TNG908 (Ralometostat) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

A clinical trial sponsored by Tango Therapeutics, Inc. evaluated TNG908 (Ralometostat) in a multi-center, open-label Phase 1/2 study assessing safety, tolerability, and preliminary anti-tumor activity. The investigation targeted patients with locally advanced solid tumors harboring specific metabolic vulnerabilities. However, recruitment for this early-phase study has been terminated prior to completion.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05275478	TERMINATED	Locally Advanced Solid Tumor	Tango Therapeutics, Inc.	2022-03-23	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-15)

Check the TNG908 (Ralometostat) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ralometostat (TNG908) selectively binds protein arginine methyltransferase 5 in an MTA-cooperative manner, inhibiting symmetric arginine dimethylation and disrupting crucial downstream RNA processing and proliferative pathways. This molecular blockade selectively impairs cellular viability in sensitive cancer cells, leading to tumor growth inhibition in locally advanced 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>).