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Nizoral®

Ache Laboratorios Farmaceuticos S.A. · FDA-approved active Small molecule Under review Quality 0/100

Nizoral® is a Imidazole antifungal Small molecule drug developed by Ache Laboratorios Farmaceuticos S.A.. It is currently FDA-approved for Seborrheic dermatitis (topical formulation), Dandruff (topical formulation), Tinea corporis, tinea pedis, tinea cruris (topical formulation). Also known as: ketoconazole.

Nizoral inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in the fungal cell membrane and causing cell death.

Nizoral, also known as ketoconazole, is a small molecule inhibitor of the cytochrome P450 51 enzyme, specifically targeting lanosterol 14-alpha demethylase. It has been studied for various conditions, including Tinea Pedis, and is available in cream form, with a non-inferiority Phase III trial comparing its efficacy to dapaconazole cream in treating Tinea Pedis.

At a glance

Generic nameNizoral®
Also known asketoconazole
SponsorAche Laboratorios Farmaceuticos S.A.
Drug classImidazole antifungal
TargetLanosterol 14α-demethylase (CYP51)
ModalitySmall molecule
Therapeutic areaInfectious Disease
PhaseFDA-approved

Mechanism of action

Ketoconazole, the active ingredient in Nizoral, is an imidazole antifungal that blocks the demethylation of lanosterol by inhibiting fungal CYP51 (lanosterol 14α-demethylase). This prevents the conversion of lanosterol to ergosterol, a critical component of the fungal cell membrane. Without adequate ergosterol, the fungal cell membrane becomes unstable and permeable, leading to cell lysis and fungal death.

Approved indications

Common side effects

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

SourceUsed for
ClinicalTrials.govTrial enrolment, design, endpoints, results

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Frequently asked questions about Nizoral®

What is Nizoral®?

Nizoral® is a Imidazole antifungal drug developed by Ache Laboratorios Farmaceuticos S.A., indicated for Seborrheic dermatitis (topical formulation), Dandruff (topical formulation), Tinea corporis, tinea pedis, tinea cruris (topical formulation).

How does Nizoral® work?

Nizoral inhibits fungal cytochrome P450 enzymes, disrupting ergosterol synthesis in the fungal cell membrane and causing cell death.

What is Nizoral® used for?

Nizoral® is indicated for Seborrheic dermatitis (topical formulation), Dandruff (topical formulation), Tinea corporis, tinea pedis, tinea cruris (topical formulation), Pityriasis versicolor (topical formulation), Systemic fungal infections (oral formulation, historical use).

Who makes Nizoral®?

Nizoral® is developed and marketed by Ache Laboratorios Farmaceuticos S.A. (see full Ache Laboratorios Farmaceuticos S.A. pipeline at /company/ache-laboratorios-farmaceuticos-s-a).

Is Nizoral® also known as anything else?

Nizoral® is also known as ketoconazole.

What drug class is Nizoral® in?

Nizoral® belongs to the Imidazole antifungal class. See all Imidazole antifungal drugs at /class/imidazole-antifungal.

What development phase is Nizoral® in?

Nizoral® is FDA-approved (marketed).

What are the side effects of Nizoral®?

Common side effects of Nizoral® include Pruritus, Irritation at application site, Erythema, Hepatotoxicity (oral formulation, rare).

What does Nizoral® target?

Nizoral® targets Lanosterol 14α-demethylase (CYP51) and is a Imidazole antifungal.

Related

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