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Zipalertinib - Cullinan Therapeutics

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Drug Profile

Zipalertinib - Cullinan Therapeutics

Alternative Names: CLN-081; TAS-6417; TPC-064

Latest Information Update: 16 Jun 2025

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Non-small cell lung cancer

Most Recent Events

  • 22 May 2025 Efficacy and adverse events data from a phase I/II trial in Non-small cell lung cancer released by Cullinan Therapeutics
  • 03 Feb 2025 Updated efficacy data from the phase I/II REZILIENT1 trial in Non-small cell lung cancer released by Cullinan Therapeutics
  • 28 Jan 2025 Taiho Pharmaceutical and Cullinan Therapeutics plan to submit NDA to US FDA for Non small cell lung cancer in the second half of 2025

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