Trospium chloride Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Multiple clinical trials have evaluated trospium chloride across distinct therapeutic areas and development stages. Completed studies include a Phase 1 trial sponsored by Karuna Therapeutics assessing combination therapy for schizophrenia, as well as a Phase 4 trial sponsored by Allergan investigating its pharmacokinetics in elderly patients with overactive bladder. These completed investigations demonstrate the clinical evaluation of trospium chloride across early and late-stage settings, supporting its application in central nervous system research and urological indications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02831231	Completed	Schizophrenia	Karuna Therapeutics	2016-09-07	Phase 1
NCT00863551	Completed	Elderly\|Pharmacokinetics\|Overactive Bladder	Allergan	2009-04	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Trospium chloride competitively binds to muscarinic acetylcholine receptors, preventing endogenously released acetylcholine from triggering intracellular parasympathetic signaling cascades. By blocking cholinergic stimulation, it suppresses detrusor muscle contraction and decreases smooth muscle tone in the bladder wall, providing therapeutic relief for patients suffering from overactive bladder.

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>).