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Novel OPV2 candidate 2
Novel OPV2 candidate 2 is a Biologic drug developed by Pierre Van Damme. It is currently in Phase 2 development.
A Phase II clinical trial (NCT04693286) is evaluating the safety and immunogenicity of a novel oral polio type 2 vaccine (nOPV2) in healthy newborns in Bangladesh. The vaccine is a protein-based candidate, also known as Phekellistatin 2, being studied for its potential to prevent poliomyelitis.
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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).
| 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 | Novel OPV2 candidate 2 |
|---|---|
| Sponsor | Pierre Van Damme |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Clinical Trial of Novel OPV2 Vaccine (PHASE2)
- A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates (PHASE2)
- Phase 1 Novel Live Attenuated Serotype 2 Oral Polio Vaccine Study in Inactivated Polio Vaccine (IPV) Primed Adults (PHASE1)
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:
- Novel OPV2 candidate 2 CI brief — competitive landscape report
- Novel OPV2 candidate 2 updates RSS · CI watch RSS
- Pierre Van Damme portfolio CI
Frequently asked questions about Novel OPV2 candidate 2
What is Novel OPV2 candidate 2?
Who makes Novel OPV2 candidate 2?
What development phase is Novel OPV2 candidate 2 in?
Related
- Manufacturer: Pierre Van Damme — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing