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Luliconazole | CAS No: 187164-19-8 | GMP-certified suppliers
A medication that treats interdigital tinea pedis, tinea cruris, and tinea corporis to support management of superficial fungal infections.
Therapeutic categories
Primary indications
- Luliconazole is indicated for the treatment of interdigital tinea pedis, tinea cruris, or tinea corporis infections caused by Trichophyton rubrum and Epidermophyton floccosum
Product Snapshot
- Topical small‑molecule API used in cream formulations
- Primary use is for dermatophyte infections such as interdigital tinea pedis, tinea cruris, and tinea corporis
- Approved for the US market
Clinical Overview
The clinical indication includes interdigital tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum. Its pharmacodynamic activity is fungicidal against these organisms, with effects attributed to disruption of fungal cell membrane integrity.
Luliconazole’s mechanism of action has not been fully defined. Available evidence supports inhibition of lanosterol demethylase, a key enzyme required for ergosterol biosynthesis. Reduced ergosterol content compromises fungal membrane structure and function, contributing to loss of viability.
As a topical agent, luliconazole demonstrates minimal systemic involvement, and systemic pharmacokinetic parameters are not central to its clinical use. Published information indicates low systemic exposure after dermal administration, but detailed absorption, distribution, metabolism, or excretion values are not established in the provided data.
Safety considerations primarily relate to local tolerability. Application-site reactions such as erythema or irritation have been observed. Systemic adverse events are uncommon due to limited absorption. Luliconazole is classified among azole antifungals and is identified as an inhibitor of CYP2C19 and CYP3A isoenzymes, but the clinical significance of these interactions is minimal in topical treatment settings where systemic concentrations are low.
Luliconazole is used in dermatological practice where short-course, once-daily regimens are common for the approved indications. Its approval status and global dermatology usage contexts support its role in managing superficial fungal infections.
For API procurement, suppliers should provide material produced under appropriate GMP conditions with defined impurity controls, stereochemical integrity, and verification of identity consistent with regulatory documentation to support downstream formulation and registration activities.
Identification & chemistry
| Generic name | Luliconazole |
|---|---|
| Molecule type | Small molecule |
| CAS | 187164-19-8 |
| UNII | RE91AN4S8G |
| DrugBank ID | DB08933 |
Pharmacology
| Summary | Luliconazole is an antifungal agent that primarily targets fungal lanosterol demethylase (CYP51), a key enzyme in ergosterol biosynthesis. Inhibiting this pathway disrupts ergosterol production and alters fungal cell membrane integrity. Its pharmacodynamic effect includes fungicidal activity against Trichophyton rubrum and Epidermophyton floccosum. |
|---|---|
| Mechanism of action | The exact mechanism of action for luliconazole's anti-fungal activity is still not known, but luliconazole is thought to inhibit the enzyme lanosterol demethylase. Lanosterol demethylase is needed for the synthesis of ergosterol, which is a major component of the fungus cell membranes. |
| Pharmacodynamics | Luliconazole kills the organisms Trichophyton rubrum and Epidermophyton floccosum, most likely by altering their fungal cell membranes. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Cytochrome P450 51 | Yeast | inhibitor |
ADME / PK
| Absorption | Although luliconazole is administered topically, clinical studies have shown that after the first dose in patients with tina pedis, a maximum plasma concentration of 0.40 ± 0.76 ng/mL (mean ± SD) occurred in 16.9 ± 9.39 hours (mean ± SD). |
|---|---|
| Half-life | The half life of luliconazole has yet to be determined. |
| Protein binding | Plasma protein binding of luliconazole is >99%. |
| Metabolism | The metabolism of luliconazole has yet to be determined. |
| Route of elimination | The route of elimination of luliconazole has yet to be determined. |
| Volume of distribution | The volume of distribution was not quantified. |
| Clearance | The clearance of luliconazole has yet to be determined. |
Formulation & handling
- Low aqueous solubility and lipophilicity support incorporation into topical cream or ointment bases with suitable solubilizers or emulsifiers.
- Solid API requires controlled blending and dispersion to ensure uniformity in semi‑solid formulations.
- Chemical stability is generally good for a small aromatic molecule, but protection from excessive heat and light helps maintain potency in topical products.
Regulatory status
| Lifecycle | The API remains in a protected market phase in the US, with multiple patents extending into 2033–2034. Given these expiry dates and its sole presence in the US market, the product is still in an early‑to‑mid lifecycle stage with limited generic entry expected before the early 2030s. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Luliconazole is supplied primarily by a single originator company, with manufacturing focused on supporting the branded product marketed in the United States. Its commercial presence is largely limited to the U.S. market, with no broad evidence of established EU or other international branded distribution. Although an early patent has expired, multiple later‑expiring U.S. patents running into 2033–2034 indicate that significant generic competition is unlikely in the near term. |
|---|
Safety
| Toxicity | In clinical trials, no serious toxicity was reported, only local irritation (mild contact dermatitis and cellulitis) at the site of application was found. |
|---|
- Reported adverse effects were limited to mild, localized reactions such as contact dermatitis and cellulitis at application sites
- No systemic or serious toxicity signals were identified in clinical evaluations
- Handling considerations primarily relate to minimizing dermal exposure to reduce the likelihood of local irritation
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Luliconazole is a type of 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.
Luliconazole API manufacturers & distributors
Compare qualified Luliconazole API suppliers worldwide. We currently have 8 companies offering Luliconazole 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 |
|---|---|---|---|---|---|
| ACE Japan | Producer | Japan | Japan | CoA | 76 products |
| Dalian Wista Pharma Co Lt... | Producer | China | China | CoA | 16 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Hamari Chemicals | Producer | Japan | Japan | CoA, JDMF, USDMF | 12 products |
| Maithri Drugs | Producer | India | India | CoA, USDMF | 12 products |
| Prachi Pharmaceuticals | Producer | India | India | CoA, FDA, GMP, ISO9001, USDMF, WHO-GMP | 12 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Viwit Pharmaceutical Co.,... | Producer | China | China | CoA, FDA, GMP, MSDS, USDMF | 18 products |
When sending a request, specify which Luliconazole 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 Luliconazole 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.
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Technical
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