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Fudanafil is a potent and selective phosphodiesterase type 5 (PDE5) inhibitor developed by Xianzhu Biotechnology, a subsidiary of Sihuan Pharmaceutical. It is currently under clinical investigation for the treatment of pulmonary arterial hypertension (PAH) and erectile dysfunction (ED). By inhibiting the PDE5 enzyme, fudanafil prevents the hydrolysis of cyclic guanosine monophosphate (cGMP), thereby increasing intracellular cGMP levels in smooth muscle cells. This mechanism promotes nitric oxide-mediated vasodilation in the pulmonary vasculature and the corpus cavernosum, which serves to reduce pulmonary vascular resistance and improve erectile function, respectively. Fudanafil is designed to offer a competitive therapeutic profile within the PDE5 inhibitor class, aiming for improved efficacy or safety compared to established agents like sildenafil and tadalafil.
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