VESIcare

(solifenacin)

ApprovedSmall molecule

Solifenacin is used to treat overactive bladder, helping to reduce urinary urgency, frequency, and incontinence by relaxing the bladder muscles.[2] VESIcare is currently approved and in use across 14 indications[4].[1]

VESIcare is one of 314 small molecule programs targeting Hyperplasia. It is currently in Approved.

Indications

115

Total Trials

Active Trials

313

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HyperplasiaActive, not recruiting

Benign Prostatic HyperplasiaApproved

Parkinson DiseaseActive, not recruiting

Lower Urinary Tract SymptomActive, not recruiting

PolyuriaActive, not recruiting

Urinary UrgencyActive, not recruiting

Urinary IncontinenceActive, not recruiting

Breast CancerActive, not recruiting

Multiple SclerosisActive, not recruiting

DementiaActive, not recruiting

HyperplasiaPhase 3

Active, not recruiting

Benign Prostatic HyperplasiaApproved

Approved

Parkinson DiseasePhase 3

Active, not recruiting

Lower Urinary Tract SymptomApproved

Active, not recruiting

PolyuriaApproved

Active, not recruiting

Urinary UrgencyPreclinical

Active, not recruiting

Urinary IncontinenceApproved

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

Multiple SclerosisApproved

Active, not recruiting

DementiaPhase 2

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

VESIcare

Astellas

Approved

1 2

MS Contin

Merck & Co.

Preclinical

2 3

Zolymbus

AbbVie

Preclinical

1 4

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 5

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 6

Chirocaine

PPurdue Pharma LP

Preclinical

1 7

Acupan

YYonsei University

Preclinical

1 8

Vfend

PPrism Pharmaceuticals

Paracetamol

1 10

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Overactive Bladder

NCT07416968

Not yet recruiting

Age-Related Macular Degeneration

NCT07305298

Phase 3Recruiting

Ureteral Stent-Related Symptom

NCT06803030

Q4 2027

Post-ApprovalRecruiting

Urinary Incontinence

NCT06465576

Post-ApprovalRecruiting

Overactive Bladder

NCT07473310

Phase 3Recruiting

Urinary Incontinence

NCT06551246

Clinical

Trials by Indication[1]

Overactive Bladder47 trials

Study of 2 Doses of Solifenacin Succinate in Female Subjects With Overactive Bladder.

Completed· Astellas logo

Astellas·Phase 4·NCT01093534·547 enrolled

Safety And Efficacy Of Solifenacin In Men With Overactive Bladder (OAB) And Detrusor Underactivity

Completed·UUniversity of L'Aquila··NCT00441428

A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks

Completed·KKYU-SUNG LEE·Phase 4·NCT00884104·307 enrolled

Show 44 more trials

Pharmacologic Effect for Female Overactive Bladder Syndrome: Mirabegron Versus Solifenacin

Unknown status·FFar Eastern Memorial Hospital·Phase 3·NCT04023253·120 enrolled

The Efficacy of Solifenacin With or Without Tamsulosin in Adult Women With Overactive Bladder (OAB)

Completed·SSoonchunhyang University Hospital·Phase 4·NCT01533597·70 enrolled

Evaluation of Adherence to Solifenacin Treatment in Overactive Bladder Patients

Completed· Astellas logo

Astellas··NCT00985387·1,215 enrolled

A Study to Evaluate the Effect of Mirabegron + Solifenacin in Overactive Bladder Patients

Completed· Astellas logo

Astellas·Phase 4·NCT01745094·223 enrolled

A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT00189800

Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate)

Completed· Astellas logo

Astellas·Phase 4·NCT01747577·68 enrolled

A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

Completed· Astellas logo

Astellas·Phase 3·NCT00368706·246 enrolled

Efficacy and Safety of Gabapentin in Treating Overactive Bladder

Completed·MMichael E. Chua·Phase 2/3·NCT01486706·94 enrolled

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

Completed· Astellas logo

Astellas·Phase 3·NCT01972841·3,527 enrolled

A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 2·NCT01340027·1,307 enrolled

A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.

