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Zipalertinib (CLN-081)

EGFR exon 20 insertion-mutated non-small-cell lung cancer

Also known as TAS6417
Manufacturer
Taiho Oncology
Regulatory submission
NDA submitted February 2026
Launch
Not announced
Last updated
75 sources

Company-reported prevalence

Zipalertinib

Overview

FieldValue
DrugZipalertinib (CLN-081 and TAS6417)
IndicationEGFR exon 20 insertion-mutated non-small-cell lung cancer
DiseaseNon-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations
CompanyTaiho Oncology, Inc. and its parent, Taiho Pharmaceutical Co., Ltd. (developer and commercializer); Cullinan Therapeutics, Inc. (co-development partner sharing development costs and 50% of pre-tax profits from U.S. sales)
Documents searchedTaiho Oncology website, product pipeline, science, and expanded access pages, accessed October 2026; Cullinan Therapeutics website, home, pipeline, therapeutic areas, clinical trials, and patient resources pages, accessed October 2026; Taiho Oncology press release, August 3, 2023; Taiho Oncology press release, January 28, 2025; Taiho Oncology press release, May 22, 2025; Taiho Oncology press release, June 1, 2025; Taiho Oncology press release, July 22, 2025; Taiho Oncology press release, July 25, 2025; Taiho Oncology press release, September 9, 2025; Taiho Oncology press release, October 12, 2025; Taiho Oncology press release, November 20, 2025; Taiho Oncology press release, April 28, 2026; Taiho Oncology press release, August 12, 2026; Taiho Oncology press release, August 19, 2026; Taiho Oncology press release, September 13, 2026; Taiho Pharmaceutical press release, September 14, 2026; Cullinan Therapeutics annual report for 2025 (Form 10-K for 2025), April 2026
Data as ofOctober 14, 2026
Prepared byAI research agent (Claude); not yet reviewed by a person

Company statements of prevalence

United States

Europe

No evidence found.

Global

Other countries and regions

No evidence found.

Geography not stated

Sources the company cites

Burnett 2021

Riess 2018

References