Raltegravir

Drug Profile

Raltegravir

Alternative Names: Isentress; L 900612; MK-0518

Latest Information Update: 14 Nov 2016

Price : $50

At a glance

  • Originator Merck & Co
  • Developer Merck & Co; The French National Agency for Research on AIDS and Viral Hepatitis
  • Class Antiretrovirals; Naphthyridines; Organic chemicals; 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

Most Recent Events

  • 14 Nov 2016 Planned Prescription Drug User Fee Act (PDUFA) date for HIV-1 infections (Combination therapy) in USA (PO) is 2017-05-27
  • 25 Oct 2016 Preregistration for HIV-1 infections (Combination therapy, Treatment-naive) in USA (PO) before October 2016
  • 22 Jul 2016 Preregistration for HIV-1 infections (Combination therapy, Treatment-naive) in European Union (PO; 1200mg Once daily)
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