Completed· Astellas logo

Astellas·Phase 4·NCT00333112·398 enrolled

Solifenacin Succinate Versus Placebo in Inner City Women Ages 20-45 With Overactive Bladder

Withdrawn·SStamford Hospital·Phase 4·NCT00773552

A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076

Completed· Astellas logo

Astellas·Phase 3·NCT01655069·148 enrolled

Efficacy and Safety of High Dose Vitamin D Supplementation for Overactive Bladder Dry in Children

Completed·XXing Liu·N/A·NCT05709990·303 enrolled

Efficacy and Safety of the Mirabegron Compared With Solifenacin in Treatment of Overactive Bladder

Completed·—·Phase 4·NCT03558919·81 enrolled

Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women

Recruiting·MMansoura University·Phase 4·NCT07473310·70 enrolled

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

Completed· Astellas logo

Astellas·Phase 3·NCT02045862·1,829 enrolled

Study of VESIcare® In Overactive Bladder (OAB) Subjects to Evaluate Symptom Bother and Health Related Quality of Life

Completed· Astellas logo

Astellas·Phase 4·NCT00573508·768 enrolled

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.

Completed· Astellas logo

Astellas·Phase 3·NCT01638000·1,887 enrolled

A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)

Completed· Astellas logo

Astellas·Phase 4·NCT00337558·643 enrolled

A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug

Completed· Astellas logo

Astellas·Phase 3·NCT01565707·189 enrolled

Efficacy of Electroacupuncture Versus Solifenacin Succinate for Female Overactive Bladder

Recruiting·YYin Ping·N/A·NCT05798403·204 enrolled

Open-label Study of the Efficacy and Safety of VESIcare® in Patients With Overactive Bladder Symptoms

Completed· Astellas logo

Astellas·Phase 3·NCT00463541·2,225 enrolled

Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder

Completed· Astellas logo

Astellas·Phase 1·NCT01539707·14 enrolled

Efficacy & Safety Study of VESIcare® (Solifenacin Succinate) in Patients Wishing to Switch From Detrol LA® for Treatment of Overactive Bladder

Completed· Astellas logo

Astellas·Phase 3·NCT00454740·441 enrolled

Effect of beta3-adrenoceptor Agonist on Patients With Overactive Bladder and as a Urinary Biomarker

Unknown status·—··NCT04693897·400 enrolled

Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease

Completed·UUniversity of South Florida·Phase 4·NCT01018264·23 enrolled

Therapy of the Overactive Bladder Syndrome

Completed·—·Phase 4·NCT01314781·66 enrolled

A Study to Evaluate Response of Overactive Bladder Symptom Score (OABSS) to Treatment

Completed· Astellas logo

Astellas··NCT01122563·55 enrolled

A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder

Completed·KKYU-SUNG LEE·Phase 4·NCT00699049·94 enrolled

Bacterial Genomic Sequencing in Overactive Bladder

Completed·LLoyola University·Phase 2·NCT01642277·134 enrolled

Post-treatment Novmalized Urodynamiz Findings as the Golden Standard of Objective Cure for Female Overactive Bladder Patients Receiving Antimuscarinic Drug

Unknown status·NNational Taiwan University Hospital·N/A·NCT01627145·300 enrolled

Treatment Persistence Among Patients With Overactive Bladder: A Retrospective Secondary Data Analysis in Asia Oceania

Completed· Astellas logo

Astellas··NCT03602508·5,589 enrolled

Solifenacin Plus Tadalafil vs Solifenacin Alone for Overactive Bladder in Females

Completed·—·N/A·NCT07312955·80 enrolled

Comparison of Solifenacin and Oxybutynin in the Treatment of Overactive Bladder

Unknown status·—·Phase 4·NCT01423838·500 enrolled

Study to Compare the Safety and Efficacy of Solifenacin With Oxybutynin for the Treatment of Overactive Bladder (VECTOR)

Completed· Astellas logo

Astellas·Phase 4·NCT00431041·132 enrolled

Predictors Affecting Long-term Use of Solifenacin or Mirabegron in Women With Overactive Bladder Syndrome

Unknown status·FFar Eastern Memorial Hospital··NCT05040984·500 enrolled

A Study to Evaluate the Efficacy and Safety of DA-8010 in Patients With Overactive Bladder

Completed·DDong-A ST Co., Ltd.·Phase 3·NCT05282069·607 enrolled

Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study

Recruiting·MMansoura University·Phase 4·NCT07416968·480 enrolled

A Therapeutic Exploratory Clinical Study of DA-8010 in Patients With Overactive Bladder

Completed·DDong-A ST Co., Ltd.·Phase 2·NCT03566134·306 enrolled

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

Not yet recruiting·FFar Eastern Memorial Hospital·Phase 3·NCT07114640·220 enrolled

Comparison of Solifenacin and Mirabegron in Treatment of Overactive Bladder Symptoms in Men After TURP

Unknown status·—·Phase 2·NCT03632772·130 enrolled

Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment' Effects in Women With Overactive Bladder

Completed·—·N/A·NCT06024005·34 enrolled

Postmarketing Study to Evaluate add-on Therapy With Anticholinergics in Patients With Overactive Bladder (OAB) on Mirabegron.

Completed· Astellas logo

Astellas·Phase 4·NCT02294396·649 enrolled

Treatment9 trials

Comparison of Tamsulosin and Solifenacin in Treatment of Ureteral Stent Symptoms

Completed·MMansoura University·Phase 4·NCT01880619·131 enrolled

Reproducibility Study of OABSS and Its Response to Treatment

Completed· Astellas logo

Astellas·Phase 4·NCT02667470·50 enrolled

Solifenacin Succinate 5mg or 10mg Once Daily in the Treatment of Urgency Symptoms

Completed· Astellas logo

Astellas·Phase 3·NCT00801944·973 enrolled

Show 6 more trials

Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms

Unknown status·MMansoura University·Phase 3·NCT04325880·240 enrolled

A Study With Combination Treatment (Tamsulosin Hydrochloride and Solifenacin Succinate) in Male Patients With LUTS/BPH

Completed· Astellas logo

Astellas·Phase 2·NCT00510406·919 enrolled

Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Efficacy Study

Unknown status·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·N/A·NCT02452879·180 enrolled

A Study to Evaluate Response of Over Active Bladder Symptom Score to Solifenacin Treatment

Completed· Astellas logo

Astellas·Phase 4·NCT01318837·100 enrolled

Incontinence & Intimate Partners: Assessing the Contribution of Treatment

Completed·LLoyola University·Phase 4·NCT01559389·138 enrolled

A Trial Comparing Combination Treatment (Solifenacin Plus Mirabegron) With One Treatment Alone (Solifenacin)

Completed· Astellas logo

Astellas·Phase 3·NCT01908829·2,174 enrolled

Urinary incontinence8 trials

Electroacupuncture and Solifenacin for Urgency-predominant Mixed Urinary Incontinence

Unknown status·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·N/A·NCT03787654·282 enrolled

Treatment of Urge Urinary Incontinence in Women After Failure of Cesa or Vasa

Unknown status·—·Phase 1/2·NCT01737918·120 enrolled

Strategy for Withdrawal of Pharmacological Treatment for Urinary Incontinence in Children (StayDry)

Recruiting·UUniversity of Aarhus·Phase 4·NCT06465576·216 enrolled

Show 5 more trials

A Study Evaluating the Efficacy and Safety of BOTOX® or Solifenacin in Patients With Overactive Bladder and Urinary Incontinence

Completed· AbbVie logo

AbbVie·Phase 3·NCT01767519·356 enrolled

Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's Disease

Withdrawn·UUniversity of South Florida·Phase 4·NCT00584090

Efficacy of Solifenacin, Mirabegron and Combination Therapy in Children With Daytime Urinary Incontinence (BeDry)

Recruiting·UUniversity of Aarhus·Phase 3·NCT06551246·236 enrolled

Effect of Electroacupuncture Versus PFMT Plus Solifenacin for Mixed Urinary Incontinence

