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Spinosad | CAS No: 168316-95-8 | GMP-certified suppliers
A medication that treats head lice and scabies infestations in adults and children, offering effective topical control for parasitic conditions across key markets.
Therapeutic categories
Primary indications
- Spinosad is indicated for the topical treatment of head lice infestation in adult and pediatric patients ≥6 months old
- It is also indicated for the topical treatment of scabies infestation in adult and pediatric patients ≥4 years old
Product Snapshot
- Spinosad is available as oral and topical small‑molecule formulations including tablets, chewable tablets, and suspensions
- It is used for the management of head lice and scabies infestations
- It holds US approval with additional investigational and veterinary‑approved statuses
Clinical Overview
Spinosad is derived from compounds produced by the actinomycete Saccharopolyspora spinosa and is classified among aminoglycoside-related polyketide lactones. Its pharmacology is characterized by insect-specific neuroexcitation that results in rapid paralysis. Pharmacodynamic studies show that spinosyn A exhibits slightly higher biological activity than spinosyn D. Unlike conventional insecticides targeting well-defined neural receptors, spinosyn A demonstrates a distinctive mechanism with features resembling GABA antagonism. The combined activity of spinosyn A and D primarily reflects alteration of nicotinic acetylcholine receptor function in insects, inducing sustained neuronal activation and subsequent organism death.
Systemic absorption following topical application in humans is minimal, and clinically meaningful plasma concentrations are generally not observed. As a result, classical ADME parameters such as systemic clearance or volume of distribution are not well defined for topical use. Local tolerability is typically favorable, although application-site erythema or irritation may occur. Due to its insecticidal class effects, accidental oral exposure could theoretically result in neurotoxic manifestations, reinforcing the importance of appropriate handling in household and clinical settings.
Commercial formulations are commonly marketed for lice management, though naming conventions vary by region. Veterinary and agricultural applications remain context dependent and may be regulated differently across jurisdictions.
For API procurement, suppliers should provide confirmation of spinosyn A to spinosyn D ratio, residual solvent profiles, and control of microbial and fermentation-derived impurities. Consistent characterization of potency and stereochemical integrity is essential for quality-assured formulation development.
Identification & chemistry
| Generic name | Spinosad |
|---|---|
| Molecule type | Small molecule |
| CAS | 168316-95-8 |
| UNII | XPA88EAP6V |
| DrugBank ID | DB08823 |
Pharmacology
| Summary | Spinosad, a mixture of spinosyn A and D, acts primarily by altering nicotinic acetylcholine receptor function in ectoparasites, leading to neuronal hyperexcitation. This activity produces paralysis and death of lice and scabies mites, with spinosyn A showing slightly greater biological activity and additional GABA‑antagonist–like effects. The agent’s pharmacology reflects a novel neurotoxic mechanism distinct from conventional insecticidal targets. |
|---|---|
| Mechanism of action | Spinosad is a mixture of spinosyn A and spinosyn D in a 5:1 ratio. This combination causes neuronal hyperexcitation through mostly alteration of nicotinic acetylcholine receptors, which ultimately leads to lice paralysis and death. |
| Pharmacodynamics | Spinosyn A does not appear to directly interact with any known relevant insecticidal targets, but instead boasts a novel mechanism that resembles a GABA antagonist. Spinosyn A is also slightly more biologically active than spinosyn D. |
ADME / PK
| Absorption | Not absorbed if administered topically. |
|---|---|
| Protein binding | Not plasma protein bound if administered topically. |
| Volume of distribution | No distribution if administered topically. |
Formulation & handling
- Oral formulations require solubilization strategies due to very low aqueous solubility and high lipophilicity.
- Topical suspensions should account for its liquid state and hydrophobic profile to ensure uniform dispersion and physical stability.
- High molecular weight for a small molecule may influence permeability and may require absorption enhancers in oral solid dosage forms.
