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Norovirus
Norovirus is a Biologic drug developed by Children's Hospital Medical Center, Cincinnati. It is currently in Phase 1 development. Also known as: Norovirus challenge pool.
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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).
| 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 | Norovirus |
|---|---|
| Also known as | Norovirus challenge pool |
| Sponsor | Children's Hospital Medical Center, Cincinnati |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Phase 2 Study Adding Ascorbate to Chemotherapy and Radiation Therapy for NSCLC (PHASE2)
- Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age (PHASE1, PHASE2)
- A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer (PHASE3)
- Viral Infections in Healthy and Immunocompromised Hosts
- Nursing Intervention Guided by an ICD Nursing Guideline (NA)
- A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis (PHASE3)
- SNAP AF-52: Dose Appropriateness and Adherence to Oral Anticoagulation in Adults ≥65 With Atrial Fibrillation in Primary Care (Ordu, Türkiye)
- A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CDI-988 in Healthy Adults After Challenge With Snow Mountain Virus (PHASE1, PHASE2)
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:
- Norovirus CI brief — competitive landscape report
- Norovirus updates RSS · CI watch RSS
- Children's Hospital Medical Center, Cincinnati portfolio CI
Frequently asked questions about Norovirus
What is Norovirus?
Who makes Norovirus?
Is Norovirus also known as anything else?
What development phase is Norovirus in?
Related
- Manufacturer: Children's Hospital Medical Center, Cincinnati — full pipeline
- Therapeutic area: All drugs in Other
- Also known as: Norovirus challenge pool
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing