Udenafil Clinical Trials

Size	Price	Qty
5mg	USD 107

Clinical Trials

Several clinical trials have evaluated udenafil and related treatment protocols in healthy male volunteers and patients with erectile dysfunction. Industry-sponsored by entities such as Dong-A ST Co. Ltd. and Pfizer (subsequently Viatris Inc.), these investigations predominantly comprise Phase 1 pharmacokinetic studies and non-interventional prospective studies. Across the recorded protocols, recruitment statuses range from unknown to completed.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01928563	Unknown status	Healthy Male Subjects	Dong-A Pharmaceutical Co. Ltd.\|Dong-A ST Co. Ltd.	2013-09	Phase 1
NCT01929213	Unknown status	Healthy Volunteers	Dong-A Pharmaceutical Co. Ltd.\|Dong-A ST Co. Ltd.	2013-08	Phase 1
NCT01108900	Completed	Erectile Dysfunction	Pfizer''s Upjohn has merged with Mylan to form Viatris Inc.\|Pfizer	2010-07	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Udenafil functions as a potent selective antagonist of human phosphodiesterase type 5 (PDE5) with an IC50 of 8.25 nM, effectively preventing the enzymatic degradation of cyclic guanosine monophosphate (cGMP). Consequently, the accumulation of intracellular cGMP promotes vascular smooth muscle relaxation and enhanced blood flow, offering clinical relevance in the treatment of erectile dysfunction as 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>).