; Kherif, Ferath ; Raynaud, Quentin ; Pitteloud, Nelly ; Latypova, Adeliya ; Jacobs, An ; Gayer, Mihaly

Abstract:

Despite major progress in understanding the impact of the triplicated chromosome 21 on the brain and behaviour in Down syndrome, our knowledge of the underlying neurobiology in humans is still limited. We sought to address some of the pertinent questions about the drivers of brain structure differences and their associations with cognitive function in Down syndrome. To this aim, in a pilot magnetic resonance imaging (MRI) study, we monitored brain anatomy in individuals with Down syndrome receiving pulsatile gonadotropin-releasing hormone (GnRH) therapy over 6 months in comparison with typically developed age- and sex-matched healthy controls. We analysed cross-sectional (Down syndrome/healthy controls n = 11/27; Down syndrome—2 females/9 males, age 26.7 ± 5.0 years old; healthy controls—8 females/19 males, age 24.1 ± 2.5 years old) and longitudinal (Down syndrome/healthy controls n = 8/13; Down syndrome—1 female/7 males, age 26.4 ± 5.3 years old; healthy controls—4 females/9 males, 24.7 ± 2.2 years old) relaxometry and diffusion-weighted MRI data alongside standard cognitive assessment. The statistical tests looked for cross-sectional baseline differences and for differential changes over time between Down syndrome and healthy controls. The post hoc analysis confined to the Down syndrome group, tested for potential time-dependent interactions between individuals’ overall cognitive performance and associated brain anatomy changes. The brain MRI statistical analyses covered both grey and white matter regions across the whole brain allowing for investigation of regional volume, macromolecular/myelin and iron content, additionally to diffusion tensor and neurite orientation and dispersion density characterization across major white matter tracts. The cross-sectional analysis showed reduced frontal, temporal and cerebellar volumes in Down syndrome with only the cerebellar differences remaining significant after adjustment for the presence of microcephaly (Pfamily-wise-corrected < 0.05). The volume reductions were paralleled by decreased cortical and subcortical macromolecular/myelin content confined to the cortical motor system, thalamus and basal ganglia (Pfamily-wise-corrected < 0.05). All major white matter tracts showed a ubiquitous mean diffusivity and intracellular volume fraction reduction contrasted with no differences in magnetization transfer saturation metrics (Pfamily-wise-corrected < 0.05). Compared with healthy controls over the same period, Down syndrome individuals under GnRH therapy showed cognitive improvement (Montreal Cognitive Assessment from 11.4 ± 5.5 to 15.1 ± 5.6; P < 0.01) on the background of stability of the observed differential neuroanatomical patterns. Despite the lack of adequate Down syndrome control group, we interpret the obtained cross-sectional and longitudinal findings in young adults as evidence for predominant neurodevelopmental neuronal loss due to dysfunctional neurogenesis without signs for short-term myelin loss.

2025-02-25·JOURNAL OF PEDIATRIC ENDOCRINOLOGY & METABOLISM

Central precocious puberty in a toddler with hypothalamic hamartoma

Article

作者: Büyükyılmaz, Gönül ; Turhan, Banu ; Boyraz, Mehmet

Abstract:

Objectives:

Hypothalamic hamartoma (HH) is a rare condition that causes epilepsy and central precocious puberty (CPP) at an early age. In this report, we describe a child with CPP secondary to HH and discuss the current literature.

Case presentation:

A 26-month-old girl was brought to our hospital for evaluation of breast enlargement. Her parents were first-degree relatives. Her breast development was categorized as Tanner stage 3, and her bone age was 7 years/4 months. Laboratory investigations were consistent with CPP. Brain magnetic resonance imaging (MRI) revealed a smooth, spherical lesion in the hypothalamus, located in the tuber cinereum and measuring 11 × 9 × 10 mm. The lesion was identified as a HH. The patient was started on gonadotropin-releasing hormone analogue therapy, specifically 200 μg/kg/month of leuprolide acetate (3.75 mg depot) administered intramuscularly every 28 days. During the 2-year follow-up, her breast development remained at Tanner stage 3, and she did not develop axillary or pubic hair. Her bone age was 7 years/6 months (chronological age; 4 years/2 months). 2-year follow-up MRI showed no change in the size or contours of the HH compared with the initial diagnosis. No side effects from the medical treatment were observed during the follow-up period.

Conclusions:

In patients under the age of 4 years showing signs of CPP, HH should be considered as diagnosis. All patients receiving medical treatment should be closely monitored.

134

项与双羟萘酸曲普瑞林相关的新闻（医药）

2025-09-04

·debiopharm.com

Debiopharm’S Pamorelin® Receives Swiss Approval for subcutaneous Administration, Enhancing Treatment Flexibility for Prostate Cancer Patients

Swissmedic has approved subcutaneous administration of Pamorelin® LA 3.75 mg and 11.25 mg for prostate cancer treatment Lausanne, Switzerland – September 4th, 2025 – Debiopharm (www.debiopharm.com), an independently-owned Swiss biopharmaceutical company committed to developing tomorrow’s standard-of-care treatments to cure cancer and infectious diseases, announced that Swissmedic approved, as of May 16, 2025, the subcutaneous administration of Pamorelin® LA 3.75 mg and Pamorelin® LA 11.25 mg (triptorelin embonate) for the treatment of prostate cancer. This new administration route complements the doses already approved for intramuscular injection (3.75mg, 11.25mg and 22.5mg). Subcutaneous administration of Pamorelin® has demonstrated equivalent efficacy and safety compared to the well-established intramuscular route¹,². A comfortable and flexible alternative for patients and healthcare professionals, in general, the subcutaneous injection is less painful, better tolerated by patients on anticoagulants, reduces the risk of hematoma, and is ideal for individuals with low muscle mass or those who are averse to intramuscular injections. For healthcare professionals, it offers the same efficacy and safety as intramuscular administration, with no changes to dosing schedules, storage conditions, or preparation requirements. This allows seamless integration into existing protocols. Having both options enables tailoring treatment to each patient’s profile and preferences, supporting a more personalized approach. Prostate cancer is the most common cancer among men in Switzerland, with an average of 7,827 new cases and 1,356 deaths annually³,⁴. The medical care of these patients highlights the critical need for better-tolerated and more comfortable treatment options to improve the quality of life of patients throughout their care journey. “ This is great news for men facing prostate cancer in Switzerland. This approval marks a meaningful step towards more personalized and practical care for patients, giving healthcare professionals the flexibility to adapt administration to individual patient needs and clinical settings”, said Catalin Tamas, Head of Medical Affairs at Debiopharm. “Continuous development of new, long-acting-release formulations of triptorelin, reflects our commitment to advancing prostate cancer care, addressing the evolving clinical needs in the management of this disease.” Already approved in several other countries, this new administration option enhances flexibility by allowing healthcare providers to tailor treatment based on clinical needs, institutional practices, and individual patient preferences. Updated product information for Pamorelin® LA 3.75 mg and 11.25 mg is available at https://www.swissmedicinfo.ch Pamorelin® is a GnRH agonist used in the treatment of prostate cancer. Debiopharm has developed three long-acting formulations (1-, 3-, and 6-month) of triptorelin pamoate and is currently developing a 12-month formulation. Triptorelin is manufactured in Switzerland at Debiopharm’s production site in Martigny and is marketed in Switzerland by Debiopharm and in over 80 countries through selected big pharmaceutical partners. It is a market leader and reference treatment in many regions worldwide. Debiopharm aims to develop innovative treatments that address high unmet medical needs, primarily in oncology and bacterial infections. Bridging the gap between breakthrough discoveries and real-world patient access, the company identifies high-potential molecules and technologies for licensing, clinically demonstrates their safety and efficacy, and partners with major pharmaceutical companies to ensure global patient access. For more information, visit https://www.debiopharm.com Follow us on LinkedIn: https://www.linkedin.com/company/debiopharminternational/ 1 Klippel K, Winkler, C, Jocham D. et al. Efficacy and tolerability of 2 application forms (s.c. and i.m.) of Decapeptyl® depot in patients with advanced prostate cancer. Urologe A 1999;38(3):270-275. 2 Lebret T, Rouanne M, Hublarov O, Jinga V, Petkova L, Kotsev R, Sinescu I, Dutailly P. Efficacy of triptorelin pamoate 11.25 mg administered subcutaneously for achieving medical castration levels of testosterone in patients with locally advanced or metastatic prostate cancer. Ther Adv Urol 2015 Jun;7(3):125-34. 3 https://krebs-monitoring.bfs.admin.ch/fr/comparaison/nouveaux-cas/ 4 https://krebs-monitoring.bfs.admin.ch/fr/comparaison/deces/

上市批准

2025-08-30

·健识局

两款独家品种被调出，今年医保准入更严了

8月28日，国家医保局发布了一份调整后的2025年通过医保目录形式审查的药品名单。国家医保局表示，形式审查名单公示期间，收到业界反馈意见，因此做出调整。有变动的产品均为申报医保目录的药品，共调进、调出了6款药。形式审查名单并不等于最终进入谈判的名单，每年的形式审查名单都会有细微调整，主要是筛过不符合医保政策下“临床价值”、“药物经济性”等观念的产品。随着医保基金精细化管理，医保目录准入标准每年都在不同的细节方面有着更高要求。此次调入的4款产品，基本都是临床价值更高的品种。其中，湘北威尔曼制药的注射用头孢曲松钠舒巴坦钠抗菌谱更广，且是目前唯一长效复方抗生素；紫程众投的葡萄糖酸钙氯化钠注射液安全性更高；左旋多巴注射液、熊去氧胆酸口服混悬液是罕见病用药。今年国家医保局调出的两款产品，均是独家品种，分别是注射用利培酮微球、注射用双羟萘酸曲普瑞林。经整理分析，健识局发现：未通过国谈的“雷点”主要就是临床价值不够。今年2月，圣兆药物的注射用利培酮微球在中国大陆上市，是国内首仿产品。首仿不是不能进医保。2023年，国内罕见病戈谢病无药可医，国家就新增凯莱天成医药的一款首仿药艾格司他。不过，就以注射用利培酮微球而论，目前医保内有更好的选择。据健识局查询国家药品监督管理局，目前注射用利培酮微球共有5个生产批文，除了圣兆药物，还有绿叶制药。绿叶制药的注射用利培酮缓释微球（Ⅱ）很早就已经获批上市，并已经进入医保多年。绿叶的这款产品对释放技术进行了再升级，技术上显然优于圣兆药物的产品。目前，通过形式审查名单的只留了绿叶的注射用利培酮微球（Ⅱ），进行续约谈判。另一款被拿掉的注射用双羟萘酸曲普瑞林是跨国药企益普生的原研产品，2023年在中国上市，目前主要用于治疗前列腺癌、子宫内膜异位症以及中枢性性早熟。但是该药不是稀缺产品，只是曲普瑞林类药大家族中的一款。市面上同类品种已有注射用醋酸曲普瑞林微球，与益普生的注射用双羟萘酸曲普瑞林差别主要在于给药时间，临床意义改善并不大。并且，益普生的品种与同类产品适应症覆盖相似。此次通过形式审查的名单中，丽珠集团自研的注射用醋酸曲普瑞林微球就申报了前列腺癌、子宫内膜异位症。国家医保局可能是认为：前列腺癌、性早熟等领域，医保内早就有了亮丙瑞林可用。从这两个被拿掉的品种来看，国家医保局对新药产品的准入“口味”没有太大变化，整体都在强调“真创新”临床价值。有数据表明，2020年29种临床价值不高且可替代等就被调出；去年，医保目录还因临床已替代或长期未生产供应理由，调出43种药品。值得注意的是，国家对可能“超适应症”的安全边际监管也在收紧。曲普瑞林具有医疗和消费双重属性。这种药物对中枢性性早熟有抑制效果，对性早熟患者会延缓骨龄生长，又可以延缓有长高需求人群延缓发育，临床中多被与生长激素搭配使用。众所周知，国内家长对孩子“长高”的需求导致了生长激素的滥用。相应的，抑制性早熟的药物也被大量使用。这类药物可能会触及敏感的用药安全边界，也会给医保基金带来风险，监管难度很大。限制这类药物进入医保，是有充分考虑的。撰稿丨苗苗编辑丨江芸贾亭运营丨晨曦插图丨视觉中国声明：健识局原创内容，未经许可请勿转载玛仕度肽上市即脱销，信达200亿的目标就靠它了？老百姓大药房“自救”，谢子龙：今后药店主要提供情绪价值恒瑞淋巴瘤1类新药获批上市

