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Butenafine | CAS No: 101828-21-1 | GMP-certified suppliers
A medication that treats dermatologic fungal infections including tinea versicolor, athlete’s foot, ringworm, and jock itch with potent topical antifungal activity and low systemic absorption.
Therapeutic categories
Primary indications
- For the topical treatment of the following dermatologic infections: tinea (pityriasis) versicolor due to <i>M
- Furfur</i>, interdigital tinea pedis (athlete&rsquo
- S foot), tinea corporis (ringworm) and tinea cruris (jock itch) due to <i>E
- Floccosum</i>, <i>T
Product Snapshot
- Butenafine is available as topical formulations including creams, lotions, sprays, and solutions
- It is primarily indicated for the treatment of dermatologic fungal infections such as tinea versicolor, tinea pedis, tinea corporis, and tinea cruris
- Butenafine is approved for use in the US and Canadian markets
Clinical Overview
Pharmacologically, butenafine is structurally related to allylamine antifungals and is classified within the naphthalene chemical family, characterized by two fused benzene rings. Its antifungal activity is believed to involve inhibition of sterol synthesis within fungal cells. Specifically, butenafine inhibits the enzyme squalene epoxidase (also known as squalene monooxygenase), which catalyzes the conversion of squalene to 2,3-oxidosqualene, a key step in ergosterol synthesis. Ergosterol is essential for maintaining fungal cell membrane integrity. Inhibition of its production leads to increased membrane permeability and leakage of intracellular contents. Additionally, accumulation of squalene due to enzyme blockade may exert direct fungicidal effects.
Butenafine demonstrates potent activity mainly against dermatophytes, with a superior fungicidal profile compared to terbinafine, naftifine, tolnaftate, clotrimazole, and bifonazole. It is also active against Candida albicans with greater efficacy than terbinafine and naftifine, and exhibits low minimal inhibitory concentrations (MICs) against Cryptococcus neoformans and Aspergillus species.
Key ADME parameters following topical administration indicate minimal systemic absorption, reducing systemic exposure and associated risks. Safety concerns primarily relate to local tolerability; adverse reactions may include mild irritation or allergic contact dermatitis. Systemic toxicity is not commonly observed due to limited systemic bioavailability.
Butenafine is marketed under various brand names globally and is utilized in standard clinical practice for fungal skin infections. From an API sourcing perspective, ensuring high purity and consistent particle size is critical for formulation performance and stability. Reliable suppliers should provide comprehensive certificates of analysis and demonstrate compliance with relevant pharmacopeial standards to support regulatory submissions and quality assurance.
Identification & chemistry
| Generic name | Butenafine |
|---|---|
| Molecule type | Small molecule |
| CAS | 101828-21-1 |
| UNII | 91Y494NL0X |
| DrugBank ID | DB01091 |
Pharmacology
| Summary | Butenafine is a synthetic antifungal agent that primarily targets squalene monooxygenase, inhibiting ergosterol biosynthesis critical for fungal cell membrane integrity. This action increases membrane permeability and leads to fungal cell death, particularly against dermatophytes, Candida albicans, Cryptococcus neoformans, and Aspergillus species. Its pharmacodynamic profile includes superior fungicidal activity compared to several other antifungals within its class. |
|---|---|
| Mechanism of action | Although the mechanism of action has not been fully established, it has been suggested that butenafine, like allylamines, interferes with sterol biosynthesis (especially ergosterol) by inhibiting squalene monooxygenase, an enzyme responsible for converting squalene to 2,3-oxydo squalene. As ergosterol is an essential component of the fungal cell membrane, inhibition of its synthesis results in increased cellular permeability causing leakage of cellular contents. Blockage of squalene monooxygenase also leads to a subsequent accumulation of squalene. When a high concentration of squalene is reached, it is thought to have an effect of directly kill fungal cells. |
| Pharmacodynamics | Butenafine is a synthetic antifungal agent that is structurally and pharmacologically related to allylamine antifungals. The exact mechanism of action has not been established, but it is suggested that butenafine's antifungal activity is exerted through the alteration of cellular membranes, which results in increased membrane permeability, and growth inhibition. Butenafine is mainly active against dermatophytes and has superior fungicidal activity against this group of fungi when compared to that of terbinafine, naftifine, tolnaftate, clotrimazole, and bifonazole. It is also active against <i>Candida albicans</i> and this activity is superior to that of terbinafine and naftifine. Butenafine also generates low MICs for <i>Cryptococcus neoformans</i> and <i>Aspergillus spp.</i> as well. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Squalene monooxygenase | Humans | inhibitor |
ADME / PK
| Absorption | The total amount absorbed through the skin into the systemic circulation has not been quantified. |
|---|---|
| Half-life | Following topical application, a biphasic decline of plasma butenafine concentrations was observed with the half-lives estimated to be 35 hours initial and over 150 hours terminal. |
| Metabolism | The primary metabolite in urine was formed through hydroxylation at the terminal <i>t</i>-butyl side-chain. |
Formulation & handling
- Butenafine is a small molecule with high lipophilicity, formulated primarily for topical and cutaneous use due to low water solubility.
- Its stability profile supports formulations such as creams, lotions, and sprays without the need for special handling related to peptide or biologic degradation.
- Formulations should consider its high logP for optimizing skin penetration while maintaining product uniformity in semi-solid vehicles.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient's primary patent in the United States expired in October 2010. The API is currently marketed in the US and Canada, reflecting a mature market status. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Butenafine is supplied by multiple packagers, indicating a diversified manufacturing base supporting its availability primarily in the US and Canada markets. The presence of branded products under the same indication suggests established market recognition, with patents expiring around 2010, which likely enables existing generic competition. This patent landscape points to an environment where generic manufacturers can source the API for B2B purposes. |
|---|
Butenafine 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.
Butenafine (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.
Butenafine API manufacturers & distributors
Compare qualified Butenafine API suppliers worldwide. We currently have 5 companies offering Butenafine API, with manufacturing taking place in 5 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 |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Inist St Co. | Producer | South Korea | South Korea | CoA, JDMF | 8 products |
| Kaken Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 1 products |
| Shandong Boyuan | Producer | China | China | BSE/TSE, CoA, MSDS | 55 products |
When sending a request, specify which Butenafine 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.).
Use the list above to find high-quality Butenafine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
