Ledipasvir/sofosbuvir

Drug Profile

Ledipasvir/sofosbuvir

Alternative Names: GS 5885/PSI 7977; GS-5885/GS-7977; GS-5885/sofosbuvir; GS-7977/GS-5885; Harvoni; LDV/SOF; PSI 7977/GS 5885; Sofosbuvir/GS-5885; Sofosbuvir/ledipasvir

Latest Information Update: 12 Jul 2017

Price : $50

At a glance

  • Originator Gilead Sciences
  • Developer Gilead Sciences; The French National Agency for Research on AIDS and Viral Hepatitis
  • Class Antivirals; Azabicyclo compounds; Benzimidazoles; Carbamates; Fluorenes; Imidazoles; Phosphoric acid esters; Pyrimidine nucleotides; Small molecules; Spiro compounds
  • Mechanism of Action Hepatitis C virus NS 5 protein inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Hepatitis C

Most Recent Events

  • 27 Jun 2017 Gilead Sciences initiates the phase II LDV/SOF ESRD trial for Hepatitis C in Belgium, Italy and Switzerland (NCT03036839)
  • 22 Jun 2017 The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending ledipasvir/sofosbuvir for Hepatitis C (In adolescents, Treatment-naive, Treatment-experiences) in European Union
  • 21 Jun 2017 Preregistration for Hepatitis C (In adolescents, Treatment-experienced, Treatment-naive) in European Union (PO) before June 2017
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