PleoPharma, Inc.
PleoPharma is a pharmaceutical company dedicated to developing therapies for unmet medical needs in the CNS and substance abuse space, particularly focusing on cannabis-related health issues. Their mission is to provide safe and effective treatments for conditions like Cannabis Use Disorder and Cannabis Withdrawal Syndrome, which currently lack FDA-approved solutions. The company is advancing a lead program, PP-01, which has completed Phase 2 and is progressing towards Phase 3, with a focus on mitigating cannabis withdrawal symptoms and related sleep disturbances. PleoPharma emphasizes high standards of ethics and aims to be a first-in-class treatment provider.
Industries
Nr. of Employees
small (1-50)
PleoPharma, Inc.
518 Kimberton Road, Suite 339, Phoenixville, PA 19460
Patents
Methods and compositions for treating cannabis use disorder and mitigating cannabinoid withdrawal
US-12268659-B2
View DetailsMethods and compositions for treating cannabis use disorder and mitigating cannabinoid withdrawal
US-11931334-B2
View DetailsMethods and compositions for treating cannabis use disorder and mitigating cannabinoid withdrawal
US-11197846-B2
View Details
Methods and compositions for treating cannabis use disorder and mitigating cannabinoid withdrawal
US-12268659-B2
View DetailsMethods and compositions for treating cannabis use disorder and mitigating cannabinoid withdrawal
US-11931334-B2
View DetailsMethods and compositions for treating cannabis use disorder and mitigating cannabinoid withdrawal
US-11197846-B2
View DetailsProducts
Investigational oral dual-mechanism therapeutic for mitigation of cannabis withdrawal
A once-daily oral investigational medicine in development to mitigate cannabis withdrawal symptoms in people with cannabis use disorder; dual mechanism targets suppressed CB1 receptor activity and neurotransmitter dysregulation in the mesolimbic reward pathway. Clinical development completed through Phase 2b with Phase 3 preparations underway.
Investigational oral dual-mechanism therapeutic for mitigation of cannabis withdrawal
A once-daily oral investigational medicine in development to mitigate cannabis withdrawal symptoms in people with cannabis use disorder; dual mechanism targets suppressed CB1 receptor activity and neurotransmitter dysregulation in the mesolimbic reward pathway. Clinical development completed through Phase 2b with Phase 3 preparations underway.
Services
Management of multicenter clinical studies including protocol design, site coordination, data collection, safety monitoring and statistical analysis for addiction therapeutics.
Support for regulatory interactions including preparation for End-of-Phase-2 meetings and pursuit of expedited designations to facilitate development timelines.
Case-by-case review and management of expanded access requests in line with regulatory guidance and ethical requirements; physician-initiated application process described.
Engagement with potential partners and investors to support clinical development and commercialization efforts; experience raising Series A financing.
Management of multicenter clinical studies including protocol design, site coordination, data collection, safety monitoring and statistical analysis for addiction therapeutics.
Support for regulatory interactions including preparation for End-of-Phase-2 meetings and pursuit of expedited designations to facilitate development timelines.
Case-by-case review and management of expanded access requests in line with regulatory guidance and ethical requirements; physician-initiated application process described.
Engagement with potential partners and investors to support clinical development and commercialization efforts; experience raising Series A financing.
Expertise Areas
- Clinical trial management
- Clinical pharmacology (PK/PD)
- Addiction therapeutics development
- Regulatory strategy and FDA interactions
Key Technologies
- Randomized double-blind placebo-controlled trial methodologies
- Pharmacokinetic and pharmacodynamic studies
- Oral small-molecule formulation and dosing schedules
- Dual-mechanism pharmacology targeting CB1 receptor pathways and neurotransmitter modulation
News & Updates
In June 2023, PleoPharma announced the completion of a Series A financing of $17.5 million led by DynaGrow Capital, MintPharma Capital, and other biotech executives. The funds supported a Phase 2b study of PP-01 for cannabis withdrawal syndrome.
In June 2025, PleoPharma presented data from their Phase 2b clinical trial demonstrating significant mitigation of Cannabis Withdrawal Syndrome symptoms with PP-01, including reduced withdrawal scores and increased abstinence.
In February 2025, the FDA granted Fast Track designation to PP-01, highlighting its potential to address a serious unmet medical need in Cannabis Use Disorder.
PleoPharma received a new patent protecting methods and compositions for treating cannabis withdrawal syndrome, with patent protection until March 2041.
In October 2024, PleoPharma announced the issuance of two U.S. patents related to treating cannabis withdrawal syndrome, with patent protection until March 2041.
In June 2023, PleoPharma announced the completion of a Series A financing of $17.5 million led by DynaGrow Capital, MintPharma Capital, and other biotech executives. The funds supported a Phase 2b study of PP-01 for cannabis withdrawal syndrome.
In June 2025, PleoPharma presented data from their Phase 2b clinical trial demonstrating significant mitigation of Cannabis Withdrawal Syndrome symptoms with PP-01, including reduced withdrawal scores and increased abstinence.
In February 2025, the FDA granted Fast Track designation to PP-01, highlighting its potential to address a serious unmet medical need in Cannabis Use Disorder.
PleoPharma received a new patent protecting methods and compositions for treating cannabis withdrawal syndrome, with patent protection until March 2041.
In October 2024, PleoPharma announced the issuance of two U.S. patents related to treating cannabis withdrawal syndrome, with patent protection until March 2041.