NDAORALSUSPENSIONPriority Review
Approved
May 2020
Lifecycle
Peak
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VESICARE LS is an oral suspension formulation of solifenacin succinate, a muscarinic receptor antagonist approved in 2020 for overactive bladder and related lower urinary tract conditions. It works by blocking muscarinic receptors that control urinary bladder smooth muscle contractions, reducing urgency and incontinence episodes. The suspension formulation enables easier dosing for patients with swallowing difficulties compared to traditional tablets.
$0.032BPart D
Peak5.0 years to LOEVESICARE LS is in peak commercial stage with modest Medicare utilization, indicating a niche product with limited team expansion opportunity compared to blockbuster competitors in the overactive bladder space.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
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)
Started May 2022
30 enrolled
Healthy
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
Started Mar 2014
1,829 enrolled
Urinary Bladder OveractiveOveractive BladderUrgency Incontinence+1 more
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
Started Nov 2013
3,527 enrolled
Urinary Bladder OveractiveUrinary Bladder Diseases\Urologic DiseasesOveractive Bladder+1 more
The Efficacy of Solifenacin Succinate as Adjuvant Therapy for Urinary Tract Infection in Females
Started Apr 2013
126 enrolled
Urinary Tract Infection
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
Started Sep 2012
72 enrolled
Phase 1BioavailabilityHealthy Subjects
Worked on VESICARE LS at Astellas? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.