Last reviewed 2026-05-30 · How we verify

Latoconazole (LANOCONAZOLE)

Phase 2 active Small molecule ✓ Verified May 2026

Latoconazole (generic name: LANOCONAZOLE) is a lanoconazole drug. It is currently in Phase 2 development.

Lanoconazole works by blocking the production of ergosterol, a key component of fungal cell membranes.

Latoconazole is a small molecule. It is also known by the synonyms ASTAT, LANOCONAZOL, and LANOCONAZOLE.

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	LANOCONAZOLE
Drug class	lanoconazole
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Mechanism of action

Think of it like a building block of a house. Ergosterol is like a brick that helps hold the fungal cell together. When lanoconazole blocks its production, the cell can't repair itself and eventually dies.

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:

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

Frequently asked questions about Latoconazole

What is Latoconazole?

Latoconazole (LANOCONAZOLE) is a lanoconazole drug.

How does Latoconazole work?

Lanoconazole works by blocking the production of ergosterol, a key component of fungal cell membranes.

What is the generic name of Latoconazole?

LANOCONAZOLE is the generic (nonproprietary) name of Latoconazole.

What drug class is Latoconazole in?

Latoconazole belongs to the lanoconazole class. See all lanoconazole drugs at /class/lanoconazole.

What development phase is Latoconazole in?

Latoconazole is in Phase 2.

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

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