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Vaccination with FluvalAB
Vaccination with FluvalAB is a Biologic drug developed by Fluart Innovative Vaccine Ltd, Hungary. It is currently in Phase 1 development. Also known as: FluvalAB.
Vaccination with FluvalAB is a small molecule intervention that has been studied for its safety and immunogenicity in treating influenza. The study, identified as NCT01408290, investigated the efficacy of FluvalAB-like flu vaccines with varying doses of HA in adult and elderly populations.
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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 | Vaccination with FluvalAB |
|---|---|
| Also known as | FluvalAB |
| Sponsor | Fluart Innovative Vaccine Ltd, Hungary |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Safety and Immunogenicity Study of Fluval AB-Like Flu Vaccines With 3.5, 6, 9 or 15 μg HA in Adult and Elderly People (NA)
- A Study to Evaluate Safety and Immunogenicity of FluvalAB-like Influenza Vaccine in Non-Elderly Adult and Elderly Subjects (NA)
- Immunogenicity and Tolerability Study of FluvalAB FL-K-004 Trivalent Influenza Vaccine (NA)
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:
- Vaccination with FluvalAB CI brief — competitive landscape report
- Vaccination with FluvalAB updates RSS · CI watch RSS
- Fluart Innovative Vaccine Ltd, Hungary portfolio CI
Frequently asked questions about Vaccination with FluvalAB
What is Vaccination with FluvalAB?
Who makes Vaccination with FluvalAB?
Is Vaccination with FluvalAB also known as anything else?
What development phase is Vaccination with FluvalAB in?
Related
- Manufacturer: Fluart Innovative Vaccine Ltd, Hungary — full pipeline
- Also known as: FluvalAB
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing