PleoPharma Awarded $6.5 Million NIDA Grant to Support Phase 3 Trial of PP-01 for Cannabis Withdrawal in Patients with Cannabis Use Disorder

NIH/NIDA funding will support a pivotal clinical program for an investigational treatment for adults with cannabis use disorder

PHOENIXVILLE, Pa., Aug. 20, 2026 /PRNewswire/ -- PleoPharma, Inc., a clinical-stage development company focused on cannabis-related health issues, today announced the award of a $6.5 million, three-year grant from the National Institute on Drug Abuse (NIDA), a division of the National Institutes of Health (NIH). The funding will support the advancement of the company's pivotal Phase 3 CAN-004 clinical trial of PP-01, an investigational treatment for cannabis withdrawal symptoms (CWS) in adults with cannabis use disorder (CUD).

More than 19 million people in the United States were reported by SAMHSA to have CUD. Symptoms of withdrawal, including sleep problems, anxiety, irritability, restlessness, cravings, physical symptoms, and more, complicate efforts to quit and serve as a driver of relapse. Despite the scale of the problem, there are currently no FDA-approved pharmacologic treatments for cannabis withdrawal syndrome or cannabis use disorder.

"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," said Shelli Grahm, Ph.D., senior vice president - medical/clinical research. "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."

PleoPharma has completed Phase 1 and Phase 2b studies of PP-01, and in the Phase 2b CAN-002 trial, the primary endpoint of mitigating cannabis withdrawal symptoms in participants with cannabis use disorder was achieved, demonstrating a dose response with no serious adverse events reported. Importantly, PP-01 received Fast Track designation from the U.S. Food and Drug Administration, underscoring the unmet need and seriousness of the condition.

These successful results have paved the way for CAN-004, the ongoing pivotal Phase 3 trial, with the first patient dosed in June 2026. The study is evaluating the safety and efficacy of PP-01 in adults with moderate to severe CUD.

"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," said Ginger Constantine, co-founder, CEO and chairperson of the board at PleoPharma. "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."

Research noted in this publication was supported by the National Institute on Drug Abuse of the National Institutes of Health under Award Number 1U01DA0660079-1.

About PP-01

PP-01 is a dual mechanism of action investigational product that targets suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. PP-01 is in Phase 3 and has the potential to be the first-in-class treatment to mitigate the withdrawal symptoms experienced by many patients with cannabis use disorder (dependence/addiction). PP-01 is intended as a once daily oral product with a rapid onset of action and excellent safety and tolerability.

About PleoPharma

PleoPharma, Inc. is a privately held clinical stage development company in addiction medicine focused on finding solutions for people suffering from cannabis addiction and other cannabis-related health problems.

The PleoPharma team includes a world class team and board of directors who have produced multiple high value exits, >50 worldwide product approvals, and 100+ INDs.

For more information on PleoPharma Inc., please visit www.PleoPharma.com or for media inquiries, please contact Brendi Bluitt at [email protected].

SOURCE PleoPharma, Inc