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CB-003 (Amur) is a GMP-manufactured, full-spectrum psilocybin botanical oral capsule developed by Cubed Biotech for the treatment of Treatment-Resistant Depression (TRD) and Major Depressive Disorder (MDD). As a botanical drug product, it contains psilocybin along with a natural profile of secondary alkaloids derived from Psilocybe species, which are intended to provide a therapeutic profile potentially enhanced by an entourage effect. The primary mechanism of action involves the agonism of the 5-hydroxytryptamine receptor 2A (5-HT2A), a key mediator of psychedelic-induced neuroplasticity and rapid antidepressant activity. Cubed Biotech is positioning CB-003 for direct entry into Phase 2a clinical trials under the FDA's Botanical Drug Guidance, utilizing historical human use data to waive Phase 1 safety studies.
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