CLINICAL TRIALS PROFILE FOR CANNABIDIOL

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.
OTC	NCT06695195 ↗	A Randomized Controlled Trial of Oral CBD for the Treatment of Upper Extremity Musculoskeletal Pain	NOT_YET_RECRUITING	The Plastic Surgery Foundation	PHASE1	2025-06-01	The goal of this clinical trial is to learn about the use of cannabidiol (CBD) capsules as a treatment for musculoskeletal pain. CBD is commonly being used as an over-the-counter treatment for musculoskeletal pain. Clinical trials have demonstrated a pain-relief benefit for hand and wrist osteoarthritis with topical CBD, however patients prefer oral CBD and no clinical trial has been performed to establish efficacy of oral CBD in humans for upper extremity musculoskeletal pain. The main questions it aims to answer are: Is CBD more effective than placebo at relieving pain for upper extremity musculoskeletal pain ? Is CBD safe for participants with upper extremity musculoskeletal pain? Participants will: take 4 weeks of daily CBD capsules take 4 weeks of daily placebo capsules answer surveys about how they are feeling and functioning. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\].

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.
NCT00397605 ↗	Cannabinoids in Bipolar Affective Disorder	Withdrawn	University of British Columbia	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.

Clinical Trial Conditions for CANNABIDIOL

Condition Name

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

Condition MeSH

Condition MeSH for CANNABIDIOL
Intervention	Trials
Marijuana Abuse	54
Syndrome	29
Epilepsy	23
Anxiety Disorders	20

Clinical Trial Locations for CANNABIDIOL

Trials by Country

Trials by Country for CANNABIDIOL
Location	Trials
United States	474
Canada	46
Australia	30
United Kingdom	26
Israel	25

Trials by US State

Trials by US State for CANNABIDIOL
Location	Trials
California	44
New York	42
Florida	30
Pennsylvania	23
Texas	22

Clinical Trial Progress for CANNABIDIOL

Clinical Trial Phase

Clinical Trial Phase for CANNABIDIOL
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	8
PHASE2	36

Clinical Trial Status

Clinical Trial Status for CANNABIDIOL
Clinical Trial Phase	Trials
Recruiting	126
Not yet recruiting	109
Completed	84

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

Sponsor Type

Sponsor Type for CANNABIDIOL
Sponsor	Trials
Other	516
Industry	137
NIH	46

Cannabidiol (CBD) Clinical Trials and Market Outlook

Last updated: February 19, 2026

This report analyzes the current landscape of clinical trials for cannabidiol (CBD) and projects the market trajectory for CBD-based therapeutics. Regulatory hurdles, clinical development progress, and market demand are key drivers shaping the future of CBD pharmaceuticals.

What is the current status of clinical trials for CBD?

Clinical trials for CBD are actively investigating its efficacy and safety across a range of therapeutic areas. These trials are primarily focused on neurological disorders, pain management, and inflammatory conditions. The majority of ongoing trials are in Phase 2 or Phase 3, indicating a progression towards regulatory submission for specific indications.

Key Therapeutic Areas Under Investigation:

• Neurological Disorders:
  • Epilepsy: Epidiolex (cannabidiol) is the first FDA-approved drug containing a purified CBD ingredient for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex.
  • Multiple Sclerosis (MS): Trials are assessing CBD's potential in managing spasticity and pain associated with MS.
  • Parkinson's Disease: Research is exploring CBD's effects on motor symptoms and anxiety in Parkinson's patients.
  • Alzheimer's Disease: Early-stage research is examining CBD's neuroprotective properties.
• Pain Management:
  • Chronic Pain: CBD is being studied for its analgesic properties in various chronic pain conditions, including osteoarthritis and neuropathic pain.
  • Inflammatory Pain: Trials are evaluating CBD's anti-inflammatory effects in conditions like rheumatoid arthritis.
• Mental Health:
  • Anxiety Disorders: Research is investigating CBD's anxiolytic effects in generalized anxiety disorder, social anxiety disorder, and post-traumatic stress disorder (PTSD).
  • Schizophrenia: Some trials are exploring CBD as an adjunctive therapy for positive symptoms of schizophrenia.
• Other Conditions:
  • Inflammatory Bowel Disease (IBD): CBD's anti-inflammatory properties are being studied for Crohn's disease and ulcerative colitis.
  • Dermatological Conditions: Topical CBD formulations are being evaluated for acne and psoriasis.

Summary of Clinical Trial Phases:

Phase	Number of Trials (Approximate)	Focus
Phase 1	20	Safety, tolerability, pharmacokinetics, and pharmacodynamics
Phase 2	75	Efficacy, dose-ranging, and further safety evaluation
Phase 3	40	Large-scale efficacy and safety confirmation for regulatory approval
Registrational/Post-Market	15	Post-approval studies, real-world evidence, and expanded indications

Note: Trial counts are approximate and fluctuate based on ongoing registrations and completions. Data sourced from clinical trial registries and pharmaceutical company reports.

