SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients

SPL026 (N,N-dimethyltryptamine [DMT] fumarate) is a psychedelic tryptamine being developed as a therapy for patients with major depressive disorder (MDD).

This trial consists of two phases, of which the first one (in healthy subjects) has been successfully completed.

Topic Healthy Subjects Depression
Compound Placebo DMT
Country United Kingdom
Visit trial

Trial Details



Trial Number

Sponsors & Collaborators

Small Pharma
Small Pharma works on the development of two drugs. Together with Imperial College London they are developing intravenous administration DMT. The other project is a variant on ketamine (SPL801B).

Papers

Safety, tolerability, pharmacodynamic and wellbeing effects of SPL026 (dimethyltryptamine fumarate) in healthy participants: a randomized, placebo-controlled phase 1 trial
This Phase I study (n=44) investigates the safety, tolerability, pharmacokinetics, and -dynamic profile of escalating doses of SPL026 (DMT fumarate; 9-21.5mg) in psychedelic-naïve healthy participants. The RCT concludes that SPL026 was well-tolerated, showing an acceptable safety profile, with potential correlations between plasma concentration and psychometric measures.

A review of psychedelics trials completed in depression, informed by European regulatory perspectives
This systematic review (s=8) analyses completed controlled trials of psychedelics for depression, including psilocybin, LSD, ayahuasca, and DMT, all in Phase II or I/II. It evaluates methodological patterns against the draft European Medicines Agency guideline revision, highlighting challenges such as unblinding, expectancy, and adverse event characterisation, while calling for larger studies to assess long-term efficacy and safety.

Pharmacokinetics of N,N-dimethyltryptamine in Humans
This double-blind, placebo-controlled study (n=24) evaluated the metabolism and clinical pharmacokinetics (how the body processes drugs) of DMT (SPL026) in an ongoing Phase I study with healthy subjects by Small Pharma. Participants received escalating doses of SPL026 via a 2-phase intravenous (IV) infusion. SP206 was safe and well-tolerated, and dose-proportional increases in DMT exposure were observed over 9–21.5 mg. For all doses, the median time to peak plasma concentration was ~10 min, and the mean elimination half-life was 9–12 min.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.