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Psilocybin - COMPASS Pathways

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Drug Profile

Psilocybin - COMPASS Pathways

Alternative Names: COMP-360; Psilocybine

Latest Information Update: 04 May 2026

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At a glance

  • Originator COMPASS Pathways
  • Developer COMPASS Pathways; Imperial College of Science, Technology and Medicine; Johns Hopkins University
  • Class Analgesics; Anti-infectives; Anti-inflammatories; Antidepressants; Antineoplastics; Antipsychotics; Anxiolytics; Behavioural disorder therapies; Dimethylamines; Drug withdrawal therapies; Ethylamines; Indoles; Mood stabilisers; Neuropsychotherapeutics; Organophosphorus compounds; Phosphates; Phytotherapies; Small molecules
  • Mechanism of Action ATP-binding cassette transporter modulators; Serotonin 5-HT2 receptor agonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Treatment-resistant depressive disorder
  • Phase II Anorexia nervosa; Bipolar depression; Major depressive disorder; Post-traumatic stress disorders; Somatoform disorders
  • Clinical Phase Unknown Autism spectrum disorder

Most Recent Events

  • 24 Apr 2026 US FDA grants Commissioner’s National Priority Voucher (CNPV) to psilocybin for treatment-resistant depression
  • 17 Feb 2026 COMPASS Pathways submits request for a meeting with US FDA to discuss rolling NDA of Psilocybin for Treatment-resistant depressive disorder
  • 17 Feb 2026 COMPASS Pathways announces intention to submit rolling NDA to US FDA for Treatment-resistant depressive disorder in fourth quarter of 2026

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