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An open-label, multicentre study to evaluate the safety and efficacy of Orfadin® (nitisinone) for the Treatment of Hereditary Tyrosinemia Type 1 (HT-1)

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Trial Profile

An open-label, multicentre study to evaluate the safety and efficacy of Orfadin® (nitisinone) for the Treatment of Hereditary Tyrosinemia Type 1 (HT-1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Jun 2023

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At a glance

  • Drugs Nitisinone (Primary)
  • Indications Tyrosinaemia type I
  • Focus Registrational; Therapeutic Use
  • Sponsors Swedish Orphan Biovitrum

    • Most Recent Events

    • 31 May 2023 According to an Analog Pharma media release, company announce that their 20 mg nitisinone abbreviated new drug application (ANDA) has received final approval from the U.S. Food and Drug Administration. Nitisinone Capsules are a room temperature stable, AB-rated, generic equivalent of Swedish Orphan Biovitrum's Orfadin, and are now available in 2, 5, 10 and 20 mg capsules.
    • 11 Sep 2017 New trial record

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