Last reviewed 2026-06-02 · How we verify

biotin labelled RBCs

John A Widness · Phase 1 active Small molecule ✓ Verified Jun 2026

biotin labelled RBCs is a Small molecule drug developed by John A Widness. It is currently in Phase 1 development. Also known as: biotinylated RBCs.

Biotin labelled red blood cells (RBCs) have been studied in clinical trials for the treatment of anemia. Biotin is a small molecule, classified as a vitamin, and is used in the labelling process of RBCs.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	biotin labelled RBCs
Also known as	biotinylated RBCs
Sponsor	John A Widness
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

biotin labelled RBCs CI brief — competitive landscape report
biotin labelled RBCs updates RSS · CI watch RSS
John A Widness portfolio CI

Frequently asked questions about biotin labelled RBCs

What is biotin labelled RBCs?

biotin labelled RBCs is a Small molecule drug developed by John A Widness.

Who makes biotin labelled RBCs?

biotin labelled RBCs is developed by John A Widness (see full John A Widness pipeline at /company/john-a-widness).

Is biotin labelled RBCs also known as anything else?

biotin labelled RBCs is also known as biotinylated RBCs.

What development phase is biotin labelled RBCs in?

biotin labelled RBCs is in Phase 1.

Manufacturer: John A Widness — full pipeline
Also known as: biotinylated RBCs

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing