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GSK1247446A
GSK1247446A is a Biologic drug developed by GlaxoSmithKline. It is currently in Phase 2 development. Also known as: Low dose adjuvanted influenza vaccine.
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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). -
Big-pharma sponsor
+3.0pp
GlaxoSmithKline is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | GSK1247446A |
|---|---|
| Also known as | Low dose adjuvanted influenza vaccine |
| Sponsor | GlaxoSmithKline |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Revaccination With Influenza Vaccine GSK1247446A (PHASE2)
- Study to Evaluate an Influenza Vaccine Candidate (PHASE2)
- Study to Evaluate the Immunogenicity and the Safety of an Adjuvanted Influenza Vaccine Candidate (PHASE2)
- Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate (PHASE2)
- Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate (PHASE2)
- Study to Evaluate an Influenza Vaccine Candidate (PHASE2)
- Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate (PHASE2)
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:
- GSK1247446A CI brief — competitive landscape report
- GSK1247446A updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about GSK1247446A
What is GSK1247446A?
Who makes GSK1247446A?
Is GSK1247446A also known as anything else?
What development phase is GSK1247446A in?
Related
- Manufacturer: GlaxoSmithKline — full pipeline
- Also known as: Low dose adjuvanted influenza vaccine
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing