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Silevertinib · BDTX-1535

Small molecule · Inhibitor of EGFR · developed by Black Diamond Therapeutics

Phase 1/2 Most advanced trial

BDTX Developer

1 Registered trials

What is Silevertinib?

Silevertinib is an orally bioavailable, brain-penetrating small-molecule EGFR inhibitor that irreversibly binds to and inhibits EGFR, including classical and resistance mutations. It is being studied in non-small cell lung cancer.

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

At a glance

Also known as: BDTX-1535
Drug type: Small molecule
Targets: EGFR
Mechanism: Inhibitor of EGFR
Pathways: MAPK/ERK, PI3K/Akt
Therapy area: Oncology
Developer: Black Diamond Therapeutics, Inc. (BDTX, BKHA)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 1/2
UNII: RP9F537KVY

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT05256290	Phase 1/2	Non-Small Cell Lung Cancer	Active not recruiting	BDTX

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

Conditions studied

Advanced Lung CarcinomaAdvanced Non-Small Cell Squamous Lung CancerEGF-R Positive Non-Small Cell Lung CancerEGFR-TKI Resistant MutationEpidermal Growth Factor Receptor C797SEpidermal Growth Factor Receptor G719XMetastatic Lung CancerMetastatic Lung Non-Small Cell CarcinomaNon-Small Cell Lung CancerNSCLC

Other drugs acting on EGFR

Neratinib FDA approved Osimertinib FDA approved Actinium Ac 225 FPI-2068 Phase 1 ALX2004 Phase 1 BH-30643 Phase 1/2 CUDC-101 Phase 1 EGFR-TKI inhibitor based on investigator's choice Phase 3 Enozertinib Phase 1/2 Ficerafusp Alfa Phase 2/3 Firmonertinib Phase 3 FPI-2053 Phase 1 Izalontamab Brengitecan Phase 2/3

More from Black Diamond Therapeutics

Tuxobertinib Phase 1

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