MRTX1719 (Navlimetostat) Clinical Trials

Size	Price	Qty
5mg	USD 1,970
25mg	USD 4,990

Clinical Trials

Multiple Phase 1 clinical trials are actively recruiting participants to evaluate MRTX1719 (BMS-986504) in advanced solid tumors with homozygous MTAP deletion, non-small cell lung cancer, mesothelioma, malignant peripheral nerve sheath tumors, and pancreatic adenocarcinoma. Bristol-Myers Squibb is sponsoring several clinical trials assessing the safety, pharmacokinetics, and metabolic profiles of MRTX1719 monotherapy. Additionally, M.D. Anderson Cancer Center is conducting a clinical trial evaluating its combination with PARP inhibitors to establish therapeutic efficacy.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07382544	RECRUITING	Advanced Cancer; Solid Tumor	M.D. Anderson Cancer Center	2026-02-12	PHASE1
NCT05245500	RECRUITING	Mesothelioma; Non Small Cell Lung Cancer; Malignant Peripheral Nerve Sheath Tumors; Solid Tumor; Pancreatic Adenocarcinoma; Advanced Solid Tumor	Bristol-Myers Squibb	2022-06-09	PHASE1
NCT06672523	RECRUITING	Advanced Solid Tumors With Homozygous MTAP Deletion	Bristol-Myers Squibb	2025-03-24	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-12)

Check the MRTX1719 (Navlimetostat) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MRTX1719 selectively binds to the protein arginine methyltransferase 5 and methylthioadenosine phosphorylase (PRMT5•MTA) complex, inhibiting PRMT5 methyltransferase activity and blocking downstream symmetric dimethylarginine modification of intracellular protein targets. This biochemical suppression disrupts key pre-mRNA splicing and protein translation mechanisms, leading to targeted proliferation arrest and cell death in MTAP-deleted solid tumors such as non-small cell lung cancer, mesothelioma, and pancreatic adenocarcinoma.

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>).