{"id":"solifenacin-mirabegron","safety":{"commonSideEffects":[{"rate":"20-30","effect":"Dry mouth"},{"rate":"15-25","effect":"Constipation"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Hypertension"},{"rate":"1-5","effect":"Urinary retention"},{"rate":"5-10","effect":"Blurred vision"}]},"_chembl":{"chemblId":"CHEMBL2095212","moleculeType":"Small molecule","molecularWeight":"396.52"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Solifenacin is an antimuscarinic agent that blocks M3 receptors on bladder smooth muscle, reducing involuntary contractions. Mirabegron is a beta-3 adrenergic agonist that relaxes the detrusor muscle during the storage phase of the bladder. Together, they provide dual mechanism action targeting both parasympathetic and sympathetic pathways to improve bladder storage capacity and reduce urgency and frequency.","oneSentence":"Solifenacin and mirabegron work synergistically to reduce overactive bladder symptoms by blocking muscarinic receptors (solifenacin) and activating beta-3 adrenergic receptors (mirabegron) to decrease detrusor muscle contractions and increase bladder capacity.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:08:40.540Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Overactive bladder with symptoms of urgency, frequency, and urgency incontinence"}]},"trialDetails":[{"nctId":"NCT07305298","phase":"","title":"Mirabegron in Patients With Age-Related Macular Degeneration","status":"NOT_YET_RECRUITING","sponsor":"University of Naples","startDate":"2026-04-01","conditions":"Dry AMD, Overactive Bladder","enrollment":312},{"nctId":"NCT07337252","phase":"","title":"Risk Factors for Treatment Failure in Women With Detrusor Overactivity Receiving Combined Pharmacotherapy","status":"COMPLETED","sponsor":"Mackay Memorial Hospital","startDate":"2022-06-01","conditions":"Overactive Bladder","enrollment":61},{"nctId":"NCT06465576","phase":"PHASE4","title":"Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)","status":"RECRUITING","sponsor":"University of Aarhus","startDate":"2024-05-27","conditions":"Urinary Incontinence in Children","enrollment":216},{"nctId":"NCT06551246","phase":"PHASE3","title":"Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)","status":"RECRUITING","sponsor":"University of Aarhus","startDate":"2024-06-27","conditions":"Urinary Incontinence in Children","enrollment":236},{"nctId":"NCT06110975","phase":"NA","title":"Deprescribing dRrugs for Overactive Bladder in General Practice (DROP)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Anne Estrup Olesen","startDate":"2023-12-01","conditions":"Overactive Bladder, Deprescribing, PIMS","enrollment":72},{"nctId":"NCT07199894","phase":"PHASE3","title":"Omegapres Versus Solifenacin and Mirabegron Combination Therapy in Treatment of Primary MNE","status":"RECRUITING","sponsor":"Mansoura University","startDate":"2024-12-01","conditions":"Nocturnal Enuresis in Children","enrollment":120},{"nctId":"NCT06803030","phase":"PHASE3","title":"Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms","status":"RECRUITING","sponsor":"Bir Hospital","startDate":"2025-08-30","conditions":"Ureteral Stent-Related Symptom","enrollment":189},{"nctId":"NCT07114640","phase":"PHASE3","title":"The Effect of Nighttime Mirabegron, Solifenacin, Tolterodine, or Oxybutynin on Nocturia, Sexual Function, Autonomic Function, and Lower Urinary Tract Blood Flow Perfusion in Women With Overactive Bladder Syndrome: Randomized Controlled Trial","status":"NOT_YET_RECRUITING","sponsor":"Far Eastern Memorial Hospital","startDate":"2025-08-07","conditions":"Urinary Bladder, Overactive","enrollment":220},{"nctId":"NCT07025642","phase":"NA","title":"Comparing Treatments for Overactive Bladder in Taiwan: A Study of Outcomes","status":"RECRUITING","sponsor":"Mackay Medical College","startDate":"2025-07-01","conditions":"Overactive Bladder (OAB)","enrollment":60},{"nctId":"NCT07016451","phase":"EARLY_PHASE1","title":"Efficacy of Low-Intensity Shockwave Therapy in Treating Radiation Cystitis","status":"ENROLLING_BY_INVITATION","sponsor":"Thanakrit Visuthikosol","startDate":"2024-04-02","conditions":"Radiation Cystitis","enrollment":40},{"nctId":"NCT05968885","phase":"PHASE4","title":"Evaluation the Efficacy Between Botox Injection and Combination Pharmacotherapy in Patients With Detrusor Overactivity","status":"RECRUITING","sponsor":"Mackay Memorial Hospital","startDate":"2021-10-01","conditions":"Urinary Bladder, Overactive, Urodynamics, Effect of Drug","enrollment":300},{"nctId":"NCT06197295","phase":"PHASE4","title":"Efficacy of Combined Pharmacotherapy Versus Solifenacin With Vaginal Estrogen Cream for Women With Detrusor Overactivity","status":"RECRUITING","sponsor":"Mackay Memorial Hospital","startDate":"2022-06-16","conditions":"Urinary Bladder, Overactive, Effect of Drug","enrollment":200},{"nctId":"NCT06479720","phase":"PHASE4","title":"Efficacy of Solifenacin or Mirabegron With Local Estrogen Versus Combination Pharmacotherapy for Overactive Bladder","status":"RECRUITING","sponsor":"Mackay Memorial Hospital","startDate":"2022-06-16","conditions":"Effect of Drug, Urinary Bladder, Overactive","enrollment":300},{"nctId":"NCT05067478","phase":"","title":"Composur: Study to Understand the Performance of Vibegron in Participants with Overactive Bladder (OAB)","status":"COMPLETED","sponsor":"Urovant Sciences GmbH","startDate":"2021-10-28","conditions":"Overactive Bladder","enrollment":403},{"nctId":"NCT01638000","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Patients With Overactive Bladder Who Were Previously Treated With Another Medicine But Were Not Satisfied With That Treatment.","status":"COMPLETED","sponsor":"Astellas Pharma Europe Ltd.","startDate":"2012-06-12","conditions":"Urologic Diseases, Urinary Bladder, Overactive, Urinary Bladder Diseases","enrollment":1887},{"nctId":"NCT02294396","phase":"PHASE4","title":"Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2014-10-28","conditions":"Overactive Bladder (OAB)","enrollment":649},{"nctId":"NCT01972841","phase":"PHASE3","title":"This Was a Multinational Study Comparing the Efficacy and Safety of Two Medicines , Solifenacin Succinate and Mirabegron Taken Together, or Separately, or a Mock Treatment (Placebo) in Subjects With Symptoms of Overactive Bladder","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2013-11-05","conditions":"Urinary Bladder Overactive, Urinary Bladder Diseases\\Urologic Diseases, Overactive Bladder","enrollment":3527},{"nctId":"NCT01908829","phase":"PHASE3","title":"A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)","status":"COMPLETED","sponsor":"Astellas Pharma Europe Ltd.","startDate":"2013-07-10","conditions":"Urinary Bladder Diseases, Urinary Bladder Overactive, Urologic Diseases","enrollment":2174},{"nctId":"NCT02045862","phase":"PHASE3","title":"A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2014-03-17","conditions":"Urinary Bladder Overactive, Overactive Bladder, Urgency Incontinence","enrollment":1829},{"nctId":"NCT01340027","phase":"PHASE2","title":"A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2011-03-29","conditions":"Urologic Diseases, Urinary Bladder Diseases, Urological Manifestations","enrollment":1307},{"nctId":"NCT03602508","phase":"","title":"Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania","status":"COMPLETED","sponsor":"Astellas Pharma Singapore Pte. Ltd.","startDate":"2018-07-20","conditions":"Overactive Bladder (OAB)","enrollment":5589},{"nctId":"NCT02386072","phase":"","title":"A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB)","status":"COMPLETED","sponsor":"Astellas Scientific & Medical Affairs, Inc.","startDate":"2015-01-05","conditions":"Urinary Bladder Overactive, Overactive Bladder, Urinary Bladder Diseases","enrollment":1524},{"nctId":"NCT03106623","phase":"PHASE2","title":"Study of ONO-8577 in Patients With Overactive Bladder","status":"COMPLETED","sponsor":"Ono Pharmaceutical Co. Ltd","startDate":"2017-04-07","conditions":"Overactive Bladder","enrollment":207},{"nctId":"NCT06184334","phase":"NA","title":"Management of OAB in Female Patients .","status":"COMPLETED","sponsor":"Elsayed Abdelhalim Elsayed","startDate":"2022-09-14","conditions":"Overactive Bladder","enrollment":300},{"nctId":"NCT03817931","phase":"PHASE4","title":"Higher Neural Changes Following Anticholinergic, Beta 3 Agonist, or Placebo in Patients With Overactive Bladder","status":"COMPLETED","sponsor":"Baylor Research Institute","startDate":"2019-08-05","conditions":"Overactive Bladder, Dementia, Lower Urinary Tract Symptoms","enrollment":12},{"nctId":"NCT04023253","phase":"PHASE3","title":"Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin","status":"UNKNOWN","sponsor":"Far Eastern Memorial Hospital","startDate":"2019-08-01","conditions":"Overactive Bladder Syndrome","enrollment":120},{"nctId":"NCT05040984","phase":"","title":"Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome","status":"UNKNOWN","sponsor":"Far Eastern Memorial Hospital","startDate":"2021-04-30","conditions":"Overactive Bladder Syndrome","enrollment":500},{"nctId":"NCT02540707","phase":"PHASE4","title":"Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2015-09-08","conditions":"Overactive Bladder Syndrome","enrollment":113},{"nctId":"NCT05767632","phase":"PHASE1","title":"Bioequivalence Study of Solifenacin Succinate & Mirabegron From Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma, Egypt) Versus Vesicare 5 mg FCT & Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V, the Netherlands / Astellas Pharma Europe B.V, the Netherlands)","status":"COMPLETED","sponsor":"Genuine Research Center, Egypt","startDate":"2022-05-30","conditions":"Healthy","enrollment":30},{"nctId":"NCT05490082","phase":"PHASE3","title":"Mirabegron, Propevirine, Solifenacin