上市批准

2025-08-29

·EINPresswire

July - September 2021 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Ajovy (fremanezumab-vfrm) Emgality (galcanezumab-gnlm) Nurtec ODT (rimegepant) Ubrelvy (ubrogepant) Vyepti (eptinezumab-jjmr) Hypertension The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2025 to include information about the risk of hypertension. Example: Ajovy labeling Apriso (mesalamine) Asacol (mesalamine) Asacol HD (mesalamine) Azulfidine (sulfasalazine) Azulfidine EN-Tabs (sulfasalazine) Canasa (mesalamine) Colazal (balsalazide disodium) Delzicol (mesalamine) Dipentum (osalazine sodium) Giazo (balsalazide disodium) Lialda (mesalamine) Rowasa (mesalamine) Pentasa (mesalamine) Severe cutaneous adverse reactions The Warnings and Precautions section of the labeling was updated November 2021 to include severe cutaneous adverse reactions. Example: Delzicol labeling Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Pancreatitis FDA determined that no action is necessary at the time based on available information. Avastin (bevacizumab) Mvasi (bevacizumab-awwb) Zirabev (bevacizumab-bvzr) Anaphylactic shock The "Warnings and Precautions" section of the labeling was updated between September 2022 and February 2023 to include anaphylactoid/anaphylactic reactions. Example: Avastin labeling Ayvakit (avapritinib) Photosensitivity reaction The "Warnings and Precautions", "Adverse Reactions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in March 2023 to include information about photosensitivity. Ayvakit labeling Azacitidine Onureg (azacitidine) Vidaza (azacitidine) Generic products containing azacitidine Pericarditis The "Adverse Reactions" section of the labeling was updated between September 2022 and June 2023 to include pericarditis. Example: Vidaza labeling FDA determined that no action is necessary at the time based on available information for Onureg. Bavencio (avelumab) Imfinzi (durvalumab) Libtayo (cemiplimab-rwlc) Keytruda (pembrolizumab) Opdivo (nivolumab) Tecentriq (atezolizumab) Yervoy (ipilimumab) Tumour lysis syndrome FDA determined that no action is necessary at the time based on available information. Cymbalta (duloxetine hydrochloride) Drizalma Sprinkle (duloxetine hydrochloride) Generic products containing duloxetine hydrochloride Anosmia, Hyposmia This issue is posted as two individual newly identified safety signal (NISS) entries in the January-March 2022 quarter, to reflect the focus on the potential signals of anosmia and hyposmia, separately. Darzalex (daratumumab) Darzalex Faspro (daratumumab and hyaluronidase-fihj) Blood stem cell transplant failure FDA determined that no action is necessary at the time based on available information. Dipeptidyl peptidase-4 (DPP-4) inhibitors Glyxambi (empagliflozin and linagliptin) Janumet (metformin hydrochloride and sitagliptin phosphate) Janumet XR (metformin hydrochloride and sitagliptin phosphate) Jentadueto (linagliptin and metformin hydrochloride) Jentadueto XR (linagliptin and metformin hydrochloride) Kazano (alogliptin and metformin hydrochloride) Kombiglyze XR (metformin hydrochloride and saxagliptin) Nesina (alogliptin) Onglyza (saxagliptin) Oseni (alogliptin and pioglitazone) Steglujan (ertugliflozin and sitagliptin) Tradjenta (linagliptin) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Qtern (saxagliptin and dapagliflozin) Generic products containing dipeptidyl peptidase-4 inhibitors Tubulointerstitial nephritis The "Adverse Reactions" section of the labeling was updated between March 2022 and June 2022 for products containing alogliptin and sitagliptin to include tubulointerstitial nephritis. Example: Janumet labeling FDA determined that no action is necessary for products containing linagliptin and saxagliptin at the time based on available information. *An administrative error resulted in the omission of Januvia from the list of product names after the initial quarterly report was posted. Dupixent (dupilumab) Angioedema The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include angioedema. Dupixent labeling Glucagon-like peptide-1 (GLP-1) analogues Adlyxin (lixisenatide) Bydureon (exenatide) Bydureon BCise (exenatide) Byetta (exenatide) Ozempic (semaglutide) Rybelsus (semaglutide) Saxenda (liraglutide) Soliqua 100/33 (insulin glargine and lixisenatide injection) Trulicity (dulaglutide) Victoza (liraglutide) Wegovy (semaglutide) Xultophy 100/3.6 (insulin degludec and liraglutide injection) Generic products containing glucagon-like peptide-1 analogues Gallbladder related disorders The "Warnings and Precautions", "Adverse Reactions", and "Patient Counseling Information" sections of the GLP-1 analogues labeling were updated between March 2022 and June 2022 to include information about acute gallbladder