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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 Mar 2026

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At a glance

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

Most Recent Events

  • 04 Mar 2026 According to AnnJi Pharmaceutical media release, early signals of efficacy observed in the Phase 2 study were presented 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.
  • 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.

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