PHOENIXVILLE, PA — PleoPharma has dosed the first patient in a Phase 3 clinical trial of an investigational treatment for cannabis withdrawal symptoms, advancing a drug candidate that could become the first FDA-approved therapy targeting a condition affecting millions of Americans with cannabis use disorder.
The clinical-stage biotechnology company announced the start of the CAN-004 study, a pivotal trial evaluating PP-01 in adults with moderate to severe cannabis use disorder who are seeking to stop using cannabis.
The trial marks a key regulatory milestone for PP-01, which has received Fast Track designation from the U.S. Food and Drug Administration and is intended to support a future new drug application.
Cannabis use disorder affects an estimated 20.6 million people in the United States, according to information provided by the company.
PleoPharma noted that more than 1.4 million people received treatment for cannabis use disorder in 2024 despite the absence of any approved medication-assisted treatment.
Many patients attempting to reduce or discontinue cannabis use experience withdrawal symptoms that can contribute to relapse, including anxiety, irritability, cravings, sleep disturbances, depression, and restlessness.
“Dosing the first patient in our Phase 3 trial is a significant milestone for PleoPharma and an important step forward to help those patients with cannabis use disorder who are seeking to quit or reduce cannabis,” Chief Executive Officer Ginger Constantine stated. She added that there are currently no FDA-approved treatments for either cannabis withdrawal syndrome or cannabis use disorder.
CAN-004 is designed as a multicenter, randomized, double-blind, placebo- and active-controlled study evaluating the efficacy and safety of PP-01.
The company indicated the trial builds on positive Phase 2b data and is intended to support regulatory submission efforts.
PP-01 is a once-daily oral therapy designed to address biological mechanisms associated with cannabis withdrawal, including cannabinoid receptor suppression and neurotransmitter dysregulation in reward pathways.
Additional information about the study is available through ClinicalTrials.gov under identifier NCT07644052.
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