Pinometostat (EPZ5676) Clinical Trials

Size	Price	Qty
10mg	USD 270
50mg	USD 970

Clinical Trials

Multiple clinical trials have evaluated pinometostat (EPZ5676) in adult and pediatric patients with hematologic malignancies, including acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, and MLL-rearranged acute leukemias. These early-stage Phase 1 and Phase 1/2 studies investigated pinometostat as both monotherapy and combination therapy with agents such as azacitidine or induction chemotherapy. Sponsored by organizations including Epizyme, Celgene, Ipsen, and the National Cancer Institute, these trials have recruitment statuses listed as completed or terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03724084	TERMINATED	Acute Myeloid Leukemia	National Cancer Institute (NCI)	2019-04-10	PHASE1; PHASE2
NCT03701295	COMPLETED	Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL; Leukemia Cutis; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	National Cancer Institute (NCI)	2020-03-06	PHASE1; PHASE2
NCT02141828	COMPLETED	Leukemia; Acute Myeloid Leukemia; Acute Lymphocytic Leukemia; Acute Leukemias	Epizyme, Inc.	2014-05	PHASE1
NCT01684150	COMPLETED	Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Myeloproliferative Disorders	Epizyme, Inc.	2012-09	PHASE1
NCT02141828	Completed	Leukemia\|Acute Myeloid Leukemia\|Acute Lymphocytic Leukemia\|Acute Leukemias	Epizyme Inc.\|Celgene Corporation\|Ipsen	2014-05	Phase 1
NCT01684150	Completed	Acute Myeloid Leukemia\|Acute Lymphoblastic Leukemia\|Myelodysplastic Syndrome\|Myeloproliferative Disorders	Epizyme Inc.\|Celgene\|Ipsen	2012-09	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-06-18)

Check the Pinometostat (EPZ5676) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pinometostat (EPZ5676) acts as a potent, S-adenosyl methionine-competitive inhibitor of the histone methyltransferase DOT1L, selectively blocking the methylation of histone H3 on lysine 79. By disrupting this H3K79 methylation, the compound downregulates oncogenic gene expression programs, inhibiting cell proliferation in MLL-rearranged acute myeloid leukemia and acute lymphoblastic leukemia.

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>).