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OVX836 shot
OVX836 shot is a Biologic drug developed by Osivax. It is currently in Phase 2 development.
OVX836 is a vaccine candidate being studied for its safety and immune response in preventing Influenza and Vaccine-Preventable Diseases. It is administered through intramuscular or intranasal routes in a Phase I clinical trial.
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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 | OVX836 shot |
|---|---|
| Sponsor | Osivax |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Safety and Immunogenicity of Two Dose Levels of OVX836 Influenza Vaccine as a Booster on Participants Previously Administered With OVX836 (PHASE2)
- Immunogenicity and Safety of the Concomitant Administration of OVX836 and Quadrivalent Influenza Vaccine in Healthy Volunteers. (PHASE2)
- Immunogenicity and Safety of the Concomitant Administration of OVX836 Influenza Vaccine, Quadrivalent Inactivated Influenza Vaccines and Placebo in Healthy Subjects. (PHASE2)
- Safety and Immune Response of Increasing Doses of OVX836 After Intramuscular or Intranasal Administrations in Healthy Subjects (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:
- OVX836 shot CI brief — competitive landscape report
- OVX836 shot updates RSS · CI watch RSS
- Osivax portfolio CI
Frequently asked questions about OVX836 shot
What is OVX836 shot?
Who makes OVX836 shot?
What development phase is OVX836 shot in?
Related
- Manufacturer: Osivax — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing