{"id":"botulinum-toxin-a-gsk1358820","safety":{"commonSideEffects":[{"rate":null,"effect":"Injection site pain or bruising"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Muscle weakness or paralysis (off-target)"},{"rate":null,"effect":"Ptosis (eyelid drooping)"},{"rate":null,"effect":"Dry mouth or dysphagia"}]},"_chembl":{"chemblId":"CHEMBL4297862","moleculeType":"Protein"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"GSK1358820 is a recombinant botulinum toxin A that irreversibly cleaves SNAP-25, a protein essential for acetylcholine vesicle fusion and release. This prevents neuromuscular transmission, leading to localized muscle relaxation. The effect is temporary, typically lasting 3–4 months, after which nerve terminals regenerate and muscle function returns.","oneSentence":"Botulinum toxin A blocks acetylcholine release at the neuromuscular junction by cleaving SNARE proteins, causing temporary muscle paralysis.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:41:48.276Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Cervical dystonia"},{"name":"Blepharospasm"},{"name":"Hemifacial spasm"},{"name":"Chronic migraine"},{"name":"Spasticity"},{"name":"Aesthetic/cosmetic indications (wrinkles, hyperhydrosis)"}]},"trialDetails":[{"nctId":"NCT02849418","phase":"PHASE3","title":"Efficacy and Safety Study of GSK1358820 in Japanese Patients With Urinary Incontinence Due to Neurogenic Detrusor Overactivity","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-10-11","conditions":"Urinary Bladder, Overactive","enrollment":21},{"nctId":"NCT02820844","phase":"PHASE3","title":"Efficacy and Safety of GSK1358820 in Subjects With Overactive Bladder","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2016-08-10","conditions":"Urinary Bladder, Overactive","enrollment":250},{"nctId":"NCT03261167","phase":"PHASE3","title":"A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 in Subjects With Post-stroke Upper Limb Spasticity","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-08-02","conditions":"Spasticity, Post-Stroke","enrollment":124},{"nctId":"NCT01153815","phase":"PHASE3","title":"A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Upper Limb Spasticity","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-04","conditions":"Cerebrovascular Accident","enrollment":170},{"nctId":"NCT00460564","phase":"PHASE3","title":"Study Of GSK1358820 In Patients With Post-Stroke Upper Limb Spasticity","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-05","conditions":"Post-Stroke Spasticity, Cerebrovascular Accident","enrollment":109},{"nctId":"NCT01205451","phase":"PHASE3","title":"A Multicenter, Open-label, Single Dose Study of the Safety and Efficacy of GSK1358820 (Botulinum Toxin Type A) in Chinese Subjects With Post-stroke Focal Upper Limb Spasticity","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-09","conditions":"Spasticity, Post-Stroke","enrollment":109},{"nctId":"NCT01584843","phase":"PHASE3","title":"Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Strabismus","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-05","conditions":"Strabismus","enrollment":41},{"nctId":"NCT01128738","phase":"PHASE3","title":"GSK1358820 (Botulinum Toxin A) PhIII DB & OL Study in Patients With Axillary Hyperhidrosis","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-04","conditions":"Hyperhidrosis","enrollment":152},{"nctId":"NCT00460655","phase":"PHASE3","title":"Study of GSK1358820 In Patients With Post-Stroke Lower Limb Spasticity","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2007-05","conditions":"Post-Stroke Spasticity, Cerebrovascular Accident","enrollment":120}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Botulinum toxin A (GSK1358820)","genericName":"Botulinum toxin A (GSK1358820)","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Botulinum toxin A blocks acetylcholine release at the neuromuscular junction by cleaving SNARE proteins, causing temporary muscle paralysis. Used for Cervical dystonia, Blepharospasm, Hemifacial spasm.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}