NIDA Awards PleoPharma $6.5 Million Grant to Advance Phase 3 Trial of PP-01 for Cannabis Use Disorder

PleoPharma today announced the award of a $6.5 million, 3-year grant from the National Institute on Drug Abuse (NIDA). The funding will support the advancement of PleoPharma’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).¹

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

"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, PhD, the senior vice president of 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."

CUD

According to the Substance Abuse and Mental Health Services Administration, more than 19 million people in the United States have CUD.² Additionally, research suggests that approximately 3 in 10 individuals who use cannabis have CUD.³ If someone uses cannabis before the age of 18, the risk of developing CUD is even greater.⁴

Symptoms of withdrawal in CUD include sleep problems, anxiety, irritability, restlessness, cravings, physical symptoms, and more. These symptoms ultimately complicate a patient’s efforts to quit and can lead to relapse.

Currently, there are no FDA-approved pharmacologic treatments for CWS or CUD.

Previous Research

PleoPharma has already completed phase 1 and phase 2b studies of PP-01. 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. Following this study, PP-01 received Fast Track designation from the US Food and Drug Administration.

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

"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, the cofounder, 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."

References

1. PleoPharma awarded $6.5 million NIDA grant to support phase 3 trial of PP-01 for cannabis withdrawal in patients with cannabis use disorder. News release. August 20, 2026. Accessed August 20, 2026. https://www.prnewswire.com/news-releases/pleopharma-awarded-6-5-million-nida-grant-to-support-phase-3-trial-of-pp-01-for-cannabis-withdrawal-in-patients-with-cannabis-use-disorder-302856379.html

2. Release of the 2025 National Survey on Drug Use and Health: Using Data to Drive the Great American Recovery. SAMHSA. July 27, 2026. Accessed August 20, 2026. https://www.samhsa.gov/blog/release-2025-nsduh-using-data-to-drive-great-american-recovery

3. Hasin DS, Saha TD, Kerridge BT, et al. Prevalence of marijuana use disorders in the United States between 2001-2002 and 2012-2013. JAMA Psychiatry. 2015;72(12):1235-1242.

4. Winters KC, Lee C-YS. Likelihood of developing an alcohol and cannabis use disorder during youth: association with recent use and age. Drug Alcohol Depend. 2008;92(1-3):239-247.