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Agrippal S1
Agrippal S1 is a Inactivated influenza vaccine Biologic drug developed by SK Chemicals Co., Ltd.. It is currently in Phase 3 development for Seasonal influenza prevention in adults and children.
Agrippal S1 is an inactivated influenza vaccine that stimulates the immune system to produce antibodies against seasonal influenza virus strains.
Agrippal S1 is a small molecule used in a trivalent subunit inactivated flu vaccine. It has been studied for its safety and immunogenicity in treating Seasonal Influenza, Influenza, and Rheumatoid Arthritis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Agrippal S1 |
|---|---|
| Sponsor | SK Chemicals Co., Ltd. |
| Drug class | Inactivated influenza vaccine |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains inactivated (killed) influenza virus antigens from three seasonal strains, which trigger both humoral and cellular immune responses. This leads to the production of protective antibodies and memory immune cells that recognize and neutralize circulating influenza viruses, reducing infection risk and disease severity.
Approved indications
- Seasonal influenza prevention in adults and children
Common side effects
- Injection site reactions (pain, redness, swelling)
- Myalgia
- Headache
- Fever
- Fatigue
Key clinical trials
- Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Healthy Children and Adolescents (PHASE3)
- Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents (PHASE3)
- Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects (PHASE3)
- Safety and Immunogenicity of One Dose of Inactivated Trivalent Flu Vaccine Administered to Non-elderly Adult and Elderly Subjects (PHASE2)
- Cell Immunity Response to Vaccination Against Influenza in Patients With Rheumatoid Arthritis (PHASE4)
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:
- Agrippal S1 CI brief — competitive landscape report
- Agrippal S1 updates RSS · CI watch RSS
- SK Chemicals Co., Ltd. portfolio CI
Frequently asked questions about Agrippal S1
What is Agrippal S1?
How does Agrippal S1 work?
What is Agrippal S1 used for?
Who makes Agrippal S1?
What drug class is Agrippal S1 in?
What development phase is Agrippal S1 in?
What are the side effects of Agrippal S1?
Related
- Drug class: All Inactivated influenza vaccine drugs
- Manufacturer: SK Chemicals Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for Seasonal influenza prevention in adults and children
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing