Darifenacin HBr Clinical Trials

Size	Price	Qty
10mg	USD 147
1g	USD 1,470

Clinical Trials

Numerous clinical trials spanning Phase I through Phase IV evaluate the pharmacokinetics and therapeutic profile of Darifenacin HBr in healthy volunteers and patient populations. Sponsored by pharmaceutical companies and academic institutions, these studies address urological conditions like overactive bladder, urge urinary incontinence, neurogenic detrusor overactivity, and ureteric stent-related symptoms, alongside neurological diseases such as Parkinson's disease and amyotrophic lateral sclerosis. While the majority of these trials are completed, others are currently recruiting, terminated, or withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06249867	RECRUITING	Amyotrophic Lateral Sclerosis	Oliver Blanchard	2024-11-08	PHASE2
NCT06616675	COMPLETED	HTLV-1; Overactive Bladder Syndrome	Hospital Universitário Professor Edgard Santos	2022-03-16	PHASE4
NCT07206706	COMPLETED	Management of Ureteric Stent Related LUTS and Pain	Ain Shams University	2022-05-01	PHASE1; PHASE2
NCT02143570	COMPLETED	Overactive Bladder	Universidad de Valparaiso	2014-05	PHASE3
NCT00892450	COMPLETED	Parkinson's Disease; Overactive Bladder	US Department of Veterans Affairs	2009-05
NCT00712322	TERMINATED	Neurogenic Detrusor Overactivity	Warner Chilcott	2008-10-07	PHASE2
NCT00800462	COMPLETED	Spinal Cord Injury; Neurogenic Detrusor Overactivity	Toronto Rehabilitation Institute	2008-03	PHASE4
NCT01189071	TERMINATED	Overactive Bladder; Renal Colic; Pain, Postoperative	University of Missouri-Columbia	2009-08
NCT01229280	UNKNOWN	Bioequivalency	Center for Clinical Pharmacology Research Bdbeq S.A.	2010-12	PHASE1
NCT01227811	UNKNOWN	Bioequivalency	Center for Clinical Pharmacology Research Bdbeq S.A.	2010-11	PHASE1
NCT00703703	COMPLETED	Healthy	Novartis	2008-05	PHASE1
NCT00703703	Completed	Healthy	Novartis\|Procter and Gamble	2008-05	Phase 1
NCT00845338	TERMINATED	Multiple Sclerosis; Overactive Detrusor	Bayer	2007-02	PHASE2
NCT00921245	Completed	Overactive Bladder	Bayer	2007-06	--
NCT00413790	Completed	Healthy	Novartis\|Procter and Gamble	2006-11	Phase 4
NCT00413426	Completed	Healthy	Novartis\|Procter and Gamble	2006-06	Phase 1
NCT00366002	Completed	Overactive Bladder (OAB)	Novartis\|Procter and Gamble	2006-06	Phase 4
NCT00366002	COMPLETED	Overactive Bladder (OAB)	Novartis	2006-06	PHASE4
NCT01018225	WITHDRAWN	Nocturia	Cognitive Research Corporation	2009-11	PHASE4
NCT00170755	COMPLETED	Overactive Bladder Syndrome	Novartis	2002-04	PHASE3
NCT00171184	COMPLETED	Overactive Bladder	Novartis	2005-04	PHASE4
NCT00127270	COMPLETED	Urinary Incontinence	Novartis	2005-05	PHASE4
NCT00170768	COMPLETED	Healthy Volunteers	Novartis	2005-02	PHASE2
NCT00413790	COMPLETED	Healthy	Novartis	2006-11	PHASE4
NCT00413426	COMPLETED	Healthy	Novartis	2006-06	PHASE1
NCT00171145	COMPLETED	Overactive Bladder Syndrome	Novartis	2004-04	PHASE3

(data from https://clinicaltrials.gov, updated on 2025-09-05)

Check the Darifenacin HBr product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Darifenacin HBr functions as a potent and selective antagonist of the M3 muscarinic acetylcholine receptor with a pKi of 8.9, blocking acetylcholine-mediated activation of Gq protein-coupled signaling cascades. By inhibiting M3 receptor signaling, the compound suppresses intracellular calcium mobilization and prevents smooth muscle contraction, directly reducing involuntary detrusor muscle spasms to provide clinical benefit in overactive bladder and urge urinary 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>).