Last reviewed 2026-04-19 · How we verify

BUTOFILOLOL

Phase 2 active Small molecule

BUTOFILOLOL is a butofilolol drug. It is currently in Phase 2 development.

BUTOFILOLOL is thought to work by blocking certain receptors in the body to produce its therapeutic effects.

BUTOFILOLOL is a small molecule drug in the butofilolol class, but its original developer and current owner are unknown. Its target and exact mechanism of action are also unclear. BUTOFILOLOL is not FDA-approved for any indications, and its commercial status, half-life, bioavailability, and generic manufacturers are unknown. As a result, there is limited information available on its safety profile and potential side effects. Further research is needed to fully understand this medication.

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	BUTOFILOLOL
Drug class	butofilolol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and BUTOFILOLOL is a key that fits into those locks. By blocking these locks, BUTOFILOLOL can prevent certain chemical signals from being sent, which can help to treat various conditions. However, the exact locks and signals it targets are still unknown.

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:

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

Frequently asked questions about BUTOFILOLOL

What is BUTOFILOLOL?

BUTOFILOLOL is a butofilolol drug.

How does BUTOFILOLOL work?

BUTOFILOLOL is thought to work by blocking certain receptors in the body to produce its therapeutic effects.

What drug class is BUTOFILOLOL in?

BUTOFILOLOL belongs to the butofilolol class. See all butofilolol drugs at /class/butofilolol.

What development phase is BUTOFILOLOL in?

BUTOFILOLOL is in Phase 2.

Drug class: All butofilolol drugs
Therapeutic area: All drugs in Other

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