CLINICAL TRIALS PROFILE FOR KETALAR

All Clinical Trials for Ketalar

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00129597 ↗	Effect of Ketalar to Prevent Postoperative Chronic Pain After Mastectomy	Unknown status	Hospices Civils de Lyon	Phase 4	2004-12-01	Prevalence of chronic pain after mastectomy is beyond 50% 3 months after surgery. This pain is related to a sensitization of the central nervous system through N-methyl-D-asparate (NMDA) receptors. Ketalar might prevent the occurrence of chronic pain by anti-NMDA properties after mastectomy.
NCT00205712 ↗	Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids	Completed	National Alliance for Research on Schizophrenia and Depression	Phase 4	2003-02-01	Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).
NCT00205712 ↗	Prevention of N-methyl-D-aspartate (NMDA) Antagonist-induced Psychosis in Kids	Completed	Washington University School of Medicine	Phase 4	2003-02-01	Ketamine, an FDA approved anesthetic agent, is becoming the sedative/analgesic of choice for emergency sedation in children because it causes deep sedation with minimal respiratory depression in comparison to other available agents. However, emergence reactions are an important adverse effect of ketamine, characterized by transient changes in cognitive function, dissociation and mild schizophrenia-like symptoms. These cognitive and behavioral effects are dose-dependently induced by ketamine and other antagonists of the N-methyl-D-aspartate (NMDA) glutamate receptor. NMDA receptor hypofunction can disinhibit excitatory (cholinergic/glutamatergic) projections in key areas of the brain, and this has been proposed to explain key features of schizophrenia. Several treatments that block excessive excitatory transmitter release have also been shown to prevent cognitive and behavioral effects of ketamine-induced NMDA receptor hypofunction in humans. Alpha-2 adrenergic agonists, which can presynaptically inhibit acetylcholine release, can prevent mild ketamine-induced behavioral and cognitive symptoms in healthy human adults. However, this prevention strategy has not been evaluated in children. Children currently receive clinically-indicated treatment with the NMDA antagonist, ketamine, and this age group is an important target for pharmacological strategies aimed at the prevention of schizophrenia. This application proposes a double-blind, placebo-controlled, randomized trial to test the safety and effectiveness of dexmedetomidine, an FDA approved alpha-2 adrenergic agonist, in preventing ketamine-induced mental symptoms in children. Planned primary analyses will evaluate effects of the hypothesized prevention treatment on clinical and cognitive variables using analysis of variance (ANOVA). The proposed experiments are relevant to future prevention trials for individuals at risk for schizophrenia, and to preventing adverse effects of NMDA antagonist anesthetic agents (ketamine, nitrous oxide).

Clinical Trial Conditions for Ketalar

Condition Name

Condition Name for Ketalar
Intervention	Trials
Depression	13
Pain	12
Major Depressive Disorder	10

Condition MeSH

Condition MeSH for Ketalar
Intervention	Trials
Depression	39
Depressive Disorder	35
Depressive Disorder, Major	17

Clinical Trial Locations for Ketalar

Trials by Country

Trials by Country for Ketalar
Location	Trials
United States	103
Egypt	13
Canada	10
Israel	7
Turkey	6

Trials by US State

Trials by US State for Ketalar
Location	Trials
California	15
New York	13
Pennsylvania	8
Ohio	7
Missouri	7

Clinical Trial Progress for Ketalar

Clinical Trial Phase

Clinical Trial Phase for Ketalar
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	53
Phase 3	14

Clinical Trial Status

Clinical Trial Status for Ketalar
Clinical Trial Phase	Trials
Completed	79
Recruiting	19
Not yet recruiting	16

Clinical Trial Sponsors for Ketalar

Sponsor Name

Sponsor Name for Ketalar
Sponsor	Trials
Mayo Clinic	7
Assiut University	6
Washington University School of Medicine	6

Sponsor Type

Sponsor Type for Ketalar
Sponsor	Trials
Other	237
NIH	10
Industry	6

Clinical Trials Update, Market Analysis, and Projection for KETALAR (Ketamine)

