Last reviewed 2026-05-29 · How we verify

Buterazine (BUDRALAZINE)

Phase 2 active Small molecule ✓ Verified May 2026

Buterazine (generic name: BUDRALAZINE) is a budralazine drug. It is currently in Phase 2 development.

Buterazine works by inhibiting the enzyme aldose reductase, which plays a key role in the development of diabetic complications.

Buterazine is a small molecule. It is also known by the synonyms BUDRALAZINA, BUDRALAZINE.

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	BUDRALAZINE
Drug class	budralazine
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of it like a traffic jam in your body. When you have diabetes, your body produces too much sugar, which can cause damage to your organs and nerves. Buterazine helps to reduce this traffic jam by blocking the enzyme that allows sugar to build up in the first place.

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:

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

Frequently asked questions about Buterazine

What is Buterazine?

Buterazine (BUDRALAZINE) is a budralazine drug.

How does Buterazine work?

Buterazine works by inhibiting the enzyme aldose reductase, which plays a key role in the development of diabetic complications.

What is the generic name of Buterazine?

BUDRALAZINE is the generic (nonproprietary) name of Buterazine.

What drug class is Buterazine in?

Buterazine belongs to the budralazine class. See all budralazine drugs at /class/budralazine.

What development phase is Buterazine in?

Buterazine is in Phase 2.

Drug class: All budralazine drugs
Therapeutic area: All drugs in Metabolic

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