Sofosbuvir

Drug Profile

Sofosbuvir

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

Latest Information Update: 09 Dec 2016

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

  • 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
  • 01 Nov 2016 Gilead Sciences completes a phase III trial in Hepatitis C (Combination therapy, Treatment-naive, Treatment-experienced) in China, Hong Kong, Taiwan, South Korea and Vietnam (PO) (NCT02021643)
  • 13 Apr 2016 Final safety and efficacy data from a European compassionate use programme in Hepatitis C released by Bristol-Myers Squibb
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