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學(xué)調(diào)查。中國(guó)男科學(xué)雜志，2003（03）:191-193.
[2]Prevalence and Risk Factors for Erectile Dysfunction in Chinese Adult Males.Journal of Sexual Medicine, 2017:1201.
[3]南充城區(qū)中老年男性對(duì)勃起功能障礙認(rèn)知態(tài)度的調(diào)查研究。首屆男性大健康中西醫(yī)協(xié)同創(chuàng)新論壇暨第三屆全國(guó)中西醫(yī)結(jié)合男科青年學(xué)術(shù)論壇論文集。川北醫(yī)學(xué)院附屬醫(yī)院泌尿外科；2019:284-285。
[4]中華醫(yī)學(xué)會(huì)男科學(xué)分會(huì)勃起功能障礙診斷與治療指南編寫組。勃起功能障礙診斷與治療指南。中華男科學(xué)雜志，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.
3.The information contained in this press release is for reference only and cannot in any way replace professional medical guidance, nor should it be construed as diagnostic or treatment advice. For specific information on disease diagnosis and treatment, please follow the advice or guidance of a physician or other qualified healthcare professional.