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Trivalent OPV Birmex
Trivalent OPV Birmex is a vaccine Biologic drug developed by Laboratorios de Biologicos y Reactivos de México, S.A. de C.V.. It is currently in Phase 3 development for Prevention of poliomyelitis. Also known as: tOPV.
Trivalent OPV Birmex is a vaccine that stimulates the body's immune response to protect against poliovirus.
Trivalent OPV Birmex is a vaccine used to study the prevention of Poliomyelitis in newborns. It is a small molecule supplement, specifically a ferric hydroxide sucrose complex, used in a vaccine formulation.
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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 | Trivalent OPV Birmex |
|---|---|
| Also known as | tOPV |
| Sponsor | Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. |
| Drug class | vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 3 |
Mechanism of action
It works by introducing inactivated poliovirus particles to the body, which triggers an immune response and helps the body develop antibodies to fight the virus. This provides long-term immunity against poliovirus infection.
Approved indications
- Prevention of poliomyelitis
Common side effects
- Pain, redness, or swelling at the injection site
- Fever
- Fatigue
Key clinical trials
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:
- Trivalent OPV Birmex CI brief — competitive landscape report
- Trivalent OPV Birmex updates RSS · CI watch RSS
- Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. portfolio CI
Frequently asked questions about Trivalent OPV Birmex
What is Trivalent OPV Birmex?
How does Trivalent OPV Birmex work?
What is Trivalent OPV Birmex used for?
Who makes Trivalent OPV Birmex?
Is Trivalent OPV Birmex also known as anything else?
What drug class is Trivalent OPV Birmex in?
What development phase is Trivalent OPV Birmex in?
What are the side effects of Trivalent OPV Birmex?
Related
- Drug class: All vaccine drugs
- Manufacturer: Laboratorios de Biologicos y Reactivos de México, S.A. de C.V. — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for Prevention of poliomyelitis
- Also known as: tOPV
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing