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Last Updated: December 16, 2025

CLINICAL TRIALS PROFILE FOR CANNABIDIOL


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505(b)(2) Clinical Trials for cannabidiol

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT04423341 ↗ Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Completed Benign Essential Blepharospasm Research Foundation Phase 2/Phase 3 2020-05-20 The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
OTC NCT04423341 ↗ Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Completed GW Pharmaceuticals Ltd. Phase 2/Phase 3 2020-05-20 The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
OTC NCT04423341 ↗ Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Completed Smith-Kettlewell Eye Research Institute Phase 2/Phase 3 2020-05-20 The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
OTC NCT04423341 ↗ Effect of Non-psychoactive Cannabidiol as an Adjunct to Botulinum Toxin in Blepharospasm Completed Silkiss Eye Surgery Phase 2/Phase 3 2020-05-20 The planned study is a prospective analysis of non-psychoactive Cannabidiol (without THC) as an adjunctive therapy for blepharospasm in a masked double cross-over study. This prospective study is a follow-up to a retrospective study completed by the researchers using over-the-counter, self purchased CBD. This study will use FDA approved Cannabidiol medication, Epidiolex, directly from GW pharmaceuticals, rather than self-purchased CBD from the internet. Patients will undergo videorecording with a high resolution videocamera system at days 0, 45, 90, 135, and 180 using a novel blink analysis to gather objective data measurements of changes induced by CBD in Blepharospasm patients. This study will attempt to codify the data and quantify if adjunctive CBD therapy improves those areas compared to botulinum injection alone.
OTC NCT04611347 ↗ Topical CBD in Joint Arthritis Recruiting University of Virginia Phase 2 2020-11-01 Rationale: CBD is commonly being used as an over-the-counter treatment for arthritis-related pain, however no clinical trial has been performed to establish efficacy. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for thumb basal joint arthritis. Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the cream at the thumb base twice daily for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
OTC NCT05170451 ↗ Topical CBD for Musculoskeletal Pain Not yet recruiting University of Virginia Phase 2/Phase 3 2022-01-01 Rationale: CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain; however, no clinical trial has been performed to establish efficacy of CBD in humans for musculoskeletal pain. Hypothesis: CBD is more effective than placebo for relieving pain and improving patient-reported outcomes for musculoskeletal pain. Study Design: The study design with be a double-blind, randomized controlled trial with crossover. Treatment will be blinded to the subjects and investigators. Patients will be randomly assigned 2 weeks of the CBD or control and then crossover to the other condition for 2 additional weeks. Patients will apply the CBD or control cream to the affected area twice daily (approximately every 12 hours) for 1 hour. Subjects will be advised to observe for physiologic changes, skin changes, or other adverse effects.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for cannabidiol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00241592 ↗ Vaporization as a Smokeless Cannabis Delivery System Completed University of California, San Francisco Phase 1 2004-08-01 A study to evaluate the use of a vaporization system as a smokeless delivery system for inhaled marijuana.
NCT00241592 ↗ Vaporization as a Smokeless Cannabis Delivery System Completed Center for Medicinal Cannabis Research Phase 1 2004-08-01 A study to evaluate the use of a vaporization system as a smokeless delivery system for inhaled marijuana.
NCT00309413 ↗ A Clinical Trial on the Antipsychotic Properties of Cannabidiol Completed Coordinating Centre for Clinical Trials Cologne Phase 2 2006-03-01 The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study.
NCT00309413 ↗ A Clinical Trial on the Antipsychotic Properties of Cannabidiol Completed Stanley Medical Research Institute Phase 2 2006-03-01 The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study.
NCT00309413 ↗ A Clinical Trial on the Antipsychotic Properties of Cannabidiol Completed University of Cologne Phase 2 2006-03-01 The purpose of this study is to determine whether cannabidiol, a herbal cannabinoid, is effective in the treatment of acute schizophrenic or schizophreniform psychosis in a placebo-controlled, randomized double-blind study.
NCT00397605 ↗ Cannabinoids in Bipolar Affective Disorder Withdrawn Vancouver General Hospital N/A 2006-11-01 Some people with bipolar disorder who use cannabis (marijuana) claim that it eases the symptoms of depression and mania. There are many chemicals (called cannabinoids) found in cannabis but two particular ones appear to have medicinal (therapeutic) effects. These two compounds are: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). These cannabinoids appear to have mood, anxiety, and sedative effects as well as have antipsychotic and anticonvulsant properties. This study will try to find out if these cannabinoids can be of benefit as an add-on treatment in bipolar disorder and what effects it has on thinking power and memory.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for cannabidiol

Condition Name

Condition Name for cannabidiol
Intervention Trials
Cannabis 25
Epilepsy 21
CBD 15
Pain 13
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Condition MeSH

