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**SM-001** is an investigational standardized ayahuasca analog developed by Advanced Integrative Medical Science Institute. It is an oral hot-water decoction prepared from proprietary clonal cultivars of *Banisteriopsis caapi* and *Psychotria viridis*. The registered Phase 1 program evaluates single-dose safety, dose range, and systemic exposure to dimethyltryptamine, harmine, tetrahydroharmine, and harmaline in healthy adults; the program is associated with development for major depressive disorder and post-traumatic stress disorder. Its pharmacology is expected to reflect the combined activity of dimethyltryptamine at serotonergic receptors and beta-carboline monoamine oxidase A inhibition, which enables oral dimethyltryptamine exposure. ([clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05894902))
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