LB Pharmaceuticals Inc. has announced the initiation of a Phase 2 clinical trial, ILLUMINATE-1, to evaluate the efficacy and safety of LB-102 in patients with bipolar depression. LB-102 is a novel, once-daily oral small molecule and a selective antagonist of D2, D3, and 5HT7 receptors. The randomized, double-blind, placebo-controlled trial will enroll approximately 320 patients with bipolar 1 depression across 30 sites in the U.S., with participants receiving either 25 mg or 50 mg doses of LB-102 or placebo over six weeks. The primary endpoint is the Montgomery-Åsberg Depression Rating Scale (MADRS)-10 at week six. Secondary endpoints include MADRS-6, CGI-BP, cognition, anhedonia, safety, and tolerability. Topline results from the trial are expected in the first quarter of 2028. Results have not yet been presented.

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