{"id":"spinosad-topical","safety":{"commonSideEffects":[{"rate":null,"effect":"Application site erythema"},{"rate":null,"effect":"Application site pruritus"},{"rate":null,"effect":"Ocular irritation"},{"rate":null,"effect":"Skin irritation"}]},"_chembl":{"chemblId":"CHEMBL2040681","moleculeType":"Small molecule","molecularWeight":"1477.96"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"Spinosad is a natural insecticide that activates nicotinic acetylcholine receptors and GABA-gated chloride channels in insects, causing paralysis and death.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:37:56.344Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Head lice (Pediculosis capitis)"},{"name":"Body lice (Pediculosis corporis)"},{"name":"Pubic lice (Phthirus pubis)"}]},"trialDetails":[{"nctId":"NCT06720896","phase":"PHASE2","title":"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.","status":"RECRUITING","sponsor":"Aperta Biosciences, LLC","startDate":"2025-11-01","conditions":"Blepharitis","enrollment":100},{"nctId":"NCT05310734","phase":"PHASE4","title":"PK and Safety Study of Natroba Topical Suspension 0.9% in Subjects 1 Month to 3 Years 11 Months of Age With Scabies","status":"RECRUITING","sponsor":"Cipher Pharmaceuticals Inc.","startDate":"2022-03-04","conditions":"Scabies","enrollment":50},{"nctId":"NCT02485704","phase":"PHASE3","title":"Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies","status":"COMPLETED","sponsor":"ParaPRO LLC","startDate":"2017-05-10","conditions":"Scabies","enrollment":280},{"nctId":"NCT02485717","phase":"PHASE3","title":"Phase 3 Trial to Assess the Safety and Efficacy of Natroba for the Treatment of Scabies","status":"COMPLETED","sponsor":"ParaPRO LLC","startDate":"2017-05-02","conditions":"Scabies","enrollment":291},{"nctId":"NCT00858481","phase":"PHASE2","title":"A Pilot Dose Ranging Study of Spinosad Creme Rinse","status":"COMPLETED","sponsor":"ParaPRO LLC","startDate":"2005-09","conditions":"Pediculosis Capitis, Head Lice","enrollment":36},{"nctId":"NCT01660321","phase":"PHASE4","title":"Pharmacokinetic (PK) and Tolerance Study of Natroba Topical Suspension in Pediatrics With an Active Head Lice Infestation","status":"COMPLETED","sponsor":"ParaPRO LLC","startDate":"2011-09","conditions":"Pediculosis","enrollment":26},{"nctId":"NCT00545168","phase":"PHASE3","title":"Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice","status":"COMPLETED","sponsor":"ParaPRO LLC","startDate":"2007-09","conditions":"Pediculus Capitis Infestation","enrollment":480},{"nctId":"NCT00545753","phase":"PHASE3","title":"Safety and Efficacy Study of NatrOVA Creme Rinse - 1% and NIX Creme Rinse in Subjects 6 Months or Older With Head Lice","status":"COMPLETED","sponsor":"ParaPRO LLC","startDate":"2007-09","conditions":"Pediculosis","enrollment":558},{"nctId":"NCT00311779","phase":"PHASE2","title":"A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis","status":"COMPLETED","sponsor":"ParaPRO LLC","startDate":"2006-03","conditions":"Pediculosis Capitis (Head Lice)","enrollment":120}],"_emaApprovals":[],"_faersSignals":[{"count":1,"reaction":"DRUG INEFFECTIVE"},{"count":1,"reaction":"PRODUCT COMPLAINT"}],"_approvalHistory":[],"publicationCount":69,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Natroba","benzyl alcohol"],"phase":"marketed","status":"active","brandName":"Spinosad Topical","genericName":"Spinosad Topical","companyName":"Cipher Pharmaceuticals Inc.","companyId":"cipher-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}