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Imvanex
Imvanex is a Biologic drug developed by Janssen Research & Development, LLC. It is currently in Phase 1 development. Also known as: Imvamune.
Imvanex is a vaccine component that induces an immune response, used to prevent smallpox infection caused by the variola virus. It is a live, modified vaccinia virus, derived from the cowpox virus, which was first used by Edward Jenner in 1796 to confer immunity against smallpox.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Imvanex |
|---|---|
| Also known as | Imvamune |
| Sponsor | Janssen Research & Development, LLC |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
- Hyperbilirubinaemia
- Furuncle
- Herpes zoster
- Upper respiratory tract infection
- Oropharyngeal pain
- Sinus congestion
- Inguinal hernia
- Vomiting
- Influenza like illness
- Non-cardiac chest pain
- Influenza
- Rhinitis
Key clinical trials
- JYNNEOS Smallpox Vaccine in Adult Healthcare Personnel at Risk for Mpox in the Democratic Republic of the Congo (PHASE3)
- A Study Exploring the Use of Vaccine and Antigen Challenges for Immune Monitoring in Healthy Participants (EARLY_PHASE1)
- Follow-up of People at Risk of Monkeypox Infection: a Prospective Cohort Study (NA)
- Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection (PHASE2)
- Cohort Study of Healthcare Workers Receiving Imvanex®
- A Non-inferiority Trial to Compare MVA-BN® Smallpox Vaccine to ACAM2000® (PHASE3)
- Safety and Immunogenicity of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in HIV Infected Patients (PHASE2)
- A Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE® (MVA-BN®) Smallpox Vaccine in Healthy, Vaccinia-naïve Subjects (PHASE3)
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:
- Imvanex CI brief — competitive landscape report
- Imvanex updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Imvanex
What is Imvanex?
Who makes Imvanex?
Is Imvanex also known as anything else?
What development phase is Imvanex in?
What are the side effects of Imvanex?
Related
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Imvamune
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing