Data updated: Sep 20, 2026
VESICARE (solifenacin succinate) · ASTELLAS
Urology
Approved 2004-11-19
VESICARE is FDA-approved to treat 2 conditions (same as SOLIFENACIN SUCCINATE).
1
Indication
--
Phase 3 Trials
21
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2004-11-19
- Routes
- ORAL
- Dosage Forms
- TABLET
VESICARE Approval History
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
32 FDA actions from 2004 to 2020
Apr 2007 SUPPL
Mfg
What VESICARE Treats
2 indicationsVESICARE is approved for 2 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Overactive Bladder
- Urge Urinary Incontinence
Same approved indications as SOLIFENACIN SUCCINATE (same active ingredient).
Source: FDA Label
ASTELLAS's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
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Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01638000 BEYOND results posted | 178-EC-001 2011-005713-37 | Ph 3 | completed | 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. |
| NCT01371994 results posted | 905-UC-050 | Ph 4 | completed | A Study to Assess Efficacy and Safety With Solifenacin Succinate to Improve Urinary Continence After Robotic Assisted Radical Prostatectomy |
| NCT01565694 results posted | 905-CL-047 2011-000330-11 | Ph 3 | completed | 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 |
| NCT00629642 SONIC | 905-EC-005 2006-005523-42 | Ph 4 | completed | Clinical Study of Solifenacin Succinate in Patients With Bladder Symptoms Due to Spinal Cord Injury or Multiple Sclerosis |
| NCT01747577 POST-TURP | VC-OAB-12-01 | Ph 4 | completed | 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) |
| NCT01972841 SYNERGY results posted | 178-CL-101 2012-005735-91, U1111-1153-9095 | Ph 3 | completed | 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 |
| NCT02045862 SYNERGY II results posted | 178-CL-102 2012-005736-29 | Ph 3 | completed | 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 |
| NCT01981954 results posted | 905-CL-074 2012-003178-22 | Ph 3 | completed | 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) |
| NCT01340027 Symphony results posted | 178-CL-100 2010-020601-32 | Ph 2 | completed | A Study to Evaluate the Efficacy, Safety and Tolerability of Mirabegron and Solifenacin Succinate Alone and in Combination for the Treatment of Overactive Bladder |
| NCT01486706 OAB | SLMC10-010 | Ph 2, Ph 3 | completed | Efficacy and Safety of Gabapentin in Treating Overactive Bladder |
| NCT00773552 | 08-0917.01 | Ph 4 | withdrawn | Solifenacin Succinate Versus Placebo in Inner City Women Ages 20-45 With Overactive Bladder |
| NCT02634489 | 905-CL-071 2007-005155-41 | Ph 1 | completed | EC905 Pharmacokinetic Profile Study |
| NCT01777217 results posted | VESI-12J03 | Ph 4 | terminated | VESIcare For Improving OAB Symptoms in Patients Undergoing IGRT of the Prostate |
| NCT02169713 | 178-CL-109 2013-004230-15 | Ph 1 | completed | Study to Evaluate the Effect of Solifenacin and Mirabegron on the Tamsulosin Hydrochloride (HCl) Concentrations in Blood in Healthy Male Subjects |
| NCT02010944 | 178-CL-103 2012-002650-23 | Ph 1 | completed | 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 |
| NCT01297192 | 178-CL-069 2008-007929-40 | Ph 1 | completed | A Clinical Study to Assess the Effect on Pharmacokinetics of Dosing Mirabegron (YM178) and Solifenacin Simultaneously |
| NCT00771394 | 905-JC-001 | Ph 4 | completed | Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia |
| NCT01406158 | 905-CL-080 | Ph 1 | completed | A Study in Healthy Volunteers Comparing Two Different Liquid Formulations of Solifenacin With Each Other and With the Tablet Formulation |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VESICARE FDA Label Details
Indications & Usage
FDA Label (PDF)VESICARE is FDA-approved to treat 2 conditions — same approved indications as SOLIFENACIN SUCCINATE.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.