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Zipalertinib · CLN-081, TAS-6417

Small molecule · Inhibitor of epidermal growth factor receptor (EGFR) · developed by Taiho Oncology

Phase 1/2 Most advanced trial
1 Registered trials

What is Zipalertinib?

Zipalertinib is an orally available small molecule that specifically and covalently binds to and inhibits a range of EGFR mutations, with particularly high selectivity for EGFR exon 20 insertion mutations and minimal activity against wild-type EGFR. It is studied in non-small cell lung cancer with EGFR exon 20 mutations.

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

At a glance

Also known as
CLN-081, TAS-6417
Drug type
Small molecule
Targets
epidermal growth factor receptor (EGFR)
Mechanism
Inhibitor of epidermal growth factor receptor (EGFR)
Pathways
EGFR mutant-mediated signaling, tumor cell proliferation, tumor vascularization
Therapy area
Oncology
Developer
Taiho Oncology, Inc.
In trials of
CGEM
FDA status
Investigational, not approved in the US. Most advanced trial: Phase 1/2
UNII
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🧪 Clinical trials

TrialPhaseConditionStatusSponsor
NCT04036682 Phase 1/2 Non Small Cell Lung Cancer Active not recruiting CGEM

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

Conditions studied

EGFR Exon 20 MutationNon Small Cell Lung Cancer

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

Sources

Updated Oct 11, 2026.

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

This data is for informational purposes only, not investment advice. BioRadar does not provide buy/sell recommendations. Past performance does not guarantee future results. Always do your own due diligence.