cannabis use disorder clinical trial pipeline gain 5

Cannabis Use Disorder Clinical Trial Pipeline Gains Momentum

CED Clinical Relevance
#65
Notable Clinical Interest
Emerging findings or policy developments worth monitoring closely.
ResearchMental HealthIndustry
Why This Matters
The federal executive order on cannabis rescheduling does NOT make recreational marijuana legal—it eases research restrictions and tax burdens, but full legalization still requires an act of Congress.
Clinical Summary

OpenPR reports that the clinical trial pipeline for cannabis use disorder (CUD) treatments is gaining momentum, with pharmaceutical R&D intensifying focus on targeted therapies. Aelis Farma is advancing AEF0117, a selective CB1 modulator, through Phase II trials. The growing pipeline reflects the recognition that 8-19% of cannabis users develop CUD, and there are currently no FDA-approved pharmacotherapies. With cannabis legalization expanding and use rising—particularly among older adults—the need for evidence-based CUD treatments has become a pressing public health priority. The market is projected to grow significantly through 2035.

Dr. Caplan’s Take
“Too many people hear ‘rescheduling’ and think ‘legalization’,they are fundamentally different things, and the gap between Schedule III and legal is a canyon that only Congress can bridge.”
Clinical Perspective

THE CUD TREATMENT PIPELINE

8-19% of cannabis users develop CUD. Zero FDA-approved pharmacotherapies. Aelis Farma’s AEF0117, a selective CB1 modulator, is in Phase II—unlike earlier CB1 antagonists (rimonabant was withdrawn), modulators fine-tune receptor activity without eliminating it.

As cannabis legalization matures, the industry must embrace the full spectrum of cannabis medicine—including treating the conditions cannabis itself can cause. Legalization without addiction treatment infrastructure is half a reform.

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