First offline prescription issued! ED patients now have access to a highly active, highly selective PDE5 inhibitor.

On September 4, 2025, the first offline prescription for simenafil hydrochloride tablets—a highly active, highly selective phosphodiesterase type 5 (PDE5) inhibitor featuring a novel chemical structure—was issued at the First Affiliated Hospital of Hunan University of Chinese Medicine. Prescribed for the treatment of erectile dysfunction (ED), this milestone marked the dawn of a new era for domestically developed innovative urological drugs in the field of ED therapy.

ED is a common condition among adult males. The overall prevalence of ED in adult males is 26.1% [1], with a prevalence rate of 40.6% among men over 40 years old, which increases progressively with age [2]. However, the current rate of ED patients seeking medical treatment is only 13.4% [3]. PDE5 inhibitors, as the first-line treatment for ED [4], constitute the preferred initial therapy for the vast majority of patients. Nevertheless, the utilization rate of anti-ED medications in China remains low, at less than 5%. Beyond the influence of traditional beliefs and medical practices, concerns regarding the efficacy and safety of drug therapy may be significant contributing factors to this phenomenon.

Simenafil hydrochloride exhibits potent inhibition of PDE5, with a clinically recommended starting dose significantly lower than that of marketed drugs targeting the same pathway. A Phase III clinical trial demonstrated [5] that simenafil hydrochloride delivers remarkable clinical efficacy, restoring erectile function scores to normal levels when administered according to the clinical protocol. Simenafil hydrochloride exhibits outstanding safety advantages, with a lower incidence of adverse reactions compared to other marketed drugs targeting the same pathway. No adverse reactions such as visual abnormalities, back pain, or muscle pain were observed.

Simenafil hydrochloride, a highly potent and selective phosphodiesterase type 5 (PDE5) inhibitor with a novel chemical structure, offers broad applicability across diverse patient populations and usage scenarios. It holds the potential to become a best-in-class medication, providing a new treatment option for patients with erectile dysfunction.

[1]三城市2226例男性勃起功能流行病学调查。中国男科学杂志，2003（03）:191-193.

[2]Prevalence and Risk Factors for Erectile Dysfunction in Chinese Adult Males.Journal of Sexual Medicine, 2017:1201.

[3]南充城区中老年男性对勃起功能障碍认知态度的调查研究。首届男性大健康中西医协同创新论坛暨第三届全国中西医结合男科青年学术论坛论文集。川北医学院附属医院泌尿外科；2019:284-285。

[4]中华医学会男科学分会勃起功能障碍诊断与治疗指南编写组。勃起功能障碍诊断与治疗指南。中华男科学杂志，2022。

[5] Efficacy and safety of simenafil in men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group, phase 3 trial. The Journal of Sexual Medicine, 2025.