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Phase III trial of mesdopetam

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Trial Profile

Phase III trial of mesdopetam

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 26 Feb 2025

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At a glance

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

Most Recent Events

  • 20 Feb 2025 According to IRLAB Therapeutics AB media release, company announces that the European Medicines Agency (EMA) has provided positive feedback on the company proposed design for the Phase III program of mesdopetam. Based on EMA guidance, company can now proceed with preparations for the registration studies of the drug candidate.
  • 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.

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