PleoPharma Secures $6.5 Million NIDA Grant for Cannabis Addiction Trial

A $6.5 million grant from the National Institute on Drug Abuse will accelerate the Phase 3 clinical trial of PP-01, an investigational therapy designed to manage withdrawal symptoms in adults with cannabis use disorder. This funding marks a critical step toward addressing a condition that currently lacks any FDA-approved pharmacological treatment.

Corp and Tech·August 20, 2026·reads: 1,316

The clinical-stage company PleoPharma, based in Phoenixville, Pennsylvania, is utilizing the three-year award to advance its CAN-004 study. With over 19 million Americans estimated to suffer from cannabis use disorder, the physical and psychological toll of withdrawal—including anxiety, insomnia, and intense cravings—remains a primary barrier to recovery. The current trial, which dosed its first patient in June 2026, builds on successful Phase 2b results that demonstrated both safety and efficacy in mitigating these symptoms.

PP-01 targets suppressed CB1 receptors and neurotransmitter dysregulation within the mesolimbic reward pathway. Having already secured Fast Track designation from the FDA, the once-daily oral treatment aims to become the first-in-class option for patients struggling with dependence. Shelli Grahm, senior vice president of clinical research, noted that the NIDA support validates the urgent need for medical interventions in this space. CEO Ginger Constantine emphasized that the goal is to provide the same level of scientific rigor for cannabis use disorder as is already available for other substance use issues, helping patients remain engaged in long-term treatment.