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Pralsetinib - Blueprint Medicines

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Drug Profile

Pralsetinib - Blueprint Medicines

Alternative Names: BLU-667; CS 3009; GAVRETO; Gavreto; Phukiva®; Pratinib; Pujihua; RG 6396

Latest Information Update: 17 Dec 2025

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At a glance

  • Originator Blueprint Medicines
  • Developer Blueprint Medicines; CStone Pharmaceuticals; Rigel Pharmaceuticals; Roche
  • Class Amides; Amines; Antineoplastics; Cyclohexanes; Ethers; Fluorinated hydrocarbons; Pyrazoles; Pyridines; Pyrimidines; Small molecules
  • Mechanism of Action Proto-oncogene protein c-ret inhibitors
  • Orphan Drug Status

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

    Yes - Thyroid cancer; Non-small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Non-small cell lung cancer; Thyroid cancer
  • Phase III Solid tumours

Most Recent Events

  • 25 Nov 2025 Phase-III clinical trials in Solid tumours (Metastatic disease, Late-stage disease) in Spain (PO) (CTIS2025-523158-15-00)
  • 31 Jul 2025 Registered for Non-small cell lung cancer in China (PO)
  • 18 Jul 2025 Blueprint Medicines has been acquired by Sanofi

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