Drugs / Opevesostat
Opevesostat
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT07548606 | May → Jun 2026 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06860243 | May 2025 → Feb 2026 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06814132 | Apr → Oct 2025 | chronic renal failure syndrome, end stage renal failure | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06633419 | Dec 2024 → Feb 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06566989 | Sep → Oct 2024 | metastatic prostate carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06554639 | Jul → Aug 2024 | prostate neoplasm | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06136598 | Jan 2024 → Mar 2026 | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06104449 | Nov 2023 → Feb 2026 | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06863272 | Jul 2025 → Oct 2031 expected | castration-resistant prostate carcinoma, metastatic neoplasm | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06353386 | May 2024 → Jan 2029 expected | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 1/2 | NCT03436485 | Mar 2018 → Jul 2026 overdue | prostate cancer | Orion Corporation, Orion Pharma | Active not recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06979596 | Aug 2025 → Nov 2027 expected | cancer | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06136624 | Dec 2023 → Aug 2028 expected | metastatic prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06136650 | Dec 2023 → May 2028 expected | castration-resistant prostate carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-01-26 | Orion Corporation, Orion Pharma | Results Additional ODM-208/MK-5684 Phase II data presented at ASCO-GU 2024 orionpharma.com ↗
A decrease in PSA levels of 50% or more occurred in 55.6% of patients with AR- LBD mutation and in 16.7% of AR-wild-type patients. |
| 2023-12-27 | Orion Corporation, Orion Pharma | Results NEJM Evidence publishes results from Phase I/IIa CYPIDES trial with ODM-208 orionpharma.com ↗
Results from the Phase I/IIa CYPIDES trial suggest that ODM-208 potently inhibits all steroid-hormone biosynthesis with observed antitumor activity in a heavily pretreated mCRPC population, especially in patients with androgen receptor gene (AR) ligand-binding-domain (LBD) mutations. |
| 2022-02-18 | Orion Corporation, Orion Pharma | Results Results from an Ongoing Phase I/II CYPIDES Trial of ODM-208 Presented at ASCO-GU orionpharma.com ↗
Overall, 32% of the patients achieved a PSA (prostate specific antigen) decrease of ≥50%. |
All press releases naming this drug 12 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Opevesostat | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06860243 ↗ |
| Known as | MK-5684 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06554639 ↗ |
| Known as | ODM-208 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03436485 ↗ |
| Action | Inhibit | “ODM-208, a novel inhibitor of cytochrome P450 11A1” PMID 38320513 ↗ Dec 2023 |
| Modality | Small molecule | — CHEMBL5314533 ↗ |
| Route | Oral | “co-administered with glucocorticoid and fludrocortisone, orally daily” NCT03436485 ↗ |