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
Status Recruiting
Results Published
Start date 02 April 2021
End date 01 February 2023
Phase Phase I Phase II
Design Blinded
Type Interventional
Generation Second
Participants 68
Sex All
Age 18- 99
Therapy No

Trial Details

2-part study. Part A in psychedelic-naïve healthy volunteers. Part B in patients with MDD who score moderate-severe on Ham-D. Healthy volunteers will receive a single dose of SPL026 in a dose-escalation parallel group study. Patients will receive up to 2 single doses of SPL026, 2 weeks apart. Dose 1 will be randomised double-blind with placebo. Dose 2 will be open label, active SPL026. SPL026 will be administered by IV injection. Safety and tolerability, PK, PD and efficacy will be measured.

Trial Number NCT04673383

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

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