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Relugolix-Containing Product
Relugolix-Containing Product is a Small molecule drug developed by Sumitomo Pharma Switzerland GmbH. It is currently in Phase 2 development. Also known as: TAK-385, T-1331285, RVT-601, MVT-601.
Relugolix is a small molecule gonadotropin-releasing hormone receptor antagonist used to treat various conditions, including endometriosis-related pain, uterine fibroids, and stages of prostate cancer. It is classified as an antagonist and works by blocking the gonadotropin-releasing hormone receptor.
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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).
| 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 | Relugolix-Containing Product |
|---|---|
| Also known as | TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A |
| Sponsor | Sumitomo Pharma Switzerland GmbH |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Androgen Deprivation Therapy (Relugolix) for the Improvement of Diagnostic Imaging (PSMA PET/CT Scan) in Patients With High Risk or Very High Risk Prostate Cancer, The EnrichPSMA Trial (PHASE2)
- 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)
- Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer (PHASE1, PHASE2)
- Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer (PHASE2)
- Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) (PHASE2)
- Assessing Efficacy of Neoadjuvant ADT in Localized High-Risk Prostate Cancer Patients Utilizing 18F-Flotufolastat PSMA PET/CT (PHASE2)
- Relugolix + Enzalutamide Study in High-Risk Prostate Cancer (PHASE1)
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:
- Relugolix-Containing Product CI brief — competitive landscape report
- Relugolix-Containing Product updates RSS · CI watch RSS
- Sumitomo Pharma Switzerland GmbH portfolio CI
Frequently asked questions about Relugolix-Containing Product
What is Relugolix-Containing Product?
Who makes Relugolix-Containing Product?
Is Relugolix-Containing Product also known as anything else?
What development phase is Relugolix-Containing Product in?
Related
- Manufacturer: Sumitomo Pharma Switzerland GmbH — full pipeline
- Also known as: TAK-385, T-1331285, RVT-601, MVT-601, MVT-601A
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing