Zipalertinib

Zipalertinib (CLN-081, TAS6417) is a small-molecule drug developed by Taiho Oncology. Its target is EGFR (the sponsor names EGFR exon 20 insertion (ex20ins) mutations). It is the investigational product in 3 recruiting or active industry-led phase 2 and phase 3 interventional cancer trials, including phase 3 studies NCT05973773 (REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumours)) and NCT07128199 (A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumour Resection), in non-small-cell lung cancer. The largest, NCT07128199, plans to enrol 360 participants with primary completion expected 2029-10-01. Status reflects the highest phase registered on ClinicalTrials.gov at the 2026-09-11 check; no efficacy results are recorded here.