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Fedratinib - Celgene Corporation

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Drug Profile

Fedratinib - Celgene Corporation

Alternative Names: FEDR; INREBIC; Inrebic; SAR-302503; TG-101348

Latest Information Update: 06 Oct 2025

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At a glance

  • Originator TargeGen
  • Developer Bristol-Myers Squibb; Celgene Corporation; Sanofi
  • Class Antifibrotics; Antihaemorrhagics; Antineoplastics; Phenyl ethers; Pyrimidines; Pyrrolidines; Small molecules; Sulfonamides
  • Mechanism of Action Fms-like tyrosine kinase 3 inhibitors; Janus kinase 2 inhibitors
  • Orphan Drug Status

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

    Yes - Polycythaemia vera; Myelofibrosis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Myelofibrosis
  • Discontinued Essential thrombocythaemia; Polycythaemia vera; Solid tumours

Most Recent Events

  • 28 Jul 2025 Celgene completes a phase III FREEDOM2 clinical trials in Myelofibrosis in Australia, Austria, Belgium, China, Czech Republic, England, France, Germany, Hungary, Ireland, Italy, Multinational, Netherlands, Poland, Portugal, Russia, South Korea, Spain, United Kingdom (PO) (NCT03952039) (EudraCT2018-003411-21)
  • 24 Jun 2025 Registered for Myelofibrosis in Japan (PO)
  • 28 May 2025 Pharmacodynamics data from a phase-I trial (In volunteers) presented at the 126th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT-2025)

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