Drugs / Decapeptyl
Decapeptyl
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed prostate cancer, hereditary, X-linked 3 1 milestone | |||||
| Filed | EU (EMA) | Decapeptyl | prostate cancer, hereditary, X-linked 3 | 2008-09-25 | “announces the filing of an application with the European Agencies for the approval of its new 6-month formulation of Decapeptyl®” debiopharm.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | TRELSTAR | — | 2000-06-15 | fda.gov ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT02908438 | Sep 2016 → Sep 2017 | — | Northwest Women's and Children's Hospital, Xi'an, Shaanxi | Unknown | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05557604 | Feb 2021 → Feb 2024 overdue | prostate cancer | Regina Elena Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT00194792 | Aug 2005 → Jul 2011 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, progesterone-receptor positive breast cancer | University of Washington | Terminated | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04356664 | Mar 2021 → Jun 2026 overdue | adenomyosis, endometriosis, female infertility | Hopital Foch | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06525155 | Jan 2024 → Feb 2025 overdue | endometriosis | Rumah Sakit Pusat Angkatan Darat Gatot Soebroto | Recruiting | No outcome recorded |
| Phase 3 | NCT05019846 | Sep 2021 → Dec 2025 overdue | prostate cancer | Marco Lorenzo Bonu | Recruiting | No outcome recorded |
| Phase 3 | NCT02862782 | Sep 2016 → Sep 2019 | — | Tel-Aviv Sourasky Medical Center | Unknown | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02048891 | Oct 2014 → Jan 2015 | infertility disorder | Rambam Health Care Campus | Completed | No outcome recorded |
| Phase 4 | NCT02749825 | Sep 2002 → May 2006 | prostate cancer | Pharmatech | Terminated | No outcome recorded Stop: Business |
| Phase not applicable3 trials | ||||||
| — | NCT03660813 | Jul 2018 → Aug 2021 | — | Sheba Medical Center | Completed | No outcome recorded |
| — | NCT02827656 | Aug 2016 → Aug 2017 | infertility disorder | Meir Medical Center | Unknown | No outcome recorded |
| — | NCT02368964 | Feb 2015 → Jun 2020 | infertility disorder | Sheba Medical Center | Completed | No outcome recorded |
| Comparator or background therapy24 trials | ||||||
| Phase 1 | NCT03332797 Background | Nov 2017 → Jul 2027 expected | breast cancer | Genentech, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07142551 Background | Mar 2026 → Jun 2030 expected | castration-resistant prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT06922318 Background | Aug 2025 → Aug 2031 expected | castration-resistant prostate carcinoma | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT06059118 Background | Oct 2023 → Jan 2027 expected | prostate cancer | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | No outcome recorded |
| Phase 2 | NCT03809000 Background | Apr 2019 → Apr 2023 overdue | prostate cancer | RTOG Foundation, Inc. | Active not recruiting | Missed primary |
| Phase 2 | NCT03311555 Background | Mar 2018 → Dec 2022 | prostate cancer | Andrew J. Armstrong, MD | Completed | No outcome recorded |
| Phase 2 | NCT02429999 Comparator | Apr 2015 → Oct 2016 | — | Assiut University | Unknown | No outcome recorded |
| Phase 2 | NCT02168062 Background | Jun 2014 → May 2018 | prostate adenocarcinoma | University of California, San Francisco | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT01790126 Comparator | Mar 2013 → Mar 2019 | prostate cancer | Aragon Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT06282588 Background | Dec 2023 → Jul 2030 expected | prostate cancer | Cancer Research Antwerp | Recruiting | No outcome recorded |
| Phase 3 | NCT04961996 Background | Aug 2021 → Aug 2025 overdue | breast cancer | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT04537078 Comparator | Sep 2020 → Mar 2021 | female infertility | El Shatby University Hospital for Obstetrics and Gynecology | Completed | No outcome recorded |
| Phase 3 | NCT04064840 Comparator | Sep 2019 → Sep 2024 overdue | infertility disorder | The University of Hong Kong | Recruiting | No outcome recorded |
| Phase 3 | NCT02342197 Comparator | Jan → Dec 2011 | infertility disorder | Kasr El Aini Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01888744 Comparator | Sep 2010 → Jun 2013 | infertility disorder | University Hospital Brussels | Completed | No outcome recorded |
| — | NCT06739759 Comparator | Nov 2024 → Jun 2025 overdue | ovarian hyperstimulation syndrome | Aljazeera Hospital | Recruiting | No outcome recorded |
| — | NCT05838105 Comparator | Oct 2022 → Jan 2025 | — | Shaare Zedek Medical Center | Unknown | No outcome recorded |
| — | NCT04749979 Comparator | Feb → Jun 2021 | infertility disorder | Aljazeera Hospital | Unknown | No outcome recorded |
| — | NCT02737800 Comparator | Apr 2016 → Aug 2017 | ovarian endometriosis | Kasr El Aini Hospital | Completed | No outcome recorded |
| — | NCT02346253 Background | Jan 2015 → Dec 2021 | prostate adenocarcinoma | Stanford University | Completed | No outcome recorded |
| — | NCT02144818 Comparator | Jan 2014 → Jul 2015 | ovarian dysfunction | Sheba Medical Center | Unknown | No outcome recorded |
| — | NCT01790282 Background | Mar 2013 → Dec 2014 | infertility disorder | Mansoura Integrated Fertility Center | Completed | No outcome recorded |
| — | NCT01389713 Comparator | Sep 2008 → Dec 2010 | infertility disorder | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Completed | No outcome recorded |
| — | NCT00542126 Comparator | Dec 2007 → Sep 2009 | — | Shaare Zedek Medical Center | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 8
| Date | Issuer | Release |
|---|---|---|
| 2025-09-04 | Debiopharm International SA | Regulatory Debiopharm’S Pamorelin® Receives Swiss Approval for subcutaneous Administration, Enhancing Treatment Flexibility for Prostate Cancer Patients debiopharm.com ↗
Debiopharm ( ), 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. |
| 2017-04-11 | Xbrane Biopharma AB | Results Xbrane Biopharma reports positive in-vivo efficacy data on Spherotide xbrane.com ↗
Spherotide demonstrated no significant difference vs. the originator product on the clinically relevant endpoint, testosterone suppression 1 month after injection. |
| 2009-10-13 | Debiopharm International SA | Regulatory Ipsen and Debiopharm Group announce that Decapeptyl® (triptorelin embonate) 6-month successfully completes the European Decentralised Procedure for the treatment of locally advanced or metastatic prostate cancer debiopharm.com ↗
announced that the 6-month sustained-release formulation of Decapeptyl® (triptorelin embonate 22.5 mg) successfully completed its European decentralised registration procedure involving nine countries: Germany (reference member state), France, Austria, Finland, Norway, Belgium, Denmark, Spain and The Netherlands. |
| 2008-11-14 | Debiopharm International SA | Regulatory Debiopharm announces U.S. NDA filing of Trelstar® 6-month formulation for locally advanced or metastatic prostate cancer debiopharm.com ↗
today announced that the New Drug Application (NDA) for the 6 month formulation of Trelstar® (triptorelin pamoate) has been accepted for filing by the United States (U.S.) Food and Drug Administration (FDA). |
| 2008-09-25 | Debiopharm International SA | Regulatory Debiopharm moves towards a new 6-month formulation of Decapeptyl® to further help prostate cancer patients debiopharm.com ↗
This submission in Europe of our first 6-month-formulation for the treatment of prostate cancer is another demonstration of Debiopharm’s commitment to supporting and enhancing the life of cancer patients. |
| 2008-02-12 | Debiopharm International SA | Results Clinical Update – Decapeptyl®/Trelstar® 6-Month Formulation in Advanced Prostate Cancer debiopharm.com ↗
These results show similar efficacy and safety to the already marketed 1- and 3-month formulations. |
| 2004-03-23 | Debiopharm International SA | Regulatory Debiopharm´s Pamorelin Long Acting, Formulated Using Debio® PLGA Technology, receives Final Marketing Autorisation in Germany debiopharm.com ↗
Debiopharm S.A., the independent drug-development company specialising in oncology, endocrinology, CNS and niche diseases, today announces that Pamorelin long acting (LA) 11.25mg, a three month formulation, was granted final marketing authorization in Germany on March 18, 2004 by the Bundesinstitut für Arzneimittel und Medizinprodukte, also known as BfArM. |
| 2001-07-05 | Debiopharm International SA | Regulatory Swiss drug developer Debiopharm announces FDA approval of Trelstar TM LA for therapeutic use debiopharm.com ↗
The Swiss-based pharmaceutical development company Debiopharm S.A., part of the Debio group, today announced that the FDA has granted marketing authorization for Debiopharm’s luteinizing hormone releasing hormone (LHRH) agonist, triptorelin pamoate, TRELSTAR TM LA, to treat advanced stage prostate cancer. |
All press releases naming this drug 25 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 36 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Decapeptyl | “GnRHa group receive three injections of GnRHa(Decapeptyl) ,0.1 mg s.c. on the day of ET, and D3 and D6 after ET in addition to routine LPS.” NCT02908438 ↗21“ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.” NCT02048891 ↗ “daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle” NCT01389713 ↗ “Single intramuscular 0.1 mg decapeptyl are given on day of transfer” NCT01790282 ↗ “One or two intramuscular injections of Decapeptyl 3 mg” NCT04356664 ↗ “Day 3 after ET - Ovitrelle 125mcg + Decapeptyl 0.1mg” NCT05838105 ↗ “antagonist protocol with triggering by Decapeptyl” NCT06739759 ↗ “0.1 decapeptyl from day 21 in the previous cycle” NCT02429999 ↗ “GnRH agonist - Decapeptyl , hCG - Ovitrelle” NCT02368964 ↗ “Decapeptyl® 0,1 mg subcutaneously daily” NCT01888744 ↗ |
| Known as | Trelstar | “Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix...” NCT03311555 ↗6“Patients will continue on ADT with LHRH agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix) if not surgically castrated throughout...” NCT06922318 ↗ “Choice of LHRHa per investigator discretion/site practice guidelines (e.g, Eligard®, Zoladex®, Lupron Depot®, Trelstar®) and ARN-509 Tablets, 240 mg/day administered orally” NCT01790126 ↗ “luteinizing hormone-releasing hormone (LHRH) agonist (i.e. Zoladex, Trelstar, Eligard, or Lupron) or LHRH antagonist (Degarelix or Relugolix)” NCT06059118 ↗ “Trelstar®” NCT03809000 ↗ |
| Known as | Triptorelin Embonate | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06525155 ↗ |
| Known as | triptorelin pamoate | “Either leuprolide acetate (Lupron Depot, 22.5 mg or 45 mg IM), triptorelin pamoate (Trelstar, 11.25 mg or 22.5 mg IM), goserelin acetate (Zoladex, 10.8mg SC) or degarelix...” NCT03311555 ↗5“The LHRH agonist (leuprolide acetate, goserelin acetate, or triptorelin pamoate) will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according...” NCT03332797 ↗ “LHRH agonists may include, but are not limited to, leuprolide acetate, goserelin acetate, or triptorelin pamoate.” NCT04961996 ↗ |
| Action | Inhibit | “to inhibit endogenous testosterone production” NCT06922318 ↗ |
| Route | Intramuscular | “triptorelin pamoate intramuscularly (IM)” NCT00194792 ↗ |