BDTX-1535 / DARAXON portfolio
Silevertinib API
Silevertinib (BDTX-1535) active pharmaceutical ingredient for EGFR research, drug development and registration programs. U.S. FDA Type II DMF 44854.
Product overview
Active pharmaceutical ingredient
Silevertinib, also known as BDTX-1535, is an investigational, brain-penetrant EGFR tyrosine kinase inhibitor studied in EGFR-mutant non-small cell lung cancer and EGFR-altered glioblastoma. Daraxon offers the API for professional development programs, with product specifications, quantities and technical documentation defined for each project.
Black Diamond Therapeutics · Silevertinib / BDTX-1535↗- Product
- Silevertinib API
- Development code
- BDTX-1535
- Material format
- Active pharmaceutical ingredient
- Research context
- EGFR-mutant NSCLC / EGFR-altered glioblastoma
- U.S. FDA DMF
- 44854 · Type II
- Submission date
- 2026-09-22
- Status in the 2026 Q3 list
- A — Active
- FDA-listed holder
- SHANGHAI DA'AN XIN BIOMEDICAL CO LTD
Traceable filing record
FDA DMF 44854
Filing details checked against the FDA 2026 Q3 DMF list. 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.