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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: 02 Oct 2021

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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

  • Market Withdrawal Surgical blood loss
  • Discontinued Soft tissue injuries

Most Recent Events

  • 21 Nov 2019 Mallinckrodt terminates a phase II trial for Surgical blood loss (In children, In infants, In neonates, In adolescents) in USA due to non-safety device related issues (Topical) (NCT02117349)
  • 28 Oct 2019 No recent reports of development identified for preclinical development in Soft tissue injuries in Netherlands (Topical, Powder)
  • 31 Dec 2018 Discontinued - Phase-II for Surgical blood loss (In adolescents, In children, In infants, In neonates) in USA (Topical)
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