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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle Weakness

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Efgartigimod alfa (Primary) ; Acetylcholinesterase inhibitors; Steroids
  • Indications Myasthenia gravis
  • Focus Registrational; Therapeutic Use
  • Acronyms ADAPT
  • Sponsors argenx

Most Recent Events

  • 20 Jan 2025 According to Handok Inc media release, the Ministry of Food and Drug Safety (MFDS) said it approved Handok's rare disease treatment Vyvgart (ingredient: efgartigimod alfa) on Monda.
  • 20 Jan 2025 Results presented in a Handok Inc media release.
  • 16 Jul 2024 According to a ZAI Lab media release, National Medical Products Administration (NMPA) approved the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous injection) (efgartigimod SC), 1,000mg (5.6ml)/vial indicated as an add on to standard therapy for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive based on ADAPT-SC study.

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