Drug intelligence / Profile preview

clomipramine + sildenafil

Development stage
Discontinued
Lead developer
CTC Bio
Modality
Small Molecules
Administration
Oral
01

Overview

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].

Brand names
CDFR-0812CDFR0812CDFR 0812
Other names
clomipramine/sildenafilclomipramine and sildenafil combination
02

Targets

SERT (Sodium-dependent serotonin transporter)NET (Norepinephrine Transporter)PDE5 (Phosphodiesterase 5A)

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