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Psilocybine
Psilocybine is a Small molecule drug developed by University of Zurich. It is currently in Phase 2 development. Also known as: Psilocybin, CY-39, Indocybin.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Psilocybine |
|---|---|
| Also known as | Psilocybin, CY-39, Indocybin |
| Sponsor | University of Zurich |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression (PHASE1, PHASE2)
- "A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder" (PHASE3)
- Feasibility, Clinical Effects, and Safety of Psilocybin-assisted Psychotherapy for Treatment-resistant OCD (PHASE1)
- Psilocybin-Assisted Psychotherapy for the Treatment of Severe Alcohol Use Disorder (PHASE2)
- Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids (PHASE2)
- Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder (PHASE2)
- Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies (PHASE2)
- Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects (PHASE1)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Psilocybine CI brief — competitive landscape report
- Psilocybine updates RSS · CI watch RSS
- University of Zurich portfolio CI
Frequently asked questions about Psilocybine
What is Psilocybine?
Who makes Psilocybine?
Is Psilocybine also known as anything else?
What development phase is Psilocybine in?
Related
- Manufacturer: University of Zurich — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Psilocybin, CY-39, Indocybin
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing