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CYB 003

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Drug Profile

CYB 003

Alternative Names: CYB-003; Deuterated psilocin - Cybin; Deuterated-Psilocin - Cybin

Latest Information Update: 02 Dec 2025

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At a glance

  • Originator Cybin
  • Class Antidepressants; Antipsychotics; Behavioural disorder therapies; Drug withdrawal therapies; Small molecules; Tryptamines
  • Mechanism of Action Serotonin 5-HT2A 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

Highest Development Phases

  • Phase III Major depressive disorder
  • Discontinued Alcoholism; Psychiatric disorders

Most Recent Events

  • 30 Nov 2025 Cybin initiates a phase III EMBRACE trial in Major Depressive Disorder (Adjunctive treatment) in the USA (PO) (NCT06793397)
  • 24 Nov 2025 Cybin has been granted approval to initiate phase III EMBRACE trial in the United States, Australia, Ireland, Poland, Greece, and the United Kingdom
  • 26 Aug 2025 TGA approves Clinical Trial Notification application for the phase III EMBRACE trial in Major depressive disorder (Adjunctive treatment) in Australia

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