# Zipalertinib

Source: https://onco.cc/drugs/zipalertinib/  
OnCo record `zipalertinib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- 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.

## Sources

- ClinicalTrials.gov: trials of Zipalertinib: https://clinicaltrials.gov/search?intr=CLN-081
- Sponsor pipeline page: https://www.taihooncology.com/us/

## Connected records

- cancers: [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- companies: [Taiho Oncology (Otsuka)](https://onco.cc/companies/taiho-oncology/)
- trials: [A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer](https://onco.cc/trials/nct04036682/), [A Study to Assess Zipalertinib Versus Placebo in Participants With Early Stage NSCLC With Uncommon EGFR Mutations, Following Complete Tumor Resection](https://onco.cc/trials/nct07128199/), [Adjuvant ctDNA-Adapted Treatment With Zipalertinib in Early-Stage Atypical EGFR-Mutant NSCLC](https://onco.cc/trials/nct07802834/), [REZILIENT3 (REsearching ZIpaLertinib In Egfr Non-small Cell Lung Cancer Tumors)](https://onco.cc/trials/nct05973773/), [Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer](https://onco.cc/trials/nct07229339/)
- biomarkers: [EGFR exon 20 insertion](https://onco.cc/biomarkers/egfr-exon-20-insertion/)

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