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Decapeptyl
Decapeptyl is a Small molecule drug developed by Sheba Medical Center. It is currently in Phase 3 development. Also known as: GnRH agonist, Enantone.
Decapeptyl, also known as triptorelin, is a medication that acts as a protein modality, specifically an agonist analog of gonadotropin-releasing hormone. It is used to repress the expression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and is approved for medical use, including for conditions such as prostate cancer and infertility.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Decapeptyl |
|---|---|
| Also known as | GnRH agonist, Enantone |
| Sponsor | Sheba Medical Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 3 |
Approved indications
Common side effects
Key clinical trials
- Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (PHASE2, PHASE3)
- Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. (PHASE3)
- Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer (PHASE3)
- Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (PHASE3)
- Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (PHASE3)
- Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis (PHASE2, PHASE3)
- Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer (PHASE3)
- Does Recombinant FSH (rFSH, i.g. Gonal F®) as Compared to Human Menopausal Gonadotrophin (hMG) Affect Telomere Length of Cumulus Cells During Antral Follicle Growth and Impact Blastocyst Status?
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Decapeptyl CI brief — competitive landscape report
- Decapeptyl updates RSS · CI watch RSS
- Sheba Medical Center portfolio CI
Frequently asked questions about Decapeptyl
What is Decapeptyl?
Who makes Decapeptyl?
Is Decapeptyl also known as anything else?
What development phase is Decapeptyl in?
Related
- Manufacturer: Sheba Medical Center — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: GnRH agonist, Enantone
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing