Silibinin - Rottapharm Madaus

Drug Profile

Silibinin - Rottapharm Madaus

Alternative Names: Legalon; Legalon SIL

Latest Information Update: 25 Jun 2015

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At a glance

  • Originator Rottapharm Madaus
  • Developer Rottapharm Madaus; University of Leipzig
  • Class Antidotes; Antivirals; Chromans; Dioxins; Hepatoprotectants
  • Mechanism of Action DNA-directed RNA polymerase inhibitors
  • Orphan Drug Status

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

    Yes - Hepatitis C
  • New Molecular Entity No

Highest Development Phases

  • Marketed Liver disorders; Poisoning
  • Phase II Hepatitis C

Most Recent Events

  • 04 Mar 2015 Rottapharm Madaus withdraws the phase II/III HEPASIL trial prior to enrolment for Hepatitis C (treatment-naive) in Egypt (NCT01871662)
  • 19 Feb 2015 University of Leipzig completes a phase II trial in Hepatitis C (Adjunctive treatment, Treatment-experienced) in Germany (EudraCT2012-004442-15) before February 2015
  • 20 Jan 2015 Rottapharm Madaus discontinues a phase II pharmacokinetics trial of silibinin, alone or in combination with ribavirin, in patients with chronic hepatitis C undergoing liver transplantation (EudraCT2012-000281-38), sometime before January 2015
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