for Treatment of Lower Urinary Tract Symptoms During Intravesical BCG Instillation","status":"UNKNOWN","sponsor":"Mansoura University","startDate":"2022-03-01","conditions":"Voiding Disorders","enrollment":100},{"nctId":"NCT05240456","phase":"PHASE1, PHASE2","title":"Beta 3 Agonists in Treatment of Non-neurogenic Voiding Dysfunction in Children","status":"UNKNOWN","sponsor":"Mansoura University","startDate":"2022-02","conditions":"Voiding Disorders, Overactive Bladder","enrollment":70},{"nctId":"NCT04325880","phase":"PHASE3","title":"Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms","status":"UNKNOWN","sponsor":"Mansoura University","startDate":"2021-12-01","conditions":"Ureteral Stent, Stent Related Symptoms","enrollment":240},{"nctId":"NCT04909255","phase":"PHASE4","title":"Beta-3 Agonist and Anti-muscarinic Agent for Sjogren's Syndrome With Overactive Bladder","status":"UNKNOWN","sponsor":"China Medical University Hospital","startDate":"2021-03-23","conditions":"Sjogren's Syndrome, Overactive Bladder Syndrome","enrollment":50},{"nctId":"NCT04693897","phase":"","title":"Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker","status":"UNKNOWN","sponsor":"Chang Gung Memorial Hospital","startDate":"2021-03-01","conditions":"Overactive Bladder Syndrome, Detrusor Overactivity","enrollment":400},{"nctId":"NCT03572231","phase":"","title":"A Registry Study of Patients Initiating a Course of Drug Therapy for Overactive Bladder in Taiwan, Korea and China","status":"COMPLETED","sponsor":"Astellas Pharma Singapore Pte. Ltd.","startDate":"2018-07-19","conditions":"Overactive Bladder (OAB)","enrollment":805},{"nctId":"NCT03632772","phase":"PHASE2","title":"Comparison of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After TURP","status":"UNKNOWN","sponsor":"Buddhist Tzu Chi General Hospital","startDate":"2018-08-01","conditions":"Overactive Bladder Syndrome","enrollment":130},{"nctId":"NCT03558919","phase":"PHASE4","title":"Efficacy and Safety of the Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder","status":"COMPLETED","sponsor":"Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh","startDate":"2017-01-01","conditions":"Overactive Bladder","enrollment":81},{"nctId":"NCT01745094","phase":"PHASE4","title":"A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2012-10-01","conditions":"Overactive Bladder","enrollment":223},{"nctId":"NCT03059134","phase":"PHASE3","title":"Mirabegron Treatment on Patients With Overactive Bladder Syndrome in Taiwan","status":"COMPLETED","sponsor":"Buddhist Tzu Chi General Hospital","startDate":"2015-04-28","conditions":"Urinary Incontinence, Overactive Bladder Syndrome","enrollment":168},{"nctId":"NCT02169713","phase":"PHASE1","title":"Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2014-05","conditions":"Healthy Subjects, Pharmacokinetics, Drug-Drug Interaction (DDI)","enrollment":20},{"nctId":"NCT02127034","phase":"PHASE1","title":"Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2014-03","conditions":"Healthy Subjects, Pharmacokinetics, Drug-Drug Interaction (DDI)","enrollment":26},{"nctId":"NCT02010944","phase":"PHASE1","title":"A Study to Compare How Much Solifenacin Succinate and Mirabegron Reach the Blood When Administered Together as Fixed-dose Combination Tablets and With Single Individual Tablets of the Same Medications at Three Dose Levels","status":"COMPLETED","sponsor":"Astellas Pharma Europe B.V.","startDate":"2012-09","conditions":"Phase 1, Bioavailability, Healthy Subjects","enrollment":72},{"nctId":"NCT01297192","phase":"PHASE1","title":"A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2009-03","conditions":"Healthy Volunteers, Pharmacokinetics of Mirabegron","enrollment":41}],"_emaApprovals":[],"_faersSignals":[{"count":2,"reaction":"ATRIAL FIBRILLATION"},{"count":2,"reaction":"HYPERTENSION"},{"count":2,"reaction":"HYPERTENSIVE CRISIS"},{"count":2,"reaction":"HYPOTENSION"},{"count":2,"reaction":"OVERDOSE"},{"count":2,"reaction":"PNEUMONIA"},{"count":1,"reaction":"ABDOMINAL PAIN UPPER"},{"count":1,"reaction":"ACCIDENTAL OVERDOSE"},{"count":1,"reaction":"ATRIAL FLUTTER"},{"count":1,"reaction":"BRADYCARDIA"}],"_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":"marketed","status":"active","brandName":"Solifenacin + Mirabegron","genericName":"Solifenacin + Mirabegron","companyName":"University of Aarhus","companyId":"university-of-aarhus","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Solifenacin and mirabegron work synergistically to reduce overactive bladder symptoms by blocking muscarinic receptors (solifenacin) and activating beta-3 adrenergic receptors (mirabegron) to decrease detrusor muscle contractions and increase bladder capacity. Used for Overactive bladder with symptoms of urgency, frequency, and urgency incontinence.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}