disease. Example: Adlyxin labeling FDA has determined that the last approved labeling for Saxenda and Wegovy is adequately labeled for acute gallbladder disease, and that no further regulatory action is needed at this time. Gonadotropin releasing hormone (GnRH) analogues Fensolvi (leuprolide acetate) Lupron Depot-PED (leuprolide acetate) Supprelin LA (histrelin acetate) Synarel (nafarelin acetate) Triptodur (triptorelin) Idiopathic intracranial hypertension The "Warnings", "Precautions", and "Adverse Reactions" sections of the labeling were updated in April 2022 to include idiopathic intracranial hypertension. Example: Fensolvi labeling Jakafi (ruxolitinib phosphate) Herpes simplex virus (HSV) reactivation and/or disseminated HSV The "Dosage and Administration", "Warnings and Precautions", and "Adverse Reactions" sections of the labeling were updated in January 2023 to include information about herpes simplex and herpes zoster infections. Jakafi labeling Ibrance (palbociclib) Kisqali (ribociclib) Kisqali Femara Co-Pack (letrozole and ribociclib) Embolic and thrombotic events, venous The "Adverse Reactions" section of the Ibrance labeling was updated in December 2024 to include venous thromboembolism. Ibrance labeling FDA determined that no action is necessary at the time for Kisqali and Kisqali Femara Co-Pack based on available information. Ocrevus (ocrelizumab) Myocardial infarction FDA determined that no action is necessary at the time based on available information. Potassium Chloride Product preparation error The “Warnings” section of the labeling was updated in December 2022 to include information about fatal cardiac adverse reactions with intravenous administration of undiluted potassium chloride. Praxbind (idarucizumab) Wrong dose errors The carton labeling and "Dosage and Administration" sections of the labeling were revised in February 2022 to clarify the number of vials included in each carton and the recommended dosing. Praxbind labeling Qbrexza (glycopyrronium tosylate) Accidental exposure to product The container label, carton labeling, "Dosage and Administration", "Warnings and Precautions", "Patient Counseling Information", and "Patient Information" sections of the labeling were updated in October 2022 to include information about accidental exposure. Qbrexza labeling Qbrexza (glycopyrronium tosylate) Urinary retention The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in October 2022 to include information about new or worsening urinary retention. Qbrexza labeling Sodium-glucose cotransporter-2 (SGLT-2) inhibitors Farxiga (dapagliflozin) Glyxambi (empagliflozin and linagliptin) Invokamet (canagliflozin and metformin hydrochloride) Invokamet XR (canagliflozin and metformin hydrochloride) Invokana (canagliflozin) Jardiance (empagliflozin) Qtern (saxagliptin and dapagliflozin) Steglatro (ertugliflozin) Steglujan (ertugliflozin and sitagliptin) Segluromet (ertugliflozin and metformin hydrochloride) Synjardy (empagliflozin and metformin hydrochloride) Synjardy XR (empagliflozin and metformin hydrochloride) Trijardy XR (empagliflozin, linagliptin and metformin hydrochloride) Xigduo XR (dapagliflozin and metformin) Generic products containing sodium-glucose cotransporter-2 (SGLT-2) inhibitors Tubulointerstitial nephritis FDA determined that no action is necessary at the time based on available information. Somatostatin Receptor Imaging Agents Detectnet (copper Cu-64 dotatate injection) Gallium Dotatoc (GA 68) Octreoscan (Indium In 111 Pentetreotide) Netspot (Gallium GA 68 Dotatate) Hypersensitivity The "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in December 2021 to include hypersensitivity reactions. Example: Netspot labeling Stromectol (ivermectin) Generic products containing ivermectin Off label use FDA determined that no action is necessary at the time based on available information. Stromectol (ivermectin) Generic products containing ivermectin Neurotoxicity The "Warnings", "Adverse Reactions", and "Overdosage" sections of the labeling were updated in March 2022 to include neurotoxicity. Example: Stromectol labeling Sunosi (solriamfetol hydrochloride) Hypersensitivity FDA determined that no action is necessary at the time based on available information. Vivitrol (naltrexone) Incorrect route of product administration The container label (vial), carton labeling, "Dosage and Administration", "Warnings and Precautions", and "Description", sections of the labeling were revised in September 2022 to emphasize the appropriate route and site of administration. Vivitrol labeling Xcopri (cenobamate) Psychiatric disorders The "Adverse Reactions" section of the labeling was updated in June 2022 to include psychiatric disorders. Xcopri labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

上市批准

100 项与双羟萘酸曲普瑞林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06248	双羟萘酸曲普瑞林	L02AE04	DB06825

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
性早熟	美国	Azurity Pharmaceuticals, Inc.	2017-06-29
激素依赖性前列腺癌	澳大利亚	Ipsen Pty Ltd.	2006-08-28
前列腺癌	韩国	Ferring Pharmaceuticals Korea Co., Ltd.	1996-11-04

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
家族性睾丸毒症	申请上市	中国	Ipsen SA	2007-01-22
囊肿	临床3期	印尼	-	2024-01-02
子宫内膜异位症	临床3期	中国	博福--益普生（天津）制药有限公司	2017-07-28
子宫内膜异位症	临床3期	中国	Ipsen Pharma SAS	2017-07-28
晚期前列腺癌	临床3期	比利时	Ipsen SA	2009-11-01
晚期前列腺癌	临床3期	丹麦	Ipsen SA	2009-11-01
晚期前列腺癌	临床3期	法国	Ipsen SA	2009-11-01
晚期前列腺癌	临床3期	意大利	Ipsen SA	2009-11-01
晚期前列腺癌	临床3期	拉脱维亚	Ipsen SA	2009-11-01
晚期前列腺癌	临床3期	立陶宛	Ipsen SA	2009-11-01

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临床结果

适应症

分期

评价

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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


NCT05590793 (CTgov)	临床3期	晚期前列腺癌	195	Triptorelin Pamoate	選構鏇範遞鑰廠製築鑰 = 簾範築襯壓鏇壓範顧願窪糧廠餘顧獵鏇網築齋 (憲窪齋糧壓顧顧簾膚鬱, 蓋鏇願衊廠鏇願醖繭構 ~ 鏇簾繭築顧構構積艱選) 更多	-	2025-09-09
NCT05458856 (TriptoSwitch, CTgov)	临床3期	转移性前列腺癌	147	Triptorelin Embonate	網鬱構選餘獵鏇鹽廠廠 = 襯襯積夢築齋憲艱夢顧餘廠衊醖襯窪鏇蓋壓膚 (憲夢觸餘壓淵廠窪廠範, 夢淵淵製遞選醖網蓋齋 ~ 鹹鹹選糧鹽範積築顧鑰) 更多	-	2025-07-23
NCT05029622 (Pubmed \| Adv Ther)	临床3期	性早熟	66	Triptorelin pamoate 22.5 mg	膚遞築願齋糧醖簾窪鹹(襯構衊鑰蓋淵憲選艱鏇) = Thirteen patients (19.7%) had 22 drug-related treatment emergent adverse events (TEAEs); no grade ≥ 3 TEAEs were reported 糧膚艱網壓獵鹽壓獵鹽 (願範鹽糧憲鏇願範夢鑰 ) 更多	积极	2024-12-01
ESMO2024 人工标引	N/A	AR阳性唾液腺肿瘤 AR Positive	20	Bicalutamide Triptorelinelin 4-weekly	淵艱壓憲憲衊鏇膚獵齋(繭顧淵繭鹹鹹鏇願廠繭) = 網鹹製艱鏇構鹹襯鹹顧壓艱艱願蓋選觸餘築積 (膚膚觸淵壓壓糧積鹽憲, 0.5 ~ 62.5) 更多	积极	2024-09-14
NCT04736602 (CTgov)	临床3期	性早熟	32	triptorelin pamoate	醖醖選餘網夢繭鹽鏇鹹 = 壓獵壓鏇鏇鹹醖鑰獵繭選網鏇範襯鏇範鏇餘選 (積鏇選構觸願鹹襯蓋膚, 夢範選範蓋獵膚艱製廠 ~ 獵遞簾簾廠製繭衊範構) 更多	-	2024-08-01
NCT04736602 (Pubmed \| Adv Ther)	临床3期	性早熟 luteinizing hormone (LH) \| follicle-stimulating hormone	32	Triptorelin pamoate 15 mg	網艱壓構餘餘築製鹽顧(遞簾築積糧餘繭範鹹鏇) = 選遞艱鬱鹹淵蓋鑰夢積衊襯築齋壓齋淵淵範遞 (鹽憲壓齋積製糧簾製獵 ) 更多	积极	2023-10-01
NCT04736602 (ESPE2023)	临床3期	性早熟	32	Triptorelin 3-month PR formulation	積構鑰選製廠襯遞鹹簾(遞窪網鏇構鏇積憲鬱襯) = There were no deaths 繭壓夢蓋構鑰獵遞構廠 (獵齋餘築選願蓋襯淵鏇 ) 更多	积极	2023-09-21
NCT04537078 (CTgov)	临床3期	女性不孕症	90	Gonadotropin+Decapeptyl+Cyclo-Progynova+progesterone+Duphaston (the Progestin Primed Double Stimulation Group)	鬱艱願夢鹽選鏇鹹艱窪(簾繭衊鏇夢壓築繭製壓) = 衊顧願艱糧糧憲憲窪淵夢夢艱壓鬱鏇鏇積鑰夢 (窪壓餘構壓醖醖壓蓋鹹, 顧夢簾鬱製糧鏇襯衊願 ~ 鏇鹽窪餘獵鹽襯窪構選) 更多	-	2022-02-17
NCT04537078 (CTgov)	临床3期	女性不孕症	90	Chorionic Gonadotropin+Cetrotide Injectable Product+Decapeptyl+Cyclo-Progynova+progesterone (the Flexible GnRh Antagonist)	艱鏇憲鏇衊壓築繭觸鬱(壓淵鏇鑰製齋製餘選鬱) = 選憲壓範願膚選鑰憲夢鹹築鏇鬱繭願構膚築壓 (顧憲願衊積顧簾顧窪糧, 積鹹壓鏇選積網窪構壓 ~ 襯鏇觸鏇鏇齋蓋壓衊衊) 更多	-	2022-02-17
NCT03232281 (CTgov)	临床3期	子宫内膜异位症	300	Triptorelin Pamoate (Triptorelin Pamoate PR 3-month)	壓製願選夢積鏇醖網醖 = 醖壓窪鏇構願醖觸廠糧範製襯鑰鑰齋艱蓋鬱顧 (壓鹽壓鏇製鑰窪襯窪簾, 鏇選構壓憲獵糧顧餘觸 ~ 網範窪製膚餘壓襯糧夢) 更多	-	2021-10-14
NCT03232281 (CTgov)	临床3期	子宫内膜异位症	300	Triptorelin Acetate (Triptorelin Acetate PR 1-month)	壓製願選夢積鏇醖網醖 = 廠構壓築廠積糧鹹選繭範製襯鑰鑰齋艱蓋鬱顧 (壓鹽壓鏇製鑰窪襯窪簾, 簾願獵網獵構積構壓齋 ~ 壓窪願餘衊範餘糧窪積) 更多	-	2021-10-14
NCT00311636 (PROMISE-GIM6, ASCO2021)	临床3期	早期乳腺癌辅助	281	CT+GnRHa	積範鬱構網壓範鏇淵獵(膚廠獵網醖憲網淵鏇衊) = 鑰遞築鏇艱顧構鑰艱壓糧廠顧選繭蓋獵範鑰觸 (顧簾壓網繭餘鑰鏇齋選 ) 更多	积极	2021-05-28
NCT00311636 (PROMISE-GIM6, ASCO2021)	临床3期	早期乳腺癌辅助	281	CT alone	積範鬱構網壓範鏇淵獵(膚廠獵網醖憲網淵鏇衊) = 鹽觸構願簾壓範願鹹製糧廠顧選繭蓋獵範鑰觸 (顧簾壓網繭餘鑰鏇齋選 ) 更多	积极	2021-05-28