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Spinosad Topical
Spinosad Topical is a Natural insecticide Small molecule drug developed by Cipher Pharmaceuticals Inc.. It is currently FDA-approved for Head lice (Pediculosis capitis), Body lice (Pediculosis corporis), Pubic lice (Phthirus pubis). Also known as: Natroba, benzyl alcohol.
Spinosad is a natural insecticide that activates nicotinic acetylcholine receptors and GABA-gated chloride channels in insects, causing paralysis and death.
Spinosad Topical is a small molecule used to treat various conditions, including Pediculosis Capitis (Head Lice), Pediculosis, Blepharitis, and Scabies. It is available in different formulations, including Spinosad Creme Rinse and Spinosad, and has been compared to Permethrin 1% in clinical trials.
At a glance
| Generic name | Spinosad Topical |
|---|---|
| Also known as | Natroba, benzyl alcohol |
| Sponsor | Cipher Pharmaceuticals Inc. |
| Drug class | Natural insecticide |
| Target | Nicotinic acetylcholine receptors; GABA-gated chloride channels |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Spinosad is a fermentation product of Saccharopolyspora spinosa that acts as a neurotoxin in arthropods. It binds to nicotinic acetylcholine receptors and enhances GABA-gated chloride channel activity, leading to uncontrolled neuronal firing, paralysis, and death of target parasites. When applied topically, it kills lice and other ectoparasites on contact or ingestion.
Approved indications
- Head lice (Pediculosis capitis)
- Body lice (Pediculosis corporis)
- Pubic lice (Phthirus pubis)
Common side effects
- Application site erythema
- Application site pruritus
- Ocular irritation
- Skin irritation
Key clinical trials
- A Phase 2, Controlled, Double Blind, Randomized and Multicenter Study to Compare Efficacy and Safety of a Novel Topical Therapy (APT-001, Spinosad 1.8%) in Patients With Blepharitis. (PHASE2)
- PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies (PHASE4)
- Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies (PHASE3)
- Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies (PHASE3)
- A Pilot Dose Ranging Study of Spinosad Creme Rinse (PHASE2)
- Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation (PHASE4)
- Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice (PHASE3)
- Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Spinosad Topical CI brief — competitive landscape report
- Spinosad Topical updates RSS · CI watch RSS
- Cipher Pharmaceuticals Inc. portfolio CI
Frequently asked questions about Spinosad Topical
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Related
- Drug class: All Natural insecticide drugs
- Target: All drugs targeting Nicotinic acetylcholine receptors; GABA-gated chloride channels
- Manufacturer: Cipher Pharmaceuticals Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology
- Indication: Drugs for Head lice (Pediculosis capitis)
- Indication: Drugs for Body lice (Pediculosis corporis)
- Indication: Drugs for Pubic lice (Phthirus pubis)
- Also known as: Natroba, benzyl alcohol
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing