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Clomipramine + sildenafil is a fixed-dose combination of two small-molecule drugs: clomipramine, a tricyclic antidepressant that acts as a serotonin and norepinephrine reuptake inhibitor, and sildenafil, a phosphodiesterase type 5 (PDE5) inhibitor. This combination has been developed primarily as an on-demand therapy for premature ejaculation (PE), aiming to increase intravaginal ejaculation latency time (IELT) and improve sexual satisfaction compared to either monotherapy. Clomipramine is well-established for increasing ejaculatory latency through enhancement of serotonergic neurotransmission, while sildenafil improves erectile function and may enhance sexual performance. Clinical studies, including randomized controlled trials, have demonstrated that the combination provides better outcomes in IELT and patient-reported measures than either agent alone in PE, with a safety profile similar to monotherapy. The fixed dose formulation has undergone phase 2 trials, but development for this indication was discontinued in South Korea after phase 2. The combination is not widely marketed or approved but has been studied under the code name CDFR-0812[2][4][5].
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