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Psychedelic
Psychedelic is a Small molecule drug developed by Canadian Forces Health Services Centre Ottawa. It is currently in Phase 2 development.
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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 | Psychedelic |
|---|---|
| Sponsor | Canadian Forces Health Services Centre Ottawa |
| 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)
- MDMA-Assisted Therapy for Mental Healthcare Providers (PHASE1)
- "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)
- Psychedelic Virtual Reality
- Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects (PHASE1)
- A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder (PHASE3)
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:
- Psychedelic CI brief — competitive landscape report
- Psychedelic updates RSS · CI watch RSS
- Canadian Forces Health Services Centre Ottawa portfolio CI
Frequently asked questions about Psychedelic
What is Psychedelic?
Who makes Psychedelic?
What development phase is Psychedelic in?
Related
- Manufacturer: Canadian Forces Health Services Centre Ottawa — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing