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VXA-A1.1
VXA-A1.1 is a Biologic drug developed by Vaxart. It is currently in Phase 2 development. Also known as: Oral H1N1 Ad5 Tableted Vaccine.
VXA-A1.1 is an H1N1 HA ad-vector seasonal flu vaccine administered orally. It was studied in a Phase 2 randomized, controlled, human influenza A challenge study to prevent seasonal influenza.
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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 | VXA-A1.1 |
|---|---|
| Also known as | Oral H1N1 Ad5 Tableted Vaccine |
| Sponsor | Vaxart |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine (PHASE2)
- Pharmacodynamic Open-Label Trial With VXA-A1.1 Oral H1 Vaccine in Healthy Adults (PHASE1)
- Safety Study of an Oral Vaccine to Prevent Seasonal Influenza (PHASE1)
- Immunogenicity of Seasonal Influenza by Delivery Directly to Ileum (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-A1.1 CI brief — competitive landscape report
- VXA-A1.1 updates RSS · CI watch RSS
- Vaxart portfolio CI
Frequently asked questions about VXA-A1.1
What is VXA-A1.1?
Who makes VXA-A1.1?
Is VXA-A1.1 also known as anything else?
What development phase is VXA-A1.1 in?
Related
- Manufacturer: Vaxart — full pipeline
- Also known as: Oral H1N1 Ad5 Tableted Vaccine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing