GH001 is a synthetic inhaled formulation of 5-MeO-DMT, described in its 2026 trial as “a synthetic formulation of inhaled mebufotenin” (Cubała et al., 2026). It is the furthest-developed 5-MeO-DMT drug program, run by GH Research. ClinicalTrials.gov lists eight GH001 studies; trials in bipolar II disorder and postpartum depression were terminated, and none lists a site in Canada (ClinicalTrials.gov).
The first published trial was small and uncontrolled: in 16 adults with treatment-resistant depression in the Netherlands, 7 of 8 in the individualized-regimen group were in remission at day 7 (Reckweg et al., 2023). Without a comparison group, that cannot separate the drug from expectation.
The phase 2b trial randomized 81 adults at 16 sites in Europe. At day 8, 23 of 40 on GH001 (57.5%) were in remission, against 0 of 41 on placebo. Adverse events affected 72.5% of the GH001 group, most often nausea (Cubała et al., 2026). The drug’s effects are obvious, which can reveal who got it, and the blinded period lasted one week. It is one trial, and GH001 is not an approved medicine. This is not medical advice.
Sources
- Cubała et al., 2026, JAMA Psychiatry: GH001 vs placebo in treatment-resistant depression
- Reckweg et al., 2023, Frontiers in Psychiatry: phase 1/2 trial of GH001
- ClinicalTrials.gov API: studies with intervention GH001
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