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PleoPharma

Full company profile

uuid0000m83

Namestring
PleoPharma
Legal namestring
PleoPharma, Inc.
Websiteurl
pleopharma.com
Company typeenum
Private
Founded yearint
2019
Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
11–50
akta.pro rankint
HeadquartersPhoenixville, United States
HQ citystring
Phoenixville
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Offices2 records

Each record includes

City, Country, Type, Description, Source

Keyword5 values
cannabis use disorder treatment, CNS pharmaceuticals, substance abuse therapeutics, clinical-stage pharmaceuticals, withdrawal syndrome therapy
NAICS code1 code
  • Medicinal and Botanical Manufacturing325411
SIC code1 code
  • Pharmaceutical Preparations2834
Product category
CNS Pharmaceuticals / Addiction Therapeutics
Social media profiles1 record
GTM motion1 record

Each record includes

Type, Description, Source

Revenue model1 record
1Pharmaceutical Product Sales
TypeOne Time License
Description

Once PP-01 receives FDA approval, PleoPharma will generate revenue through prescription pharmaceutical sales. As a first-in-class treatment for cannabis withdrawal syndrome with no FDA-approved alternatives, the product addresses an underserved market with an estimated $1.8 billion market opportunity. The company will distribute through pharmacies and healthcare providers targeting patients with cannabis use disorder.

pleopharma.com
Marketing channels5 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components4 values
Technology or R&D, Personnel, Operations, Marketing or Sales
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

PleoPharma is developing PP-01, an investigational once-daily oral prescription pharmaceutical that combines titrating doses of nabilone (a synthetic cannabinoid) and gabapentin to mitigate Cannabis Withdrawal Syndrome in adults with Cannabis Use Disorder. PP-01 employs a dual mechanism of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. The product is currently in Phase 3 clinical development with FDA Fast Track designation and is positioned to be the first FDA-approved medication assisted therapy for cannabis withdrawal syndrome.

Differentiator
Functional benefit
Problem solved
Quantifiable outcome1 of 5 values shown
  • 43% reduction in Irritability Domain vs placebo (P = 0.01) during Days 2-5
+4 more records
Product overview1 text field

PleoPharma is a clinical-stage pharmaceutical company developing a single lead product candidate, PP-01, an oral investigational drug for the treatment of cannabis use disorder (CUD) and mitigation of cannabis withdrawal syndrome (CWS). PP-01 is a dual-mechanism therapy combining nabilone and gabapentin in titrating doses. The company is advancing PP-01 through Phase 3 clinical trials following successful Phase 1b and Phase 2b studies, with FDA Fast Track designation granted. There are currently no FDA-approved medications for cannabis withdrawal syndrome or cannabis use disorder.

Product and service1 record
1PP-01
CategoryPrescription pharmaceutical / CNS therapeutics
Description

PP-01 is a dual-mechanism investigational once-daily oral prescription therapy combining titrating doses of nabilone (synthetic cannabinoid) and gabapentin. It targets suppressed CB1 receptors and addresses neurotransmitter dysregulation in the mesolimbic reward pathway to mitigate Cannabis Withdrawal Syndrome (CWS) in adults with Cannabis Use Disorder (CUD). It is being developed to be the first FDA-approved medication assisted treatment for cannabis withdrawal.

Scale indicator8 records

Each record includes

Type, Value, Description, Source

Recent move7 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight6 records

Each record includes

Type, Description

Peers10 records
1Anebulo Pharmaceuticals
TypeDirect peer
Description

Clinical-stage biotech developing ANEB-001 for acute cannabis intoxication and cannabinoid-related disorders. Closest direct peer — both companies target FDA-approved pharmacotherapy for cannabis-related conditions with no approved alternatives.

2Aelis Farma
TypeDirect peer
Description

French biotech developing AEF0117, a CB1 receptor-signaling-specific therapeutic for cannabis use disorder. Highly comparable in mechanism class (CB1 signaling) and indication (CUD), making it one of the most direct competitors to PP-01.

3Indivior
TypeBroad incumbent
Description

Global addiction-treatment leader (Sublocade, Suboxone) focused on opioid and substance use disorders. Comparable as the established addiction pharma incumbent that would likely commercialize or compete with any new CUD pharmacotherapy.

4Alkermes
TypeBroad incumbent
Description

CNS-focused pharma with Vivitrol (naltrexone) for alcohol and opioid use disorder. Comparable as an addiction-medicine incumbent with established specialty sales infrastructure relevant to a future PP-01 launch.

5Jazz Pharmaceuticals
TypeBroad incumbent
Description

Owns Epidiolex (cannabidiol) and has deep CNS and cannabinoid pharmaceutical infrastructure. Comparable as a cannabinoid-focused commercial pharma and a likely strategic acquirer or competitor in the cannabis-medicine space.

6Corbus Pharmaceuticals
TypeEmerging player
Description

Clinical-stage biotech developing cannabinoid-derived therapeutics for inflammatory and fibrotic diseases. Comparable as an emerging developer leveraging cannabinoid biology, sharing regulatory and scientific infrastructure expertise.

7BioCorRx
TypeEmerging player
Description

Emerging company developing pharmaceutical and behavioral programs for substance use disorders, including cannabis. Comparable as a smaller-scale competitor addressing the same CUD treatment gap.

8Braeburn Pharmaceuticals
TypeEmerging player
Description

Specialty pharma focused on addiction and serious psychiatric disorders (Probuphine, Brixadi). Comparable as an addiction-focused specialty player with established relationships to the same prescriber base PleoPharma would target.

9Pfizer
TypeBroad incumbent
Description

Global pharma giant and acquirer of Wyeth (where PleoPharma's CEO previously led clinical development). Comparable as a broad CNS incumbent and a natural strategic acquirer given the executive pedigree.

10Eli Lilly
TypeBroad incumbent
Description

Major CNS pharma with growing interest in addiction and obesity-related disorders. Comparable as a broad incumbent that could either compete with or acquire late-stage CNS assets like PP-01.

Market position
Strengths5 records

Each record includes

Headline, Details, Source

Weaknesses5 records

Each record includes

Headline, Details, Source

Competitive moat4 records

Each record includes

Type, Details

Key risks6 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Named customers2 records

Each record includes

Name, Industry, Type, Use case, Source, UUID

Segment2 records

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile2 records

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature3 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Profiles12 records

Each record includes

Name, Designation, Designation category, Overview, Profile commentary, Source

No data
No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds5 records

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors1 record

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

PleoPharma

CNS Pharmaceuticals / Addiction Therapeuticspleopharma.com

PleoPharma firmographics

Firmographics
Name
PleoPharma
Legal name
PleoPharma, Inc.
Website
https://pleopharma.com
Company type
Private
Founded year
2019
Operating status
Operating
Headcount range
11–50 employees
Ownership category
akta.pro rank

Where PleoPharma is headquartered

Location

Headquarters

HQ city
Phoenixville
HQ country
United States
HQ region
North America

Offices2 records

Markets served

PleoPharma business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

  1. Pharmaceutical Product Sales: Once PP-01 receives FDA approval, PleoPharma will generate revenue through prescription pharmaceutical sales. As a first-in-class treatment for cannabis withdrawal syndrome with no FDA-approved alternatives, the product addresses an underserved market with an estimated $1.8 billion market opportunity. The company will distribute through pharmacies and healthcare providers targeting patients with cannabis use disorder.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

PleoPharma product offering

Product offering

Core offering

PleoPharma is developing PP-01, an investigational once-daily oral prescription pharmaceutical that combines titrating doses of nabilone (a synthetic cannabinoid) and gabapentin to mitigate Cannabis Withdrawal Syndrome in adults with Cannabis Use Disorder. PP-01 employs a dual mechanism of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. The product is currently in Phase 3 clinical development with FDA Fast Track designation and is positioned to be the first FDA-approved medication assisted therapy for cannabis withdrawal syndrome.

Product overview

PleoPharma is a clinical-stage pharmaceutical company developing a single lead product candidate, PP-01, an oral investigational drug for the treatment of cannabis use disorder (CUD) and mitigation of cannabis withdrawal syndrome (CWS). PP-01 is a dual-mechanism therapy combining nabilone and gabapentin in titrating doses. The company is advancing PP-01 through Phase 3 clinical trials following successful Phase 1b and Phase 2b studies, with FDA Fast Track designation granted. There are currently no FDA-approved medications for cannabis withdrawal syndrome or cannabis use disorder.

Differentiator

Problem solved

Functional benefit

Products and services

  • PP-01 PP-01 is a dual-mechanism investigational once-daily oral prescription therapy combining titrating doses of nabilone (synthetic cannabinoid) and gabapentin. It targets suppressed CB1 receptors and addresses neurotransmitter dysregulation in the mesolimbic reward pathway to mitigate Cannabis Withdrawal Syndrome (CWS) in adults with Cannabis Use Disorder (CUD). It is being developed to be the first FDA-approved medication assisted treatment for cannabis withdrawal.

Quantifiable outcome

  • 43% reduction in Irritability Domain vs placebo (P = 0.01) during Days 2-5
  • +4 more outcomes

Companies that use PleoPharma

Customer profile

Named customers2 records

Segments2 records

Ideal customer profiles2 records

PleoPharma technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature3 records

PleoPharma partnerships and signals

Strategic signal

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

PleoPharma competitors and assessment

Company assessment

Direct peers

  • Anebulo Pharmaceuticals: Clinical-stage biotech developing ANEB-001 for acute cannabis intoxication and cannabinoid-related disorders. Closest direct peer — both companies target FDA-approved pharmacotherapy for cannabis-related conditions with no approved alternatives.
  • Aelis Farma: French biotech developing AEF0117, a CB1 receptor-signaling-specific therapeutic for cannabis use disorder. Highly comparable in mechanism class (CB1 signaling) and indication (CUD), making it one of the most direct competitors to PP-01.

Broad incumbents

  • Indivior: Global addiction-treatment leader (Sublocade, Suboxone) focused on opioid and substance use disorders. Comparable as the established addiction pharma incumbent that would likely commercialize or compete with any new CUD pharmacotherapy.
  • Alkermes: CNS-focused pharma with Vivitrol (naltrexone) for alcohol and opioid use disorder. Comparable as an addiction-medicine incumbent with established specialty sales infrastructure relevant to a future PP-01 launch.
  • Jazz Pharmaceuticals: Owns Epidiolex (cannabidiol) and has deep CNS and cannabinoid pharmaceutical infrastructure. Comparable as a cannabinoid-focused commercial pharma and a likely strategic acquirer or competitor in the cannabis-medicine space.
  • Pfizer: Global pharma giant and acquirer of Wyeth (where PleoPharma's CEO previously led clinical development). Comparable as a broad CNS incumbent and a natural strategic acquirer given the executive pedigree.
  • Eli Lilly: Major CNS pharma with growing interest in addiction and obesity-related disorders. Comparable as a broad incumbent that could either compete with or acquire late-stage CNS assets like PP-01.

Emerging players

  • Corbus Pharmaceuticals: Clinical-stage biotech developing cannabinoid-derived therapeutics for inflammatory and fibrotic diseases. Comparable as an emerging developer leveraging cannabinoid biology, sharing regulatory and scientific infrastructure expertise.
  • BioCorRx: Emerging company developing pharmaceutical and behavioral programs for substance use disorders, including cannabis. Comparable as a smaller-scale competitor addressing the same CUD treatment gap.
  • Braeburn Pharmaceuticals: Specialty pharma focused on addiction and serious psychiatric disorders (Probuphine, Brixadi). Comparable as an addiction-focused specialty player with established relationships to the same prescriber base PleoPharma would target.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

PleoPharma social profiles

Digital presence

PleoPharma financial estimates

Financial estimate

Revenue estimate

Valuation estimate

PleoPharma leadership team

Management profile

Number of profiles

Profiles12 records

PleoPharma funding detail

Funding detail

Funding overview

Funding rounds5 records

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

PleoPharma M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about PleoPharma

What does PleoPharma do?

PleoPharma is developing PP-01, an investigational once-daily oral prescription pharmaceutical that combines titrating doses of nabilone (a synthetic cannabinoid) and gabapentin to mitigate Cannabis Withdrawal Syndrome in adults with Cannabis Use Disorder. PP-01 employs a dual mechanism of action targeting suppressed CB1 receptors and neurotransmitter dysregulation in the mesolimbic reward pathway. The product is currently in Phase 3 clinical development with FDA Fast Track designation and is positioned to be the first FDA-approved medication assisted therapy for cannabis withdrawal syndrome.

Is PleoPharma a public or private company?

PleoPharma is a private company. It is classified as venture growth investor backed and is currently operating.

When was PleoPharma founded?

PleoPharma was founded in 2019. It employs 11 to 50 people.

Where is PleoPharma based?

PleoPharma is headquartered in Phoenixville, United States, in the North America region.

How does PleoPharma make money?

One revenue line is on record: pharmaceutical Product Sales.

Who are PleoPharma's main competitors?

Direct peers on record are Anebulo Pharmaceuticals and Aelis Farma. Broad incumbents are Indivior, Alkermes, Jazz Pharmaceuticals, Pfizer and Eli Lilly. Emerging players are Corbus Pharmaceuticals, BioCorRx and Braeburn Pharmaceuticals.

Does PleoPharma have an API?

No public API is recorded for PleoPharma.

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Live signals
PR NewswirePLEOPHARMA TO PRESENT SURVEY DATA ON CANNABIS WITHDRAWAL IN WOMEN SEEKING CANNABIS CESSATION PleoPharma, Inc. October 22PleoPharma will present survey data on women's cannabis withdrawal at the Menopause Society's 2026 Annual Meeting. The survey of 146 women found 90% reported at least one withdrawal symptom, 61% within 24 hours, and 84% sought medical help. The company is developing PP-01, a once-daily oral product for cannabis withdrawal.Pulse 2.0PleoPharma Wins $6.5 Million NIDA Grant To Advance Phase 3 Cannabis Withdrawal TreatmentPleoPharma has secured a $6.5 million, three-year grant from the National Institute on Drug Abuse (NIDA) to fund its pivotal Phase 3 clinical trial for PP-01, an investigational treatment for cannabis withdrawal symptoms. The funding supports the ongoing CAN-004 trial, which began dosing patients in June 2026, aiming to address the lack of FDA-approved pharmacologic treatments for cannabis use disorder. This development validates the company's progress toward a potential first-in-class therapy following positive Phase 2b results.PR NewswirePleoPharma Awarded $6.5 Million NIDA Grant to Support Phase 3 Trial of PP-01 for Cannabis Withdrawal in Patients with Cannabis Use DisorderPleoPharma, Inc. has been awarded a $6.5 million, three-year grant from the National Institute on Drug Abuse (NIDA) to support its pivotal Phase 3 clinical trial of PP-01 for treating cannabis withdrawal symptoms in adults with cannabis use disorder. The funding advances the CAN-004 trial, which began dosing patients in June 2026, following successful Phase 2b results and FDA Fast Track designation for the investigational treatment. This development addresses a significant unmet medical need, as there are currently no FDA-approved pharmacologic treatments for cannabis withdrawal syndrome.FinSMEsPleoPharma Receives $6.5M NIDA GrantPleoPharma, a cannabis-related health company, received a $6.5M grant from the National Institute on Drug Abuse. The funds will support its pivotal Phase 3 CAN-004 trial of PP-01, a once-daily oral investigational product targeting cannabis withdrawal symptoms.PR NewswirePleoPharma, Inc. to Present at BIO International Convention 2026PleoPharma, Inc. announced its participation at the BIO International Convention 2026 conference scheduled for June 22-25, 2026, at the San Diego Convention Center, with its presentation scheduled for June 23. The company will present clinical data on its lead investigational asset PP-01, a once-daily dual-mechanism product for cannabis use disorder currently in Phase 3 trials, with the first patient recently dosed. Cannabis use disorder affects an estimated 20.6 million people in the United States, and more than 1.4 million people received treatment for CUD in 2024 despite the absence of an approved medication-assisted treatment.MorningstarPleoPharma, Inc. to Present at BIO International Convention 2026PleoPharma will present at BIO International Convention 2026 on June 23, covering its lead asset PP-01, a once-daily dual-mechanism product for cannabis withdrawal. PP-01 is in Phase 3, with the first patient recently dosed. The company also highlighted data on cannabis withdrawal in adults with cannabis use disorder.PR NewswirePleoPharma, 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 DisorderPleoPharma, Inc. announced that the first patient has been dosed in its CAN-004 Phase 3 clinical trial evaluating PP-01, an investigational once-daily oral therapy for mitigating cannabis withdrawal symptoms in adults with cannabis use disorder. The trial builds on positive Phase 2b data and follows FDA Fast Track designation, positioning PP-01 as a potential first-in-class and first-approved treatment for a condition affecting an estimated 20.6 million people in the United States with no existing FDA-approved medications. The company expects the CAN-004 data to support a New Drug Application submission to the FDA.MorningstarPleoPharma, 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 DisorderPleoPharma announced the first patient dosed in its Phase 3 trial of PP-01, an investigational once-daily therapy for cannabis withdrawal symptoms in adults with cannabis use disorder. The trial, CAN-004, is randomized, double-blind, and placebo-controlled, building on positive Phase 2b data. PP-01 has FDA Fast Track designation and could be the first approved treatment for cannabis withdrawal.AijournPLEOPHARMA TO PRESENT NEWDATA ON CANNABIS WITHDRAWAL In PATIENTS WITH CANNABIS USE DISORDER AND PHASE 2 PP-01 RESULTS AT THE COLLEGE ON PROBLEMS OF DRUG DEPENDENCE 88TH ANNUAL SCIENTIFIC MEETINGPleoPharma announced it will present two poster presentations at the College on Problems of Drug Dependence 88th Annual Scientific Meeting in Portland, Oregon, featuring data on cannabis withdrawal in adults with cannabis use disorder. The Phase 2 CAN-002 trial results showed that investigational PP-01 produced a statistically significant 43% reduction in the Irritability Domain versus placebo during Days 2-5. There are currently no FDA-approved therapies for cannabis withdrawal or cannabis use disorder, representing a significant unmet medical need that PP-01 aims to address.AInvestThe Cannabis Withdrawal Drug That Could Be First in Class - If Private Markets Can Back It ThroughPleoPharma reported Phase 2b results for its cannabis withdrawal drug PP-01, showing statistically significant symptom reduction and five-fold greater abstinence rates versus placebo in the CAN-002 study. The FDA granted Fast Track designation in February 2025, recognizing Cannabis Withdrawal Syndrome as an unmet medical need with no approved pharmacological treatments currently available. The $36 million Series B financing closed in October 2025 funds the already-registered Phase 3 trial, but analysts question whether this capital is sufficient given the multi-year approval cycle and commercial buildout required for a first-in-class drug targeting an estimated $1.8 billion market.