PleoPharma has received a $6.5 million, three-year grant from the National Institute on Drug Abuse to support its pivotal Phase 3 clinical program evaluating PP-01 as an investigational treatment for cannabis withdrawal symptoms in adults with cannabis use disorder. NIDA is part of the National Institutes of Health.
The grant will support PleoPharma’s ongoing CAN-004 Phase 3 trial, which is evaluating the safety and efficacy of PP-01 in adults with moderate to severe cannabis use disorder.
The first patient in CAN-004 was dosed in June 2026.
PleoPharma is developing PP-01 to mitigate withdrawal symptoms that can make it difficult for people with cannabis dependence to stop using cannabis and remain engaged in treatment.
The company cited SAMHSA data indicating that more than 19 million people in the U.S. have cannabis use disorder.
Withdrawal can involve sleep problems, anxiety, irritability, restlessness, cravings and physical symptoms, which can contribute to relapse.
There are currently no FDA-approved pharmacologic treatments specifically for cannabis withdrawal syndrome or cannabis use disorder.
PP-01 uses a dual mechanism of action designed to address suppressed CB1 receptors and neurotransmitter dysregulation within the mesolimbic reward pathway.
PleoPharma is developing PP-01 as a once-daily oral product with the potential to become a first-in-class treatment for cannabis withdrawal symptoms.
The company has already completed Phase 1 and Phase 2b studies.
In the Phase 2b CAN-002 trial, PleoPharma said the study achieved its primary endpoint of mitigating cannabis withdrawal symptoms in participants with cannabis use disorder.
The company also reported a dose response and no serious adverse events in that study.
PP-01 has received Fast Track designation from the U.S. Food and Drug Administration.
The NIDA funding will help PleoPharma generate additional clinical evidence through its pivotal program as the company works toward a potential pharmacologic treatment option for cannabis dependence.
PleoPharma is a privately held clinical-stage company focused on addiction medicine and other cannabis-related health conditions.
The company’s team and board have collectively been involved in more than 50 worldwide product approvals and more than 100 investigational new drug applications.
KEY QUOTES:
“Receiving this NIDA award is an important validation of the substantial unmet need for a treatment for cannabis use disorder and the potential of PP-01 to alleviate the withdrawal symptoms that can stand in the way of recovery. 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, Ph.D., Senior Vice President Of Medical And Clinical Research At PleoPharma
“People with cannabis use disorder are in need of the same scientific rigor, medical attention and treatment innovation afforded to people living with other substance use disorders. We are very grateful for NIDA’s support as we work to advance a potential medication assisted treatment option that may help patients with cannabis dependence remain engaged in treatment and facilitate recovery.”
Ginger Constantine, Co-Founder, CEO And Chairperson Of PleoPharma
