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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

Product information and disease descriptionPlace of product in therapyApproaches to treatmentCurrent treatment options and standard of care

EGFR tyrosine kinase inhibitors

3 evidence topics · 4 sources

Comparator regulatory information: sunvozertinib

“granted accelerated approval to sunvozertinib” (opens the source at this quote in a new tab)

“on or after platinum-based chemotherapy.” (opens the source at this quote in a new tab)

“200 mg orally once daily with food” (opens the source at this quote in a new tab)

Treatment alternatives: sunvozertinib, WU-KONG1B

“Sunvozertinib is efficacious at both 200 and 300 mg once daily in treating platinum-pretreated patients with advanced EGFR exon20ins NSCLC.” (opens the source at this quote in a new tab)

Treatment alternatives: first-line sunvozertinib, WU-KONG28

“The percentage of patients with an objective response was 58.9% in the sunvozertinib group and 31.1% in the chemotherapy group” (opens the source at this quote in a new tab)