Last reviewed 2026-04-19 · How we verify

OMOCONAZOLE

Phase 2 active Small molecule

OMOCONAZOLE is a omoconazole drug. It is currently in Phase 2 development for Candidal vulvovaginitis, Candidiasis of skin, Dermatophytosis.

Omoconazole works by inhibiting the growth of fungal cells.

Omoconazole is a small molecule antifungal medication developed for the treatment of various fungal infections, including Candidal vulvovaginitis, Candidiasis of skin, Dermatophytosis, and Pityriasis versicolor. The current owner of omoconazole is unknown, and its commercial status is also unclear. As an antifungal agent, omoconazole works by inhibiting the growth of fungal cells, thereby treating the underlying infection. Key safety considerations for omoconazole include unknown half-life and bioavailability, as well as potential side effects that are not well-documented. Further research is needed to fully understand the pharmacokinetics and safety profile of omoconazole.

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	OMOCONAZOLE
Drug class	omoconazole
Modality	Small molecule
Therapeutic area	Dermatology
Phase	Phase 2

Mechanism of action

Imagine your body is under attack by tiny fungal invaders. Omoconazole is like a special tool that stops these invaders from growing and multiplying, allowing your body's natural defenses to fight off the infection.

Approved indications

Candidal vulvovaginitis
Candidiasis of skin
Dermatophytosis
Pityriasis versicolor

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:

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

Frequently asked questions about OMOCONAZOLE

What is OMOCONAZOLE?

OMOCONAZOLE is a omoconazole drug, indicated for Candidal vulvovaginitis, Candidiasis of skin, Dermatophytosis.

How does OMOCONAZOLE work?

Omoconazole works by inhibiting the growth of fungal cells.

What is OMOCONAZOLE used for?

OMOCONAZOLE is indicated for Candidal vulvovaginitis, Candidiasis of skin, Dermatophytosis, Pityriasis versicolor.

What drug class is OMOCONAZOLE in?

OMOCONAZOLE belongs to the omoconazole class. See all omoconazole drugs at /class/omoconazole.

What development phase is OMOCONAZOLE in?

OMOCONAZOLE is in Phase 2.

Drug class: All omoconazole drugs
Therapeutic area: All drugs in Dermatology
Indication: Drugs for Candidal vulvovaginitis
Indication: Drugs for Candidiasis of skin
Indication: Drugs for Dermatophytosis

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