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Bromodeoxyuridine (BROXURIDINE)

Phase 2 active Small molecule ✓ Verified May 2026

Bromodeoxyuridine (generic name: BROXURIDINE) is a broxuridine drug. It is currently in Phase 2 development.

Bromodeoxyuridine works by mimicking the structure of thymidine, a building block of DNA, and inhibiting the action of thymidine kinase, an enzyme essential for viral DNA replication.

Bromodeoxyuridine is a small molecule used in clinical trials for various conditions, including stage I and II prostate cancer, cytogenetic abnormalities, and radiation exposure. It has been studied in combination with conventional surgery and laboratory biomarker analysis in these trials.

Likelihood of approval
17.3% vs 15.3% industry baseline
If approved by FDA: likely 2031–2034
Steps remaining: Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • 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).
  • Anti-infectives pathway favourability +2.0pp
    Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
Predicted approval windows by jurisdiction (conditional on FDA approval)
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 nameBROXURIDINE
Drug classbroxuridine
TargetThymidine kinase, cytosolic, Thymidylate kinase
ModalitySmall molecule
Therapeutic areaInfectious Disease
PhasePhase 2

Mechanism of action

Imagine your body's cells are like factories that build new DNA. Bromodeoxyuridine is a fake building block that gets in the way of the factory's machinery, preventing the virus from making more copies of itself. This can help slow down or stop the spread of the virus.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Bromodeoxyuridine

What is Bromodeoxyuridine?

Bromodeoxyuridine (BROXURIDINE) is a broxuridine drug.

How does Bromodeoxyuridine work?

Bromodeoxyuridine works by mimicking the structure of thymidine, a building block of DNA, and inhibiting the action of thymidine kinase, an enzyme essential for viral DNA replication.

What is the generic name of Bromodeoxyuridine?

BROXURIDINE is the generic (nonproprietary) name of Bromodeoxyuridine.

What drug class is Bromodeoxyuridine in?

Bromodeoxyuridine belongs to the broxuridine class. See all broxuridine drugs at /class/broxuridine.

What development phase is Bromodeoxyuridine in?

Bromodeoxyuridine is in Phase 2.

What does Bromodeoxyuridine target?

Bromodeoxyuridine targets Thymidine kinase, cytosolic, Thymidylate kinase and is a broxuridine.

Related

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