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Factor X - Bio Products Laboratory

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Drug Profile

Factor X - Bio Products Laboratory

Alternative Names: Coagadex

Latest Information Update: 10 Jul 2026

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At a glance

  • Originator Bio Products Laboratory
  • Developer Bio Products Laboratory; Kedrion Biopharma
  • Class Antihaemorrhagics; Blood coagulation factors; Coagulants
  • Mechanism of Action Blood coagulation factor replacements
  • Orphan Drug Status

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

    Yes - Factor X deficiency
  • New Molecular Entity No

Highest Development Phases

  • Marketed Factor X deficiency

Most Recent Events

  • 29 Jun 2026 Kedrion Biopharma withdrew phase III trial in Factor X deficiency before enrollment due non-safety reasons and the rapidly evolving treatment landscape for AL amyloidosis (NCT06963216)
  • 29 Jul 2025 US FDA grants ODD to factor X for the treatment of acquired Factor X Deficiency
  • 29 Jul 2025 US FDA provides "Study may proceed letter" for the initiation of phase III trial in Factor X deficiency

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