Last reviewed 2026-04-20 · How we verify

Bentos (BEFUNOLOL)

Phase 2 active Small molecule

Bentos (generic name: BEFUNOLOL) is a befunolol drug. It is currently in Phase 2 development for Ocular hypertension, Open-angle glaucoma.

Bentos works by reducing the production of fluid in the eye, thereby lowering intraocular pressure.

Bentos (Befunolol) is a small molecule drug in the befunolol class, used to treat ocular hypertension and open-angle glaucoma. Its commercial status is unknown, but it is approved for the mentioned indications. The exact target of Bentos is unknown, but it is believed to work by reducing intraocular pressure. Key safety considerations include unknown half-life and bioavailability. As its commercial status is unknown, it is unclear if it is patented or available as a generic.

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	BEFUNOLOL
Drug class	befunolol
Modality	Small molecule
Therapeutic area	Cardiovascular
Phase	Phase 2

Mechanism of action

Think of the eye like a balloon filled with water. When the balloon gets too full, the pressure inside the balloon increases. Bentos helps to reduce the amount of water in the balloon, which in turn lowers the pressure inside the eye.

Approved indications

Ocular hypertension
Open-angle glaucoma

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:

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

Frequently asked questions about Bentos

What is Bentos?

Bentos (BEFUNOLOL) is a befunolol drug, indicated for Ocular hypertension, Open-angle glaucoma.

How does Bentos work?

Bentos works by reducing the production of fluid in the eye, thereby lowering intraocular pressure.

What is Bentos used for?

Bentos is indicated for Ocular hypertension, Open-angle glaucoma.

What is the generic name of Bentos?

BEFUNOLOL is the generic (nonproprietary) name of Bentos.

What drug class is Bentos in?

Bentos belongs to the befunolol class. See all befunolol drugs at /class/befunolol.

What development phase is Bentos in?

Bentos is in Phase 2.

Drug class: All befunolol drugs
Therapeutic area: All drugs in Cardiovascular
Indication: Drugs for Ocular hypertension
Indication: Drugs for Open-angle glaucoma

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