Last reviewed · How we verify
Low or upper respiratory tract sample
Low or upper respiratory tract sample is a Biologic drug developed by Hospices Civils de Lyon. It is currently in Phase 1 development.
-
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 | Low or upper respiratory tract sample |
|---|---|
| Sponsor | Hospices Civils de Lyon |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- CTNNB1 Neurodevelopmental Syndrome - Natural History Study
- Parental Stress and Attachment in Preterm Infants
- LA Function and Dimensions As Predictors of Disease Activity in RA
- Host-pathogen Interactions During SARS-CoV-2 Infection (NA)
- Volatiles in Breath and Headspace Analysis - Diagnostic Markers
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:
- Low or upper respiratory tract sample CI brief — competitive landscape report
- Low or upper respiratory tract sample updates RSS · CI watch RSS
- Hospices Civils de Lyon portfolio CI
Frequently asked questions about Low or upper respiratory tract sample
What is Low or upper respiratory tract sample?
Who makes Low or upper respiratory tract sample?
What development phase is Low or upper respiratory tract sample in?
Related
- Manufacturer: Hospices Civils de Lyon — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing