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MYCO-001 is a clinical-stage, synthetic, 99% pure psilocybin drug product being developed by Mydecine Innovations Group as a first‑generation psychedelic therapeutic, primarily for smoking cessation and post‑traumatic stress disorder (PTSD).[1][5][7] Psilocybin is a small-molecule indole that acts as a serotonin 5‑HT2 receptor agonist, modulating cortical and thalamic circuits involved in mood, cognition, and addiction, and is typically administered with structured psychotherapy to produce sustained changes in addictive behaviors and trauma-related symptoms.[3][9] MYCO-001 is supplied under an FDA-cleared IND for a multi‑site, NIH/NIDA‑funded randomized trial evaluating psilocybin-assisted therapy for smoking cessation, and is also planned for an industry-sponsored seamless phase 2/3 trial in nicotine dependence and development for PTSD in veterans.[1][2][6][7][10][11]
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