NIH awarded PleoPharma a $6.5 million grant to advance the Phase 3 CAN-004 trial of PP-01 for cannabis withdrawal in adults with cannabis use disorder.
Written By: Anshu Gupta, PharmD
Reviewed By: Pharmacally Editorial Team
PleoPharma has received a $6.5 million, three-year grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH), to support its pivotal Phase 3 CAN-004 trial of PP-01 (NCT07644052), an investigational treatment for cannabis withdrawal symptoms in adults with cannabis use disorder (CUD).
The funding comes as the company advances PP-01 through late-stage development, with the first patient dosed in CAN-004 in June 2026. Cannabis withdrawal remains a major barrier to cessation, while no pharmacologic treatment is currently FDA-approved specifically for cannabis withdrawal syndrome or CUD.
Cannabis Withdrawal Remains an Unmet Treatment Need
More than 19 million people in the United States have CUD, according to data cited from the Substance Abuse and Mental Health Services Administration. Withdrawal can include sleep disturbances, anxiety, irritability, restlessness, cravings, and other physical and psychological symptoms.
These symptoms can make cessation difficult and contribute to relapse, highlighting the need for pharmacologic interventions that can help patients remain engaged in treatment.
PP-01 has a dual mechanism of action that targets suppressed cannabinoid CB1 receptors and neurotransmitter dysregulation within the mesolimbic reward pathway. The investigational therapy is being developed as a once-daily oral treatment intended to act rapidly against cannabis withdrawal symptoms.
Phase 2b Results Supported Phase 3 Development
PleoPharma has completed Phase 1 and Phase 2b studies of PP-01. In the Phase 2b CAN-002 study, PP-01 met its primary endpoint for mitigating cannabis withdrawal symptoms in participants with CUD and demonstrated a dose-response relationship.
The company reported no serious adverse events in the study. These findings supported progression into CAN-004, the pivotal Phase 3 program evaluating PP-01 in adults with moderate to severe CUD.
The FDA has also granted PP-01 Fast Track designation, reflecting the significant unmet medical need associated with cannabis withdrawal and CUD.
CAN-004 Evaluates PP-01 in Adults with Moderate to Severe CUD
CAN-004 is assessing the safety and efficacy of PP-01 in adults with moderate to severe CUD. The trial represents the next major clinical milestone for the program and is intended to generate the evidence required for potential regulatory submission.
The $6.5 million NIDA award will provide additional support for execution of the pivotal clinical program. Research associated with the grant is supported under NIH/NIDA Award Number 1U01DA0660079-1.
NIDA Funding Advances Late-Stage Development
PleoPharma executives said the federal funding recognizes the need for evidence-based treatment options for cannabis dependence and will generate additional clinical evidence for PP-01.
For the program, the immediate priority is completion of the Phase 3 CAN-004 study and characterization of PP-01’s efficacy, safety, and tolerability in the target population. If the trial confirms the earlier findings, the results could establish a clinical foundation for regulatory evaluation of PP-01 as a pharmacologic treatment for cannabis withdrawal in adults with CUD.
The program therefore moves into a critical development stage, with Phase 3 data expected to determine whether PP-01 can translate its earlier clinical signal into a viable treatment option for a population that currently has no FDA-approved pharmacologic therapy.
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About the Writer
Anshu Gupta (LinkedIn) is a PharmD professional and healthcare writer with interests in clinical research, pharmacovigilance, regulatory affairs, and medical writing. She has presented research at academic conferences and completed certifications in Good Clinical Practice (GCP), ICH-GCP, and drug safety. Passionate about clinical trials and evidence-based medicine, she is committed to translating scientific evidence into accurate, reliable, and accessible healthcare content.