Last reviewed 2026-04-20 · How we verify

Isophenethanol (NIFENALOL)

Phase 2 active Small molecule

Isophenethanol (generic name: NIFENALOL) is a nifenalol drug. It is currently in Phase 2 development.

Nifenalol is thought to work by interacting with cellular pathways, although the exact mechanism is unknown.

Isophenethanol, also known as Nifenalol, is a small molecule drug of the nifenalol class. Its exact target and mechanism of action are unknown, but it is believed to work by interacting with certain cellular pathways. Nifenalol is not FDA-approved for any indications, and its commercial status, including patent and generic availability, is unclear. Further research is needed to determine its safety and efficacy. As a result, there is limited information available on its half-life, bioavailability, and potential side effects.

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	NIFENALOL
Drug class	nifenalol
Target	Beta-2 adrenergic receptor
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Imagine your body's cells as a complex network of roads and intersections. Nifenalol is like a traffic controller that helps regulate the flow of signals between cells, but we don't know exactly how it does this or which roads it affects.

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:

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

Frequently asked questions about Isophenethanol

What is Isophenethanol?

Isophenethanol (NIFENALOL) is a nifenalol drug.

How does Isophenethanol work?

Nifenalol is thought to work by interacting with cellular pathways, although the exact mechanism is unknown.

What is the generic name of Isophenethanol?

NIFENALOL is the generic (nonproprietary) name of Isophenethanol.

What drug class is Isophenethanol in?

Isophenethanol belongs to the nifenalol class. See all nifenalol drugs at /class/nifenalol.

What development phase is Isophenethanol in?

Isophenethanol is in Phase 2.

What does Isophenethanol target?

Isophenethanol targets Beta-2 adrenergic receptor and is a nifenalol.

Drug class: All nifenalol drugs
Target: All drugs targeting Beta-2 adrenergic receptor
Therapeutic area: All drugs in Other

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