ORIC-944 Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Multiple clinical trials sponsored by ORIC Pharmaceuticals are evaluating ORIC-944 (rinzimetostat) in patients with metastatic prostate cancer and metastatic castration-resistant prostate cancer. This portfolio includes a Phase 1/1b study evaluating ORIC-944 as a single agent or combined with androgen receptor pathway inhibitors, alongside a randomized Phase 3 trial comparing combination therapy against standard-of-care options. Recruitment is currently ongoing across these studies to further evaluate therapeutic efficacy and tolerability in advanced disease settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07723248	RECRUITING	Metastatic Castration Resistant Prostate Cancer	ORIC Pharmaceuticals	2026-08-03	PHASE3
NCT05413421	RECRUITING	Metastatic Prostate Cancer	ORIC Pharmaceuticals	2022-06-01	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the ORIC-944 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

ORIC-944 selectively binds to the embryonic ectoderm development subunit of polycomb repressive complex 2, thereby blocking methyltransferase activity and downstream histone H3 lysine 27 trimethylation. Consequently, the loss of repressive histone marking restores tumor suppressor gene expression and inhibits cell proliferation, providing a mechanistically targeted approach to suppress tumor growth in 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>).