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A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis

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Trial Profile

A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jul 2024

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At a glance

  • Drugs Zilucoplan (Primary)
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms RAISE
  • Sponsors Ra Pharmaceuticals

    • Most Recent Events

    • 11 Jul 2024 According to an UCB media release, based on results from this trial, the ZILBRYSQTM (zilucoplan injection) received authorization from Health Canada for the treatment of generalized Myasthenia Gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
    • 04 Dec 2023 According to an UCB media release, based on this trial the European Commission (EC) has granted a marketing authorization for ZILBRYSQ (zilucoplan) as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive.
    • 10 Nov 2023 According to an UCB media release, Zilucoplan is currently under review by the Australian Therapeutic Goods Administration (TGA) and Health Canada for the treatment of adults with gMG. Responses from regulatory agencies to these submissions are expected during H2 2023 and H1 2024.

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