GSK3326595 (Pemrametostat, EPZ015938) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Multiple clinical trials have evaluated GSK3326595 (Pemrametostat) for the treatment of advanced neoplasms, solid tumors, and breast cancer. Spanning Phase 1, Phase 2, and combined Phase 1/2 designs, these investigations were sponsored by industry leaders like GlaxoSmithKline as well as academic institutions such as the Ottawa Hospital Research Institute. Encompassing both completed and terminated studies, these trials assessed parameters including safety, dose escalation, and biological efficacy to map the trajectory of PRMT5 inhibition in oncology.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02783300	COMPLETED	Neoplasms	GlaxoSmithKline	2016-08-30	PHASE1
NCT04676516	COMPLETED	Breast Cancer	Ottawa Hospital Research Institute	2021-06-08	PHASE2
NCT03614728	TERMINATED	Neoplasms	GlaxoSmithKline	2018-10-16	PHASE1; PHASE2
NCT04676516	Completed	Breast Cancer	Ottawa Hospital Research Institute\|Ontario Institute for Cancer Research\|GlaxoSmithKline\|London Regional Cancer Program Canada\|Hamilton Health Sciences Corporation	2021-06-08	Phase 2
NCT03614728	Terminated	Neoplasms	GlaxoSmithKline	2018-10-16	Phase 1\|Phase 2
NCT02783300	Completed	Neoplasms	GlaxoSmithKline	2016-08-30	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-03-10)

Check the GSK3326595 (Pemrametostat, EPZ015938) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pemrametostat selectively binds to protein arginine methyltransferase 5 (PRMT5), potently inhibiting its enzymatic activity and blocking downstream symmetric arginine dimethylation of target histone and non-histone proteins. This inhibition disrupts cellular pre-mRNA splicing machinery and transcriptional regulation to induce cell cycle arrest and apoptosis, providing a clear mechanistic basis for suppressing tumor proliferation in clinical conditions such as breast cancer and advanced neoplasms.

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>).