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serodiagnosis
serodiagnosis is a Biologic drug developed by Centre Hospitalier Universitaire, Amiens. It is currently in Phase 1 development.
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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 | serodiagnosis |
|---|---|
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Prevalence of Circulating Parvovirus Genome in Recently Diagnosed Graves' Disease: a Case-control Study (NA)
- Diagnostic Innovations for Pediatric Tuberculosis in Bolivia
- Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department (NA)
- Monitoring the IgG/IgM Antibodies in COVID-19 Patients
- COVID-19 Detection Test in Oncology
- Implementation and Evaluation of an Electronic Alert to Encourage Targeted Screening for HIV Infection at Foch Hospital According to Socio-demographic Criteria (NA)
- Herpes Simplex Virus Type 2 (HSV-2) Suppression to Prevent HIV Transmission (PHASE3)
- Impact of the Chikungunya Outbreak in Reunion Island on the Quality of Life After 10 Years
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:
- serodiagnosis CI brief — competitive landscape report
- serodiagnosis updates RSS · CI watch RSS
- Centre Hospitalier Universitaire, Amiens portfolio CI
Frequently asked questions about serodiagnosis
What is serodiagnosis?
Who makes serodiagnosis?
What development phase is serodiagnosis in?
Related
- Manufacturer: Centre Hospitalier Universitaire, Amiens — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing