PF-06821497 Clinical Trials

Size	Price	Qty
5mg	USD 590

Clinical Trials

Multiple Pfizer-sponsored clinical trials are evaluating the investigational compound PF-06821497 (mevrometostat), ranging from Phase 1 dose-escalation and pharmacokinetic studies to Phase 3 efficacy evaluations. These trials assess healthy volunteers as well as patients with advanced malignancies, including metastatic castration-resistant prostate cancer, metastatic castration-sensitive prostate cancer, small cell lung cancer, and follicular lymphoma. Recruitment statuses across these studies vary, encompassing completed, active but not recruiting, actively recruiting, and withdrawn trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07028853	RECRUITING	Metastatic Castration Sensitive Prostate Cancer (mCSPC); Hormone Sensitive Prostate Cancer; Prostate Cancer; Cancer of the Prostate	Pfizer	2025-09-28	PHASE3
NCT03460977	RECRUITING	Metastatic Castration Resistant Prostate Cancer (mCRPC); Small Cell Lung Cancer (SCLC); Follicular Lymphoma (FL)	Pfizer	2018-04-17	PHASE1
NCT06551324	ACTIVE_NOT_RECRUITING	Metastatic Castrate Resistant Prostate Cancer (mCRPC)	Pfizer	2024-10-21	PHASE3
NCT06629779	RECRUITING	Metastatic Castration-Resistant Prostate Cancer	Pfizer	2024-10-22	PHASE3
NCT06661694	WITHDRAWN	Healthy	Pfizer	2025-04-28	PHASE1
NCT06392230	COMPLETED	Healthy Participants	Pfizer	2024-08-30	PHASE1
NCT05767905	COMPLETED	Healthy	Pfizer	2023-03-17	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-14)

Check the PF-06821497 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PF-06821497 is a potent, selective, and orally active inhibitor of enhancer of zeste homolog 2 (EZH2) that targets the catalytic subunit to block histone H3 lysine 27 trimethylation. By suppressing this repressive epigenetic modification, the compound restores tumor-suppressive transcription to inhibit cell proliferation, providing a mechanistically targeted strategy for treating EZH2-driven malignancies such as metastatic castration-resistant prostate cancer, small cell lung cancer, and follicular lymphoma.

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>).