TNG462 / DARAXON portfolio
Vopimetostat API
TNG462 active pharmaceutical ingredient for PRMT5 / MTAP-deletion research and development. U.S. FDA DMF 44318.
Product overview
Active pharmaceutical ingredient
Vopimetostat, also known as TNG462, is an investigational MTA-cooperative PRMT5 inhibitor being studied in MTAP-deleted cancers. Daraxon offers vopimetostat API with project-specific technical and regulatory documentation requirements agreed before supply.
Tango Therapeutics · Vopimetostat / PRMT5↗- Product
- Vopimetostat API
- Development code
- TNG462
- Material format
- Active pharmaceutical ingredient
- Research context
- PRMT5 / MTAP-deleted cancers
- U.S. FDA DMF
- 44318 · Type II
- Submission date
- 2026-06-11
- Status in the 2026 Q3 list
- A — Active
- FDA-listed holder
- SHANGHAI DA'AN XIN BIOMEDICAL CO LTD
Traceable filing record
FDA DMF 44318
Filing details checked against the FDA 2026 Q3 DMF list and reflect that quarterly snapshot. A DMF filing is not FDA drug approval.
Technical documentation
Define the package for your program.
- Batch Certificate of Analysis and agreed product specification
- Identity and chromatographic records within the agreed documentation package
- DMF reference and Letter of Authorization requirements
Product inquiry
Talk to the Daraxon team.
Include intended use, quantity, destination and documentation requirements.