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A phase 2b multi-site smoking cessation study of MYCO-001

Trial Profile

A phase 2b multi-site smoking cessation study of MYCO-001

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Jun 2022

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At a glance

  • Drugs Psilocybin (Primary)
  • Indications Smoking withdrawal
  • Focus Therapeutic Use
  • Most Recent Events

    • 17 Jun 2022 According to a Mydecine Innovations Group media release, the U.S. Food and Drug Administration (FDA) has cleared MYCO-001 in a recent Investigational New Drug (IND) application, this Investigator Initiated trial is funded by a near $4 million grant from the National Institutes of Health.
    • 24 Mar 2022 Status changed from planning to not yet recruiting, according to a Mydecine Innovations Group media release.
    • 24 Mar 2022 According to a Mydecine Innovations Group media release, the Company will move rapidly into the patient recruitment phase upon FDA clearance. Mydecines Phase 2b study is investigating a primary endpoint of six months, indicating it could publish data as early as Q4 2023.
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