{"id":"ambroxol-hydrochloride","safety":{"commonSideEffects":[{"rate":null,"effect":"Gastrointestinal disturbances (nausea, vomiting, diarrhea)"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Rash or allergic reactions"},{"rate":null,"effect":"Dizziness"}]},"_chembl":{"chemblId":"CHEMBL1514634","moleculeType":"Small molecule","molecularWeight":"414.57"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Ambroxol works by stimulating serous cells in the respiratory tract to increase mucus secretion while simultaneously reducing mucus viscosity through its mucolytic properties. 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Istituto Neurologico Carlo Besta","startDate":"2022-03-09","conditions":"Parkinson Disease, GBA Gene Mutation","enrollment":65},{"nctId":"NCT05778617","phase":"PHASE3","title":"Ambroxol to Slow Progression in Parkinson Disease","status":"RECRUITING","sponsor":"University College, London","startDate":"2025-02-25","conditions":"Parkinson Disease","enrollment":330},{"nctId":"NCT06693362","phase":"PHASE1","title":"A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Uterine Blood Mesenchymal Stem Cells Injection for the Treatment of Severe Pneumonia Caused by Viruses","status":"RECRUITING","sponsor":"Ruijin Hospital","startDate":"2025-01-20","conditions":"Severe Viral Pneumonia(Not Include COVID-19)","enrollment":60},{"nctId":"NCT06193421","phase":"PHASE1, PHASE2","title":"High-Dose Ambroxol in GBA1-Related Parkinson","status":"UNKNOWN","sponsor":"Agyany Pharma LTD","startDate":"2023-10-24","conditions":"Parkinson Disease, GBA Gene Mutation","enrollment":40},{"nctId":"NCT05663905","phase":"PHASE4","title":"Efficacy of Intravenous Amboxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients","status":"COMPLETED","sponsor":"National University of Malaysia","startDate":"2023-01-07","conditions":"Severe Pneumonia, Community-acquired Pneumonia, Hospital-acquired Pneumonia","enrollment":32},{"nctId":"NCT04405596","phase":"PHASE1, PHASE2","title":"Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia","status":"NOT_YET_RECRUITING","sponsor":"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","startDate":"2025-01","conditions":"Lewy Body Disease","enrollment":15},{"nctId":"NCT05959850","phase":"PHASE2","title":"A Double-blind Randomised, Placebo-controlled Clinical Trial to Test Ambroxol Treatment in ALS","status":"UNKNOWN","sponsor":"The Florey Institute of Neuroscience and Mental Health","startDate":"2023-06-13","conditions":"Amyotrophic Lateral Sclerosis","enrollment":50},{"nctId":"NCT05830396","phase":"PHASE2, PHASE3","title":"GRoningen Early-PD Ambroxol Treatment","status":"UNKNOWN","sponsor":"University Medical Center Groningen","startDate":"2023-05","conditions":"Parkinson, Parkinson Disease","enrollment":80},{"nctId":"NCT03950050","phase":"PHASE2","title":"Ambroxol Therapy for Patients With Type 1 Gaucher Disease and Suboptimal Response to Enzyme Replacement Therapy","status":"COMPLETED","sponsor":"Shaare Zedek Medical Center","startDate":"2019-03-01","conditions":"Gaucher Disease, Type 1","enrollment":40},{"nctId":"NCT03583658","phase":"PHASE3","title":"Efficacy and Safety Study of New Ambroxol Hardboiled Lozenges in Acute Pharyngitis","status":"COMPLETED","sponsor":"Sanofi","startDate":"2018-06-30","conditions":"Pharyngitis","enrollment":390},{"nctId":"NCT03415269","phase":"PHASE2","title":"A Study of the Effect of 20 mg Ambroxol Hydrochloride on Acute Cough.","status":"COMPLETED","sponsor":"Hull University Teaching Hospitals NHS Trust","startDate":"2018-02-15","conditions":"Cough","enrollment":14},{"nctId":"NCT00148499","phase":"PHASE3","title":"Efficacy and Tolerability of Ambroxol Lozenge 20 mf in Relieving Pain of Sore Throat in Pat. With Acute/Viralpharyngitis","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2005-10","conditions":"Pharyngitis","enrollment":751},{"nctId":"NCT01713179","phase":"PHASE1, PHASE2","title":"Effects of Oral Mucolytics on Tear Film and Ocular Surface","status":"COMPLETED","sponsor":"Hallym University Kangnam Sacred Heart Hospital","startDate":"2011-08","conditions":"In the Present Study, we Investigated the Effects of Oral Ambroxol on Tear Film and Ocular Surface.","enrollment":20},{"nctId":"NCT02572609","phase":"PHASE1","title":"Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2011-11","conditions":"Healthy","enrollment":""},{"nctId":"NCT02036775","phase":"PHASE1","title":"Pharmacokinetics and Bioavailability Study of Lasolvan Hard Capsules and Effervescent Tablets in Healthy Volunteers","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2014-03","conditions":"Healthy","enrollment":24},{"nctId":"NCT02194270","phase":"PHASE1","title":"Relative Bioavailability of Ambroxol Hydrochloride of Soft Pastilles Compared to Ambroxol Hydrochloride Syrup in Healthy Male and Female Volunteers","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2004-09","conditions":"Healthy","enrollment":24},{"nctId":"NCT02194296","phase":"PHASE1","title":"Relative Bioavailability of Ambroxol Hydrochloride Lozenge in Comparison to Ambroxol Hydrochloride Syrup (Mucosolvan®) in Healthy Female and Male Volunteers","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"1999-06","conditions":"Healthy","enrollment":20},{"nctId":"NCT01573663","phase":"PHASE1","title":"A Drug-Drug Interaction Study of Ambroxol and Levodropropizine","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company Limited","startDate":"2012-02","conditions":"Healthy","enrollment":21}],"_emaApprovals":[],"_faersSignals":[{"count":327,"reaction":"PYREXIA"},{"count":326,"reaction":"PNEUMONIA"},{"count":324,"reaction":"DYSPNOEA"},{"count":273,"reaction":"OFF LABEL USE"},{"count":226,"reaction":"COUGH"},{"count":201,"reaction":"ANAEMIA"},{"count":198,"reaction":"CONSTIPATION"},{"count":176,"reaction":"NASOPHARYNGITIS"},{"count":173,"reaction":"NAUSEA"},{"count":167,"reaction":"MALAISE"}],"_approvalHistory":[],"publicationCount":182,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Mucosolvan®","Lasolvan®","Mucosolvan","Ambroxol","Lysopain Ambr Mint™"],"phase":"marketed","status":"active","brandName":"Ambroxol Hydrochloride","genericName":"Ambroxol Hydrochloride","companyName":"National University of Malaysia","companyId":"national-university-of-malaysia","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ambroxol Hydrochloride is a small molecule intervention used in clinical trials to study its potential effects on various conditions, including Parkinson Disease and Gaucher Disease. It is being investigated as a disease-modifying treatment, specifically in the context of GBA-PD, a subtype of Parkinson Disease associated with a GBA gene mutation.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}