Engineering Next-Generation Psychedelic Neuromedicines
Neurala is advancing a proprietary DMT–harmala platform involving structural refinement of naturally occurring alkaloids, combined with advanced pharmaceutical development, to generate differentiated and clinically scalable neuromedicines for psychiatric indications with high unmet needs.
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Phase 1 Clinical Validation
Our completed Phase 1 PoC study represents the world’s first controlled evaluation of a fully standardised multi-alkaloid DMT–harmala formulation. Published in Scientific Reports, the data confirmed a robust therapeutic signal, with acute effect scores (MEQ-30 and 5D-ASC total scores) exceeding those previously reported for both psilocybin and LSD.
Crucially, this intensity was strongly associated with persisting psychological benefits while maintaining a favourable safety profile.
Platform R&D and Product Development
Our proprietary DMT-harmala platform is built on extensive pharmaceutical development and compound optimisation, supported by targeted preclinical studies, to engineer multi-alkaloid formulations with differentiated pharmacological profiles. Through systematic compound selection, structural modifications, dosing ratios, and delivery routes, we create product candidates precisely targeted to specific neuropsychiatric indications.
DMT (N,N-Dimethyltryptamine) is a naturally occurring tryptamine that modulates multiple receptor systems, including serotonin (5-HT2A and others) and sigma-1 receptors. It promotes emotional processing, cognitive flexibility, and neuroplasticity, and demonstrates strong potential as a rapid-acting therapeutic agent for neuropsychiatric conditions.
Harmala alkaloids are naturally occurring monoamine oxidase inhibitors that enhance the bioavailability of DMT and raise serotonin and norepinephrine levels. They also activate neural pathways involved in emotional regulation and neuroplasticity, and have demonstrated antidepressant and anti-addictive effects.
Our Pipeline
Neurala’s clinical pipeline focuses on high-value psychiatric and addictive disorders with significant unmet need. Our lead candidates, NBX-100 (substance use disorders) and NBX-200 (chronic depression), are engineered to deliver differentiated pharmacokinetic and pharmacodynamic profiles tailored to specific therapeutic contexts. Each candidate incorporates distinct structural refinements, dosing paradigms, and delivery strategies designed to optimise clinical performance and scalability.
