{"id":"drotaverine","rwe":[{"pmid":"41147568","year":"2025","title":"[Endothelial protective properties of sacubitril-valsartan and drotaverine in influenza A(H1N1)pdm09 virus infection (Orthomyxoviridae: Alphainfluenzavirus: influenza A virus)].","finding":"","journal":"Voprosy virusologii","studyType":"Clinical Study"},{"pmid":"41099963","year":"2025","title":"Comparison of Efficacy of Peppermint Oil and Drotaverine for the Treatment of Functional Abdominal Pain in Children Aged 4-18 Years: A Single Blind, Exploratory Randomized Controlled Trial.","finding":"","journal":"Indian journal of pediatrics","studyType":"Clinical Study"},{"pmid":"40776874","year":"2025","title":"Effect of Transcutaneous Electrical Acupoint Stimulation at the Sanyinjiao Point on Preventing Bladder Spasm after Transurethral Laser Prostatectomy.","finding":"","journal":"Archivos espanoles de urologia","studyType":"Clinical Study"},{"pmid":"40412591","year":"2025","title":"Smooth muscle relaxants for intrauterine device placement: A systematic review.","finding":"","journal":"Contraception","studyType":"Clinical Study"},{"pmid":"40377579","year":"2025","title":"[Results of treatment of acute uncomplicated cystitis in 440 women of working age in a large industrial city].","finding":"","journal":"Urologiia (Moscow, Russia : 1999)","studyType":"Clinical Study"}],"tags":[{"label":"drotaverine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Voltage-dependent L-type calcium channel subunit alpha-1C","category":"target"},{"label":"CACNA1C","category":"gene"},{"label":"PDE4B","category":"gene"},{"label":"A03AD02","category":"atc"},{"label":"Active","category":"status"},{"label":"Analgesics","category":"pharmacology"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Central Nervous System Agents","category":"pharmacology"},{"label":"Parasympatholytics","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Sensory System Agents","category":"pharmacology"},{"label":"Vasodilator Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":47.981,"date":"","count":35,"signal":"Abdominal pain","source":"DrugCentral FAERS","actionTaken":"Reported 35 times (LLR=48)"}],"commonSideEffects":[{"effect":"Abdominal pain","drugRate":"LLR 48","severity":"common"}]},"trials":[],"aliases":[],"patents":[],"pricing":[],"allNames":"drotaverin","offLabel":[],"synonyms":["dihydroisoperparine","drotaverin hydrochloride","drotaverine hydrochloride","drotaverine HCl","drotaverine","drotaverin","isodihydroperparine"],"timeline":[],"aiSummary":"Drotaverine is a small molecule drug that targets the voltage-dependent L-type calcium channel subunit alpha-1C. It belongs to the drotaverine class and is used to treat smooth muscle spasms. The commercial status of drotaverine is unknown, and it is not FDA-approved. Drotaverine has a half-life of 9.3 hours and bioavailability of 58%. It is a generic medication, but the availability of generic manufacturers is unknown.","approvals":[],"brandName":"Drotaverin","ecosystem":[],"mechanism":{"target":"Voltage-dependent L-type calcium channel subunit alpha-1C, cAMP-specific 3',5'-cyclic phosphodiesterase 4B","targets":[{"gene":"CACNA1C","source":"DrugCentral","target":"Voltage-dependent L-type calcium channel subunit alpha-1C","protein":"Voltage-dependent L-type calcium channel subunit alpha-1C"},{"gene":"PDE4B","source":"DrugCentral","target":"cAMP-specific 3',5'-cyclic phosphodiesterase 4B","protein":"cAMP-specific 3',5'-cyclic phosphodiesterase 4B"}],"modality":"Small Molecule","drugClass":"drotaverine","explanation":"Imagine your muscles are like a group of people trying to get through a doorway. Calcium channels are like the door handles that let the people (calcium ions) in. When these channels are blocked, the people can't get in, and the muscle doesn't contract as much, reducing spasms.","oneSentence":"Drotaverine works by blocking calcium channels in smooth muscle cells, preventing muscle spasms.","technicalDetail":"Drotaverine acts as a selective blocker of the L-type calcium channel subunit alpha-1C, inhibiting the influx of calcium ions into smooth muscle cells and thereby reducing muscle contraction and spasm."