Regulatory status
| Lifecycle | Most U.S. patents covering this API have expired, with a single later-expiring patent lasting until 2033, indicating a market that is largely mature with some remaining protection. With commercialization limited to the United States, the product is in a late lifecycle phase aside from the coverage provided by the final patent. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Spinosad appears to be supplied primarily through a limited number of originator manufacturers, with branded products marketed mainly in the United States and limited evidence of broad commercialization in the EU or other regions. Earlier U.S. patents have expired, but a later-expiring patent extending to 2033 indicates that full generic entry may be restricted for certain protected uses or formulations. As a result, current generic competition is likely limited, with broader entry dependent on remaining patent coverage. |
|---|
Safety
| Toxicity | Natroba contains benzyl alcohol, which should be avoided in neonates due to associated severe adverse effects and potential fatality. For use only on the scalp and associated hair. Avoid ingestion and contact with eyes. Spinosad itself is not hazardous by the oral, dermal, ocular, or inhalational routes. |
|---|
- Contains benzyl alcohol
- Associated with severe toxicity in neonates and requires controlled handling to prevent exposure in this population
- Intended for topical application only
Spinosad is a type of Scabicides
Scabicides are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of scabies, a highly contagious skin infestation caused by the mite Sarcoptes scabiei. This category includes various chemical compounds specifically designed to eradicate scabies mites and alleviate the symptoms associated with the condition.
The primary function of scabicides is to eliminate the mites by targeting their nervous system, reproductive abilities, or exoskeleton. These APIs typically work by interfering with the mites' nerve impulses or metabolic processes, ultimately leading to their paralysis or death. Commonly employed scabicidal ingredients include permethrin, malathion, benzyl benzoate, and sulfur compounds.
Scabicides can be formulated into different dosage forms such as creams, lotions, or soaps for topical application. These formulations are designed to ensure optimal delivery of the active ingredient to the affected areas of the skin, maximizing efficacy while minimizing potential side effects.
When applied as directed, scabicides can effectively eliminate scabies infestations and provide relief from symptoms such as itching, rash, and skin irritation. It is essential to follow proper hygiene practices, including washing and disinfecting clothing, bedding, and personal items to prevent reinfestation.
In conclusion, scabicidal APIs play a crucial role in the treatment of scabies, offering an effective solution to combat the infestation and relieve associated symptoms. By targeting the mites' nervous system or metabolism, scabicides can effectively eliminate the parasite and provide much-needed relief for individuals affected by scabies.
Spinosad (Scabicides), classified under Dermatological Agents
Dermatological agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of various skincare and dermatology products. These APIs are specifically designed to target and treat skin conditions, offering effective solutions for a wide range of dermatological concerns.
Dermatological agents encompass a diverse array of compounds, including corticosteroids, antifungal agents, antibacterials, retinoids, and immunomodulators. Each API within this category possesses unique properties and mechanisms of action, enabling them to address specific skin-related issues.
Corticosteroids, for instance, are potent anti-inflammatory agents commonly used in the treatment of skin conditions like eczema, psoriasis, and dermatitis. Antifungal agents, on the other hand, combat fungal infections such as athlete's foot or ringworm. Antibacterials are effective against bacterial infections, while retinoids promote skin cell turnover and treat acne and photoaging. Immunomodulators regulate the immune response, providing relief from conditions like atopic dermatitis.
The development and application of dermatological APIs involve rigorous research, clinical trials, and regulatory compliance. These APIs are typically integrated into topical creams, ointments, gels, and lotions, ensuring targeted delivery to the affected areas of the skin.
Dermatological agents play a crucial role in the management and treatment of various skin disorders. By harnessing the therapeutic properties of these APIs, pharmaceutical companies can develop innovative skincare products that cater to the diverse needs of individuals seeking effective dermatological solutions.
Spinosad API manufacturers & distributors
Compare qualified Spinosad API suppliers worldwide. We currently have 3 companies offering Spinosad 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA | 229 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 235 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
When sending a request, specify which Spinosad 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 Spinosad 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 Spinosad API
Sourcing
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Technical
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Regulatory
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Pharmaoffer
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