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Natroba (SPINOSAD)
Natroba works by activating glutamate-gated chloride channels in the nervous system of lice, leading to an influx of chloride ions and eventual death.
Natroba (Spinosad) is a small molecule pediculicide developed by PARAPRO LLC and currently owned by Cipher. It was FDA approved in 2011 for the treatment of pediculosis capitis. Natroba works by targeting the nervous system of lice, ultimately leading to their death. It is a patented medication with no generic manufacturers available. Key safety considerations include potential skin irritation and allergic reactions.
At a glance
| Generic name | SPINOSAD |
|---|---|
| Sponsor | Cipher |
| Drug class | Pediculicide [EPC] |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2011 |
Mechanism of action
Spinosad causes neuronal excitation in insects. After periods of hyperexcitation, lice and mites become paralyzed and die.
Approved indications
- Pediculosis capitis
Common side effects
- Application site erythema
- Ocular erythema
- Application site irritation
- Dry skin
- Application site dryness
- Application site exfoliation
- Alopecia
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)
Patents
| Patent | Expiry | Type |
|---|---|---|
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Natroba CI brief — competitive landscape report
- Natroba updates RSS · CI watch RSS
- Cipher portfolio CI