TNG-462 (Vopimetostat) Clinical Trials

Size	Price	Qty
1mg	USD 197
5mg	USD 347

Clinical Trials

Multiple Phase I/II clinical trials sponsored by Tango Therapeutics, Inc. and Servier Bio-Innovation LLC are evaluating TNG-462 as monotherapy and combination therapy for MTAP-deleted solid tumors, non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma (PDAC), and RAS-mutated malignancies. These multi-center studies assess the safety, tolerability, pharmacokinetics, and antineoplastic activity of TNG-462 in patients with locally advanced, thoracic, and metastatic pancreatic cancers. Currently, several clinical trials are actively recruiting patients, while others remain active but not recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06922591	RECRUITING	PDAC; PDAC - Pancreatic Ductal Adenocarcinoma; NSCLC; RAS Mutation; MTAP Deletion; Lung Cancer; Pancreatic Cancer Metastatic; Thoracic Cancer	Tango Therapeutics, Inc.	2025-05-31	PHASE1; PHASE2
NCT06188702	ACTIVE_NOT_RECRUITING	MTAP-deleted Solid Tumors	Servier Bio-Innovation LLC	2024-04-29	PHASE1; PHASE2
NCT05732831	RECRUITING	Locally Advanced Solid Tumor	Tango Therapeutics, Inc.	2023-05-26	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-05-14)

Check the TNG-462 (Vopimetostat) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TNG-462 selectively binds to methylthioadenosine (MTA)-bound PRMT5, blocking its methyltransferase catalytic activity and suppressing downstream symmetric arginine dimethylation of target proteins. This target inhibition impairs RNA splicing and cellular proliferation specifically in MTAP-deleted tumor cells, translating to significant antitumor regression in clinical trial indications such as MTAP-deficient pancreatic ductal adenocarcinoma and non-small cell lung cancer.

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>).