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Sertaconazole | CAS No: 99592-32-2 | GMP-certified suppliers
A medication that supports the topical management of interdigital tinea pedis in adolescents and adults, helping address common dermatophyte infections in localized foot disease.
Therapeutic categories
Primary indications
- For the topical treatment of interdigital tinea pedis in immunocompetent patients 12 years of age and older, caused by <i>Trichophyton rubrum</i>, <i>Trichophyton mentagrophytes</i>, and <i>Epidermophyton floccosum</i>
Product Snapshot
- Topical and vaginal small‑molecule imidazole formulations are available as creams, solutions, inserts, and related semi-solid forms
- They are used for fungal infection management, including interdigital tinea pedis caused by common dermatophytes
- Products are marketed in the US with both approved and investigational regulatory status
Clinical Overview
Pharmacologically, sertaconazole acts as a fungistatic agent through selective inhibition of fungal cytochrome P450 14‑alpha‑demethylase, the enzyme responsible for conversion of lanosterol to ergosterol. Disruption of ergosterol synthesis alters membrane integrity, leading to increased permeability and leakage of intracellular components. Secondary actions described in experimental systems include interference with endogenous respiration, interaction with membrane phospholipids, impaired yeast‑to‑mycelium transformation, reduced purine uptake, and inhibition of triglyceride or phospholipid biosynthesis. These combined effects support broad in vitro activity across dermatophytes, Candida species, and Cryptococcus neoformans, with fungistatic effects demonstrated in several animal infection models.
Systemic exposure following topical use is expected to be minimal, and no detailed absorption, distribution, metabolism, or excretion parameters are established for clinically relevant concentrations. Safety experience largely reflects local administration, with adverse effects primarily limited to transient erythema, pruritus, or burning at the application site. Clinically significant systemic toxicity has not been characterized in topical use, but class effects of azole antifungals should be considered when evaluating potential interactions or off‑label uses.
Sertaconazole is marketed in various regions in dermatological antifungal preparations. Its status includes both approved and investigational use categories, depending on jurisdiction.
For API procurement, sourcing should prioritize suppliers with documented control of polymorphic form, impurity profile, and nitrate counterion consistency. Verification of GMP compliance, validated analytical methods, and stability data supporting the intended formulation route is essential for reliable integration into topical product development.
Identification & chemistry
| Generic name | Sertaconazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 99592-32-2 |
| UNII | 72W71I16EG |
| DrugBank ID | DB01153 |
Pharmacology
| Summary | Sertaconazole is an imidazole antifungal that inhibits fungal CYP51 (14‑α‑demethylase), blocking the conversion of lanosterol to ergosterol and disrupting cell membrane integrity. This sterol depletion increases membrane permeability and contributes to fungistatic activity against dermatophytes, Candida species, and Cryptococcus neoformans. Additional actions may include interference with membrane phospholipids, respiration, and fungal morphologic transitions. |
|---|---|
| Mechanism of action | Sertaconazole interacts with 14-α demethylase, a cytochrome P-450 enzyme necessary to convert lanosterol to ergosterol. 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. Sertaconazole may also inhibit endogenous respiration, interact with membrane phospholipids, inhibit the transformation of yeasts to mycelial forms, inhibit purine uptake, and impair triglyceride and/or phospholipid biosynthesis. |
| Pharmacodynamics | Sertaconazole is an imidazole/triazole type antifungal agent. Sertaconazole is a highly selective inhibitor of fungal cytochrome P-450 sterol C-14 α-demethylation via the inhibition of the enzyme cytochrome P450 14α-demethylase. This enzyme converts lanosterol to ergosterol, and is required in fungal cell wall synthesis. The subsequent loss of normal sterols correlates with the accumulation of 14 α-methyl sterols in fungi and may be partly responsible for the fungistatic activity of fluconazole. Mammalian cell demethylation is much less sensitive to fluconazole inhibition. Sertaconazole exhibits <i>in vitro</i> activity against <i>Cryptococcus neoformans</i> and <i>Candida spp.</i> Fungistatic activity has also been demonstrated in normal and immunocompromised animal models for systemic and intracranial fungal infections due to <i>Cryptococcus neoformans</i> and for systemic infections due to Candida albicans. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cytochrome P450 51 | Yeast | inhibitor |
ADME / PK
| Absorption | Bioavailability is negligible. |
|---|---|
| Protein binding | >99% to plasma |
Formulation & handling
- Sertaconazole is a highly lipophilic small‑molecule antifungal suited for topical and vaginal delivery due to very low aqueous solubility.
- Formulation typically relies on emulsions, creams, or other lipid‑rich vehicles to enhance dispersion and maintain uniformity of the poorly soluble solid API.
- Handling considerations include protection from moisture and ensuring adequate wetting or solubilization steps during topical or vaginal product manufacturing.
Regulatory status
| Lifecycle | The U.S. patent for this API expired in 2014, indicating a long‑established and mature market. With products marketed only in the United States, the API is likely subject to full generic competition and stable late‑lifecycle dynamics. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Sertaconazole appears to have a single identified originator/packager, with branded products marketed primarily in the United States. No evidence of broader EU or other international market presence is shown in the available data. The key U.S. patent expired in 2014, indicating that generic competition is already possible and may be established. |
|---|
Sertaconazole is a type of Triazoles
Triazoles are a prominent subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that possess a chemical structure containing a five-membered ring composed of three nitrogen atoms and two carbon atoms. These compounds have gained significant attention in the pharmaceutical industry due to their diverse pharmacological activities and therapeutic applications.
Triazoles exhibit a broad spectrum of biological activities, including antimicrobial, antifungal, antiviral, anticancer, and anti-inflammatory properties. These characteristics make them valuable in the development of new drugs and treatment options for various diseases.
One notable application of triazoles is their role as antifungal agents. Certain triazole-based drugs, such as fluconazole and itraconazole, have proven highly effective in treating fungal infections. They work by inhibiting the synthesis of ergosterol, a vital component of fungal cell membranes, thus disrupting their growth and replication.
Triazoles have also demonstrated potential as antiviral agents. Compounds like voriconazole and posaconazole exhibit antiviral activity against certain RNA viruses, including influenza and respiratory syncytial virus (RSV). They function by targeting specific viral enzymes or proteins, preventing viral replication and spread.
In addition to their antifungal and antiviral properties, triazoles have been investigated for their anticancer potential. Some derivatives of triazoles have shown promising results in inhibiting cancer cell growth and inducing apoptosis, making them potential candidates for future cancer therapies.
Overall, the versatile nature of triazoles makes them a promising class of compounds in pharmaceutical research and drug development, offering a wide range of therapeutic possibilities for various medical conditions.
Sertaconazole (Triazoles), 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.
Sertaconazole API manufacturers & distributors
Compare qualified Sertaconazole API suppliers worldwide. We currently have 2 companies offering Sertaconazole API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
When sending a request, specify which Sertaconazole 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 Sertaconazole 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.
Frequently asked questions about Sertaconazole API
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Technical
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Regulatory
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