SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients

Summary

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

Timeline

Start

2021-02-04

Primary completion

2022-10-01

Completion

2022-12-22

Outcome

Met primary endpoint

paper At 2 weeks, the DMT group showed a significantly greater reduction in MADRS score than placebo (mean difference = -7.35; 95% CI = -13.62 to -1.08; P = 0.023). PMID 41699126 ↗

Publications

• Results Good M, Joel Z, Benway T, Routledge C, Timmermann C, Erritzoe D, Weaver R, Allen G, Hughes C, Topping H, Bowman A, James E. Pharmacokinetics of N,N-dimethyltryptamine in Humans. Eur J Drug Metab Pharmacokinet. 2023 May;48(3):311-327. doi: 10.1007/s13318-023-00822-y. Epub 2023 Apr 22.
• Results James E, Erritzoe D, Benway T, Joel Z, Timmermann C, Good M, Agnorelli C, Weiss BM, Barba T, Campbell G, Baker Jones M, Hughes C, Topping H, Boyce M, Routledge C. Safety, tolerability, pharmacodynamic and wellbeing effects of SPL026 (dimethyltryptamine fumarate) in healthy participants: a randomized, placebo-controlled phase 1 trial. Front Psychiatry. 2024 Jan 11;14:1305796. doi: 10.3389/fpsyt.2023.1305796. eCollection 2023.
• Erritzoe D, Barba T, Benway T, Joel Z, Good M, Layzell M, Jones MB, Campbell G, Murphy-Beiner A, Rands P, Boyce M, Topping H, Weiss B, Timmermann C, Nutt D, Carhart-Harris R, Routledge C, James E. A short-acting psychedelic intervention for major depressive disorder: a phase IIa randomized placebo-controlled trial. Nat Med. 2026 Feb;32(2):591-598. doi: 10.1038/s41591-025-04154-z. Epub 2026 Feb 16.

Drugs

Indications