Completed·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·N/A·NCT02047032·500 enrolled

Surgical vs. Medical Treatment of Urge Urinary Incontinence in Women

Unknown status·—·Phase 1/2·NCT01737411·120 enrolled

NAC4 trials

Solifenacin Flexible Dosing Study in Frequent Micturition Patients With and Without Urgency

Completed·—·Phase 4·NCT00979472·291 enrolled

Feasibility of "At-home" Titration of Solifenacin

Terminated·NNYU Langone Health·Phase 4·NCT00759577·36 enrolled

A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation

Completed· Astellas logo

Astellas·Phase 1·NCT01406158·24 enrolled

Show 1 more trial

Solifenacin Succinate Versus Tolterodine 4mg Once Daily

Completed· Astellas logo

Astellas·Phase 3·NCT00802373·1,355 enrolled

Lower Urinary Tract Symptom4 trials

Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

Completed· Astellas logo

Astellas·Phase 2·NCT00507455·222 enrolled

Pilot Trial Of Urinary Nerve Growth Factor (NGF) As Biomarker for Male Lower Urinary Tract Symptoms

Completed·—·Phase 4·NCT01457573·10 enrolled

Treatment of Symptoms in Male Patients With Lower Urinary Tract Symptoms (LUTS) Predominant Storage Symptoms (Overactive Bladder Syndrome)

Completed· Astellas logo

Astellas··NCT01799902·86 enrolled

Show 1 more trial

Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms

Completed· Astellas logo

Astellas·Phase 4·NCT02715024·52 enrolled

36 more indications

Clinical Trial3 trials

Clinical Trial to Investigate the Pharmacokinetic Drug Interaction Between Solifenacin and Tamsulosin

Completed· Jeil Pharmaceutical Co., Ltd. logo

Jeil Pharmaceutical Co., Ltd.·Phase 1·NCT02180997·36 enrolled

Efficacy and Mechanism of High-Dose Vitamin D Supplementation in Pediatric OAB-Dry: A Randomized Clinical Trial Integrating Urinary Myelin Basic Protein as a Theranostic Biomarker

Completed·XXing Liu·N/A·NCT06489951·180 enrolled

Clinical Trial of Solifenacin Versus Placebo Plus Pessary for Women With Vaginal Prolapse

Terminated·HHartford Hospital·Phase 4·NCT01092624·94 enrolled

Medication3 trials

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

Completed· Astellas logo

Astellas·Phase 1·NCT02010944·72 enrolled

A Study to Compare Two Medications With an Inactive Medication and Look at the Effect on a Person's Mental Ability

Completed· Astellas logo

Astellas·Phase 4·NCT01126424·26 enrolled

Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters

Completed·UUniversity of Alabama at Birmingham·N/A·NCT01028014·56 enrolled

Neurogenic Detrusor Overactivity2 trials

A Clinical Study to Investigate How Solifenacin Fluid is Taken up, How Long it Stays in the Body and How Effective and Safe it is in Treating Children Aged From 6 Months to Less Than 5 Years With Symptoms of Neurogenic Detrusor Overactivity (NDO)

Completed· Astellas logo

Astellas·Phase 3·NCT01981954·23 enrolled

A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity

Completed· Astellas logo

Astellas·Phase 3·NCT01565694·76 enrolled

Efficacy and Safety2 trials

A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy

Completed· Astellas logo

Astellas·Phase 4·NCT01371994·640 enrolled

Efficacy and Safety of Vitamin D in the Treatment of OAB-wet in Children

Unknown status·XXing Liu·N/A·NCT06201013·150 enrolled

Concentration2 trials

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT02169713·20 enrolled

Study to Evaluate the Effect of Solifenacin and Mirabegron on the Digoxin Concentrations in Blood in Healthy Subjects

Completed· Astellas logo

Astellas·Phase 1·NCT02127034·26 enrolled

Breast Cancer1 trial

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients

Recruiting·UUniversity of Arkansas·Phase 2·NCT01530373·110 enrolled

Efficacy1 trial

Efficacy of Li-SWT on Persistent Storage Symptoms After Transurethral Surgery for BPO

