PHOENIXVILLE, Pa., June 20, 2026
PleoPharma, Inc. has announced the dosing of the first patient in CAN-004, its pivotal Phase 3 clinical trial evaluating PP-01, an investigational once-daily oral therapy designed to mitigate cannabis withdrawal symptoms in adults with Cannabis Use Disorder (CUD). The milestone marks the official launch of the company’s late-stage clinical development program and represents a significant advancement toward addressing one of the largest unmet needs in addiction medicine. With an estimated 20.6 million people in the United States affected by CUD and no FDA-approved therapies currently available to treat cannabis withdrawal syndrome or cannabis use disorder, PP-01 has the potential to become the first approved medication specifically developed to manage cannabis withdrawal symptoms. The investigational therapy has already received Fast Track designation from the U.S. Food and Drug Administration (FDA), highlighting the urgent need for innovative treatment options in this rapidly growing public health challenge.
Pivotal Phase 3 Program Targets Major Unmet Medical Need
The CAN-004 Phase 3 study is a multicenter, randomized, double-blind, placebo- and active-controlled clinical trial designed to evaluate the efficacy and safety of PP-01 in adults with moderate to severe Cannabis Use Disorder who are seeking to discontinue cannabis use. The study builds on encouraging Phase 2b clinical results and is intended to support a future New Drug Application (NDA) submission to the FDA. Researchers will evaluate the therapy’s ability to reduce the withdrawal symptoms that frequently prevent patients from successfully quitting cannabis.
Withdrawal symptoms can include anxiety, irritability, cravings, sleep disturbances, restlessness, depression, mood changes, and physical discomfort, often leading to relapse. By targeting these symptoms directly, PP-01 aims to improve treatment success rates and help patients maintain long-term abstinence. The initiation of the Phase 3 program represents a critical step toward establishing a new standard of care for individuals struggling with cannabis dependence.
Innovative Dual-Mechanism Therapy Designed for Addiction Treatment
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PP-01 is a dual-mechanism investigational therapy designed to address both suppressed CB1 receptors and neurotransmitter dysregulation within the brain’s mesolimbic reward pathway, which plays a central role in addiction and substance dependence. According to PleoPharma, the therapy is intended to provide rapid symptom relief while maintaining a favorable safety and tolerability profile. The once-daily oral formulation is designed to simplify treatment and improve patient adherence, an important consideration in addiction medicine.
Unlike existing treatment approaches that rely primarily on behavioral interventions and supportive care, PP-01 is being developed specifically to target the biological mechanisms underlying cannabis withdrawal. The company believes that this differentiated approach could significantly improve outcomes for patients attempting to reduce or discontinue cannabis use and may establish a first-in-class therapeutic option in the addiction treatment landscape.
Expanding Opportunities in Addiction Medicine
The launch of the CAN-004 study comes as healthcare providers and policymakers continue to confront the increasing prevalence of cannabis use disorder. While cannabis legalization has expanded across numerous jurisdictions, rates of problematic cannabis use have also increased, creating greater demand for effective treatment options. More than 1.4 million individuals reportedly received treatment for CUD in 2024, despite the absence of approved medication-assisted therapies. Experts believe that the availability of a targeted pharmacological treatment could transform clinical management of cannabis dependence and improve long-term recovery outcomes.
PleoPharma’s leadership team, which has collectively contributed to more than 50 global product approvals and over 100 Investigational New Drug (IND) applications, remains focused on advancing innovative solutions for addiction-related health challenges. If successful, PP-01 could become a landmark therapy in the addiction medicine field, offering new hope for millions of patients seeking to overcome cannabis dependence and achieve sustained recovery.
Source: PleoPharma press release
