Also known as: dimethyltryptamine
SPL026 is an investigational short-acting serotonergic psychedelic (intravenous dimethyltryptamine, DMT) studied for major depressive disorder. A randomized placebo-controlled Phase 2a trial reported significant short-term MADRS improvement, but the sponsor stated it is not advancing intravenous SPL026 in its current form. It therefore remains non-approved and clinical-stage.
A 34-person trial found that a single 21.5mg intravenous dose of DMT with psychotherapy produced rapid antidepressant effects lasting three to six months. Separate brain-scan research across five psychedelics found a shared pattern of weaker within-network links and stronger communication between brain networks.
The FDA approved milsaperidone for bipolar I disorder and schizophrenia, while COMP360 psilocybin met its primary endpoint in a second phase 3 trial for treatment-resistant depression. Phase 2a data showed intravenous DMT (SPL026) significantly reduced depressive symptoms in major depressive disorder patients.
A phase 2 trial found that a single intravenous dose of dimethyltryptamine (DMT) alongside psychotherapy significantly reduced major depressive disorder symptoms, with effects lasting up to 6 months.
Compass Pathways reports positive Phase 3 results for synthetic psilocybin in treatment-resistant depression, while a Phase 2 trial demonstrates rapid antidepressant effects from single-dose DMT. Both studies show modest efficacy signals amid growing pharmaceutical interest in psychedelic compounds.
A phase IIa clinical trial found that a single intravenous dose of dimethyltryptamine (DMT) with psychological support rapidly reduced depressive symptoms in 34 adults with major depressive disorder, with improvements sustained for up to three months.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05553691 |
SPL026 With or Without SSRIs in Participants With MDD |
COMPLETED | PHASE1 |
| NCT04673383 |
SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients |
COMPLETED | PHASE1/PHASE2 |
