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Human prothrombin complex - CSL Behring

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Drug Profile

Human prothrombin complex - CSL Behring

Alternative Names: 4-factor PCC; 4-factor prothrombin complex concentrate; BE 1116; Beriplex; Beriplex P/N; Confidex; Kcentra

Latest Information Update: 13 Feb 2026

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At a glance

  • Originator CSL Behring
  • Class Antihaemorrhagics; Blood coagulation factors
  • Mechanism of Action Blood coagulation factor replacements; Factor IX stimulants; Factor VII stimulants; Factor X stimulants; Protein C inhibitors; Prothrombin stimulants
  • Orphan Drug Status

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

    Yes - Haemorrhage
  • New Molecular Entity No

Highest Development Phases

  • Marketed Haemorrhage

Most Recent Events

  • 15 Sep 2025 CSL Behring initiates enrollment in a phase III trial for Haemorrhage in USA (IV, Infusion) (NCT07094087)
  • 31 Jul 2025 CSL Behring plans a phase III trial for Haemorrhage (IV) in June 2025 (NCT07094087)
  • 29 Oct 2024 CSL Behring terminates phase-III trials in Haemorrhage (In adolescents, In adults, In the elderly) in United Kingdom and USA due to business reasons and slow enrollment but not for safety issue (IV) (NCT05568888)

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