Andexanet alfa

Drug Profile

Andexanet alfa

Alternative Names: AndexXa; AnXa; IndexXa; PRT-064445; PRT-4445; PRT-44545; Recombinant factor-Xa-Portola; rfXa-inhibitor-antidote

Latest Information Update: 11 Nov 2017

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At a glance

  • Originator Portola Pharmaceuticals
  • Class Antidotes; Antihaemorrhagics; Disulfides; Recombinant proteins
  • Mechanism of Action Blood coagulation 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 Yes

Highest Development Phases

  • Preregistration Haemorrhage

Most Recent Events

  • 28 Sep 2017 Portola Pharmaceuticals completes the phase I trial in Haemorrhage in USA (NCT03083704)
  • 28 Aug 2017 Portola Pharmaceuticals initiates a phase II trial for Haemorrhage in USA (IV, Injection) (NCT03310021)
  • 15 Aug 2017 FDA assigns PDUFA action date of 02/02/2018 for andexanet alfa for Haemorrhage (IV, Injection)
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