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A global Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AJ201 in ambulatory individuals with symptomatic Spinal and Bulbar Muscular Atrophy (SBMA)

Trial Profile

A global Phase 3 randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of AJ201 in ambulatory individuals with symptomatic Spinal and Bulbar Muscular Atrophy (SBMA)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 13 Mar 2026

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At a glance

  • Drugs Rosolutamide (Primary)
  • Indications X-linked bulbo-spinal atrophy
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 13 Mar 2026 New trial record
  • 04 Mar 2026 According to AnnJi Pharmaceutical media release, enrollment in this trial is anticipated to commence in late 2026.
  • 04 Mar 2026 According to AnnJi Pharmaceutical media release, the preliminary design of this phase 3 trial was shared by Dr. Christopher Grunseich, MD, the Principal Investigator, in a scientific abstract during the 2026 International Patient and Scientific Conference hosted by the Kennedy's Disease Association (KDA) held February 27 - March 2.

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