Zipalertinib - Cullinan Therapeutics
Alternative Names: CLN-081; TAS-6417; TPC-064Latest Information Update: 28 Nov 2025
At a glance
- Originator Taiho Pharmaceutical
- Developer Cullinan Therapeutics; Taiho Pharmaceutical
- Class Acrylamides; Amines; Antineoplastics; Indolizines; Pyrimidines; Quinolines; Small molecules
- Mechanism of Action Epidermal growth factor receptor antagonists
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Orphan Drug Status
No
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Preregistration Non-small cell lung cancer
Most Recent Events
- 20 Nov 2025 Preregistration for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA (PO)
- 20 Nov 2025 Taiho Pharmaceutical and Cullinan Therapeutics plans to complete the rolling NDA submission for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) to US FDA, in the first quarter of 2026
- 20 Nov 2025 Taiho Pharmaceutical and Cullinan Therapeutics plans to request priority review for Non-small cell lung cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater) to US FDA, in the first quarter of 2026