CB345

CB345 is a novel film formulation of agomelatine developed by Hangzhou Chengbang Pharmaceutical Technology for the treatment of major depressive disorder (MDD). Designed for sublingual or buccal administration, this formulation aims to improve the pharmacokinetic profile or patient convenience compared to traditional oral tablets by potentially bypassing first-pass metabolism. Agomelatine, the active pharmaceutical ingredient, acts as a potent agonist at melatonin MT1 and MT2 receptors and as a selective antagonist at serotonin 5-HT2C receptors. This dual mechanism helps resynchronize circadian rhythms and enhance monoaminergic neurotransmission (dopamine and norepinephrine) in the frontal cortex, addressing the core symptoms of depression. CB345 is currently being evaluated in Phase 1 clinical trials to compare its safety, tolerability, and bioavailability with standard 25 mg agomelatine tablets.