Opevesostat (ODM208) Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 290

Clinical Trials

Multiple clinical trials sponsored by Merck Sharp & Dohme LLC and Orion Corporation are evaluating opevesostat (ODM208/MK-5684) across Phase 1 through Phase 3 studies, encompassing recruiting, completed, and active, not recruiting statuses. These trials primarily focus on metastatic castration-resistant prostate cancer (mCRPC) and related prostatic neoplasms, as well as early-phase pharmacokinetic assessments in healthy participants and individuals with hepatic impairment. Key ongoing evaluations include Phase 3 studies comparing opevesostat against alternative androgen receptor axis therapies and Phase 1/2 combination substudies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06863272	RECRUITING	Castration-Resistant Prostatic Cancer; Metastasis	Merck Sharp & Dohme LLC	2025-07-03	PHASE1; PHASE2
NCT06353386	RECRUITING	Prostatic Neoplasms, Castration-Resistant	Merck Sharp & Dohme LLC	2024-05-20	PHASE1; PHASE2
NCT06136624	RECRUITING	Prostate Cancer Metastatic	Merck Sharp & Dohme LLC	2023-12-31	PHASE3
NCT06136650	RECRUITING	Metastatic Castration-resistant Prostate Cancer (mCRPC); Prostatic Neoplasms	Merck Sharp & Dohme LLC	2023-12-18	PHASE3
NCT06979596	RECRUITING	Malignant Neoplasm	Merck Sharp & Dohme LLC	2025-08-11	PHASE2
NCT03436485	ACTIVE_NOT_RECRUITING	Prostate Cancer Metastatic	Orion Corporation, Orion Pharma	2018-03-19	PHASE1; PHASE2
NCT07548606	COMPLETED	Healthy	Merck Sharp & Dohme LLC	2026-05-11	PHASE1
NCT06136598	COMPLETED	Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer	Merck Sharp & Dohme LLC	2024-01-30	PHASE1
NCT06104449	COMPLETED	Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer	Merck Sharp & Dohme LLC	2023-11-14	PHASE1
NCT06860243	COMPLETED	Hepatic Impairment; Healthy Participants	Merck Sharp & Dohme LLC	2025-05-13	PHASE1
NCT06633419	COMPLETED	Healthy	Merck Sharp & Dohme LLC	2024-12-18	PHASE1
NCT06566989	COMPLETED	Metastatic Prostate Cancer	Merck Sharp & Dohme LLC	2024-09-19	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-21)

Check the Opevesostat (ODM208) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Opevesostat functions as a selective, nonsteroidal inhibitor of CYP11A1, binding the enzyme to potently block the initial step of steroidogenesis and disrupt downstream steroid hormone biosynthesis. By arresting intratumoral and systemic steroid production, this inhibition deprives androgen-dependent signaling pathways of essential physiological ligands, thereby suppressing disease progression in patients with metastatic castration-resistant prostate cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).