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Sii Licensed IPV
Sii Licensed IPV is a Biologic drug developed by Serum Institute of India Pvt. Ltd.. It is currently in Phase 3 development for Prevention of poliomyelitis.
IPV vaccine works by stimulating the body's immune system to produce antibodies against the poliovirus.
The SII Licensed IPV is an inactivated poliovirus vaccine used to study poliomyelitis, as per a Phase III clinical trial (NCT05163561) conducted by the Serum Institute of India Pvt. Ltd. The vaccine is classified as a small molecule modality, according to ChEMBL.
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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). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| 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 | Sii Licensed IPV |
|---|---|
| Sponsor | Serum Institute of India Pvt. Ltd. |
| Modality | Biologic |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
The vaccine contains a weakened form of the poliovirus, which triggers an immune response and helps the body develop immunity against future infections. This immune response is specific to the poliovirus and does not provide protection against other types of viruses.
Approved indications
- Prevention of poliomyelitis
Common side effects
- Pain, redness, or swelling at the injection site
Key clinical trials
- Evaluation of Safety and Immunogenicity of Inactivated Adjuvanted Polio Vaccine in Comparison With Licensed Inactivated Poliovirus Vaccine (PHASE3)
- Safety and Immunogenicity of 1 or 2 Doses of IPV in Latin American Infants Primed With Bivalent OPV Vaccine (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:
- Sii Licensed IPV CI brief — competitive landscape report
- Sii Licensed IPV updates RSS · CI watch RSS
- Serum Institute of India Pvt. Ltd. portfolio CI
Frequently asked questions about Sii Licensed IPV
What is Sii Licensed IPV?
How does Sii Licensed IPV work?
What is Sii Licensed IPV used for?
Who makes Sii Licensed IPV?
What development phase is Sii Licensed IPV in?
What are the side effects of Sii Licensed IPV?
Related
- Manufacturer: Serum Institute of India Pvt. Ltd. — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Prevention of poliomyelitis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing