Sofosbuvir

Drug Profile

Sofosbuvir

Alternative Names: GS-7977; HEPCINAT; Hepcvir; P-7977; PSI-7977; Sovaldi; SoviHep

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Pharmasset
  • Developer Bristol-Myers Squibb; Gilead Sciences
  • Class Antivirals; Phosphoric acid esters; Pyrimidine nucleotides; Small molecules
  • 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
  • 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 Hepatitis C

Most Recent Events

  • 27 Feb 2017 Gilead Sciences has patent protection for sofosbuvir in USA and European Union (Gilead Sciences 10-K, February 2017)
  • 02 Dec 2016 The EMA’s Pharmacovigilance Risk Assessment Committee issues a warning about the risk of hepatitis B-reactivation with direct-acting antiviral drugs, including sofosbuvir
  • 11 Nov 2016 Pharmacokinetics data from a clinical trial in Hepatitis C presented at the The Liver Meeting® 2016: 67th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2016)
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