Vigonvita Life Sciences obtained approval from China's National Medical Products Administration (NMPA) on 10 July for Onvita (TPN171), a novel PDE5 inhibitor for erectile dysfunction (ED). The structurally distinct compound demonstrated superior selectivity (IC50 0.62 nM) and clinical efficacy versus existing therapies, with 92.02% vaginal insertion success rate at 10 mg dose in Phase III trials. Adverse event rates for headache (3.7%) and dyspepsia (0.5%) were lower than comparators, with no PDE6/PDE11-related side effects observed.
Onvita features rapid onset (30 minutes) and prolonged half-life (8 to 11 hours), accommodating spontaneous use. Unlike earlier PDE5 inhibitors, it maintains efficacy with alcohol consumption and is suitable for elderly patients and those with hepatic/renal impairment. The approval introduces a fifth ED therapy in China after sildenafil, vardenafil, tadalafil and aildenafil.

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