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VXA-G2.4-NS
VXA-G2.4-NS is a Biologic drug developed by Vaxart. It is currently in Phase 1 development. Also known as: GII.4 oral vaccine tablet, GII.4.
VXA-G2.4-NS is a small molecule intervention being studied in a clinical trial for Norovirus Infections and Norovirus Infection. It is part of a Phase I study evaluating an oral bivalent GI.1/GII.4 Norovirus vaccine in healthy lactating females and their nursing infants.
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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 | VXA-G2.4-NS |
|---|---|
| Also known as | GII.4 oral vaccine tablet, GII.4 |
| Sponsor | Vaxart |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate Vaxart's Oral Bivalent GI.1/GII.4 Norovirus Vaccine in Healthy Lactating Females and Their Nursing Infants (PHASE1)
- A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old (PHASE1)
- Safety & Immunogenicity Study of Ad5 Based Oral Norovirus Vaccines (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:
- VXA-G2.4-NS CI brief — competitive landscape report
- VXA-G2.4-NS updates RSS · CI watch RSS
- Vaxart portfolio CI
Frequently asked questions about VXA-G2.4-NS
What is VXA-G2.4-NS?
Who makes VXA-G2.4-NS?
Is VXA-G2.4-NS also known as anything else?
What development phase is VXA-G2.4-NS in?
Related
- Manufacturer: Vaxart — full pipeline
- Also known as: GII.4 oral vaccine tablet, GII.4
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing