Drug Development

5-MeO-DMT

5-MeO-DMT Clinical Trial Phases | Usona Institute is at the beginning of phase one

Current 5-MeO-DMT Clinical Trials

MEO101

Usona has recently been granted IND approval to conduct a phase 1, first-in-human, double-blind, placebo-controlled, randomized, single and multiple ascending dose study to determine the safety, tolerability, and pharmacokinetics of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) administered by intramuscular injection in healthy volunteers.

This study is in the start-up phase and not yet open to enrollment. Please check back soon for updates.

Light shinning through an opening of a rock structure

5-MeO-DMT Overview

5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a psychoactive indolealkylamine that is produced by a number of plants and animals, but is best known to be present, along with its active, O-demethylated metabolite bufotenine, in the skin glands of a certain toxic desert toad (Incilius alvarius, formerly Bufo alvarius).

5-MeO-DMT, first synthesized in 1936 (Hoshino 1936), is closely related in structure to serotonin (5-hydroxytryptamine [5-HT]), and therefore has a similar molecular structure to the classic psychedelics DMT (N,N-dimethyltryptamine) and psilocybin. However, its pharmacological activity may be distinct. 5-MeO-DMT works mainly as a selective serotonin receptor agonist at the 5-HT1A and 5-HT2A receptors, with functional dominance of the 5‑HT1A subtype being suggested by numerous researchers (Spencer 1987, Winter 2000, Krebs-Thomson 2006, Shen 2010a).

There are no published, placebo-controlled clinical trials of 5-MeO-DMT, and the Sponsor has not yet completed any studies in humans with the drug product. However, there are extensive reports of 5-MeO-DMT use in epidemiological studies and surveys of recreational/spiritual/medicinal uses (Weil 1994, Shulgin 1997, Barsuglia 2018, Davis 2018, Cox 2018a, Cox 2018b, Davis 2019, Uthaug 2019). Evidence from these studies suggest that 5-MeO-DMT use is related to self-reported improvement of a variety of mental health symptoms including anxiety, depression, substance use problems, and PTSD (Davis 2018, Cox 2018a, Cox 2018b, Davis 2019, Uthaug 2019).

As a potentially potent, fast-acting agent with short duration of psychedelic effect in humans, 5-MeO-DMT may have significant health care implications due to cost-savings and increased patient accessibility.