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Degarelix & Relugolix
Degarelix & Relugolix is a GnRH receptor antagonist Small molecule drug developed by VA Office of Research and Development. It is currently in Phase 2 development for Prostate cancer, Hormone-sensitive cancers.
Degarelix and Relugolix are GnRH receptor antagonists that inhibit the production of gonadotropin-releasing hormone, leading to a decrease in testosterone levels.
Degarelix and Relugolix are treatments used to study and manage conditions such as Prostate Cancer, Castration-Sensitive Prostate Carcinoma, and Metastatic Prostate Carcinoma, often in combination with other interventions like Leuprolide or Stereotactic body radiation therapy/radiosurgery (SBRT).
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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 | Degarelix & Relugolix |
|---|---|
| Sponsor | VA Office of Research and Development |
| Drug class | GnRH receptor antagonist |
| Target | GnRH receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 2 |
Mechanism of action
Degarelix and Relugolix work by binding to the GnRH receptor, preventing the release of gonadotropin-releasing hormone, which in turn reduces the production of luteinizing hormone and follicle-stimulating hormone. This decrease in hormone production leads to a reduction in testosterone levels, making them useful in the treatment of hormone-sensitive cancers and other conditions.
Approved indications
- Prostate cancer
- Hormone-sensitive cancers
Common side effects
- Injection site reaction
- Nausea
- Headache
Key clinical trials
- Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response (PHASE2)
- NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer. (PHASE1)
- Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT (PHASE2)
- Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging (PHASE3)
- ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer (PHASE2)
- Adaptive Androgen Deprivation and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (PHASE2)
- Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer (PHASE2)
- Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial (PHASE3)
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:
- Degarelix & Relugolix CI brief — competitive landscape report
- Degarelix & Relugolix updates RSS · CI watch RSS
- VA Office of Research and Development portfolio CI
Frequently asked questions about Degarelix & Relugolix
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Related
- Drug class: All GnRH receptor antagonist drugs
- Target: All drugs targeting GnRH receptor
- Manufacturer: VA Office of Research and Development — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Prostate cancer
- Indication: Drugs for Hormone-sensitive cancers
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing