Avanafil Clinical Trials

Size	Price	Qty
50mg	USD 147

Clinical Trials

Several completed clinical trials have evaluated the therapeutic efficacy, safety, and pharmacokinetic profile of avanafil across Phase I and Phase IV investigations. Research primarily addressed conditions such as erectile dysfunction, alongside safety assessments in healthy volunteers, individuals with renal impairment, and evaluations of semen exposure and sperm function. Featuring both crossover and parallel-cohort designs, these studies were sponsored by academic institutions like the University of Alexandria as well as pharmaceutical industry sponsors including VIVUS LLC.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04374994	Completed	Erectile Dysfunction	University of Alexandria	2018-09-01	Phase 4
NCT01095601	Completed	Healthy	VIVUS LLC	2010-04	Phase 1
NCT01117038	Completed	Erectile Dysfunction	VIVUS LLC	2010-04	Phase 1
NCT01054430	Completed	Erectile Dysfunction	VIVUS LLC	2010-01	Phase 1
NCT01054261	Completed	Renal	VIVUS LLC	2010-01	Phase 1
NCT00914511	Completed	Avanfil ADME\|Semen Exposure\|Sperm Function	VIVUS LLC	2009-05	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Avanafil functions as a highly potent and selective phosphodiesterase type 5 (PDE5) inhibitor (IC50 = 5.2 nM), binding to PDE5 and preventing the degradation of cyclic guanosine monophosphate (cGMP) to elevate intracellular cGMP levels and promote smooth muscle relaxation. This sustained vascular relaxation and enhanced localized blood flow provide the mechanistic basis for its therapeutic application in treating erectile dysfunction and related endothelial conditions investigated 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>).