What are the primary regulatory considerations for CBD therapeutics?

The regulatory landscape for CBD is complex and evolving, varying significantly by jurisdiction. The U.S. Food and Drug Administration (FDA) has approved one CBD-based drug, Epidiolex, for specific seizure disorders. However, the FDA has not yet established a clear regulatory pathway for CBD in dietary supplements or general food products, leading to continued enforcement actions against companies making unsubstantiated health claims.

Key Regulatory Bodies and Policies:

• U.S. Food and Drug Administration (FDA):
  • Approved Epidiolex (cannabidiol) for seizures associated with specific epilepsy syndromes in June 2018 [1].
  • Considers CBD a drug ingredient and has not approved it for use in dietary supplements or as a food additive.
  • Issues warning letters to companies making unsubstantiated medical claims for CBD products.
  • Actively reviewing scientific data to determine a pathway for CBD products [2].
• European Medicines Agency (EMA):
  • Requires rigorous clinical trial data demonstrating safety and efficacy for marketing authorization of CBD medicines.
  • Individual member states may have their own specific regulations.
• Health Canada:
  • Regulates cannabis and its derivatives, including CBD, under the Cannabis Act.
  • Products must be authorized by Health Canada for sale.
• Other Jurisdictions: Many countries are establishing their own regulatory frameworks, often aligning with a science-based approach that requires robust clinical evidence.

Challenges in Regulation:

• Lack of Standardized Quality Control: Variability in CBD product purity, potency, and contaminants remains a concern.
• Conflicting Legal Status: The legality of CBD varies widely, impacting research and commercialization efforts.
• Limited Clinical Evidence for Many Claims: While promising for certain indications, broad therapeutic claims for CBD lack sufficient scientific backing.

How has the market for CBD evolved?

The global market for CBD has experienced substantial growth, driven by increasing consumer awareness, perceived health benefits, and expanding product availability. While the wellness sector has been a primary driver, pharmaceutical applications are poised to become a significant segment as clinical validation progresses.

Market Segmentation:

• Pharmaceuticals: Prescription-based CBD products for specific medical conditions. This segment is expected to see the highest growth as regulatory approvals expand.
• Nutraceuticals/Dietary Supplements: Over-the-counter CBD products marketed for general wellness, anxiety relief, and sleep support. This segment faces significant regulatory scrutiny.
• Cosmetics/Topicals: CBD infused in skincare and beauty products for anti-inflammatory and soothing properties.
• Food & Beverages: CBD added to edible products and drinks, a segment with considerable regulatory uncertainty in many markets.

Historical Market Growth (USD billions):

Year	Global CBD Market Size
2018	4.7
2019	7.2
2020	9.3
2021	12.5
2022	15.1

Source: Market research reports (e.g., Grand View Research, Statista). Figures are indicative and may vary between sources.

What are the projected market trends and opportunities for CBD therapeutics?

The market for CBD therapeutics is projected to grow significantly, driven by clinical advancements, expanding regulatory approvals, and increasing demand for evidence-based treatments. The pharmaceutical segment, in particular, is expected to lead this growth.

Key Market Drivers:

• Clinical Validation: Successful Phase 3 trials and subsequent regulatory approvals for new indications will unlock substantial market potential.
• Increasing Physician Acceptance: As more high-quality clinical data emerges, healthcare professionals are likely to become more comfortable prescribing CBD-based medications.
• Patient Demand: Growing consumer interest in natural and alternative therapies continues to fuel demand for CBD products.
• Investment in R&D: Pharmaceutical companies are increasing investment in CBD research, signaling a commitment to developing the drug class.
• Harmonization of Regulations: Efforts to standardize regulations globally could streamline market access for approved CBD therapeutics.

Projected Market Growth (USD billions):

Year	Projected Global CBD Market Size (Pharmaceutical Segment)
2023	18.0
2024	22.5
2025	28.0
2027	45.0
2030	70.0+

Source: Industry analysis and market projections. Figures are estimates and subject to market dynamics.

Opportunities:

• Targeted Indications: Focus on neurological conditions, chronic pain, and inflammatory diseases where there is strong preliminary evidence and unmet medical needs.
• Combination Therapies: Investigating CBD in combination with existing treatments to enhance efficacy or reduce side effects.
• Novel Delivery Systems: Developing improved formulations for better bioavailability and patient compliance (e.g., advanced oral formulations, targeted delivery).
• Pediatric Neurology: Building on the success of Epidiolex, exploring CBD for other pediatric neurological conditions.
• Pain and Inflammation: The vast market for chronic pain and inflammatory conditions presents significant opportunities if robust clinical trials demonstrate efficacy and safety.

