Clinical Trials

Several clinical trials evaluate the therapeutic application and pharmacokinetics of solifenacin for urological disorders, including overactive bladder syndrome, urge incontinence, urgency-frequency syndrome, and detrusor overactivity. Ranging from Phase 1 safety studies to observational outcome assessments, these trials are sponsored by academic medical centers, state hospitals, and pharmaceutical industry entities. Across these evaluations, recruitment statuses range from actively recruiting and completed to unknown status.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05391425 Recruiting
Urge Incontinence|Urgency-frequency Syndrome
Istanbul University|Arnavutkoy State Hospital
 2021-06-03 --
NCT05040984 Recruiting
Overactive Bladder Syndrome
Far Eastern Memorial Hospital
 2021-04-30 --
NCT04693897 Unknown status
Overactive Bladder Syndrome|Detrusor Overactivity
Chang Gung Memorial Hospital
 2021-03-01 --
NCT02940314 Completed
Overactive Bladder
Hanmi Pharmaceutical Company Limited
 2016-03 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Solifenacin (YM905) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Solifenacin acts as a competitive antagonist of muscarinic acetylcholine receptors, specifically targeting the M3 receptor subtype to block endogenous acetylcholine binding and inhibit downstream signal transduction. This targeted receptor blockade prevents smooth muscle contraction within the urinary bladder detrusor muscle, effectively reducing detrusor tone and alleviating clinical symptoms of overactive bladder syndrome and urge incontinence.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.