{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T20:14:20Z","timestamp":1778530460851,"version":"3.51.4"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T00:00:00Z","timestamp":1778284800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Vigonvita Life Sciences Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Simenafil, a new potent selective phosphodiesterase-5 inhibitor (PDE5i), has been developed for erectile dysfunction (ED) treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of simenafil therapy in patients with ED.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomized, double-blind, placebo-controlled, multicenter, parallel-group, phase 2 trial was conducted in men aged \u226522\u00a0years with a history of ED of 3\u00a0months or more. The subjects were randomized in a ratio of 1:1:1:1 to on-demand receive either placebo or simenafil at fixed doses of 5, 10, and 20\u00a0mg for 8\u00a0weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcomes<\/jats:title>\n                    <jats:p>Primary efficacy endpoints were the least square mean (LSM) changes from baseline to week 8 in the erectile function (EF) domain of the International Index of Erectile Function (IIEF), percentages of \u201cyes\u201d responses to Sexual Encounter Profile (SEP) diary Question 2 (SEP Q2: Were you able to insert your penis into your partner\u2019s vagina?) and Question 3 (SEP Q3: Did your erection last long enough for you to have successful intercourse?)<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 255 patients were randomized. After 8\u00a0weeks of treatment, doses of 5, 10, and 20\u00a0mg of simenafil exhibited substantial increases than placebo in IIEF-EF score (9.7, 9.2, 9.5 vs. 5.5, P\u2009&amp;lt;\u2009.001), the percentages of \u201cyes\u201d responses to SEP Q2 (36.11%, 30.79%, 33.12% vs. 19.56%, P\u2009&amp;lt;\u2009.01), and SEP Q3 (55.96%, 51.14%, 51.05% vs. 31.02%, P\u2009&amp;lt;\u2009.001). The incidence of adverse drug reactions was 36.5%, 44.3%, 45.9%, and 61.7% for the placebo, 5\u00a0mg, 10\u00a0mg, and 20\u00a0mg simenafil groups, respectively. Overall, the adverse events were generally mild or moderate.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical Implications<\/jats:title>\n                    <jats:p>Simenafil could effectively improve erectile function and the adverse reaction profile of simenafil was consistent with its pharmacological mechanism, with most adverse reactions being mild to moderate. The results provide a rationale for further evaluation in larger and longer-term phase 3 clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Strengths &amp; Limitations<\/jats:title>\n                    <jats:p>We did not conduct a head-to-head study comparing the efficacy and safety of simenafil with other PDE5 inhibitors. Meanwhile, we did not further analyze the efficacy and safety of simenafil in specific populations, such as ED patients with diabetes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Simenafil is an effective and well-tolerated treatment for men with ED.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jsxmed\/qdag075","type":"journal-article","created":{"date-parts":[[2026,5,6]],"date-time":"2026-05-06T11:41:45Z","timestamp":1778067705000},"source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of simenafil in men with erectile dysfunction: a multicenter, randomized, double-blind, placebo-controlled, fixed dose, parallel group, phase 2 trial"],"prefix":"10.1093","volume":"23","author":[{"given":"Yuzhuo","family":"Yang","sequence":"first","affiliation":[{"name":"Department of Obstetrics and Gynecology, Peking university first hospital , Beijing 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,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Xiansheng","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Urology, the First Affiliated Hospital of Anhui Medical University , Hefei, Anhui 230022 ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junhong","family":"Deng","sequence":"additional","affiliation":[{"name":"Department of Andrology, Guangzhou First People's Hospital , Guangzhou, Guangdong 510180 ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutian","family":"Dai","sequence":"additional","affiliation":[{"name":"Department of Andrology, Nanjing Drum Tower Hospital , Nanjing, Jiangsu 21008 ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Huiliang","family":"Zhou","sequence":"additional","affiliation":[{"name":"Department of Andrology and Sexual Medicine, First Affiliated Hospital of Fujian Medical 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