Last reviewed 2026-05-28 · How we verify

FLUTRIMAZOLE

Phase 2 active Small molecule ✓ Verified May 2026

FLUTRIMAZOLE is a flutrimazole drug. It is currently in Phase 2 development.

Flutrimazole works by binding to and activating the nuclear receptor subfamily 1 group I member 2, which plays a role in regulating gene expression.

Flutrimazole is a small molecule. It is also known by other names, including Flutrimazole, Flutrimazole, Flutrimazole, Flutrimazole, Micetal, and UR-4056.

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	FLUTRIMAZOLE
Drug class	flutrimazole
Target	Nuclear receptor subfamily 1 group I member 2, Bile acid receptor
Modality	Small molecule
Therapeutic area	Metabolic
Phase	Phase 2

Mechanism of action

Think of it like a light switch - when flutrimazole binds to the receptor, it turns on a set of genes that help to regulate cell growth and function. This can be beneficial in treating certain conditions, but it's a complex process that requires careful balance to avoid unwanted effects. The exact details of how flutrimazole works are still being studied.

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:

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

Frequently asked questions about FLUTRIMAZOLE

What is FLUTRIMAZOLE?

FLUTRIMAZOLE is a flutrimazole drug.

How does FLUTRIMAZOLE work?

Flutrimazole works by binding to and activating the nuclear receptor subfamily 1 group I member 2, which plays a role in regulating gene expression.

What drug class is FLUTRIMAZOLE in?

FLUTRIMAZOLE belongs to the flutrimazole class. See all flutrimazole drugs at /class/flutrimazole.

What development phase is FLUTRIMAZOLE in?

FLUTRIMAZOLE is in Phase 2.

What does FLUTRIMAZOLE target?

FLUTRIMAZOLE targets Nuclear receptor subfamily 1 group I member 2, Bile acid receptor and is a flutrimazole.

Drug class: All flutrimazole drugs
Target: All drugs targeting Nuclear receptor subfamily 1 group I member 2, Bile acid receptor
Therapeutic area: All drugs in Metabolic

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