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Tuxobertinib · BDTX-189

Small molecule · Inhibitor of EGFR and HER2 (ERBB2) · developed by Black Diamond Therapeutics

Phase 1 Most advanced trial (none active)

BDTX Developer

1 Registered trials

What is Tuxobertinib?

Tuxobertinib is an orally bioavailable, irreversible small-molecule inhibitor of EGFR and HER2 allosteric and exon 20 insertion mutations. It selectively binds these mutant forms while sparing wild-type receptors, inhibiting cellular proliferation and angiogenesis in tumors expressing these mutations.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: BDTX-189
Drug type: Small molecule
Targets: EGFR, HER2 (ERBB2)
Mechanism: Inhibitor of EGFR and HER2 (ERBB2)
Pathways: cellular proliferation, angiogenesis
Therapy area: Oncology
Developer: Black Diamond Therapeutics, Inc. (BDTX, BKHA)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 1
UNII: 6CE2107J4T

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT04209465	Phase 1	Solid Tumor	Terminated	BDTX

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Solid Tumor

Other drugs acting on EGFR / ERBB2

Neratinib FDA approved Osimertinib FDA approved Trastuzumab Deruxtecan FDA approved Trastuzumab Emtansine FDA approved Zanidatamab FDA approved Actinium Ac 225 FPI-2068 Phase 1 ADCT-502 Phase 1 ALX2004 Phase 1 BH-30643 Phase 1/2 CGT4255 Phase 1 CUDC-101 Phase 1 EGFR-TKI inhibitor based on investigator's choice Phase 3

More from Black Diamond Therapeutics

Silevertinib Phase 1/2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the BDTX page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z