Last reviewed 2026-04-20 · How we verify

(+/-)-Bufuralol (BUFURALOL)

Phase 2 active Small molecule

(+/-)-Bufuralol (generic name: BUFURALOL) is a bufuralol drug. It is currently in Phase 2 development.

Bufuralol works by blocking the beta-2 adrenergic receptor, which helps to slow the heart rate and reduce blood pressure.

Bufuralol, a small molecule drug, is a beta-2 adrenergic receptor antagonist. It was originally developed but its current owner is unknown. Bufuralol's commercial status is unclear, and it is not FDA-approved for any indications. The drug has a half-life of 2.3 hours and bioavailability of 46%. Key safety considerations are not well-documented.

Likelihood of approval

13.3% 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).
Cardiovascular Phase 3 risk -2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.

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	BUFURALOL
Drug class	bufuralol
Target	Multidrug resistance protein 1, Beta-1 adrenergic receptor, Beta-2 adrenergic receptor
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Imagine your heart is like a revved-up engine. The beta-2 adrenergic receptor is like the accelerator pedal. When it's stimulated, your heart beats faster and stronger. Bufuralol blocks this receptor, so the engine (your heart) doesn't rev up as much, which can help lower your blood pressure and heart rate.

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:

(+/-)-Bufuralol CI brief — competitive landscape report
(+/-)-Bufuralol updates RSS · CI watch RSS

Frequently asked questions about (+/-)-Bufuralol

What is (+/-)-Bufuralol?

(+/-)-Bufuralol (BUFURALOL) is a bufuralol drug.

How does (+/-)-Bufuralol work?

Bufuralol works by blocking the beta-2 adrenergic receptor, which helps to slow the heart rate and reduce blood pressure.

What is the generic name of (+/-)-Bufuralol?

BUFURALOL is the generic (nonproprietary) name of (+/-)-Bufuralol.

What drug class is (+/-)-Bufuralol in?

(+/-)-Bufuralol belongs to the bufuralol class. See all bufuralol drugs at /class/bufuralol.

What development phase is (+/-)-Bufuralol in?

(+/-)-Bufuralol is in Phase 2.

What does (+/-)-Bufuralol target?

(+/-)-Bufuralol targets Multidrug resistance protein 1, Beta-1 adrenergic receptor, Beta-2 adrenergic receptor and is a bufuralol.

Drug class: All bufuralol drugs
Target: All drugs targeting Multidrug resistance protein 1, Beta-1 adrenergic receptor, Beta-2 adrenergic receptor
Therapeutic area: All drugs in Cardiovascular

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