Fibrinogen/thrombin dry powder - ProFibrix

Drug Profile

Fibrinogen/thrombin dry powder - ProFibrix

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: 25 Mar 2017

Price : $50

At a glance

  • Originator ProFibrix
  • Developer Mallinckrodt plc; ProFibrix
  • 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.

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Registered Surgical blood loss
  • Preclinical Soft tissue injuries

Most Recent Events

  • 01 Feb 2016 Mallinckrodt plc acquired the haemostasis portfolio of The Medicines Company
  • 01 Aug 2015 ProFibrix completes the phase IIIb Finish 3b trial in Surgical blood loss in Austria and Germany (NCT02284256, EudraCT2014-000816-32)
  • 30 Apr 2015 Registered for Surgical blood loss in USA (Topical)
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