Drug intelligence / Profile preview

SPL026

Development stage
Phase 2
Lead developer
Cybin
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
Administration
Intravenous, Intramuscular
01

Overview

SPL026 is a proprietary, pharmaceutical-grade formulation of N,N-dimethyltryptamine (DMT) fumarate developed for the treatment of major depressive disorder (MDD). It is a short-acting psychedelic administered via intravenous or intramuscular injection. The drug acts primarily as an agonist at serotonin receptors in the brain, particularly the 5-hydroxytryptamine receptor 2A (5HT2A), which are implicated in mood regulation and mental health. Clinical studies have demonstrated that SPL026, when combined with supportive therapy, produces rapid and durable antidepressant effects after a single dose in patients with moderate to severe MDD. Notably, recent trials suggest that co-administration with selective serotonin reuptake inhibitors (SSRIs) may enhance its efficacy without compromising safety or tolerability[2][4][5][9]. SPL026 is being developed by Cybin following its acquisition of Small Pharma.

Other names
DMT fumarateN,N-dimethyltryptamine fumarate
02

Targets

HTR1A (Serotonin receptor 1A (5-hydroxytryptamine receptor 1A))HTR2A (Serotonin receptor 5-HT2A)HTR2C (5-hydroxytryptamine 2C receptor)

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