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Souvenaid
Souvenaid is a Small molecule drug developed by University of Miami. It is currently in Phase 2 development.
Souvenaid is a dietary supplement in the form of a thick, yogurt-like drink that contains a mixture of ingredients including docosahexaenoic acid, eicosapentaenoic acid, phospholipids, choline, uridine monophosphate, and vitamin E. Souvenaid has been studied in clinical trials for conditions such as cognitive decline, traumatic brain injury, and risk reduction, often in conjunction with a multidomain lifestyle intervention.
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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 | Souvenaid |
|---|---|
| Sponsor | University of Miami |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Dutch Multidomain Lifestyle Intervention in Older Adults at Risk of Cognitive Decline (NA)
- Nutritional Treatment for the Amelioration of Traumatic Brain Injury (NA)
- Reducing the Effects of Aging on Cognition With Therapeutic Intervention of an Oral Nutrient (REACTION): A Pilot Trial (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:
- Souvenaid CI brief — competitive landscape report
- Souvenaid updates RSS · CI watch RSS
- University of Miami portfolio CI
Frequently asked questions about Souvenaid
What is Souvenaid?
Who makes Souvenaid?
What development phase is Souvenaid in?
Related
- Manufacturer: University of Miami — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing