IDE397 (GSK-4362676) Clinical Trials

Size	Price	Qty
5mg	USD 379
25mg	USD 970

Clinical Trials

Several clinical trials evaluate IDE397 (GSK-4362676) across Phase 1 and Phase 1/2 studies targeting MTAP-null or MTAP-deleted solid tumors, including non-small-cell lung cancer, gastroesophageal adenocarcinoma, urothelial carcinoma, mesothelioma, pancreatic cancer, and biliary tract carcinoma. Sponsored by entities such as IDEAYA Biosciences and Amgen, these evaluations investigate both monotherapy and combination regimens. With recruitment statuses ranging from active, not recruiting to actively recruiting and completed, these trials establish clinical benchmarks for MAT2A inhibition in synthetic lethal oncology contexts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07277413	RECRUITING	NSCLC Adenocarcinoma; Gastroesophageal Cancer (GC); Gastric Adenocarcinoma; Adenocarcinoma of Esophagus; Squamous Cell Car. - Esophagus; Urothelial Carcinoma (UC); Bladder Cancer; Mesothelioma; Pleural Mesothelioma; Peritoneal Mesothelioma; Non-Small Cell Lung Cancer NSCLC; Pancreatic Cancer; Biliary Tract Carcinoma	IDEAYA Biosciences	2026-03-04	PHASE1
NCT04794699	ACTIVE_NOT_RECRUITING	Solid Tumor	IDEAYA Biosciences	2021-04-14	PHASE1
NCT05975073	COMPLETED	MTAP-null Non-Small-Cell Lung Cancer; MTAP-null Solid Tumors	Amgen	2023-08-01	PHASE1; PHASE2
NCT05975073	Recruiting	MTAP-null Non-Small-Cell Lung Cancer\|MTAP-null Solid Tumors	Amgen	2023-08-01	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-05)

Check the IDE397 (GSK-4362676) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

IDE397 (GSK-4362676) functions as a potent small-molecule inhibitor of methionine adenosyltransferase 2A (MAT2A), selectively blocking the biosynthesis of S-adenosylmethionine to reduce intracellular S-adenosylmethionine levels and impair downstream protein arginine methyltransferase activity. This metabolic suppression selectively disrupts essential RNA processing and biological pathways in methylthioadenosine phosphorylase (MTAP)-deleted cells, thereby suppressing cell proliferation and driving tumor regression in clinical settings such as MTAP-null non-small-cell lung cancer and other solid tumors.

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>).