Condition MeSH for cannabidiol
Intervention Trials
Marijuana Abuse 54
Syndrome 29
Epilepsy 23
Anxiety Disorders 19
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Clinical Trial Locations for cannabidiol

Trials by Country

Trials by Country for cannabidiol
Location Trials
United States 471
Canada 46
Australia 30
United Kingdom 25
Israel 24
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Trials by US State

Trials by US State for cannabidiol
Location Trials
California 44
New York 41
Florida 29
Pennsylvania 23
Texas 22
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Clinical Trial Progress for cannabidiol

Clinical Trial Phase

Clinical Trial Phase for cannabidiol
Clinical Trial Phase Trials
PHASE4 1
PHASE3 6
PHASE2 34
[disabled in preview] 76
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Clinical Trial Status

Clinical Trial Status for cannabidiol
Clinical Trial Phase Trials
Recruiting 124
Not yet recruiting 109
Completed 84
[disabled in preview] 62
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Clinical Trial Sponsors for cannabidiol

Sponsor Name

Sponsor Name for cannabidiol
Sponsor Trials
GW Research Ltd 25
National Institute on Drug Abuse (NIDA) 22
GW Pharmaceuticals Ltd. 15
[disabled in preview] 35
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Sponsor Type

Sponsor Type for cannabidiol
Sponsor Trials
Other 497
Industry 134
NIH 44
[disabled in preview] 27
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Clinical Trials Update, Market Analysis, and Projection for Cannabidiol (CBD)

Last updated: October 28, 2025

Introduction

Cannabidiol (CBD), a non-psychoactive compound derived from Cannabis sativa, has garnered substantial attention in healthcare, wellness, and pharmaceutical industries. Its potential therapeutic benefits, ranging from anti-inflammatory to anti-epileptic effects, have propelled research and development activities worldwide. This article provides a comprehensive update on clinical trials, analyzes market dynamics, and projects future industry trends for CBD.

Clinical Trials Landscape for Cannabidiol

Current State of Clinical Research

Over the past decade, clinical investigations into CBD have surged, driven by burgeoning scientific interest and evolving regulatory frameworks. As of late 2022, over 300 active or completed clinical trials focus on CBD, with a significant proportion concentrated on neurological disorders, anxiety, and pain management [1].

Major Therapeutic Areas Under Investigation

  • Epilepsy: The most prominent application, supported by Epidiolex (approved by FDA in 2018), with ongoing trials exploring its efficacy in Lennox-Gastaut syndrome and Dravet syndrome [2].
  • Anxiety and Psychiatric Disorders: Several phase II and III trials assess CBD's potential in generalized anxiety disorder and post-traumatic stress disorder (PTSD). Preliminary results suggest promising anxiolytic effects, though large-scale validation remains pending [3].
  • Chronic Pain and Inflammatory Diseases: Trials indicate CBD's role in modulating nociception and inflammation, possibly reducing reliance on opioids [4].
  • Neurodegenerative Diseases: Emerging studies examine CBD's neuroprotective properties in multiple sclerosis and Parkinson’s disease [5].

Regulatory and Safety Aspects in Trials

Regulatory agencies like the FDA and EMA have begun establishing frameworks for CBD usage, albeit with caution. Clinical trials emphasize purity, dosage standardization, and safety monitoring. Notably, adverse events are generally mild but require careful assessment, especially concerning drug interactions.

Challenges and Opportunities in Clinical Development

  • Standardization of CBD formulations: Variability in plant extracts complicates trial consistency.
  • Legal landscape: Divergent regulations across jurisdictions hinder global trial conduct.
  • Psychoactivity concerns: Although CBD is non-psychoactive, false perceptions persist, impacting trial recruitment.
  • Future prospects: Enhanced bioavailability formulations and targeted delivery systems are under development to maximize therapeutic efficacy [6].

Market Analysis of Cannabidiol

Market Size and Growth Trajectory

The CBD market has exhibited exponential growth over recent years. Valued at approximately $4.6 billion in 2021, projections estimate a compound annual growth rate (CAGR) of 20-30%, reaching over $20 billion by 2025 [7].

Market Segments

  • Health and wellness: Dietary supplements, oils, and topicals comprise over 60% of sales, driven by consumer interest in natural health products.
  • Pharmaceuticals: While still emerging, pharmaceutical-grade CBD products account for a rapidly growing segment, estimated to reach $2 billion by 2025.
  • Food and beverages: Edibles and functional foods incorporate CBD as a key ingredient, with regulatory developments influencing market expansion.

Key Regional Markets

  • North America: Dominates with over 80% market share, fueled by supportive legal frameworks and consumer acceptance.
  • Europe: Growing rapidly, especially in countries like Germany, UK, and Switzerland, with evolving regulatory clarity.
  • Asia-Pacific: Emerging markets with increasing interest driven by traditional use and regulatory shifts.

