Science
Mechanism of Action
Mirodenafil operates by inhibiting the phosphodiesterase-5 (PDE5) enzyme, which elevates cyclic guanosine monophosphate (cGMP) levels, promoting smooth muscle relaxation and vasodilation. While this mechanism is effective for systemic conditions like erectile dysfunction, no specific mechanism of action or beneficial pathway for cosmetic purposes on the skin has been identified or researched.
Research
Clinical Evidence
Low confidenceN/A
Key findings
- 01 Oral administration of Mirodenafil at 50 mg and 100 mg doses has consistently shown significant improvements in International Index of Erectile Function (IIEF) Question 3 and Question 4 scores in men diagnosed with erectile dysfunction. A 100 mg oro-dispersible film formulation further demonstrated a significant difference compared to placebo in double-blind, randomized controlled trials.
Transparency
Dusting Analysis
Mirodenafil is a pharmaceutical active ingredient and is not commonly utilized in cosmetic formulations. Consequently, there is no existing data or established metrics regarding its 'dusting' potential within the cosmetic industry.
The Formula
Formulation
Stability
Mirodenafil dihydrochloride, a crystalline solid, exhibits excellent stability, maintaining its integrity for at least 4 years when stored at -20°C. Stock solutions prepared in organic solvents are stable for 6 months at -80°C and 1 month at -20°C.
Conflicts
- Nitrates (when orally administered, due to a severe risk of hypotension)
- Inhibits CYP3A4, CYP2C19, and CYP2D6 activities (potential for drug-drug interactions, primarily relevant for systemic pharmaceutical use)
Safety
Safety Profile
Mirodenafil is approved for oral treatment of erectile dysfunction in South Korea, but there is no information available regarding its safety assessment by cosmetic regulatory bodies such as CIR or SCCS, nor FDA approval for cosmetic use. Oral administration commonly leads to adverse effects including headache (1.8–14.8%) and facial flushing (6.7–24.1%), nasal congestion, and dizziness. While facial flushing indicates a vasodilatory effect, specific data on topical irritancy or sensitization is absent. It is contraindicated for oral use in individuals taking nitrates due to severe hypotension risk.
Your Skin
Skin Compatibility
Our Assessment
Verdict
Mirodenafil is a pharmaceutical agent with no identified mechanism of action, clinical efficacy, or established safety profile for topical application in cosmetic formulations, rendering data insufficient for its assessment in skincare.
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