Last reviewed 2026-04-19 · How we verify

BROPIRIMINE

Phase 2 active Small molecule

BROPIRIMINE is a drug. It is currently in Phase 2 development.

BROPIRIMINE works by inhibiting the enzyme xanthine dehydrogenase/oxidase.

BROPIRIMINE is a small molecule modality targeting xanthine dehydrogenase/oxidase. Its mechanism and clinical applications are not well-documented, and it is unclear if it has been approved by the FDA for any indications. As a result, there is limited information available on its commercial status, pharmacokinetics, or safety profile. Further research is needed to fully understand the properties and potential uses of BROPIRIMINE. Its development history is also unclear, with no information available on its original developer or current owner.

Likelihood of approval

15.3% 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).

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 name	BROPIRIMINE
Target	Xanthine dehydrogenase/oxidase
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of xanthine dehydrogenase/oxidase like a factory that produces a chemical called uric acid. When this factory is working too hard, it can produce too much uric acid, leading to problems like gout. BROPIRIMINE helps by slowing down the factory, reducing the amount of uric acid produced.

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:

BROPIRIMINE CI brief — competitive landscape report
BROPIRIMINE updates RSS · CI watch RSS

Frequently asked questions about BROPIRIMINE

What is BROPIRIMINE?

BROPIRIMINE is a Small molecule drug.

How does BROPIRIMINE work?

BROPIRIMINE works by inhibiting the enzyme xanthine dehydrogenase/oxidase.

What development phase is BROPIRIMINE in?

BROPIRIMINE is in Phase 2.

What does BROPIRIMINE target?

BROPIRIMINE targets Xanthine dehydrogenase/oxidase.

Target: All drugs targeting Xanthine dehydrogenase/oxidase
Therapeutic area: All drugs in Other

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