Fibrinogen/thrombin dry powder - Mallinckrodt

Drug Profile

Fibrinogen/thrombin dry powder - Mallinckrodt

Alternative Names: Factor I/factor IIa; Factor IIa/factor I; Fibrocaps; Human fibrinogen/human thrombin; Human thrombin/human fibrinogen; PRO-0601; Raplixa; Thrombin/fibrinogen

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator ProFibrix
  • Developer Mallinckrodt plc
  • Class Acute-phase proteins; Adhesives; Antifibrinolytics; Antihaemorrhagics; Blood coagulation factors; Coagulants; Serine endopeptidases
  • Mechanism of Action Fibrinogen replacements; Thrombin replacements
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Marketed Surgical blood loss
  • Preclinical Soft tissue injuries

Most Recent Events

  • 08 Sep 2017 Phase-II development for Surgical blood loss (In children, In infants, In neonates, In adolescents) is ongoing in USA (Topical) (NCT02117349)
  • 08 Sep 2017 Launched for Surgical blood loss in USA (Topical) before September 2017 (Mallinckrodt website, September 2017)
  • 08 Sep 2017 No recent reports on development identified - Registered for Surgical blood loss in Norway, Iceland and Liechtenstein (Topical)
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