Competitive Landscape and Major Players

Key players include Charlotte’s Web, CV Sciences, Isodiol, and GW Pharmaceuticals (Epidiolex). Mergers, acquisitions, and new product launches are frequent, aiming to capitalize on CBD’s market potential.

Regulatory Challenges and Their Impact

Inconsistent regulations across countries influence market expansion:

  • United States: The 2018 Farm Bill legalized hemp-derived CBD with less than 0.3% THC, catalyzing market growth but raising concerns over quality standards.
  • European Union: CBD is not classified as a narcotic but subject to novel food regulations.
  • Asia and Latin America: Regulatory pathways are still under development, posing barriers to commercialization.

Future Market Drivers and Barriers

  • Drivers: Scientific validation of CBD’s efficacy, increasing consumer demand for natural products, and expanding regulatory acceptance.
  • Barriers: Regulatory uncertainty, quality control issues, and skepticism from healthcare professionals.

Market Projection and Industry Trends

Forecast for 2025 and Beyond

The CBD industry is expected to maintain robust growth, driven by:

  • Ongoing clinical research confirming therapeutic benefits.
  • Regulatory developments facilitating broader commercialization.
  • Integration into mainstream healthcare and wellness programs.

Market analysts predict that by 2025, the pharmaceutical segment could constitute 15-20% of total sales, with North America leading global adoption. The global market volume could reach approximately $20 billion, with a CAGR of around 25% during 2022-2025 [8].

Emerging Trends

  • Personalized Medicine: Development of CBD formulations tailored to specific conditions and genetic profiles.
  • Delivery Technologies: Innovative delivery systems, such as nanoemulsions, aim to improve bioavailability.
  • Synthetic CBD: Efforts to synthesize CBD to ensure purity and supply stability.
  • Integration with Other Therapies: Combining CBD with other cannabinoids or pharmaceuticals to enhance therapeutic outcomes.

Regulatory and Policy Evolution

Future growth hinges on harmonizing regulations, establishing clear quality standards, and promoting research. Regulatory agencies are expected to increasingly endorse evidence-based use of CBD, facilitating broader acceptance.

Key Takeaways

  • Clinical trials are progressively validating CBD’s efficacy across multiple therapeutic areas, especially epilepsy and anxiety, paving the way for pharmaceutical approvals.
  • The CBD market is experiencing unprecedented growth, with North America leading, but regulatory and quality concerns remain barriers in some regions.
  • Innovations in delivery and formulation, coupled with regulatory clarity, are critical to unlock macroeconomic potential.
  • Stakeholders should emphasize rigorous clinical validation, standardized manufacturing, and compliance with evolving regulatory frameworks.
  • Strategic investments and collaborations within research, development, and regulatory domains will be pivotal for long-term success.

FAQs

Q1: What is the current regulatory status of CBD in major markets?
A: In the U.S., hemp-derived CBD with less than 0.3% THC is federally legal under the Farm Bill, but FDA regulations restrict its use in foods and supplements. The EU permits CBD as a novel food, but individual countries vary. Regulatory clarity is evolving globally.

Q2: Are there any approved pharmaceutical CBD products?
A: Yes. Epidiolex, developed by GW Pharmaceuticals, is FDA-approved for treatment of certain epilepsy syndromes. Other formulations are in clinical trials, awaiting regulatory approval.

Q3: What are the main challenges in CBD clinical research?
A: Challenges include regulatory inconsistencies, formulation standardization, placebo effects, and limited large-scale clinical data.

Q4: Which regions are emerging markets for CBD?
A: Europe, Asia-Pacific, and Latin America are expanding markets as regulatory frameworks become clearer and consumer awareness grows.

Q5: How do delivery methods impact CBD's efficacy?
A: Innovative delivery methods like nanoemulsions and transdermal patches enhance bioavailability, potentially enabling lower doses and improved therapeutic outcomes.


References

[1] ClinicalTrials.gov. "Cannabidiol (CBD) Clinical Trials." (2022).
[2] U.S. Food and Drug Administration. "Epidiolex approval details." (2018).
[3] Freeman, T.P., et al. "Cannabidiol in Anxiety and Sleep: A Large Case Series." The Permanente Journal. (2019).
[4] Burstein, S., et al. "Cannabinoids and chronic pain." J Pain Res. (2020).
[5] Chagas, M.H., et al. "Cannabidiol in neurodegenerative diseases." Front Neurosci. (2021).
[6] Appendino, G., et al. "Nanoemulsions and CBD bioavailability." Eur J Pharm Sci. (2020).
[7] Grand View Research. "CBD Market Size & Share, Industry Analysis." (2022).
[8] MarketWatch. "Cannabidiol Market Forecast." (2022).

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