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ELVN-002

Small molecule · Inhibitor of HER2 (ErbB2) receptor tyrosine kinase (ERBB2) · developed by Enliven Therapeutics

Phase 1 Most advanced trial

ELVN Developer

1 Registered trials

What is ELVN-002?

ELVN-002 is an orally bioavailable, irreversible inhibitor of the HER2 receptor tyrosine kinase, including HER2 exon 20 insertion mutants, while sparing wild-type EGFR. It is studied in HER2-mutant non-small cell lung cancer and HER2-positive metastatic breast cancer.

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

At a glance

Drug type: Small molecule
Targets: HER2 (ErbB2) receptor tyrosine kinase (ERBB2), EGFR (secondary target)
Mechanism: Inhibitor of HER2 (ErbB2) receptor tyrosine kinase (ERBB2)
Pathways: HER2-mediated signaling, tumor cell proliferation, tumor vascularization
Therapy area: Oncology
Developer: Enliven Therapeutics (ELVN)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 1

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT05650879	Phase 1	HER2 Mutant Non-small Cell Lung Cancer	Active not recruiting	ELVN

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

Conditions studied

HER2 AmplificationHER2 Gene MutationHER2 Mutant Non-small Cell Lung CancerHER2-positive Metastatic Breast Cancer

Other drugs acting on ERBB2

Neratinib FDA approved Trastuzumab Deruxtecan FDA approved Trastuzumab Emtansine FDA approved Zanidatamab FDA approved ADCT-502 Phase 1 BH-30643 Phase 1/2 CGT4255 Phase 1 CUDC-101 Phase 1 Enozertinib Phase 1/2 NVL-330 Phase 1 TTX-MC138 Phase 1/2 Tuxobertinib Phase 1

More from Enliven Therapeutics

Relcobatinib Phase 1

Sources

NCI Thesaurus

Updated Oct 11, 2026. Something wrong or missing? Report it on the ELVN 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