{"entity":{"id":"zipalertinib","kind":"drug","name":"Zipalertinib","aka":[],"tldr":"Zipalertinib is an experimental small-molecule drug from Taiho Oncology in phase 3 trials for non-small-cell lung cancer, aimed at EGFR.","summary":"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; no efficacy results are recorded here.","status":"phase-3","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov: trials of Zipalertinib","url":"https://clinicaltrials.gov/search?intr=CLN-081"},{"label":"Sponsor pipeline page","url":"https://www.taihooncology.com/us/"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc","egfr-mutant-nsclc"],"sections":[],"technologies":[],"targets":["egfr"],"drugs":[],"companies":["taiho-oncology"],"institutions":[],"pathways":[],"terms":[],"trials":["nct05973773","nct07128199","nct04036682"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"CLN-081, TAS6417","modality":"small molecule","mechanism":"Small-molecule drug directed at EGFR, as stated in the ClinicalTrials.gov intervention record; the detailed mechanism is not stated.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/zipalertinib/","neighbours":{"cancer":[{"id":"egfr-mutant-nsclc","kind":"cancer","name":"EGFR-mutated non-small-cell lung cancer","route":"/cancers/egfr-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"}],"company":[{"id":"taiho-oncology","kind":"company","name":"Taiho Oncology (Otsuka)","route":"/companies/taiho-oncology/"}],"trial":[{"id":"nct04036682","kind":"trial","name":"A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer","route":"/trials/nct04036682/"},{"id":"nct07128199","kind":"trial","name":"A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection","route":"/trials/nct07128199/"},{"id":"nct07802834","kind":"trial","name":"Adjuvant ctDNA-Adapted Treatment With Zipalertinib in Early-Stage Atypical EGFR-Mutant NSCLC","route":"/trials/nct07802834/"},{"id":"nct05973773","kind":"trial","name":"REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)","route":"/trials/nct05973773/"},{"id":"nct07229339","kind":"trial","name":"Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer","route":"/trials/nct07229339/"}],"biomarker":[{"id":"egfr-exon-20-insertion","kind":"biomarker","name":"EGFR exon 20 insertion","route":"/biomarkers/egfr-exon-20-insertion/"}]}}