Last reviewed 2026-05-24 · How we verify

SULFINALOL

Phase 2 active Small molecule ✓ Verified May 2026

SULFINALOL is a sulfinalol drug. It is currently in Phase 2 development.

Sulfinalol is thought to work by interacting with a specific target in the body, but its exact mechanism of action is unknown.

SULFINALOL is a small molecule. It is also known by the synonyms SULFINALOL HYDROCHLORIDE, SULFINALOL HYDROCHLORIDE, WIN 40808-7, and WIN-40808-7.

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	SULFINALOL
Drug class	sulfinalol
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells have locks on them, and sulfinalol is a key that fits into one of those locks. When it binds to the lock, it can affect how the cell works, but we don't know which lock it fits into or how it affects the cell's behavior. This is a simplified way of understanding how sulfinalol might work, but more research is needed to confirm its mechanism of action.

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:

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

Frequently asked questions about SULFINALOL

What is SULFINALOL?

SULFINALOL is a sulfinalol drug.

How does SULFINALOL work?

Sulfinalol is thought to work by interacting with a specific target in the body, but its exact mechanism of action is unknown.

What drug class is SULFINALOL in?

SULFINALOL belongs to the sulfinalol class. See all sulfinalol drugs at /class/sulfinalol.

What development phase is SULFINALOL in?

SULFINALOL is in Phase 2.

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

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