Dolutegravir

Drug Profile

Dolutegravir

Alternative Names: '572; 1349572; 572; Dolutegravir sodium; DTG; GSK-1349572; S-349572; S/GSK 1349572; Tivicay

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Shionogi-GlaxoSmithKline Pharmaceuticals
  • Developer Bellvitge University Hospital; GlaxoSmithKline; INSERM; National Institute of Allergy and Infectious Diseases; Shionogi-GlaxoSmithKline Pharmaceuticals; University of Liverpool; ViiV Healthcare
  • Class 3-ring heterocyclic compounds; Amides; Antiretrovirals; Oxazines; Small molecules
  • Mechanism of Action HIV integrase inhibitors
  • Orphan Drug Status

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

    Yes - HIV-1 infections
  • 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 Yes

Highest Development Phases

  • Marketed HIV-1 infections
  • Phase III HIV infections

Most Recent Events

  • 13 Feb 2017 Pharmacokinetics and pharmacodynamics data from the IMPAACT-P1093 phase I/II trial in HIV infections presented at the 24th Conference on Retroviruses and Opportunistic Infections (CROI-2017)
  • 06 Jan 2017 ViiV Healthcare and PPD plan a phase IIIb trial for HIV-1 infections (Combination therapy, In infants, In children, In adolescents, In adults, Treatment-experienced, Treatment-naive) in USA, South Africa, Thailand and Brazil (PO, Tablet) (NCT03016533)
  • 16 Dec 2016 CHMP recommends approval of reducing age and weight limit for use of dolutegravir for HIV-1 infections (In children, in adolescents) in European Union
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