Silibinin - Rottapharm Madaus

Drug Profile

Silibinin - Rottapharm Madaus

Alternative Names: Legalon; Legalon SIL

Latest Information Update: 24 Oct 2018

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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
  • Discontinued Hepatitis C

Most Recent Events

  • 24 Oct 2018 Discontinued - Phase-II for Hepatitis C (Adjunctive treatment, Treatment-experienced) in Germany (IV)
  • 24 Jun 2018 Biomarkers information updated
  • 04 Mar 2015 Rottapharm Madaus withdraws the phase II/III HEPASIL trial prior to enrolment for Hepatitis C (treatment-naive) in Egypt (NCT01871662)
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