NeuroThera Labs Inc., a clinical-stage pharmaceutical unit of SciSparc Ltd., filed a patent application in the United States covering a therapeutic combination of MDMA and N-aciletanolaminas, including palmitoiletanolamida, for the treatment of post-traumatic stress disorder, anxiety and eating disorders.
The application addresses therapeutic potency, dosage requirements, side effects and the therapeutic window for the MDMA-based regimen. The filing stems from a collaboration between NeuroThera and Clearmind Medicine Inc., which has published 13 global patent applications to date.
The patent submission follows the U.S. Food and Drug Administration’s finalization of guidance on psychedelic drug clinical investigations on July 14, 2026. The FDA document, titled Psychedelic Drugs: Considerations for Clinical Investigations, explicitly includes MDMA in its definition of psychedelic substances, encompassing classical psychedelics as well as entactogens or empathogens.
The guidance outlines requirements for clinical trial design, conduct, data collection and participant safety, while noting that psychedelic drugs present unique challenges due to their psychoactive effects and potential impacts on mood, cognition and perception. The framework applies to new drug approval applications for substances in this class.
SciSparc, through NeuroThera, also develops drug programs based on THC and CBD for conditions including Tourette’s syndrome, Alzheimer’s disease, autism spectrum disorder and status epilepticus.
