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An open-label phase 2 study evaluating the safety, tolerability, and effectiveness of AJA001 among adolescents and adults with Autism Spectrum Disorder

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Trial Profile

An open-label phase 2 study evaluating the safety, tolerability, and effectiveness of AJA001 among adolescents and adults with Autism Spectrum Disorder

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 03 Mar 2025

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At a glance

  • Drugs AJA 001 (Primary)
  • Indications Mental disorders; Neurological disorders; Pervasive child development disorders
  • Focus Therapeutic Use
  • Sponsors AJNA Australia

Most Recent Events

  • 25 Feb 2025 According to a Charlotte Web Holdings media release, Data from Phase 2 studies will be used to inform the design of larger Phase 3 clinical trials, the results from which will be submitted to FDA for drug approval
  • 24 Feb 2025 According to a DeFloria media release, the company has received IND clearance from FDA for Phase 2 Clinical Trial of AJA001 and DeFloria plans to advance through the botanical drug pathway following the guidance established by the FDA and initiate a Phase 2 clinical trial by mid-year 2025.
  • 12 Dec 2024 According to a DeFloria media release, look forward to initiating two Phase 2 trials of AJA001 in ASD in the second quarter of 2025.

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