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Biotinylated Red Blood Cells
Biotinylated Red Blood Cells is a Diagnostic agent Small molecule drug developed by John A Widness. It is currently in Phase 2 development. Also known as: BioRBC.
Red blood cells are labeled with biotin to enable tracking and quantification of cell survival and lifespan in circulation.
Biotinylated Red Blood Cells are being studied in clinical trials for various conditions, including Sarcoidosis, Diabetes Mellitus, and Neonatal Anemia, through re-infusion of biotin labeled cells. The exact mechanism of action of Biotinylated Red Blood Cells is currently unknown.
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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 | Biotinylated Red Blood Cells |
|---|---|
| Also known as | BioRBC |
| Sponsor | John A Widness |
| Drug class | Diagnostic agent |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
Biotin is covalently attached to red blood cell surface proteins, creating a stable label that persists for the cell's lifespan. The biotinylated cells can be detected and quantified using flow cytometry or other detection methods, allowing researchers to measure red blood cell survival, calculate lifespan, and assess transfusion efficacy without radioactive tracers.
Approved indications
Common side effects
Key clinical trials
- Comparative Analysis of Biotinylated, Irradiated and 51-Chromium Radiolabeled Red Blood Cells for Analysis of Recovery and Survival After Autologous Transfusion (PHASE1)
- Red Blood Cell Survival in Sickle Cell Disease (PHASE1)
- Effect of Red Blood Cell Survival on a Commonly Used Diabetes Lab Test-HbA1c (NA)
- Transfusion of Biotinylated Red Blood Cells (PHASE1)
- RBC Lifespan Measurement in Diabetic Children (PHASE1)
- Red Blood Cell (RBC) Survival Following Transfusion in Infants (PHASE2)
- BioRBC Survival in Adults With Prior Antibody Response to BioRBCs (PHASE1)
- Optimized Erythropoietin (EPO) Treatment (PHASE2)
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:
- Biotinylated Red Blood Cells CI brief — competitive landscape report
- Biotinylated Red Blood Cells updates RSS · CI watch RSS
- John A Widness portfolio CI
Frequently asked questions about Biotinylated Red Blood Cells
What is Biotinylated Red Blood Cells?
How does Biotinylated Red Blood Cells work?
Who makes Biotinylated Red Blood Cells?
Is Biotinylated Red Blood Cells also known as anything else?
What drug class is Biotinylated Red Blood Cells in?
What development phase is Biotinylated Red Blood Cells in?
Related
- Drug class: All Diagnostic agent drugs
- Manufacturer: John A Widness — full pipeline
- Also known as: BioRBC
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing