Paroxetine mesylate Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials sponsored by Noven Therapeutics have evaluated oral paroxetine mesylate for the management of postmenopausal symptoms and vasomotor hot flashes. Spanning Phase 1, Phase 2, and Phase 3, these studies assessed the agent's pharmacokinetics, safety, and therapeutic efficacy across multi-week treatment regimens. All of these trials have reached completed status, establishing a well-documented clinical profile for paroxetine mesylate as a non-hormonal therapeutic option.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01829919	Completed	Postmenopausal Symptoms	Noven Therapeutics	2011-07	Phase 1
NCT01361308	Completed	Postmenopausal Symptoms	Noven Therapeutics	2011-05	Phase 3
NCT01101841	Completed	Hot Flashes	Noven Therapeutics	2010-03	Phase 3
NCT00786188	Completed	Hot Flashes	Noven Therapeutics	2008-11	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Paroxetine mesylate selectively binds to the presynaptic serotonin transporter, potently inhibiting serotonin reuptake and thereby increasing synaptic serotonin concentration within the central nervous system. This enhancement of serotonergic signaling modulates hypothalamic thermoregulatory pathways, directly mitigating the frequency and severity of postmenopausal hot flashes and related 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>).