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Naftifine | CAS No: 65472-88-0 | GMP-certified suppliers
A medication that provides topical antifungal treatment for dermatophytic infections such as tinea pedis, tinea cruris, and tinea corporis caused by common fungal pathogens.
Therapeutic categories
Primary indications
- For the topical treatment of tinea pedis, tinea cruris, and tinea corporis caused by the organisms <i>Trichophyton rubrum</i>, <i>Trichophyton mentagrophytes</i>, <i>Trichophyton tonsurans</i> and <i>Epidermophyton floccosum</i>
Product Snapshot
- Naftifine is available as topical formulations including gel, cream, solution, and spray
- It is primarily indicated for the treatment of dermatophyte infections such as tinea pedis, tinea cruris, and tinea corporis caused by specified fungal organisms
- Naftifine is approved for use in key regulatory markets including the United States and Canada
Clinical Overview
Pharmacodynamically, naftifine exhibits broad-spectrum antifungal activity. In vitro studies demonstrate fungicidal effects against several dermatophytes including the species listed in the indications, as well as Microsporum canis, Microsporum audouini, and Microsporum gypseum. It also shows fungistatic activity against some Candida species, such as Candida albicans, though clinical use is limited to dermatophyte infections.
The mechanism of action involves inhibition of squalene 2,3-epoxidase, an enzyme critical to fungal sterol biosynthesis. This inhibition disrupts ergosterol production, a key component of fungal cell membranes, leading to depletion of membrane sterols and accumulation of squalene within fungal cells. The resulting imbalance compromises cell membrane integrity and function, contributing to antifungal effects.
Absorption following topical administration is minimal, limiting systemic exposure. Metabolic and excretion pathways have not been extensively characterized due to the topical route. Safety profiles indicate low systemic toxicity with localized adverse effects primarily confined to topical irritation or allergic contact dermatitis.
Naftifine is utilized globally in dermatological contexts for topical antifungal treatment. It is marketed under various generic formulations and branded products, subject to regional regulatory approvals.
In sourcing naftifine API, quality assurance measures should include verification of chemical purity, consistency in polymorphic form, and regulatory compliance with pharmacopeial standards applicable to topical antifungal agents. Robust supply chain validation supports reliable manufacturing and formulation integrity.
Identification & chemistry
| Generic name | Naftifine |
|---|---|
| Molecule type | Small molecule |
| CAS | 65472-88-0 |
| UNII | 4FB1TON47A |
| DrugBank ID | DB00735 |
Pharmacology
| Summary | Naftifine is a synthetic allylamine antifungal agent that targets squalene monooxygenase, an enzyme involved in fungal sterol biosynthesis. By inhibiting this enzyme, naftifine disrupts ergosterol production and causes intracellular accumulation of squalene, impairing fungal cell membrane integrity. It exhibits fungicidal activity against dermatophyte species responsible for superficial mycoses such as tinea pedis, cruris, and corporis. |
|---|---|
| Mechanism of action | Although the exact mechanism of action against fungi is not known, naftifine appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2,3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells. |
| Pharmacodynamics | Naftifine is a synthetic, broad spectrum, antifungal agent and allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftifine has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms including <i>Trichophyton rubrum</i>, <i>Trichophyton mentagrophytes</i>, <i>Trichophyton tonsurans</i>, <i>Epidermophyton floccosum</i>, and <i>Microsporum canis</i>, <i>Microsporum audouini</i>, and <i>Microsporum gypseum</i>; and fungistatic activity against <i>Candida</i> species including <i>Candida albicans</i>. However it is only used to treat the organisms listed in the indications. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Squalene monooxygenase | Humans | inhibitor |
ADME / PK
| Absorption | Following single topical applications of 3H-labeled naftifine gel 1% to the skin of healthy subjects, up to 4.2% of the applied dose was absorbed. |
|---|---|
| Half-life | Approximately 2 to 3 days following topical administration. |
| Route of elimination | Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days. |
Formulation & handling
- Naftifine is a lipophilic small molecule with low water solubility, primarily formulated for topical administration.
- It is stable in various topical forms including gels, creams, solutions, and sprays, facilitating flexibility in formulation.
- Due to its non-peptide nature and topical route, the API does not require special handling related to peptide stability or injectable use.
Regulatory status
| Lifecycle | The API is currently under patent protection in the United States until January 31, 2033, with marketed products available in the US and Canada. Market maturity is expected to advance as patent expirations approach. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Naftifine is primarily manufactured and branded by a single originator company with a presence in the US and Canadian markets. Multiple US patents for Naftifine are in force until 2033, indicating limited generic competition is expected in the near term within these regions. The supply chain involves several packagers supporting distribution primarily in North America. |
|---|
Naftifine is a type of Antimycotics
Antimycotics, a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs), are essential in the treatment of various fungal infections. These powerful medications target and eliminate harmful fungi that can cause infections in humans.
Antimycotics are classified into two main types: systemic and topical. Systemic antimycotics are administered orally or intravenously and work by circulating throughout the body, treating systemic fungal infections that affect internal organs or spread throughout the bloodstream. On the other hand, topical antimycotics are applied externally to treat localized fungal infections such as athlete's foot or yeast infections.
The efficacy of antimycotics lies in their ability to disrupt fungal cell membranes, inhibit the synthesis of fungal DNA or proteins, or interfere with essential metabolic processes specific to fungi. This targeted action minimizes damage to human cells, making these medications relatively safe for patients.
Commonly prescribed antimycotics include azoles, polyenes, allylamines, and echinocandins. Azoles inhibit the synthesis of ergosterol, a vital component of fungal cell membranes, while polyenes bind to ergosterol, resulting in the formation of pores that lead to cell death. Allylamines disrupt the synthesis of ergosterol and inhibit the activity of squalene epoxidase, an enzyme involved in ergosterol production. Echinocandins target the synthesis of β-(1,3)-D-glucan, an essential component of the fungal cell wall.
Antimycotics play a crucial role in the management of fungal infections, offering relief to patients and aiding in their recovery. As with any medication, it is important to follow healthcare professionals' guidance regarding dosage, duration of treatment, and potential side effects to ensure optimal therapeutic outcomes.
Naftifine (Antimycotics), classified under Antifungals
Antifungals are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) designed to combat fungal infections. These medications are developed to target and eliminate fungi, including yeasts and molds, which can cause a range of diseases in humans and animals.
Antifungals work by interfering with specific components or processes essential for fungal growth and reproduction. They may inhibit the synthesis of fungal cell walls or disrupt the production of ergosterol, a crucial component of fungal cell membranes. By targeting these key mechanisms, antifungal APIs effectively hinder the growth and spread of fungal infections.
The diversity within the antifungal category is reflected in the various classes of antifungal APIs available. Azoles, polyenes, echinocandins, and allylamines are common classes of antifungals. Each class exhibits unique mechanisms of action and targets specific types of fungi. This diversity enables healthcare professionals to tailor treatment plans to the specific fungal infection, optimizing therapeutic outcomes.
Antifungal APIs find application in various pharmaceutical formulations, including oral medications, topical creams, ointments, and intravenous solutions. They are crucial for the treatment of common fungal infections like athlete's foot, ringworm, vaginal yeast infections, and oral thrush. Additionally, antifungals play a crucial role in managing serious systemic fungal infections that can pose significant health risks, especially in immunocompromised individuals.
Overall, antifungal APIs are indispensable tools in the fight against fungal infections, offering effective treatment options and improving the quality of life for patients suffering from these conditions. With ongoing research and development, the antifungal category continues to evolve, providing innovative solutions to combat the ever-changing landscape of fungal pathogens.
Naftifine API manufacturers & distributors
Compare qualified Naftifine API suppliers worldwide. We currently have 3 companies offering Naftifine API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Erregierre | Producer | Italy | Italy | CoA, USDMF | 44 products |
| MSN Labs. | Producer | India | India | CoA, USDMF | 119 products |
| Shanghai Ziyuan | Producer | China | China | CoA, USDMF | 2 products |
When sending a request, specify which Naftifine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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