Avanafil (STENDRA™, SPEDRA™, Zepeeed™) is an oral phosphodiesterase type 5 inhibitor indicated for the treatment of erectile dysfunction. Avanafil is rapidly absorbed after oral administration, with a median time to maximum plasma concentration of 30 to 45 min. In a 12-week, randomized, double-blind, placebo-controlled, multicentre trial in patients with erectile dysfunction, avanafil 50, 100 and 200 mg recipients had significantly greater improvements from baseline than placebo recipients in mean international index of erectile dysfunction-erectile function domain scores and in successful vaginal penetration and sexual intercourse attempts (coprimary endpoints). Treatment effects were significantly larger in avanafil 100 and 200 mg recipients than 50 mg recipients. For avanafil recipients, approximately two-thirds of attempts at sexual intercourse that were made prior to 15 min, or more than 6 h, after drug administration were successful, compared with approximately one-quarter of attempts made during these time periods by placebo recipients. In trials in patients with erectile dysfunction in association with diabetes mellitus, and after nerve-sparing radical prostatectomy, avanafil 100 or 200 mg was significantly more efficacious than placebo for primary and most secondary endpoints. Avanafil was generally well tolerated in the above-mentioned studies. In a pooled analysis of three clinical trials, ≤2 % of avanafil and placebo recipients discontinued treatment because of adverse events. During extended treatment with avanafil for >52 weeks, 2.8 % of patients discontinued treatment because of adverse reactions and there were no drug-related serious adverse events.