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Fluarix Prefilled Syringe
Fluarix Prefilled Syringe is a Biologic drug developed by Il-Yang Pharm. Co., Ltd.. It is currently in Phase 1 development.
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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 | Fluarix Prefilled Syringe |
|---|---|
| Sponsor | Il-Yang Pharm. Co., Ltd. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Opioid, HIV and Immune System (PHASE4)
- Phase 3 Study to Evaluate the Immunogenicity and Safety of Inactived Split Influenza Vaccine in Healthy Korea Infants (PHASE3)
- Effect of infLuenza vaccInation After Myocardial INfArction on Cardiac inflammaTory responsE (PHASE4)
- A Study on the Safety and Immunogenicity of Influenza, Respiratory Syncytial Virus, Human Metapneumovirus and Parainfluenza Vaccines in Adults 18 to 49 Years of Age. (PHASE1)
- Effect of Influenza Vaccination on Global Systemic Inflammatory Markers in Patients With Stable Coronary Artery Disease (PHASE4)
- A Study to Investigate the Safety and Immunogenicity of the Quadrivalent Influenza mRNA Vaccines in Adults Aged 18 Years and Above (PHASE1, PHASE2)
- Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older (PHASE1, PHASE2)
- Study to Evaluate the Immunogenicity and Safety of 'IL-YANG Quadrivalent Influenza Vaccine Inj.' (PHASE3)
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:
- Fluarix Prefilled Syringe CI brief — competitive landscape report
- Fluarix Prefilled Syringe updates RSS · CI watch RSS
- Il-Yang Pharm. Co., Ltd. portfolio CI
Frequently asked questions about Fluarix Prefilled Syringe
What is Fluarix Prefilled Syringe?
Who makes Fluarix Prefilled Syringe?
What development phase is Fluarix Prefilled Syringe in?
Related
- Manufacturer: Il-Yang Pharm. Co., Ltd. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing