PleoPharma, Inc. Announces First Patient Dosed in Pivotal Phase 3 Clinical Trial of PP-01 (CAN-004) for Mitigation of Cannabis Withdrawal Symptoms in Patients with Cannabis Use Disorder

Phase 3 trial initiation advances PP-01, an investigational, once-daily therapy for cannabis withdrawal symptoms in patients with cannabis use disorder

Cannabis use disorder affects an estimated 20.6 million people in the U.S., underscoring the scale of this unmet medical need

PHOENIXVILLE, Pa., June 18, 2026 /PRNewswire/ -- PleoPharma, Inc., a clinical-stage development company focused on cannabis-related health issues, today announced that the first patient has been dosed in CAN-004, a Phase 3 clinical trial evaluating PP-01, an investigational medication intended for the mitigation of cannabis withdrawal symptoms in adults with cannabis use disorder (CUD).

This milestone marks the initiation of PleoPharma's pivotal Phase 3 program and represents a significant step toward addressing a critical unmet need for the millions of individuals affected by CUD. PP-01 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) and has the potential to become the first approved treatment specifically designed to mitigate cannabis withdrawal symptoms.

"Dosing the first patient in our Phase 3 trial is a significant milestone for PleoPharma and an important step forward to help those patients with cannabis use disorder who are seeking to quit or reduce cannabis," said Ginger Constantine, M.D., chief executive officer, co-founder and chairperson of the board of PleoPharma. "Despite the growing prevalence of cannabis use disorder, there are currently no FDA-approved treatments for cannabis withdrawal syndrome or cannabis use disorder."

CAN-004 is a Phase 3, multicenter, randomized, double-blind, placebo and active-controlled study evaluating the efficacy and safety of PP-01 in adults with moderate to severe CUD who are seeking to discontinue cannabis use. The CAN-004 study build upon positive Phase 2b clinical data and is intended to support an FDA submission of a new drug application for PP-01. Additional information about CAN-004 (NCT07644052) is available at www.clinicaltrials.gov.

About Cannabis Use Disorder

Cannabis use disorder (CUD) is a chronic and increasingly prevalent condition that affects an estimated 20.6 million people in the United States¹. More than 1.4 million people received treatment for CUD in 2024 despite the absence of an approved medication assisted treatment, underscoring the scale of the disease and the need for an effective treatment.¹. Many people with CUD experience a rapid onset of withdrawal symptoms when they attempt to stop or reduce cannabis, leading to relapse. Typical symptoms include anxiety, irritability, cravings, sleep disturbance, decreased appetite, restlessness, depression, mood, and physical symptoms.

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, Inc.

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 management 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].

Reference

1. Substance Abuse and Mental Health Services Administration. Key Substance Use and Mental Health Indicators in the United States: Results from the 2024 National Survey on Drug Use and Health. HHS Publication No. PEP25-07-007. Rockville, MD: SAMHSA; 2025.

SOURCE PleoPharma, Inc