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Phase IIb trial of SPL026 in DMT-assisted therapy

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Phase IIb trial of SPL026 in DMT-assisted therapy

Status: Planning
Phase of Trial: Phase II

Latest Information Update: 12 Jan 2024

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At a glance

  • Drugs N-N-dimethyltryptamine (Primary)
  • Indications Major depressive disorder
  • Focus Therapeutic Use

    • Most Recent Events

    • 25 Jan 2023 According to the Small Pharma media release, this trial is anticipated to initiate in H1 2023
    • 09 Jun 2022 According to the Small Pharma media release, further scientific advice requested from the United States Food and Drug Administration (the FDA), the UK Medicines and Healthcare products Regulatory Agency (the MHRA) and the European Medicines Agency (the EMA) and a centralized Contract Research Organization to support the execution of the study has been selected
    • 15 Nov 2021 According to the Small Pharma media release, following positive discussions with the U.S. Food and Drug Administration the preparations are now underway for the U.S. component of this trial.

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