TheraRadar
Data updated: May 26, 2026

VESICARE LS (solifenacin succinate)

Trial Activity: Declining
Urology Approved 2020-05-26
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Astellas Pharma Europe B.V. conducting 8 trials (42%)
39 indications explored (Broad Platform)
→ overactive bladder (5 trials)
→ urologic diseases (2 trials)
→ urinary bladder, overactive (2 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
6
Years on Market

Details

Status
Discontinued
First Approved
2020-05-26
Patent Cliff
2031

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SUSPENSION

Companies

ASTELLAS
Active Ingredient: SOLIFENACIN SUCCINATE

VESICARE LS Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2020 to 2020
May 2020 ORIGINAL Priority
New Form · Type 3 - New Dosage Form
FDA Letter Label

What VESICARE LS Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
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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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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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 LS FDA Label Details

View full patent landscape →
1 OB patents · 1 families · 32 international docs across 24 countries

VESICARE LS Patents & Exclusivity

Latest Patent: May 2031

Patents (1 active)

US9918970 Expires May 18, 2031
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for VESICARE LS

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2031
  • • 1 active patents

Trial Analysis

  • • 19 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA209529 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment