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A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, First-In-Patient Study Of AJ201 To Evaluate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics In Adults With Spinal And Bulbar Muscular Atrophy (SBMA)

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Trial Profile

A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, First-In-Patient Study Of AJ201 To Evaluate Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics In Adults With Spinal And Bulbar Muscular Atrophy (SBMA)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 13 Nov 2025

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At a glance

  • Drugs ALZ-002 (Primary)
  • Indications X-linked bulbo-spinal atrophy
  • Focus Adverse reactions; First in man
  • Sponsors AnnJi Pharmaceutical

Most Recent Events

  • 13 Oct 2025 According to AnnJi Pharmaceutical media release, the company announced that the Phase 2a clinical result of AJ201 for spinal and bulbar muscular atrophy was selected as one of the seven Late-Breaking Abstracts at the World Muscle Society (WMS) 2025 International Congress in Vienna. Dr. Tahseen Mozaffar, an investigator of the study, presented the study outcome, emphasizing the therapeutic potential of AJ201 for SBMA patients.
  • 21 May 2025 Results presented in the AnnJi Pharmaceutical Media Release.
  • 14 Nov 2024 According to Avenue therapeutics media release, company anticipated topline data from this trial around year-end 2024.

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