Drug Profile


Alternative Names: Galexos; JNJ-38733214-AAA; Olysio; R-494617; SMV; Sovriad; TMC-435; TMC-435350

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Medivir AB
  • Developer Janssen Pharmaceutical KK; Janssen R&D Ireland; Medivir AB
  • Class 3-ring heterocyclic compounds; Antivirals; Cyclopropanes; Quinolines; Small molecules; Sulfonamides; Thiazoles
  • Mechanism of Action Hepatitis C virus NS3 protein inhibitors; Hepatitis C virus NS4 protein inhibitors
  • Orphan Drug Status

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

  • 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.

    Hepatitis C
  • 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 simeprevir
  • 01 Dec 2016 Janssen initiates a phase II clinical trial in Hepatitis C (Combination therapy, Treatment naive, Treatment experienced) in Japan (PO) (NCT02993250)
  • 11 Nov 2016 Pharmacokinetics and adverse event data from a phase I trial in Hepatitis C (In volunteers) presented at the 67th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD-2016)
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