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ZIKA high dose
ZIKA high dose is a Biologic drug developed by University of Oxford. It is currently in Phase 1 development.
A high dose of the Zika vaccine mRNA-1893, which is a small molecule modality, has been studied in clinical trials for its effectiveness against Zika Virus, Zika Virus Infection, and Flavivirus Infections. The vaccine is administered in two doses, as part of a Phase 2 randomized study, to adult participants living in endemic and non-endemic areas.
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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 | ZIKA high dose |
|---|---|
| Sponsor | University of Oxford |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
- Injection site pain
- COVID-19
- Upper respiratory tract infection
- Headache
- Fatigue
- Bronchitis
- Nausea
- Influenza like illness
- Nasopharyngitis
- Cough
- Lymphadenopathy
- Thrombocytopenia
Key clinical trials
- Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults (PHASE1)
- A Study of Zika Vaccine mRNA-1893 in Adult Participants Living in Endemic and Non-Endemic Flavivirus Areas (PHASE2)
- Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001) (PHASE1)
- Research Study to Assess New Chikungunya and Zika Vaccines in Healthy Adults in Mexico. (PHASE1)
- Safety, Immunogenicity, and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Participants (PHASE1)
- Safety and Immunogenicity of a Novel Vaccine Formulation MV-ZIKA-RSP (V187-001) (PHASE1)
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:
- ZIKA high dose CI brief — competitive landscape report
- ZIKA high dose updates RSS · CI watch RSS
- University of Oxford portfolio CI
Frequently asked questions about ZIKA high dose
What is ZIKA high dose?
Who makes ZIKA high dose?
What development phase is ZIKA high dose in?
What are the side effects of ZIKA high dose?
Related
- Manufacturer: University of Oxford — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing