Dapoxetine HCl Clinical Trials

Size	Price	Qty
25mg	USD 147

Clinical Trials

Several clinical trials evaluate the therapeutic profile and pharmacokinetics of dapoxetine hydrochloride across Phase 1, Phase 3, and prospective observational stages. These completed studies focus on premature ejaculation, ejaculatory dysfunction, physiological sexual dysfunction, and pharmacological evaluations in healthy male subjects. The research is sponsored by academic medical centers such as Pusan National University Hospital alongside major pharmaceutical entities, including Janssen Research & Development, Johnson & Johnson, Alza Corporation, and Dong-A ST.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03018743	Unknown status	Premature Ejaculation	Pusan National University Hospital	2017-01	--
NCT01928563	Unknown status	Healthy Male Subjects	Dong-A Pharmaceutical Co. Ltd.\|Dong-A ST Co. Ltd.	2013-09	Phase 1
NCT01366664	Completed	Ejaculation	Janssen Research & Development LLC	2011-04	Phase 1
NCT01063881	Completed	Sexual Dysfunction Physiological	Johnson & Johnson Pte Ltd	2010-05	Phase 3
NCT00211094	Completed	Ejaculation	Alza Corporation DE USA		Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dapoxetine hydrochloride selectively binds to the presynaptic serotonin transporter, effectively inhibiting the reuptake of serotonin and increasing its accumulation within the synaptic cleft. By augmenting central serotonergic neurotransmission, it modulates the ejaculatory reflex circuit, which directly correlates with its clinical utility in delaying ejaculation in patients studied for premature ejaculation and sexual dysfunction.

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>).