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Ledipasvir/sofosbuvir - Gilead Sciences

Drug Profile

Ledipasvir/sofosbuvir - Gilead Sciences

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: 28 Nov 2019

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At a glance

  • Originator Gilead Sciences
  • Developer Gilead Sciences; National Institute of Diabetes and Digestive and Kidney Diseases; National Institutes of Health (USA); 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
  • Phase II Hepatitis B; Liver disorders

Most Recent Events

  • 28 Nov 2019 No recent reports of development identified for clinical-Phase-Unknown development in Hepatitis-C in Rwanda (PO, Tablet)
  • 10 Apr 2019 Final efficacy data and adverse events from a phase III trial in hepatitis C virus (HCV) and hepatitis B virus (HBV) presented at the International Liver Congress 2019 (ILC-2019)
  • 03 Feb 2019 Gilead Sciences completes the phase II Egypt Peds trial in Hepatitis C (In adolescents) in Egypt (PO) (NCT02868242)
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