Last reviewed 2026-04-19 · How we verify

FADROZOLE

Phase 2 active Small molecule

FADROZOLE is a fadrozole drug. It is currently in Phase 2 development.

Fadrozole works by blocking the aromatase enzyme, which is responsible for converting androgens into estrogens.

Fadrozole is a small molecule drug that targets aromatase, an enzyme involved in estrogen production. It is classified as a fadrozole, a type of non-steroidal aromatase inhibitor. Fadrozole's commercial status and approved indications are unknown. As a result, its safety profile and pharmacokinetic properties, such as half-life and bioavailability, are also unclear. Further research is needed to determine its potential therapeutic applications.

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	FADROZOLE
Drug class	fadrozole
Target	Cytochrome P450 11B2, mitochondrial, Aromatase, Cytochrome P450 11B1, mitochondrial
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of aromatase like a translator that helps turn male hormones into female hormones. By blocking this translator, fadrozole reduces the amount of estrogen in the body. This can be beneficial in certain medical conditions where estrogen levels are too high.

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:

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

Frequently asked questions about FADROZOLE

What is FADROZOLE?

FADROZOLE is a fadrozole drug.

How does FADROZOLE work?

Fadrozole works by blocking the aromatase enzyme, which is responsible for converting androgens into estrogens.

What drug class is FADROZOLE in?

FADROZOLE belongs to the fadrozole class. See all fadrozole drugs at /class/fadrozole.

What development phase is FADROZOLE in?

FADROZOLE is in Phase 2.

What does FADROZOLE target?

FADROZOLE targets Cytochrome P450 11B2, mitochondrial, Aromatase, Cytochrome P450 11B1, mitochondrial and is a fadrozole.

Drug class: All fadrozole drugs
Target: All drugs targeting Cytochrome P450 11B2, mitochondrial, Aromatase, Cytochrome P450 11B1, mitochondrial
Therapeutic area: All drugs in Other

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