GSK 257049

Drug Profile

GSK 257049

Alternative Names: 257049; CSP-HBsAg; FSV 1; GSK Biologicals' malaria vaccine 257049; Malaria vaccine 257049; Mosquirix; Profilam; RTS; RTS,S; RTS,S/AS; RTS,S/AS01; RTS,S/AS02; RTS,S/AS02A; S/AS01E; SB 257049

Latest Information Update: 20 Dec 2016

Price : $50

At a glance

  • Originator GlaxoSmithKline
  • Developer GlaxoSmithKline; Malaria Vaccine Initiative; University of Oxford
  • Class Antimalarials; Parasitic vaccines; Subunit vaccines
  • Mechanism of Action Immunostimulants
  • 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

Highest Development Phases

  • Preregistration Falciparum malaria

Most Recent Events

  • 15 Nov 2016 University of Oxford plans a phase II trial for Falciparum malaria in Thailand (NCT02992119)
  • 29 Feb 2016 GlaxoSmithKline plans a phase III trial for Malaria (Prevention, In infants) in Ghana (IM) (NCT02699099)
  • 24 Jul 2015 The Committee for Medicinal Products for Human Use recommends approval of GSK 257049 for Malaria prophylaxis in infants and children in Africa
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