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Serology SARS-CoV2
Serology SARS-CoV2 is a Biologic drug developed by Assistance Publique - Hôpitaux de Paris. It is currently in Phase 1 development.
Serology testing for SARS-CoV-2 involves measuring changes in antibody levels over time following Covid-19 vaccinations. This testing is studied in clinical trials for conditions such as Covid-19, post-acute Covid-19, and in residents of nursing and extended care facilities.
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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 | Serology SARS-CoV2 |
|---|---|
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- COVID-19 Immunity and Changes Over Time
- COVID-19 Infection at Samusocial in Paris: Descriptive and Serological Survey
- Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence
- Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic
- Seroprevalence of SARS-CoV-2 in Strasbourg University Hospital, Strasbourg, France (COVID-19) (NA)
- Immunity Against SARS-CoV2 in Children and Their Parents / COVID-19 (NA)
- Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection (NA)
- Patients and Health Staff of Cancer Centres During the Covid-19 Pandemic (NA)
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:
- Serology SARS-CoV2 CI brief — competitive landscape report
- Serology SARS-CoV2 updates RSS · CI watch RSS
- Assistance Publique - Hôpitaux de Paris portfolio CI
Frequently asked questions about Serology SARS-CoV2
What is Serology SARS-CoV2?
Who makes Serology SARS-CoV2?
What development phase is Serology SARS-CoV2 in?
Related
- Manufacturer: Assistance Publique - Hôpitaux de Paris — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing