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A Phase 2/3, Multicenter, Multinational, Open Label Study to Evaluate the Efficacy and Safety of ORGN001 (Formerly ALXN1101) in Neonates, Infants and Children With Molybdenum Cofactor Deficiency (MOCD) Type A

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Trial Profile

A Phase 2/3, Multicenter, Multinational, Open Label Study to Evaluate the Efficacy and Safety of ORGN001 (Formerly ALXN1101) in Neonates, Infants and Children With Molybdenum Cofactor Deficiency (MOCD) Type A

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 18 Apr 2024

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At a glance

  • Drugs Fosdenopterin (Primary)
  • Indications Molybdenum cofactor deficiency
  • Focus Registrational; Therapeutic Use
  • Sponsors Alexion AstraZeneca Rare Disease; Origin Biosciences

    • Most Recent Events

    • 16 Apr 2024 According a Sentynl Therapeutics media release, based on data from three studies, company today announced Medicines and Healthcare products Regulatory Agency (MHRA) authorization of NULIBRY (fosdenopterin) for Injection as the first therapy for the treatment of patients in Great Britain (GB) with molybdenum cofactor deficiency (MoCD) Type A.
    • 19 Dec 2022 This trial has been Prematurely ended in Germany, according to European Clinical Trials Database
    • 13 Oct 2022 Status changed from recruiting to completed.

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