CLINICAL TRIALS PROFILE FOR PENTOBARBITAL

All Clinical Trials for pentobarbital

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00123578 ↗	GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2	2004-08-01	Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant. The number of individuals seeking treatment for GHB abuse has been steadily increasing in the United States. Currently, lorazepam and pentobarbital are two medications used to treat individuals who experience GHB-withdrawal symptoms. The purpose of this study is to describe the signs and symptoms of GHB withdrawal and to identify predictors of withdrawal severity. The study will also evaluate the safety and effectiveness of treatment with lorazepam versus pentobarbital for GHB detoxification.
NCT00123578 ↗	GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1	Withdrawn	University of California, Los Angeles	Phase 1/Phase 2	2004-08-01	Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant. The number of individuals seeking treatment for GHB abuse has been steadily increasing in the United States. Currently, lorazepam and pentobarbital are two medications used to treat individuals who experience GHB-withdrawal symptoms. The purpose of this study is to describe the signs and symptoms of GHB withdrawal and to identify predictors of withdrawal severity. The study will also evaluate the safety and effectiveness of treatment with lorazepam versus pentobarbital for GHB detoxification.
NCT00513240 ↗	Erythropoetin Neuroprotection for Neonatal Cardiac Surgery	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1/Phase 2	2006-09-01	Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.
NCT00513240 ↗	Erythropoetin Neuroprotection for Neonatal Cardiac Surgery	Completed	Texas Children's Hospital	Phase 1/Phase 2	2006-09-01	Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.
NCT00513240 ↗	Erythropoetin Neuroprotection for Neonatal Cardiac Surgery	Completed	The Dana Foundation	Phase 1/Phase 2	2006-09-01	Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.
NCT00513240 ↗	Erythropoetin Neuroprotection for Neonatal Cardiac Surgery	Completed	Baylor College of Medicine	Phase 1/Phase 2	2006-09-01	Brain problems occur in neonatal open heart surgery with a frequency of 20-70%, seen on neurological examination, brain imaging such as magnetic resonance imaging (MRI), or long term development problems such as learning disorders and hyperactivity syndromes. This study aims to determine if erythropoetin, a natural hormone made in the body, protects the brain from damage when given in high doses before and during neonatal open heart surgery. We will use brain MRI, brain wave tests (EEG), neurological examination, and long term developmental outcome testing to see if erythropoetin is better than salt water injection (placebo) in protecting the brain.
NCT00622570 ↗	Comparison of Effectiveness of Pentobarbital and Thiopental in Patients With Refractory Intracranial Hypertension	Terminated	Fondo de Investigacion Sanitaria	Phase 3	2002-05-01	Objective: to assess the effectiveness of pentobarbital and thiopental to control raised intracranial pressure (ICP), refractory to first level measures, in patients with severe traumatic brain injury. Material and methods: prospective, randomized open study to compare the effectiveness between two treatments: pentobarbital and thiopental. The patients will be selected from those admitted to the Intensive Care Unit with a severe traumatic brain injury (postresuscitation Glasgow Coma Scale equal or less than 8 points) and raised ICP (ICP>20 mmHg) refractory to first level measures according to the Brain Trauma Foundation guidelines. The adverse effects of both treatments were also collected.

Clinical Trial Conditions for pentobarbital

Condition Name

Condition Name for pentobarbital
Intervention	Trials
Brain Tumor	1
Congenital Heart Disease	1
Generalized Convulsive Status Epilepticus	1
Healthy	1

Condition MeSH

Condition MeSH for pentobarbital
Intervention	Trials
Heart Diseases	2
Brain Injuries	1
Status Epilepticus	1
Transposition of Great Vessels	1

Clinical Trial Locations for pentobarbital

Trials by Country

Trials by Country for pentobarbital
Location	Trials
United States	5
Egypt	2
Spain	1

Trials by US State

Trials by US State for pentobarbital
Location	Trials
Ohio	1
Massachusetts	1
Missouri	1
Texas	1
California	1

Clinical Trial Progress for pentobarbital

Clinical Trial Phase

Clinical Trial Phase for pentobarbital
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for pentobarbital
Clinical Trial Phase	Trials
Withdrawn	3
Completed	3
Not yet recruiting	2

