Last reviewed 2026-04-20 · How we verify

Viniconazole (CROCONAZOLE)

Phase 2 active Small molecule

Viniconazole (generic name: CROCONAZOLE) is a croconazole drug. It is currently in Phase 2 development for Candidiasis of skin.

Viniconazole works by inhibiting the growth of fungi.

Viniconazole, also known as Croconazole, is a small molecule drug in the croconazole class. It is used to treat Candidiasis of the skin, a fungal infection. The commercial status of Viniconazole is not specified, but it is likely patented as its original developer and current owner are not provided. Key safety considerations are not available. Viniconazole works by inhibiting the growth of fungi.

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	CROCONAZOLE
Drug class	croconazole
Modality	Small molecule
Therapeutic area	Dermatology
Phase	Phase 2

Mechanism of action

Imagine your body is a garden, and the fungi are weeds. Viniconazole is like a weed killer that stops the weeds from growing and spreading. It does this by interfering with the way the fungi make energy, which ultimately kills the fungus.

Approved indications

Candidiasis of skin

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:

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

Frequently asked questions about Viniconazole

What is Viniconazole?

Viniconazole (CROCONAZOLE) is a croconazole drug, indicated for Candidiasis of skin.

How does Viniconazole work?

Viniconazole works by inhibiting the growth of fungi.

What is Viniconazole used for?

Viniconazole is indicated for Candidiasis of skin.

What is the generic name of Viniconazole?

CROCONAZOLE is the generic (nonproprietary) name of Viniconazole.

What drug class is Viniconazole in?

Viniconazole belongs to the croconazole class. See all croconazole drugs at /class/croconazole.

What development phase is Viniconazole in?

Viniconazole is in Phase 2.

Drug class: All croconazole drugs
Therapeutic area: All drugs in Dermatology
Indication: Drugs for Candidiasis of skin

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