{"id":"adrabetadex","rwe":[],"tags":[],"phase":"discontinued","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"discontinued","trials":["NCT03471143","NCT06679322","NCT02912793","NCT04860960","NCT03643562","NCT02224079","NCT03879655","NCT05033444","NCT02939547","NCT02534844","NCT00914745","NCT01747135","NCT02418676","NCT05607615","NCT04958642"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2002","type":"neutral","milestone":"Phase 1 Initiated","description":"Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BIIB 722 CL and HPβCD in Young H — Healthy"},{"date":"2010","type":"neutral","milestone":"Phase 2 Initiated","description":"Place Controlled Study to Treat Recurrent Herpes Labialis. — Recurrent Herpes Labialis"},{"date":"2017","type":"neutral","milestone":"Phase 4 Initiated","description":"Effect of Cyclodextrin on Sensory Nerve Activity: A Novel Anti-tussive Therapy — Cough"},{"date":"2018","type":"neutral","milestone":"Phase 3 Initiated","description":"VTS-270 to Treat Niemann-Pick Type C1 (NPC1) Disease — Niemann-Pick Disease, Type C"}],"aiSummary":"ADRABETADEX is an investigational agent evaluated in Phase 2 trials for recurrent herpes labialis, Niemann-Pick Type C disease, and acute ischemic stroke, though its exact mechanism class is not specified in the source.","brandName":"ADRABETADEX","companyId":"unknown","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Oligosaccharide","drugClass":"","explanation":"ADRABETADEX is currently being studied in several clinical trials for different conditions. It is being tested for recurrent cold sores, a genetic disorder called Niemann-Pick Type C disease, and for treating stroke. The drug is still in the early stages of research, so its exact effects and benefits are not yet fully understood.","oneSentence":"ADRABETADEX is being tested in clinical trials for cold sores, a rare genetic disorder, and stroke.","technicalDetail":"The specific molecular targets, pathway, and selectivity of ADRABETADEX are not detailed in the provided source text. As an investigational agent, its precise mechanism of action remains to be elucidated through ongoing research."},"commercial":null,"references":[],"biosimilars":[],"companyName":"","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"}],"genericName":"ADRABETADEX","indications":{"approved":[],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT03471143","phase":"Phase 1","title":"Phase 1/2a Study of 2-Hydroxypropyl-Beta-Cyclodextrin Therapy for Infantile Liver Disease Associated With Niemann-Pick Disease, Type C","status":"COMPLETED","sponsor":"Washington University School of Medicine","isPivotal":false,"enrollment":4,"indication":"Niemann-Pick Disease, Type C","completionDate":"2024-10-04"},{"nctId":"NCT06679322","phase":"Phase 2","title":"A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Trial of Androtriol Injection for the Treatment of Acute Ischemic Stroke","status":"NOT_YET_RECRUITING","sponsor":"Beijing Tiantan Hospital","isPivotal":false,"enrollment":300,"indication":"Acute Ischemic Stroke","completionDate":"2025-10-30"},{"nctId":"NCT02912793","phase":"Phase 1","title":"A Phase I/II Study to Evaluate the Safety and PK of iv Trappsol Cyclo (HP-β-CD) in Patients With Niemann-Pick Disease Type C NPC-1 and the Pharmacodynamic Effects of Treatment Upon Markers of Choleste","status":"COMPLETED","sponsor":"Cyclo Therapeutics, Inc.","isPivotal":false,"enrollment":12,"indication":"Niemann-Pick Disease, Type C1","completionDate":"2021-03-03"},{"nctId":"NCT04860960","phase":"Phase 3","title":"Phase 3, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of 2000mg/kg of Trappsol®Cyclo™ (Hydroxypropyl-B-cyclodextrin","status":"ACTIVE_NOT_RECRUITING","sponsor":"Cyclo Therapeutics, Inc.","isPivotal":true,"enrollment":94,"indication":"Niemann-Pick Disease, Type C1","completionDate":"2026-06"},{"nctId":"NCT03643562","phase":"Phase 3","title":"Open-label Evaluation of Adrabetadex in Patients With Neurologic Manifestations of Niemann-Pick Type C Disease (NPC)","status":"TERMINATED","sponsor":"Mandos LLC","isPivotal":true,"enrollment":27,"indication":"Niemann-Pick Type C Disease","completionDate":"2021-11-02"},{"nctId":"NCT02224079","phase":"Phase 1","title":"Safety, Tolerability and Preliminary Pharmacokinetics of Single Rising Doses of 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg BIIB 722 CL (Calculated","status":"COMPLETED","sponsor":"Boehringer Ingelheim","isPivotal":false,"enrollment":100,"indication":"Healthy","completionDate":""},{"nctId":"NCT03879655","phase":"Phase 2","title":"A Phase 2B/3 Open-label Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 Disease Previously Treated Under Protocol VTS301","status":"TERMINATED","sponsor":"Mandos LLC","isPivotal":true,"enrollment":2,"indication":"Niemann-Pick Disease, Type C","completionDate":"2021-10-18"},{"nctId":"NCT05033444","phase":"Phase 1","title":"A Phase 1, Randomized, Double-Blind, Placebo-Controlled, First in Human Study of the Safety, Tolerability and Pharmacokinetics of PRV-002 in Healthy Volunteers.","status":"COMPLETED","sponsor":"Odyssey Group International, Inc.","isPivotal":false,"enrollment":40,"indication":"Traumatic Brain Injury (TBI)","completionDate":"2024-09-13"},{"nctId":"NCT02939547","phase":"Phase 1","title":"A Phase I Study to Evaluate the Single and Multiple-dose Pharmacokinetics of Intravenous Trappsol Cyclo (HP-Beta-CD) in Patients With Niemann-Pick Disease Type C (NPC-1) and the Effects of Dosing Upon","status":"COMPLETED","sponsor":"Cyclo Therapeutics, Inc.","isPivotal":false,"enrollment":13,"indication":"Niemann-Pick Disease, Type C1","completionDate":"2020-02-10"},{"nctId":"NCT02534844","phase":"Phase 2","title":"A Phase 2b/3 Prospective, Randomized, Double-Blind, Sham-Controlled 3-Part Trial of VTS-270 (2-hydroxypropyl-β-cyclodextrin) in Subjects With Neurologic Manifestations of Niemann-Pick Type C1 (NPC1) D","status":"COMPLETED","sponsor":"Mandos LLC","isPivotal":true,"enrollment":56,"indication":"Niemann-Pick Disease, Type C","completionDate":"2018-03-28"},{"nctId":"NCT00914745","phase":"Phase 2","title":"Single Center Phase I/II, Placebo Controlled, Randomized, Double-Blind Study to Treat Recurrent Herpes Labialis by Topical Treatment With Hydroxypropyl-Beta-Cyclodextrin-Ointment (HPßCD-20% Ointment)","status":"COMPLETED","sponsor":"University of Zurich","isPivotal":false,"enrollment":40,"indication":"Recurrent Herpes Labialis","completionDate":"2011-05"},{"nctId":"NCT01747135","phase":"Phase 1","title":"Hydroxypropyl Beta Cyclodextrin for Niemann-Pick Type C1 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