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Serum and plasma samples
Serum and plasma samples is a Biologic drug developed by Hospices Civils de Lyon. It is currently in Phase 2 development.
Serum samples are used in clinical trials to study various conditions, including Systemic Lupus Erythematosus (SLE) and Endometrial Cancer, and to measure ceramide levels in the blood. Serum is a protein-based modality, as indicated by its classification in ChEMBL, and is collected through blood samples.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | Serum and plasma samples |
|---|---|
| Sponsor | Hospices Civils de Lyon |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- The ILERVAS Project: Assessing the Prevalence of Subclinical Vascular Disease and Hidden Kidney Disease (NA)
- Analysis of Inflammatory Biomarker Changes in Dry Blood Spot Versus Venous Blood Samples
- Genetics Of Autoimmunity In Type I Diabetes
- KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
- Liquid Biopsy Using Exosomal miRNA Enables Risk Stratification of Potential Metastasis in Patients With Intrahepatic Cholangiocarcinoma.
- An Exosomal miRNA-based Liquid Biopsy for ICC Detection
- Study in Leptomeningeal Metastases of Breast Cancer (NA)
- Precision Medicine and Neurodegenerative Diseases: Advanced Systems for the Diagnosis and Treatment of Parkinson's Disease and Alzheimer's Disease.
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:
- Serum and plasma samples CI brief — competitive landscape report
- Serum and plasma samples updates RSS · CI watch RSS
- Hospices Civils de Lyon portfolio CI
Frequently asked questions about Serum and plasma samples
What is Serum and plasma samples?
Who makes Serum and plasma samples?
What development phase is Serum and plasma samples in?
Related
- Manufacturer: Hospices Civils de Lyon — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing