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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
  • 15 Dec 2025 Launched for Myelofibrosis in Canada (PO)

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