News|Articles|August 24, 2026

Patent Application Published: MDMA-N-Acylethanolamines for the Treatment of PTSD, Anxiety, and Eating Disorders

Author(s)Leah Kuntz
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Key Takeaways

  • Clearmind’s U.S. filing covers MDMA combined with N-acylethanolamines, positioning PEA as a modulator intended to improve potency, tolerability, and dosing flexibility across several psychiatric indications.
  • FDA’s July 2026 guidance formally includes MDMA within “psychedelic drugs” and outlines expectations for trial design, conduct, safety monitoring, data collection, and NDA-enabling requirements.
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Clearmind patents MDMA plus PEA combo aiming to boost PTSD, anxiety and eating-disorder therapy as FDA issues new psychedelic trial guidance.

Clearmind Medicine today announced the publication in the United States of its patent application covering a novel combination of 3,4-methylenedioxymethamphetamine (MDMA) and N-acylethanolamines, such as palmitoylethanolamide (PEA), for the treatment of posttraumatic stress disorder (PTSD), anxiety, and eating disorders.1

The newly published application includes novel embodiments in which PEA may “enhance MDMA’s therapeutic potency, reduce required dosing, mitigate MDMA associated [adverse] effects, and broaden MDMA’s therapeutic window.”1 Any and all of these items could strengthen the clinical and commercial potential of MDMA based treatments.

FDA Spotlight on Psychedelics

This publication was encouraged by the US Food and Drug Administration (FDA)’s increased attention to psychedelics.

On July 13, 2026, the FDA shared its guidance, “Psychedelic Drugs: Considerations for Clinical Investigations.”2 In the guidance, the FDA shared considerations for sponsors developing psychedelic drugs for medical conditions, specifically for psychiatric disorders and substance use disorders. The guidance explicitly includes MDMA within its definition of psychedelic drugs. They described the category as encompassing classic psychedelics in addition to “entactogens or empathogens such as 3,4-methylenedioxymethamphetamine (MDMA).”2 Additionally, the guidance addresses considerations relating to clinical development process, such as the trial design, conduct, data collection, subject safety, and new drug application requirements.

The FDA also noted that psychedelic drugs can be uniquely difficult to develop clinically due to their psychoactive effects and alterations in mood, cognition, and perception. The guidance provided sponsors with the FDA’s latest recommendations for addressing these considerations as part of psychedelic drug development.

Collaboration With NeuroThera Labs

The publication by the United States Patent and Trademark Office marks a significant intellectual property milestone resulting from the ongoing collaboration between Clearmind and NeuroThera Labs. Through this collaboration, NeuroThera's PEA technology is integrated into Clearmind’s psychedelic-derived therapeutic programs, contributing to a joint growing intellectual property portfolio that already includes 13 patent applications generated through this collaboration globally.

References

1. Clearmind Advances MDMA-N-acylethanolamines IP for the treatment of PTSD amid rising U.S. federal support for psychedelic innovation. News release. August 24, 2026. Accessed August 24, 2026. https://www.globenewswire.com/news-release/2026/08/24/3349697/0/en/clearmind-advances-mdma-n-acylethanolamines-ip-for-the-treatment-of-ptsd-amid-rising-u-s-federal-support-for-psychedelic-innovation.html

2. Psychedelic Drugs: Considerations for Clinical Investigations. FDA. July 2026. Accessed August 24, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations