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Fedratinib - Celgene Corporation

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Drug Profile

Fedratinib - Celgene Corporation

Alternative Names: FEDR; Fedratinib dihydrochloride monohydrate-Celgene Corporation; INREBIC; Inrebic; SAR-302503; TG-101348

Latest Information Update: 19 Feb 2026

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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

  • 17 Feb 2026 Recordati plans to launch Fedratinib for Myelofibrosis in Japan in mid-2026
  • 17 Dec 2025 Recordati enters a licensing agreement with Impact Biomedicines to commercialize Fedratinib in Japan
  • 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)

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