Oxybutynin hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

Several clinical trials evaluate oxybutynin across Phase 2, Phase 3, and Phase 4 investigations sponsored by academic and medical institutions, including Cairo University, University Hospital Bordeaux, University of Southern California, and Cristália Produtos Químicos Farmacêuticos Ltda. These studies explore therapeutic indications such as aromatase inhibitor-induced vasomotor symptoms in breast cancer, pediatric male urogenital diseases with posterior urethral valves, overactive bladder with secondary xerostomia, and hyperhidrosis. Encompassing actively recruiting, unknown, and withdrawn statuses, these trials highlight the broad clinical evaluation of oxybutynin.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05637671	Recruiting	Vasomotor Symptoms	Cairo University	2022-02-10	Phase 3
NCT04526353	Unknown status	Male Urogenital Diseases	University Hospital Bordeaux	2020-09-10	Phase 2
NCT02522936	Withdrawn	Overactive Bladder\|Xerostomia\|Compliance	University of Southern California	2018-08-01	Phase 4
NCT02099695	Withdrawn	Hyperhidrosis	Cristália Produtos Químicos Farmacêuticos Ltda.\|Hospital Israelita Albert Einstein\|University of Sao Paulo	2015-12	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Oxybutynin hydrochloride functions as an acetylcholine receptor antagonist that competitively inhibits muscarinic acetylcholine receptors on smooth muscle cells, thereby blocking downstream parasympathetic signaling pathways. This blockade relaxes bladder detrusor muscle contractility and suppresses exocrine sweat gland secretion, providing clinical efficacy in treating overactive bladder, hyperhidrosis, and secondary vasomotor symptoms evaluated in clinical trials.

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>).