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Ledipasvir/sofosbuvir - Gilead Sciences

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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: 20 Apr 2023

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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 Amides; Antivirals; Azabicyclo compounds; Benzimidazoles; Carbamates; Fluorenes; Fluorinated hydrocarbons; Imidazoles; Phosphoric acid esters; Pyrimidine nucleotides; Small molecules; Spiro compounds
  • Mechanism of Action Hepatitis C virus NS 5 protein inhibitors; Virus replication 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 Porphyria cutanea tarda
  • No development reported Hepatitis B

Most Recent Events

  • 19 Feb 2023 Efficacy, adverse events and pharmacokinetics data from a phase I trial in Hepatitis C presented at 30th Conference on Retroviruses and Opportunistic Infections (CROI-2023)
  • 07 Dec 2022 No development reported - Phase-II for Hepatitis B in USA (PO)
  • 07 Dec 2022 No development reported - Phase-II for Hepatitis C (Combination therapy, In children) in USA (PO)

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