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Inactive Psilocybin therapy
Inactive Psilocybin therapy is a Small molecule drug developed by Centre Hospitalier Universitaire de Nīmes. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Inactive Psilocybin therapy |
|---|---|
| Sponsor | Centre Hospitalier Universitaire de Nīmes |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Neurobehavioral Mechanisms of Psilocybin-assisted Treatment for AUD (PHASE2)
- Psilocybin for Major Depressive Disorder (MDD) (PHASE3)
- Psilocybin in Alcohol Use Disorder With Comorbid Depression (NA)
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:
- Inactive Psilocybin therapy CI brief — competitive landscape report
- Inactive Psilocybin therapy updates RSS · CI watch RSS
- Centre Hospitalier Universitaire de Nīmes portfolio CI
Frequently asked questions about Inactive Psilocybin therapy
What is Inactive Psilocybin therapy?
Who makes Inactive Psilocybin therapy?
What development phase is Inactive Psilocybin therapy in?
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing