Reboxetine mesylate Clinical Trials

Size	Price	Qty
10mg	USD 110

Clinical Trials

Multiple completed clinical trials have evaluated reboxetine mesylate across different indications under academic and pharmaceutical sponsorship. A Phase I trial sponsored by University Hospital Basel investigated the drug's pharmacological interactions and kinetics regarding mood, substance-related, and amphetamine-related disorders. Additionally, a Phase II trial sponsored by Pfizer evaluated urethral function in women suffering from stress urinary incontinence.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00886886	Completed	Mood Disorder\|Substance-related Disorders\|Amphetamine-related Disorders	University Hospital Basel Switzerland	2009-04	Phase 1
NCT00141128	Completed	Urinary Incontinence Stress	Pfizer	2005-12	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Reboxetine mesylate's potent and selective binding to the norepinephrine transporter (Ki = 8.2 nM) blocks the presynaptic reuptake of norepinephrine, resulting in elevated extracellular neurotransmitter concentrations within synaptic spaces. This sustained activation of adrenergic signaling modulates central neurocircuitry and peripheral autonomic tone, providing a therapeutic rationale for managing mood disorders and stress 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>).