Clinical Trials

Multiple clinical trials sponsored by Cristália Produtos Químicos Farmacêuticos Ltda. evaluate the Phase IV safety and efficacy of lodenafil carbonate in patients with erectile dysfunction and comorbid type II diabetes or coronary artery disease. Among these post-marketing studies, a clinical trial examining diabetic patients with erectile dysfunction was completed. Conversely, a clinical trial designed to assess cardiovascular safety during physical effort in patients with coronary artery disease was withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT01180283 Completed
Erectile Dysfunction
Cristália Produtos Químicos Farmacêuticos Ltda.
 2009-01 Phase 4
NCT00817830 Withdrawn
Erectile Dysfunction|Coronaropathy
Cristália Produtos Químicos Farmacêuticos Ltda.
 2008-11 Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lodenafil acts as a potent inhibitor of phosphodiesterase type 5 (PDE5), binding to the catalytic site of the enzyme and blocking the degradation of cyclic guanosine monophosphate (cGMP). The resulting accumulation of intracellular cGMP induces vascular smooth muscle relaxation and enhances arterial blood flow, providing the physiological basis for treating erectile 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>).

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Note: Technical data last updated: Sep 1, 2026.