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Rotavin
Rotavin is a Small molecule drug developed by National Institute of Hygiene and Epidemiology, Vietnam. It is currently in Phase 1 development. Also known as: Rotavin-M1.
Rotavin is a liquid formulation of a vaccine used to study and treat conditions such as diarrhea, diarrhea caused by rotavirus, fever, nausea, and vomiting. It is also known as ROTAVIN-M1, and a related product called Rotarix exists, but the exact relationship between these products is not specified in the provided facts.
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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 | Rotavin |
|---|---|
| Also known as | Rotavin-M1 |
| Sponsor | National Institute of Hygiene and Epidemiology, Vietnam |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Phase III Study of Liquid Formulation of ROTAVIN (PHASE3)
- A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants (PHASE2)
- Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults (PHASE1)
- Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children (PHASE2, 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:
- Rotavin CI brief — competitive landscape report
- Rotavin updates RSS · CI watch RSS
- National Institute of Hygiene and Epidemiology, Vietnam portfolio CI
Frequently asked questions about Rotavin
What is Rotavin?
Who makes Rotavin?
Is Rotavin also known as anything else?
What development phase is Rotavin in?
Related
- Manufacturer: National Institute of Hygiene and Epidemiology, Vietnam — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Rotavin-M1
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing