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Triptoreline
Triptoreline is a Small molecule drug developed by Universitaire Ziekenhuizen KU Leuven. It is currently in Phase 2 development for Advanced Prostatic Carcinoma.
Triptorelin is a gonadotropin-releasing hormone receptor agonist, classified as an agonist. It has been studied in clinical trials for conditions such as adenomyosis, infertility, and in vitro fertilization.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 2 attrition
-2.0pp
Oncology drugs have higher Phase 2-to-Phase 3 attrition than average — many fail to show OS benefit in larger studies.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Triptoreline |
|---|---|
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Target | Gonadotropin-releasing hormone receptor, Gonadotropin-releasing hormone receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Approved indications
- Advanced Prostatic Carcinoma
Common side effects
Key clinical trials
- Exploration of Treatment Effect of Novel Hormone Therapy Combined With Local Treatment Based on PSMA PET/CT Evaluation in mHSCP Patients (PHASE2)
- Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study (PHASE3)
- Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (PHASE2, PHASE3)
- Radiotherapy After Prostatectomy for Node Positive Prostate Cancer (PHASE3)
- Refining Fertility-sparing Treatment in Endometrial Carcinoma Based on Molecular Classification (PHASE2, PHASE3)
- A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer (PHASE3)
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (PHASE2)
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:
- Triptoreline CI brief — competitive landscape report
- Triptoreline updates RSS · CI watch RSS
- Universitaire Ziekenhuizen KU Leuven portfolio CI
Frequently asked questions about Triptoreline
What is Triptoreline?
What is Triptoreline used for?
Who makes Triptoreline?
What development phase is Triptoreline in?
What does Triptoreline target?
Related
- Target: All drugs targeting Gonadotropin-releasing hormone receptor, Gonadotropin-releasing hormone receptor
- Manufacturer: Universitaire Ziekenhuizen KU Leuven — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Advanced Prostatic Carcinoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing