{"id":"dropropizine","rwe":[{"pmid":"33068328","year":"2021","title":"Catalytic, Kinetic, and Mechanistic Insights into the Fixation of CO(2) with Epoxides Catalyzed by Phenol-Functionalized Phosphonium Salts.","finding":"","journal":"ChemSusChem","studyType":"Clinical Study"},{"pmid":"32453324","year":"2020","title":"Synthesis of (18)O-labelled alcohols from unlabelled alcohols.","finding":"","journal":"Chemical communications (Cambridge, England)","studyType":"Clinical Study"},{"pmid":"31814444","year":"2021","title":"Characteristics, Properties and Analytical Methods for Determination of Dropropizine and Levodropropizine: A Review.","finding":"","journal":"Critical reviews in analytical chemistry","studyType":"Clinical Study"},{"pmid":"31407623","year":"2019","title":"Identification of biomarkers, pathways and potential therapeutic agents for white adipocyte insulin resistance using bioinformatics analysis.","finding":"","journal":"Adipocyte","studyType":"Clinical Study"},{"pmid":"30896275","year":"2020","title":"Stereoselective pharmacokinetics and tissue distribution of levodropropizine after administration of pure levodropropizine and the rac-dropropizine to Sprague-Dawley rats.","finding":"","journal":"Xenobiotica; the fate of foreign compounds in biological systems","studyType":"Clinical Study"}],"tags":[{"label":"dropropizine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"R05DB19","category":"atc"},{"label":"Active","category":"status"},{"label":"Non-productive cough","category":"indication"},{"label":"Antitussive Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"}],"phase":"phase_3","safety":{"commonSideEffects":[{"effect":"Headache","drugRate":"5.4%","placeboRate":"","totalAtRisk":92,"totalAffected":5,"trialsReporting":1},{"effect":"Dry mouth","drugRate":"2.2%","placeboRate":"","totalAtRisk":92,"totalAffected":2,"trialsReporting":1},{"effect":"Alanine aminotransferase increased","drugRate":"2.2%","placeboRate":"","totalAtRisk":92,"totalAffected":2,"trialsReporting":1},{"effect":"Hypoaesthesia oral","drugRate":"1.1%","placeboRate":"","totalAtRisk":92,"totalAffected":1,"trialsReporting":1},{"effect":"Nausea","drugRate":"1.1%","placeboRate":"","totalAtRisk":92,"totalAffected":1,"trialsReporting":1},{"effect":"Dizziness","drugRate":"1.1%","placeboRate":"","totalAtRisk":92,"totalAffected":1,"trialsReporting":1},{"effect":"Malaise","drugRate":"1.1%","placeboRate":"","totalAtRisk":92,"totalAffected":1,"trialsReporting":1},{"effect":"Aspartate aminitransferase increased","drugRate":"1.1%","placeboRate":"","totalAtRisk":92,"totalAffected":1,"trialsReporting":1},{"effect":"Haematuria","drugRate":"1.1%","placeboRate":"","totalAtRisk":92,"totalAffected":1,"trialsReporting":1},{"effect":"Gastroduodenitis","drugRate":"0.0%","placeboRate":"","totalAtRisk":92,"totalAffected":0,"trialsReporting":1},{"effect":"Abdominal pain","drugRate":"0.0%","placeboRate":"","totalAtRisk":92,"totalAffected":0,"trialsReporting":1},{"effect":"Dysgeusia","drugRate":"0.0%","placeboRate":"","totalAtRisk":92,"totalAffected":0,"trialsReporting":1},{"effect":"Sleep disorders","drugRate":"0.0%","placeboRate":"","totalAtRisk":92,"totalAffected":0,"trialsReporting":1}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"catabex","offLabel":[],"synonyms":["dropropizine","catabex","dopropizin","dipropizine"],"timeline":[],"approvals":[],"brandName":"Catabex","ecosystem":[{"indication":"Non-productive cough","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"dropropizine","explanation":"Imagine your brain has a 'cough switch' that gets triggered when you need to cough to get rid of something in your throat. Dropropizine helps to adjust this switch so that it doesn't get triggered as easily, reducing the frequency and severity of non-productive coughs.","oneSentence":"Dropropizine works by modulating the cough reflex through its action on the central nervous system.","technicalDetail":"Dropropizine is believed to exert its effects by interacting with central nervous system pathways involved in the regulation of cough, potentially through the modulation of neurotransmitter release or receptor activity."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/967","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DROPROPIZINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DROPROPIZINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:53:51.162286","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:40:48.540514+00:00","fieldsConflicting":0,"overallConfidence":0.95},"biosimilars":[],"competitors":[{"drugName":"benzonatate","drugSlug":"benzonatate","fdaApproval":"1958-02-10","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"pentoxyverine","drugSlug":"pentoxyverine","fdaApproval":"","relationship":"same-class"},{"drugName":"clofedanol","drugSlug":"clofedanol","fdaApproval":"","relationship":"same-class"}],"genericName":"dropropizine","indications":{"approved":[{"name":"Non-productive cough","source":"DrugCentral","snomedId":409596002,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"benzonatate","brandName":"benzonatate","genericName":"benzonatate","approvalYear":"1958","relationship":"same-class"},{"drugId":"pentoxyverine","brandName":"pentoxyverine","genericName":"pentoxyverine","approvalYear":"","relationship":"same-class"},{"drugId":"clofedanol","brandName":"clofedanol","genericName":"clofedanol","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT06907355","phase":"PHASE4","title":"CHAO Tos: Codeina, HederA Helix, LevOdropropizina Para la TOS","status":"COMPLETED","sponsor":"Pontificia Universidad Catolica de Chile","startDate":"2025-05-13","conditions":["Upper Resp Tract Infection"],"enrollment":196,"completionDate":"2025-12-01"},{"nctId":"NCT07017335","phase":"PHASE1","title":"Drug-Drug Interaction Between R1_PBK_M2301 and R2_PBK_M2301 in Healthy Adults","status":"COMPLETED","sponsor":"Pharmbio Korea Co., Ltd.","startDate":"2025-06-01","conditions":["Drug-Drug Interaction Healthy Volunteers"],"enrollment":24,"completionDate":"2025-08-30"},{"nctId":"NCT07161180","phase":"PHASE1","title":"Evaluation of the Pharmacokinetics of \"PBK_M2301\" in Healthy Adults","status":"RECRUITING","sponsor":"Pharmbio Korea Co., Ltd.","startDate":"2025-08-27","conditions":["Healthy Volunteers"],"enrollment":32,"completionDate":"2025-11-30"},{"nctId":"NCT03837938","phase":"PHASE3","title":"Clinical Trial of Efficacy and Safety of Levopront® 30 mg/5 ml in Patients With Dry Cough","status":"COMPLETED","sponsor":"Dompé Farmaceutici S.p.A","startDate":"2016-11-09","conditions":["Cough"],"enrollment":184,"completionDate":"2018-07-31"},{"nctId":"NCT06252454","phase":"PHASE2,PHASE3","title":"The Impact of Inhaled Furosemide and Perorally Administered Levodropropizine on Dyspnea in Patients With Respiratory Diseases","status":"RECRUITING","sponsor":"University Hospital Hradec Kralove","startDate":"2024-02-27","conditions":["Dyspnea"],"enrollment":102,"completionDate":"2025-12"},{"nctId":"NCT03489837","phase":"PHASE3","title":"Phase III Study to Evaluate the Efficacy and Safety of HOB-048 CR Tab. in Comparison With HOB-048 Syrup in Patients With Cough Due to Acute or Chronic Bronchitis","status":"COMPLETED","sponsor":"Hyundai Pharm","startDate":"2017-01","conditions":["Evaluate the Efficacy and Safety of Levotuss CR Tab. in Comparison With Levotuss Syrup in Patients With Cough Due to Acute or Chronic Bronchitis"],"enrollment":272,"completionDate":"2018-10"},{"nctId":"NCT01199497","phase":"PHASE3","title":"Study to Evaluate the Efficacy and Safety of Fixed Dose Combination of Diphenhydramine + Pseudoephedrine + Dropropizine in the Control of Cough and the Relief of Nasal Symptoms, Suffering From Non-productive Cough and Acute Rhinitis","status":"WITHDRAWN","sponsor":"Ache Laboratorios Farmaceuticos S.A.","startDate":"2011-08","conditions":["Nasal Congestion","Cough"],"enrollment":0,"completionDate":"2013-01"},{"nctId":"NCT01177852","phase":"PHASE3","title":"Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis","status":"WITHDRAWN","sponsor":"Ache Laboratorios Farmaceuticos S.A.","startDate":"2011-10","conditions":["Inflammation","Cough","Rhinitis"],"enrollment":0,"completionDate":""},{"nctId":"NCT01573663","phase":"PHASE1","title":"A Drug-Drug Interaction Study of Ambroxol and Levodropropizine","status":"COMPLETED","sponsor":"Hanmi Pharmaceutical Company 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Bronchitis"],"enrollment":332,"completionDate":"2011-05"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"crossReferences":{"NDDF":"005323","UNII":"U0K8WHL37U","CHEBI":"CHEBI:93837","INN_ID":"2332","RXNORM":"23419","UMLSCUI":"C0058425","ChEMBL_ID":"CHEMBL151445","KEGG_DRUG":"D07393","DRUGBANK_ID":"DB13785","PUBCHEM_CID":"3169","SNOMEDCT_US":"18751000122108","MESH_SUPPLEMENTAL_RECORD_UI":"C035916"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"publicationCount":26,"therapeuticAreas":["Neuroscience"],"atcClassification":{"source":"DrugCentral","atcCode":"R05DB19","allCodes":["R05DB19"]},"biosimilarFilings":[],"recentPublications":[{"date":"2021 Jan 7","pmid":"33068328","title":"Catalytic, Kinetic, and Mechanistic Insights into the Fixation of CO(2) with Epoxides Catalyzed by Phenol-Functionalized Phosphonium Salts.","journal":"ChemSusChem"},{"date":"2020 Jun 16","pmid":"32453324","title":"Synthesis of (18)O-labelled alcohols from unlabelled alcohols.","journal":"Chemical communications (Cambridge, England)"},{"date":"2021","pmid":"31814444","title":"Characteristics, Properties and Analytical Methods for Determination of Dropropizine and Levodropropizine: A Review.","journal":"Critical reviews in analytical chemistry"},{"date":"2019 Dec","pmid":"31407623","title":"Identification of biomarkers, pathways and potential therapeutic agents for white adipocyte insulin resistance using bioinformatics analysis.","journal":"Adipocyte"},{"date":"2020 Feb","pmid":"30896275","title":"Stereoselective pharmacokinetics and tissue distribution of levodropropizine after administration of pure levodropropizine and the rac-dropropizine to Sprague-Dawley rats.","journal":"Xenobiotica; the fate of foreign compounds in biological systems"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"active","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Catabex, also known as dropropizine, is a small molecule drug in the dropropizine class. It is used to treat non-productive cough, a condition characterized by a persistent cough without the production of mucus. The commercial status of Catabex is currently unknown, and it is not clear if it is patented or available as a generic medication. As a pharma professional, it is essential to consider the potential safety implications of Catabex, including any unknown side effects or interactions. Further research is needed to fully understand the pharmacology and clinical use of this medication.","enrichmentLevel":5,"visitCount":0,"trialStats":{"total":3,"withResults":1},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T08:40:48.540514+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}