Completed·MMansoura University·N/A·NCT04437108·132 enrolled

Urgency Urinary Incontinence1 trial

A Study to Estimate the Efficacy and Safety of Solifenacin in Female With Stress Urinary Incontinence and Urgency Urinary Incontinence

Completed·JJeong Gu Lee·Phase 4·NCT01505439·311 enrolled

Quality of Life1 trial

A Study to Evaluate Quality of Life in Patients Switched to Solifenacin From Other Antimuscarinics

Completed· Astellas logo

Astellas··NCT02087098·2,000 enrolled

Surgery1 trial

Over Active Bladder Patients Having Sling Surgery

Terminated·—·N/A·NCT00852696·1 enrolled

Ureteral Stent-Related Symptom1 trial

Study of Tamsulosin, Solifenacin and Mirabegron in Alleviating Ureteral Stent-related Symptoms

Recruiting·—·Phase 3·NCT06803030·189 enrolled

Benign Prostatic Hyperplasia1 trial

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

Completed· Astellas logo

Astellas·Phase 4·NCT00771394·638 enrolled

Neuromodulation1 trial

Peripheral Transcutaneous Neuromodulation of the Post-tibial Nerve for Solifenacin 10 mg. Hyperactive Bladder Syndrome

Unknown status·FFundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia·Phase 4·NCT03468465·110 enrolled

CAR1 trial

Relative Bioavailability Study of Solifenacin Succinate Liquid Suspension (Fed and Fasting) Versus VESIcare Tablet (Fasting) in Healthy Volunteers

Completed· Astellas logo

Astellas·Phase 1·NCT01015040·24 enrolled

Tics1 trial

A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously

Completed· Astellas logo

Astellas·Phase 1·NCT01297192·41 enrolled

Postmenopausal Women1 trial

Effectiveness and Safety Study of Solifenacin Succinate and Solifenacin Succinate + Estrogen to Treat OAB in Postmenopausal Women

Completed·PPeking Union Medical College Hospital·Phase 4·NCT01833663·200 enrolled

Urinary urgency1 trial

Validation of a Real-time Urodynamic Measure of Urinary Urgency

Completed·LLoyola University·Phase 4·NCT00909428·51 enrolled

Urinary Tract Infection1 trial

The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females

Unknown status·—·Phase 4·NCT02094703·126 enrolled

Prostate1 trial

VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate

Terminated·AAdvanced Research Network·Phase 4·NCT01777217·8 enrolled

Recurrence1 trial

Compare Sudden Stopping and Weaning of Anticholinergics in Recurrence of OAB Symptoms

Completed·—·N/A·NCT04064619·60 enrolled

Adolescent1 trial

Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents

Completed· Astellas logo

Astellas·Phase 1·NCT01262391·42 enrolled

Multiple Sclerosis1 trial

Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis

Completed· Astellas logo

Astellas·Phase 4·NCT00629642·249 enrolled

Trial1 trial

Solifenacin Succinate Versus Fesoterodine A Comparison Trial for Urgency Symptoms

Unknown status·RRambam Health Care Campus·N/A·NCT01595152·60 enrolled

Double J Stent1 trial

Comparing Tamsulosin and Solifenacin for Relieving Double J Stent Symptoms: Using the USSQ.

Completed·LLiaquat National Hospital & Medical College·Phase 4·NCT07114848·60 enrolled

Hyperplasia1 trial

Efficacy and Safety of Tamsulosin/Solifenacin Combination Therapy in Patients With Voiding Symptoms and Moderate to Severe Storage Symptoms Due to Benign Prostate Hyperplasia

Unknown status· IlDong Pharmaceutical Co Ltd logo

IlDong Pharmaceutical Co Ltd·Phase 3·NCT02827578·588 enrolled

Dementia1 trial

A Dose Titration Study of CPC-201 in Patients With Dementia of Alzheimer's Type

Completed· AbbVie logo

AbbVie·Phase 2·NCT02549196·28 enrolled

Arterial Stiffness1 trial

Comparisons of the Effects of Solifenacin Versus Mirabegron on Autonomic System, Arterial Stiffness and Psychosomatic Distress and Clinical Outcomes

