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microbiology
microbiology is a Biologic drug developed by CHU de Reims. 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 | microbiology |
|---|---|
| Sponsor | CHU de Reims |
| Modality | Biologic |
| Therapeutic area | Other |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Training Protocol on the Natural History of Tuberculosis
- Correlation of Inflammatory Markers and Radiological Findings in Stable Bronchiectasis Patients With Exacerbation Phenotype
- Effects of Microbiological and Immunological Factors on the Lower Urinary Tract
- Effect of Oral Microbiota on MDRO Decolonization (PHASE1, PHASE2)
- Joint Endoprostheses Can Succesfully Treat Disabling Osteoarthritis. However, Infection is an Important Cause of Failure. Adequate Diagnostics Remains Challenging. Combining Advanced Imaging With Next-generation Sequencing of Samples Obtained Endoscopically Should Aid in Mapping and Characterizing. (NA)
- A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
- The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST) (NA)
- The DECIDE-TB Trial; Validation of Treatment Decision Algorithms for Childhood Tuberculosis (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:
- microbiology CI brief — competitive landscape report
- microbiology updates RSS · CI watch RSS
- CHU de Reims portfolio CI
Frequently asked questions about microbiology
What is microbiology?
Who makes microbiology?
What development phase is microbiology in?
Related
- Manufacturer: CHU de Reims — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing