PP-01 Market Summary

Key Factors Driving PP-01 Growth

1. First-in-Class Opportunity in an Untreated Indication

No FDA-approved drugs currently exist for:

• Cannabis withdrawal syndrome (CWS)
• Cannabis use disorder (CUD)

PP-01 is being developed as the first medication-assisted therapy (MAT) for this condition

👉 Implication:

• Clear first-mover advantage
• Ability to define treatment guidelines and pricing
• High likelihood of rapid uptake if approved

2. Strong Clinical Efficacy Across Phase I–II Studies

Phase IIb (CAN-002 Study)

• Statistically significant reduction in withdrawal symptoms vs placebo (p=0.02)
• 5-fold higher abstinence rates vs placebo (secondary endpoint)

Phase Ib / Early Studies

Rapid onset:

• Symptom reduction within 4 hours of first dose
• Sustained efficacy over multiple days

Improvements in:

• Craving
• Sleep
• Overall withdrawal burden

3. Differentiated Dual Mechanism of Action

Combination therapy:

• Nabilone (CB1 receptor modulation)
• Gabapentin (GABAergic modulation)

Targets:

• Endocannabinoid system dysregulation
• Mesolimbic reward pathway

4. Favorable Safety and Tolerability Profile

Across trials:

• No serious adverse events reported
• Mostly mild side effects (e.g., headache, fatigue, nausea)

Impact:

• Essential for chronic addiction treatment

Supports

• Broad physician adoption
• Outpatient use

5. Highly Convenient Oral Dosing (Adherence Advantage)

• Once-daily oral dosing (bedtime administration)

Impact

• Improves patient compliance
• Enables scalable real-world use

6. Large and Rapidly Growing Target Population

• ~19.2 million people in the U.S. have cannabis use disorder
• ~1.64 million receiving treatment annually

Treatment demand growing:

• ~23–28% annual increase since 2018

PP-01 Market Recent Developments

• In February 2025, the Food and Drug Administration (FDA) granted Fast Track designation to PP-01 (nabilone/gabapentin) for the mitigation of cannabis withdrawal symptoms in patients with cannabis use disorder. 

“PP-01 Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of PP-01 for potential indication like Substance-related disorders in the 7MM. A detailed picture of PP-01’s existing usage in anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the PP-01 for potential indications. The PP-01 Market Report provides insights about PP-01’s Sales Forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current PP-01 performance, future market assessments inclusive of the PP-01 market forecast analysis for potential indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of PP-01 sales forecasts, along with factors driving its market.

PP-01 Drug Summary

PP-01 is an investigational, first-in-class, dual-mechanism oral therapy developed by PleoPharma for mitigating Cannabis Withdrawal Syndrome in patients with Cannabis Use Disorder (CUD), targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. Administered once daily before bedtime, it demonstrated statistically significant reductions in withdrawal symptoms (e.g., insomnia, anxiety, irritability, depressed mood) compared to placebo in the Phase IIb CAN-002 trial (NCT05494437), with the highest dose showing clinically meaningful results (p=0.02), excellent tolerability, and no safety signals across 234 participants versus comparators like nabilone and gabapentin. Granted FDA Fast Track designation in February 2025 based on this data, PP-01 is advancing to Phase III trials as a potential rapid-onset, sustained-relief treatment with no approved competitors for CUD withdrawal. The report provides PP-01’s sales, growth barriers and drivers, post usage and approvals in multiple indications. 

Scope of the PP-01 Market Report

The report provides insights into:

• A comprehensive product overview including the PP-01 MoA, description, dosage and administration, research and development activities in potential indication like Substance-related disorders.
• Elaborated details on PP-01 regulatory milestones and other development activities have been provided in the PP-01 market report.
• The PP-01 Market Report also highlights PP-01‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in potential indications across the United States, Europe, and Japan.
• The PP-01 market report also covers the patents information, generic entry and impact on cost cut.
• The PP-01 market report contains current and forecasted PP-01 sales for potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The PP-01 market report also features the SWOT analysis with analyst views for PP-01 in potential indications.

PP-01 Methodology

The PP-01 Market Report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and PP-01 Sales data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases. 

PP-01 Analytical Perspective by DelveInsight

• In-depth PP-01 Market Assessment

This PP-01 sales market forecast report provides a detailed market assessment of PP-01 for potential indication like Substance-related disorders in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted PP-01 sales data uptil 2034.

• PP-01 Clinical Assessment

The PP-01 market report provides the clinical trials information of PP-01 for potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

• PP-01 Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

PP-01 Market Potential & Revenue Forecast

• Projected market size for the PP-01 and its key indications
• Estimated PP-01 sales potential (PP-01 peak sales forecasts)
• PP-01 Pricing strategies and reimbursement landscape

PP-01 Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• PP-01 Market positioning compared to existing treatments
• PP-01 Strengths & weaknesses relative to competitors

PP-01 Regulatory & Commercial Milestones

• PP-01 Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

PP-01 Clinical Differentiation

• PP-01 Efficacy & safety advantages over existing drugs
• PP-01 Unique selling points 

PP-01 Market Report Highlights

• In the coming years, the PP-01 market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The PP-01 companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence PP-01’s dominance.
• Other emerging products for Substance-related disorders are expected to give tough market competition to PP-01 and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of PP-01 in potential indications.
• Analyse PP-01 cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted PP-01 sales data until 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of PP-01 in potential indications.

Key Questions Answered in the PP-01 Market Report

• What is the class of therapy, route of administration and PP-01 Mechanism of Action? How strong is PP-01’s clinical and commercial performance?
• What is PP-01’s clinical trial status in each individual indications such as Substance-related disorders and the study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the PP-01 Manufacturers?
• What are the key designations that have been granted to PP-01 for potential indications? How are they going to impact PP-01’s penetration in various geographies?
• What is the current and forecasted PP-01 market scenario for potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted PP-01 Sales in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan? 
• What are the other emerging products available and how are these giving competition to PP-01 for potential indications?
• Which are the late-stage emerging therapies under development for the treatment of potential indications?
• How cost-effective is PP-01? What is the duration of therapy and what are the geographical variations in cost per patient?

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