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CYB003
CYB003 is a psilocybin-assisted therapy designed to enhance psychological treatment outcomes in psychiatric conditions by facilitating neuroplasticity and emotional processing.
CYB003 is a psilocybin-assisted therapy designed to enhance psychological treatment outcomes in psychiatric conditions by facilitating neuroplasticity and emotional processing. Used for Treatment-resistant depression (Phase 3).
At a glance
| Generic name | CYB003 |
|---|---|
| Sponsor | Cybin IRL Limited |
| Drug class | Psychedelic-assisted therapy |
| Target | 5-HT2A receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Mental Health |
| Phase | Phase 3 |
Mechanism of action
CYB003 combines a proprietary formulation of psilocybin with structured psychological support to promote therapeutic breakthroughs in treatment-resistant conditions. The psilocybin acts as a serotonin 5-HT2A receptor agonist, increasing neural connectivity and reducing rigid thought patterns, while the psychological intervention leverages this neuroplastic window to address underlying psychiatric pathology.
Approved indications
- Treatment-resistant depression (Phase 3)
Common side effects
- Headache
- Nausea
- Anxiety during acute dosing
- Transient perceptual changes
Key clinical trials
- "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder" (PHASE3)
- A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder (PHASE3)
- Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND) (PHASE3)
- A Mechanistic Study to Assess a Single Dose of CYB003 in Participants With Depression and Anxiety (PHASE2)
- A Study of a Psilocybin Analog (CYB003) in Healthy Participants With and Without Major Depressive Disorder (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |