Solifenacin succinate Clinical Trials

Size	Price	Qty
10mg	USD 70

Clinical Trials

Several clinical trials evaluate solifenacin succinate for urological conditions, including overactive bladder syndrome, detrusor overactivity, urge incontinence, and urgency-frequency syndrome. Comprising Phase 1 pharmacokinetic studies and unassigned-phase observational protocols with recruiting, completed, or unknown statuses, these trials investigate pharmacological parameters, biomarker profiles, and therapeutic response predictors. Research sponsors encompass academic medical institutions such as Istanbul University and Far Eastern Memorial Hospital, alongside pharmaceutical industry partners like Hanmi Pharmaceutical Company.

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 succinate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Solifenacin succinate competitively binds to muscarinic acetylcholine receptors, thereby inhibiting acetylcholine-induced intracellular signaling pathways that trigger smooth muscle contraction. This block attenuates involuntary detrusor muscle activity in the urinary tract, providing therapeutic efficacy in managing overactive bladder syndrome, detrusor overactivity, 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>).