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CLE-100 is an investigational oral formulation of esketamine developed by Clexio Biosciences. It is designed as a daily-use adjunctive treatment for patients with Major Depressive Disorder (MDD) who have not responded adequately to at least two different antidepressants. Esketamine and its metabolite S-norketamine are potent antagonists of the N-methyl-D-aspartate (NMDA) receptor, blocking the ion channel at the PCP site. By inhibiting NMDA receptor activity, CLE-100 aims to rapidly alleviate depressive symptoms compared to traditional antidepressants such as SSRIs or SNRIs. The drug incorporates abuse-deterrent technology and is intended for convenient at-home administration[2][6][7]. Clinical trials have shown that it has a favorable tolerability profile with no serious adverse events reported in studies so far[2].
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