On September 24, 2026, Vigonvita Life Sciences Co., Ltd. (“Vigonvita”) received the Clinical Trial Approval Notice issued by the National Medical Products Administration (NMPA), authorizing the initiation of a clinical trial of TPN171 (Simenafil Hydrochloride) tablets for the treatment of Alzheimer’s disease (AD).
Preclinical studies demonstrated that TPN171 significantly improved recognition memory and spatial learning and memory across multiple animal models of cognitive impairment. Notably, in the 5xFAD transgenic mouse model of AD, TPN171 also significantly reduced amyloid plaque deposition in the brain.
AD is among the fastest-growing neurodegenerative diseases in terms of global disease burden. With an aging population, its high disability rate and long-term care requirements impose an increasingly heavy medical, social, and economic burden. However, existing therapies remain suboptimal in efficacy, underscoring the significant clinical value and societal importance of developing novel AD therapeutics.
Previously, TPN171 (Simenafil Hydrochloride) was approved for marketing in China in July 2025 for the treatment of male erectile dysfunction (ED) under the brand name 昂伟达®. The drug has demonstrated significant clinical efficacy, a favorable safety profile, broad patient applicability, and versatility across use scenarios, positioning it with Best-in-Class potential.