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/969","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DROTAVERINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DROTAVERINE","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T10:49:49.356391","biosimilars":[],"competitors":[{"drugName":"papaverine","drugSlug":"papaverine","fdaApproval":"","relationship":"same-class"}],"dataSources":[{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"drotaverine","indications":{"approved":[],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"papaverine","brandName":"papaverine","genericName":"papaverine","approvalYear":"","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT03744130","phase":"NA","title":"Contrast-enhanced Bowel Ultrasound in Making a Diagnosis and Follow-up of Patients With Inflammatory Bowel Disease","status":"UNKNOWN","sponsor":"State Scientific Centre of Coloproctology, Russian Federation","startDate":"2018-01-10","conditions":["Inflammatory Bowel Disease"],"enrollment":200,"completionDate":"2021-06-30"},{"nctId":"NCT00292747","phase":"PHASE4","title":"Drotaverine in Dysmenorrhoea Treatment","status":"TERMINATED","sponsor":"Sanofi","startDate":"2005-05-25","conditions":["Dysmenorrhea"],"enrollment":480,"completionDate":"2006-02-28"},{"nctId":"NCT02026427","phase":"","title":"Urinary Retention in Orthopedic Patients","status":"COMPLETED","sponsor":"Military Institute od Medicine National Research Institute","startDate":"2010-08","conditions":["Urinary Retention","Orthopedic Patients","Spinal Anesthesia"],"enrollment":200,"completionDate":"2014-08"},{"nctId":"NCT01639027","phase":"PHASE2,PHASE3","title":"Drotaverine to Shorten the Length of Labor","status":"COMPLETED","sponsor":"Ain Shams Maternity Hospital","startDate":"2012-05","conditions":["Prolonged First Stage of Labor","Failure of Cervical Dilation as Antepartum Condition","Labor Pain","Mild Birth Asphyxia, APGAR 4-7"],"enrollment":352,"completionDate":"2013-01"},{"nctId":"NCT01236651","phase":"PHASE2","title":"Meperidine Versus Drotaverine Regarding the Effect on the Duration of the First Stage of Labor in Full Term Primigravidae","status":"UNKNOWN","sponsor":"Ain Shams University","startDate":"2010-11","conditions":["Effect of Meperidine or Drotaverine on Effacement and Dilatation of the Cervix During Labor in Full Term Primigravidae"],"enrollment":200,"completionDate":"2011-09"},{"nctId":"NCT00731198","phase":"PHASE3","title":"Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)","status":"COMPLETED","sponsor":"Changhai Hospital","startDate":"2008-08","conditions":["ERCP","Pancreatic Diseases","Bile Duct Diseases"],"enrollment":650,"completionDate":"2009-07"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{},"crossReferences":{"NDDF":"007309","UNII":"98QS4N58TW","CHEBI":"CHEBI:135630","INN_ID":"2239","RXNORM":"23684","UMLSCUI":"C0058762","ChEMBL_ID":"CHEMBL551978","KEGG_DRUG":"D07088","DRUGBANK_ID":"DB06751","PUBCHEM_CID":"1712095","SNOMEDCT_US":"1173005008","SECONDARY_CAS_RN":"985-12-6","MESH_SUPPLEMENTAL_RECORD_UI":"C005317"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[],"pharmacokinetics":{"source":"DrugCentral","halfLife":"9.3 hours","clearance":"3.5 mL/min/kg","bioavailability":"58%","fractionUnbound":"0.12%","volumeOfDistribution":"1.9 L/kg"},"publicationCount":124,"therapeuticAreas":["Other"],"atcClassification":{"source":"DrugCentral","atcCode":"A03AD02","allCodes":["A03AD02"]},"biosimilarFilings":[],"recentPublications":[{"date":"2025 Sep 16","pmid":"41147568","title":"[Endothelial protective properties of sacubitril-valsartan and drotaverine in influenza A(H1N1)pdm09 virus infection (Orthomyxoviridae: Alphainfluenzavirus: influenza A virus)].","journal":"Voprosy virusologii"},{"date":"2025 Nov","pmid":"41099963","title":"Comparison of Efficacy of Peppermint Oil and Drotaverine for the Treatment of Functional Abdominal Pain in Children Aged 4-18 Years: A Single Blind, Exploratory Randomized Controlled Trial.","journal":"Indian journal of pediatrics"},{"date":"2025 Jul","pmid":"40776874","title":"Effect of Transcutaneous Electrical Acupoint Stimulation at the Sanyinjiao Point on Preventing Bladder Spasm after Transurethral Laser Prostatectomy.","journal":"Archivos espanoles de urologia"},{"date":"2025 May 22","pmid":"40412591","title":"Smooth muscle relaxants for intrauterine device placement: A systematic review.","journal":"Contraception"},{"date":"2025 May","pmid":"40377579","title":"[Results of treatment of acute uncomplicated cystitis in 440 women of working age in a large industrial city].","journal":"Urologiia (Moscow, Russia : 1999)"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":false,"safety":true,"trials":true,"score":3}}