PHOENIXVILLE, PA — PleoPharma Inc. secured a $6.5 million federal grant to advance a Phase 3 trial of its experimental treatment for cannabis withdrawal symptoms, providing three years of funding as the company pursues a potential therapy in a market with no FDA-approved pharmacologic treatment.
The award comes from the National Institute on Drug Abuse, part of the National Institutes of Health, and will support PleoPharma’s ongoing CAN-004 trial of PP-01 in adults with moderate to severe cannabis use disorder.
The funding adds federal support to a pivotal-stage development program targeting a condition affecting more than 19 million people in the U.S., according to Substance Abuse and Mental Health Services Administration data cited by the company.
Cannabis withdrawal can include sleep problems, anxiety, irritability, restlessness, cravings and physical symptoms. Those effects can complicate attempts to stop cannabis use and contribute to relapse, according to PleoPharma.
There are currently no FDA-approved medications for cannabis withdrawal syndrome or cannabis use disorder, leaving the Phoenixville-based clinical-stage company pursuing a potential first entrant in that treatment category.
PP-01 has already completed Phase 1 and Phase 2b testing. PleoPharma reported that its Phase 2b CAN-002 trial met its primary endpoint of mitigating cannabis withdrawal symptoms and demonstrated a dose response, with no serious adverse events reported.
The Food and Drug Administration has granted PP-01 Fast Track designation, a regulatory pathway intended to facilitate development and review of drugs addressing serious conditions and unmet medical needs.
PleoPharma dosed the first patient in CAN-004 in June 2026. The Phase 3 study is evaluating the safety and efficacy of PP-01 in adults with moderate to severe cannabis use disorder.
“This funding will help advance our pivotal Phase 3 program and build the clinical evidence needed to potentially bring a needed pharmacologic treatment option to adults living with CUD,” Shelli Grahm, senior vice president of medical and clinical research, stated.
PP-01 is an investigational, once-daily oral product designed around two mechanisms of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. Its safety and efficacy have not been established through the Phase 3 program.
Chief Executive Officer and co-founder Ginger Constantine stated that the company is seeking to develop a medication-assisted option that could help patients remain in treatment and support recovery.
The three-year grant was awarded under NIH Award No. 1U01DA0660079-1.
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