A Phase 3 Trial to Assess CYB003 (Psilocybin) in Major Depressive Disorder (EMBRACE)

EMBRACE is evaluating an investigational oral study medication, CYB003 (a compound similar to psilocin, the active ingredient in Psilocybe mushrooms), in combination with structured psychological support, while participants continue their existing antidepressant and Therapy Sessions. The goal is to better understand whether this approach may reduce symptoms of MDD. Psychological support is delivered by a licensed therapist trained in EMBARK, with an additional session monitor present during dosing for safety and support.