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Ayahuasca
Ayahuasca is a Small molecule drug developed by University of Sao Paulo. It is currently in Phase 2 development. Also known as: aya, treatment.
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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 | Ayahuasca |
|---|---|
| Also known as | aya, treatment |
| Sponsor | University of Sao Paulo |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Ayahuasca, Esketamine and Premenstrual Symptoms (NA)
- Ayahuasca, Esketamine and PTSD (PHASE2)
- Ayahuasca, Esketamine and Body Image Perception (NA)
- Ayahuasca and Esketamine for Major Depression (PHASE2)
- Antidepressant Effects of Ayahuasca: a Randomized Placebo Controlled Trial in Treatment Resistant Depression (PHASE1, PHASE2)
- Molecular Imaging Study of Harmine/DMT: a Basic Research Approach (PHASE1)
- Computer Game, Qualitative, and MEG/EEG Assessment of Serotonergic Psychedelics
- Ayahuasca Assisted Psychotherapy for Grief (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Ayahuasca CI brief — competitive landscape report
- Ayahuasca updates RSS · CI watch RSS
- University of Sao Paulo portfolio CI
Frequently asked questions about Ayahuasca
What is Ayahuasca?
Who makes Ayahuasca?
Is Ayahuasca also known as anything else?
What development phase is Ayahuasca in?
Related
- Manufacturer: University of Sao Paulo — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: aya, treatment
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing