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Phase III trial of mesdopetam

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Phase III trial of mesdopetam

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 08 Apr 2024

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At a glance

  • Drugs Mesdopetam (Primary)
  • Indications Parkinson's disease; Psychotic disorders
  • Focus Therapeutic Use

    • Most Recent Events

    • 22 Mar 2024 According to IRLAB Therapeutics AB media release, Based on the positive feedback from the FDA, company will now engage with European regulatory agencies in accordance with standard practice before initiation of the Phase III program.
    • 22 Mar 2024 According to IRLAB Therapeutics AB media release, company today announced receipt of written minutes from a recent End-of-Phase 2 meeting for mesdopetam with the US Food and Drug Administration, FDA. The minutes confirm previously communicated positive verbal feedback from meeting. At the End-of-Phase 2 meeting with the FDA, aspects related to all parts of development plan for mesdopetam, including the design of a Phase III program, were evaluated and commented upon.
    • 03 Jan 2024 According to IRLAB Therapeutics AB media release, company is working together with US advisory groups Clintrex, a clinical and regulatory strategy advisor and ProPharma Group (PPG), regulatory agent in the US, to develop the strategy for the mesdopetam Phase III program.

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