Zipalertinib
Zipalertinib is an oral EGFR exon 20 insertion-selective tyrosine kinase inhibitor developed by Taiho Oncology, in collaboration with Cullinan Therapeutics in the United States. The next event is the FDA decision on Zipalertinib, on Feb 27, 2027 (source).
- Also known as
- CLN-081, TAS6417
- Company
- Cullinan Therapeutics (CGEM) · US co-development with Taiho Oncology
- How it works
- EGFR exon 20 insertion-selective tyrosine kinase inhibitor
- Approved
- Not approved in any market we track
Development by disease
| Non-small cell lung cancer | Filed |
Upcoming events
Firm dates · a specific day set by the company or regulator
Later
- Feb 27in 137 daysZipalertinib · FDA decision · EGFR ex20ins NSCLC · relapsed
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected by end of 2026
- Year-end 2026Zipalertinib · NDA submission · EGFR ex20ins NSCLC · first-line
Past results and milestones
- Sep 14, 2026REZILIENT3 planned interim analysis completed; primary endpoint of PFS met with statistically significant 6-month median improvement (14.5 vs. 8.5 months, HR=0.50, p=0.00015). ORR and DOR also significantly improved. OS follow-up continues at 30% event maturity (HR=0.72). Source
- Mar 10, 2026Taiho completed the rolling NDA submission to FDA for zipalertinib in EGFR ex20ins NSCLC seeking accelerated approval in the relapsed/refractory setting. Source
- Jun 1, 2025Zipalertinib REZILIENT1 Phase 2b pivotal results were presented at ASCO 2025 and published in the Journal of Clinical Oncology. Source