Challenges:

• Regulatory Uncertainty: Ongoing challenges in navigating regulatory pathways for new indications and product types.
• Competition: Increasing competition from both synthetic cannabinoids and other therapeutic classes.
• Reimbursement: Securing favorable reimbursement for CBD-based pharmaceuticals from payers.
• Stigma and Misinformation: Overcoming historical stigma associated with cannabis and addressing widespread misinformation about CBD.
• Manufacturing and Supply Chain: Ensuring consistent, high-quality manufacturing and a reliable supply chain for pharmaceutical-grade CBD.

What are the key competitive factors in the CBD pharmaceutical market?

The competitive landscape for CBD pharmaceuticals is intensifying, characterized by established pharmaceutical companies, emerging biotech firms, and a complex interplay of scientific innovation and regulatory navigation.

Key Players and Strategies:

• GW Pharmaceuticals (now part of Jazz Pharmaceuticals): Pioneer with Epidiolex, demonstrating the potential for regulatory approval and market success. Their strategy focuses on specific, approved indications.
• Emerging Biotech Companies: Many smaller companies are focused on specific therapeutic niches, often targeting conditions with limited treatment options. Their strategies involve in-licensing, out-licensing, and strategic partnerships to advance their pipelines.
• Large Pharmaceutical Companies: Increasingly entering the space through acquisitions, partnerships, or internal R&D, leveraging their expertise in clinical development, regulatory affairs, and commercialization.
• Generic Manufacturers: As patents expire for early CBD drugs, generic competition will emerge, influencing pricing and market dynamics.

Competitive Differentiators:

• Clinical Efficacy and Safety Data: The strength and robustness of clinical trial data are paramount for regulatory approval and physician adoption.
• Intellectual Property (IP): Patents covering specific formulations, delivery methods, or therapeutic uses provide market exclusivity.
• Regulatory Expertise: Navigating complex regulatory pathways efficiently is a critical success factor.
• Manufacturing Capabilities: The ability to produce pharmaceutical-grade CBD consistently and at scale is essential.
• Commercialization and Market Access: Establishing effective sales forces, distribution networks, and securing reimbursement are vital for market penetration.

Key Takeaways

• CBD clinical development is advancing, with trials focused on neurological disorders, pain, and inflammation. Epidiolex is the sole FDA-approved CBD drug for specific seizure types.
• Regulatory pathways for CBD remain a significant challenge, with the FDA not yet establishing a framework for non-drug CBD products.
• The global CBD market has grown substantially, with pharmaceuticals projected to be the leading segment.
• Market projections indicate strong growth for CBD therapeutics, driven by clinical validation, physician acceptance, and patient demand.
• Key opportunities lie in targeted indications, combination therapies, and novel delivery systems.
• Competition is intensifying, with established and emerging players focusing on clinical data, IP, regulatory expertise, and manufacturing capabilities.

FAQs

1. What are the primary differences between pharmaceutical-grade CBD and over-the-counter CBD products? Pharmaceutical-grade CBD is manufactured under strict Good Manufacturing Practices (GMP) standards, ensuring high purity, consistent potency, and absence of contaminants. It is intended for use in prescription medications and is backed by rigorous clinical trial data. Over-the-counter CBD products may have less stringent manufacturing controls, leading to variability in quality and potency, and are typically marketed for wellness rather than specific medical treatments.

2. Which therapeutic areas show the most promise for future CBD drug approvals? Neurological disorders, particularly epilepsy (building on Epidiolex's success), and chronic pain and inflammatory conditions are considered areas with significant promise. Research into anxiety and certain psychiatric conditions is also ongoing and could lead to future approvals.

3. What is the current stance of major regulatory bodies like the FDA and EMA on the therapeutic use of CBD? The FDA has approved one CBD drug (Epidiolex) and is actively reviewing data for other potential uses. However, it has not approved CBD for dietary supplements or food. The EMA similarly requires robust clinical evidence for marketing authorization of CBD medicines. Both agencies emphasize a science-based approach, requiring proof of safety and efficacy for therapeutic claims.

4. How does intellectual property protection impact the development of CBD therapeutics? Intellectual property, such as patents on novel formulations, delivery mechanisms, or specific therapeutic uses, is crucial for providing market exclusivity for CBD-based drugs. This protection incentivizes significant R&D investment by pharmaceutical companies and can create barriers to entry for competitors.

5. What are the most significant hurdles to widespread physician adoption of CBD therapeutics? Key hurdles include the need for more extensive and high-quality clinical trial data for a broader range of indications, navigating complex regulatory approvals, establishing clear dosing guidelines, and securing predictable reimbursement from insurance providers. Overcoming physician skepticism and addressing concerns about product consistency are also important factors.

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Citations

[1] Food and Drug Administration. (2018, June 25). FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. U.S. Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms-epilepsy

[2] Food and Drug Administration. (2023, January 26). Cannabidiol (CBD). U.S. Food & Drug Administration. https://www.fda.gov/consumers/consumer-updates/cannabidiol-cbd-frequently-asked-questions