Helus Pharma announced publication in Nature Medicine of Phase 2a trial results showing its short-acting psychedelic SPL026 met its primary endpoint with significant reductions in depressive symptoms at two weeks in moderate-to-severe MDD patients. The company also appointed a new SVP of Medical Affairs and is advancing HLP003 (Breakthrough Therapy Designation from FDA) and HLP004 in its pipeline.
Compass Pathways reported positive late-stage COMP360 psilocybin data in treatment-resistant depression and plans FDA talks ahead of a filing between October and December. The update lifted shares across several psychedelics developers.
New findings on psychedelic-based depression treatments included a UK DMT trial in 34 adults and a mouse study of modified psilocin compounds with fewer hallucinogenic-like effects.
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.
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
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 |
|---|---|---|---|
| NCT06899334 |
Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in Healthy Participants |
RECRUITING | PHASE1 |
| NCT04716335 |
Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects |
COMPLETED | EARLY_PHASE1 |
| NCT04260711 |
Discontinuing Disease-modifying Therapies in Stable Relapsing - Onset Multiple Sclerosis (DOT-MS). |
UNKNOWN | NA |