Completed·NNational Taiwan University Hospital·Phase 4·NCT02540707·113 enrolled

Parkinson disease1 trial

Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson Disease

Completed·VVA Office of Research and Development·Phase 3·NCT03149809·77 enrolled

Drug1 trial

A Study to Compare the Amount of Drug in the Blood After a Single Tablet EC905 Containing Solifenacin and Tamsulosin is Taken by Healthy Males Compared to Separate Tablets of Solifenacin and Tamsulosin

Completed· Astellas logo

Astellas·Phase 1·NCT01953887·30 enrolled

Gastrointestinal1 trial

Multiple Dose Study To Investigate The Effects Of Fesoterodine And Solifenacin On Gastrointestinal Transit

Terminated· Pfizer logo

Pfizer·Phase 1·NCT00832650·60 enrolled

Women1 trial

The Effect of Solifenacin on Post Void Dribbling in Women

Completed·UUniversity of Wisconsin, Madison·N/A·NCT01470001·118 enrolled

Combination Therapy1 trial

Efficacy of Tadalafil/Solifenacin VS Tamsulosin/Solifenacin Combination Therapy for BPH/OAB

Unknown status·MMansoura University·Phase 4·NCT05494567·60 enrolled

Observational Study1 trial

Observational Study to Estimate the Dry Mouth in OAB Patients With Solifenacin

Completed·—··NCT01437670·262 enrolled

Age-Related Macular Degeneration1 trial

Mirabegron in Patients With Age-Related Macular Degeneration

Not yet recruiting·UUniversity of Naples··NCT07305298·312 enrolled

Botox1 trial

Anticholinergic vs. Botox Comparison Study

Completed·NNICHD Pelvic Floor Disorders Network·Phase 3·NCT01166438·249 enrolled

Unspecified1 trial

EC905 Pharmacokinetic Profile Study

Completed· Astellas logo

Astellas·Phase 1·NCT02634489·46 enrolled

Regulatory

FDA Approval Timeline[5]

Nov 19, 2004

VESICARE

NDA NDA021518

May 26, 2020

VESICARE LS

NDA NDA209529

Sources

References

[1]
ClinicalTrials.gov — 115 trial records for solifenacin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — VESIcare drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — solifenacin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for solifenacin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209529). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for VESIcare. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Astellas company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Muscarinic Acetylcholine Receptor M3 Antagonist; Muscarinic Acetylcholine Receptor M2 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Astellas

Patent Landscape[6]

Patent Cliff

May 18, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9918970May 18, 2031

VESIcare

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Trials by Indication[1]

Overactive Bladder47 trials

Treatment9 trials

Urinary incontinence8 trials

NAC4 trials

Lower Urinary Tract Symptom4 trials

Clinical Trial3 trials

Medication3 trials

Neurogenic Detrusor Overactivity2 trials

Efficacy and Safety2 trials

Concentration2 trials

Breast Cancer1 trial

Efficacy1 trial

Urgency Urinary Incontinence1 trial

Quality of Life1 trial

Surgery1 trial

Ureteral Stent-Related Symptom1 trial

Benign Prostatic Hyperplasia1 trial

Neuromodulation1 trial

CAR1 trial

Tics1 trial

Postmenopausal Women1 trial

Urinary urgency1 trial

Urinary Tract Infection1 trial

Prostate1 trial

Recurrence1 trial

Adolescent1 trial

Multiple Sclerosis1 trial

Trial1 trial

Double J Stent1 trial

Hyperplasia1 trial

Dementia1 trial

Arterial Stiffness1 trial

Parkinson disease1 trial

Drug1 trial

Gastrointestinal1 trial

Women1 trial

Combination Therapy1 trial

Observational Study1 trial

Age-Related Macular Degeneration1 trial

Botox1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News