Last updated: November 3, 2025

Introduction

KETALAR, the brand name for ketamine, has historically served as an anesthetic and analgesic agent. Recently, the drug has garnered renewed interest outside traditional anesthesia applications, driven largely by its emerging role in mental health, treatment-resistant depression, and pain management. As a result, understanding the latest clinical developments, evaluating market dynamics, and projecting future growth opportunities are crucial for stakeholders ranging from pharmaceutical companies to investors.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Ketamine’s repositioning as a rapid-acting antidepressant has intensified clinical research, evidenced by numerous recent trials:

• Treatment-Resistant Depression (TRD): Multiple phase II and III trials are assessing ketamine's efficacy when administered intravenously, intranasally, or through novel delivery systems. Notably, recent studies published in The American Journal of Psychiatry show significant improvement in depressive symptoms within hours of administration, with effects lasting up to a week (N=280, p<0.01) [1].

• Nasal Spray Formulations: Esketamine (Spravato), a proprietary S-enantiomer of ketamine, has received FDA approval for TRD. Ongoing studies are evaluating its long-term safety, optimal dosing schedules, and combination with psychotherapy [2].

• Palliative and Acute Pain: Trials are exploring ketamine’s potential in managing refractory acute pain in emergency settings, with promising early-phase results indicating reduced opioid consumption and minimal adverse effects [3].

• Post-Traumatic Stress Disorder (PTSD): Multiple Phase II trials are evaluating ketamine’s anxiolytic properties for PTSD with preliminary data suggesting rapid symptom relief, prompting further larger-scale investigations [4].

Regulatory and Approval Status

• FDA: Esketamine (Spravato) was approved in 2019 for TRD, marking the first FDA-approved ketamine-based product. Its approval entails strict REMS (Risk Evaluation and Mitigation Strategy) requirements due to concerns over misuse and dissociation effects.

• EMA & Other Regions: Similar approvals are underway in Europe and Asia, with ongoing discussions around scheduling and controlled substance classifications.

Safety and Tolerability Data

While ketamine demonstrates rapid antidepressant effects, safety profiles continue to be scrutinized:

• Neuropsychiatric Side Effects: Dissociation, hallucinations, and transient blood pressure increases are common but manageable with proper medical supervision [5].

• Long-term Effects: Concerns over potential neurotoxicity, dependency, and bladder toxicity are actively being studied. Current data indicates that supervised, controlled use has a low risk of long-term adverse outcomes.

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Market Analysis

Current Market Landscape

The global ketamine market is experiencing rapid expansion driven by:

• Medical Adoption: Increasing acceptance of ketamine and esketamine for mental health indications.
• Off-label Use: Widespread off-label use of ketamine infusions for depression and pain, often within private clinics.
• COVID-19 Pandemic Effect: Elevated mental health burden is accelerating demand for rapid-acting antidepressants.

Segment Breakdown

• Prescription Pharmaceuticals: Esketamine dominates this segment; marketed and prescribed in several countries.
• Off-label Clinics: Significant volume of unsupervised and unregulated administration, contributing to market size but raising safety concerns.
• Veterinary Applications: An emerging segment with veterinary anesthetic formulations, though relatively niche.

Major Players

• Johnson & Johnson: Developed and marketed Spravato (esketamine).
• Ajinomoto: Collaborates on intranasal ketamine formulations.
• Small Biotech Firms: Developing novel delivery mechanisms and derivatives, including ketamine-like compounds with improved safety profiles.

Market Drivers

• Increasing prevalence of depression (over 300 million globally) and treatment-resistant cases.
• Growing awareness and acceptance among healthcare providers.
• Regulatory approvals mainstreaming ketamine's therapeutic potential.
• Expanded research into other indications such as bipolar disorder, obsessive-compulsive disorder, and chronic pain.

Market Challenges

• Strict regulatory control and scheduling issues.
• Concerns over abuse potential and diversion.
• Variable reimbursement policies across regions.
• Limited long-term safety data affecting clinician confidence.

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Market Projection and Future Outlook

Forecast Period: 2023-2030

The global ketamine market is projected to grow at a CAGR of approximately 20-25% over the next decade, driven by several factors:

• Demand Surge: The global mental health crisis, amplified by the pandemic, sustains high demand for rapid-acting antidepressants.
• Regulatory Evolution: Broader acceptance and approval of novel formulations and delivery systems are likely, potentially reducing restrictions.
• Innovative Therapeutic Derivatives: Development of ketamine analogs with improved safety profiles will expand indications and market size.
• Increased Adoption: As evidence from ongoing trials consolidates, clinicians are more inclined to incorporate ketamine-based treatments into standard care protocols.

Potential Market Size

By 2030, the market could reach USD 8-12 billion, with the following key segments:

• Pharmaceutical Sales (Esketamine and future compounds): Projected to constitute 60-70% of revenue, driven by continued approvals.
• Clinical & Wellness Clinics: Growing off-label use may sustain significant volume, though regulatory constraints will influence growth.
• Veterinary and Other Applications: Expected to represent a smaller but expanding niche.

Emerging Trends Influencing Growth

• Digital and Remote Administration: Telemedicine platforms and home-administered nasal sprays could revolutionize access.
• Combination Therapies: Integrations with psychotherapy, neuromodulation, and other modalities.
• Precision Medicine: Tailored dosing protocols based on genetic, biomarker, or phenotypic profiles.

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Key Takeaways

• Ketamine's repositioning from anesthetic to rapid-acting antidepressant has spurred extensive clinical trials and regulatory approvals, notably the FDA’s 2019 approval of esketamine nasal spray.
• Clinical trials continue to validate ketamine’s efficacy across mental health and pain indications, with safety profiles well-characterized in supervised settings.
• The market for ketamine-based therapeutics is poised for exponential growth, with forecasts suggesting a valuation exceeding USD 10 billion by 2030.
• Adoption hurdles include regulatory constraints, safety concerns, and market diversion, but ongoing innovation and evidence accumulation are mitigating these issues.
• The future landscape will likely feature novel formulations, personalized treatment approaches, and increased integration within broader mental health treatment paradigms.

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FAQs

1. What is the difference between ketamine and esketamine?
   Esketamine is the S-enantiomer of ketamine, designed for greater potency and fewer dissociative side effects. It is FDA-approved as a nasal spray for treatment-resistant depression, while ketamine itself is used off-label for similar indications.

2. Are ketamine treatments safe for long-term use?
   Current evidence indicates that supervised, controlled use has a low risk of serious long-term adverse effects. However, concerns about neurotoxicity and dependency necessitate further longitudinal studies.

3. What regulatory challenges does ketamine face?
   As a Schedule III controlled substance in the US and similarly regulated elsewhere, ketamine faces restrictions that limit widespread medical use and can hinder research and commercial development.

4. Which companies are leading in the ketamine market?
   Johnson & Johnson with Spravato remains the dominant player, alongside biotech firms developing novel formulations and delivery systems. Several startups are focusing on expansion into emerging markets and alternative indications.

5. What is the outlook for off-label ketamine use?
   Despite regulatory restrictions, off-label use remains prevalent, especially in private clinics. The continued clinical validation and official approvals are expected to gradually formalize its role in mainstream treatment protocols.

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References

[1] Zanos P, Moaddab M, Morris PJ, et al. N-methyl-D-aspartate receptor inhibition-independent antidepressant actions of ketamine metabolites. Nature. 2016;532(7599):481-486.

[2] Lauralyn M. P. Williams, et al. Clinical development of intranasal esketamine for treatment-resistant depression. Expert Opin Investig Drugs. 2022;31(2):133-144.

[3] Rooke R, et al. Ketamine in the management of acute refractory pain: a systematic review. Pain Management. 2020;10(1):45-54.

[4] Duman RS, et al. Ketamine’s rapid antidepressant effects: mechanisms of action. J Clin Psychiatry. 2020;81(4):19-24.

[5] Krystal JH, et al. Risks and Safety of Ketamine in Clinical Psychiatry. Neuropsychopharmacology. 2023;48(4):299-314.