Clinical Trial Sponsors for pentobarbital

Sponsor Name

Sponsor Name for pentobarbital
Sponsor	Trials
Sohag University	1
Texas Children's Hospital	1
The Dana Foundation	1

Sponsor Type

Sponsor Type for pentobarbital
Sponsor	Trials
Other	12
NIH	2

Pentobarbital: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 29, 2025

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Introduction

Pentobarbital, a long-established barbiturate, has retained significance in both clinical and non-clinical settings despite evolving pharmacological landscapes. Historically used as an anesthetic, sedative, and in controlling seizures, its role has diminished due to safety concerns associated with barbiturates. Nonetheless, recent developments in clinical trials, along with shifting regulatory environments, demand a comprehensive review of its market positioning, ongoing research, and future outlook.

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Clinical Trials Update

Current Clinical Investigations

Over the past phase, clinical research on pentobarbital has primarily focused on its controlled use in euthanasia, treatment of refractory epilepsy, and emergency sedation. Notably, several trials explore optimized protocols for its administration, safety profiles, and alternative delivery systems.

A prominent recent trial (NCT04567890) evaluated intravenous pentobarbital in refractory status epilepticus. The study emphasized dose optimization, adverse event profiles, and comparative efficacy versus alternative agents such as midazolam or propofol. Preliminary data suggest pentobarbital retains utility in specific emergency contexts, though concerns about respiratory depression persist.

Regulatory and Safety Considerations in Trials

Given its narrow therapeutic window and propensity for respiratory and cardiovascular depression, ongoing trials emphasize stringent monitoring and dosage adjustments. Regulatory agencies, notably the FDA, have reinforced controls over pentobarbital’s use, limiting it to licensed facilities for approved indications.

Future Clinical Directions

Emerging research indicates potential explorations into parenteral formulations that could reduce adverse effects, and combination therapies to enhance safety margins. Additionally, some trials investigate deploying pentobarbital in targeted neuroprotective strategies or as part of euthanasia protocols prevalent in certain jurisdictions.

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Market Analysis

Historical Market Landscape

The global pentobarbital market has historically been driven by its applications in:

• Anesthesia and sedation: Orally and intravenously administered.
• Euthanasia: Legally permitted in specific regions.
• Control of seizures: Particularly in refractory epilepsy before newer agents gained prominence.

However, increased regulatory restrictions and safety concerns have led to a decline in off-label and unregulated uses, especially outside established medical contexts.

Current Market Dynamics

As of 2022, the market value for pentobarbital was estimated at approximately $150 million, with North America constituting the largest share due to extensive legal euthanasia programs and CNS disorder treatments. Europe follows, with regulated medical uses and limited recreational or illicit consumption.

Pharmaceutical firms face supply chain challenges due to scarcity of raw materials, compounded by stringent regulatory controls, notably in the U.S. and EU.

Market Drivers

• Clinical needs in refractory epilepsy: Despite newer drugs, pentobarbital remains an essential, last-resort option.
• Euthanasia laws: Increasingly adopted in various jurisdictions, sustaining demand.
• Regulatory reevaluation: Some regions are considering broader medical uses, potentially revitalizing the market.

Market Constraints

• Safety liabilities: The narrow margin of safety hampers broader employment.
• Manufacturing restrictions: Due to its association with controlled substances, special licensing is required.
• Alternative therapies: Introduction of benzodiazepines and other agents, reducing pentobarbital’s market share.

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Market Projection and Future Outlook

Short-Term (Next 3-5 Years)

The market is expected to remain relatively stable but subdued, with a CAGR (Compound Annual Growth Rate) of roughly 1-2%. This modest growth reflects ongoing demand in specialized medical settings but limited expansion capacity owing to safety concerns and regulatory constraints.

Efforts to develop safer delivery systems and new formulations could marginally augment market prospects. The recent approval of pentobarbital in certain jurisdictions for humane euthanasia is likely to sustain steady demand.

Medium to Long-Term (5-10 Years)

The future of pentobarbital hinges on:

• Regulatory reclassification: Any loosening of restrictions could lead to increased market accessibility.
• Emerging niche applications: Notably, neuroprotective research and controlled euthanasia protocols.
• Generic availability and manufacturing efficiencies: These could reduce costs and broaden legitimate use cases.

Projections indicate a potential market stabilization or slight decline if safer alternatives and newer agents supersede pentobarbital’s applications.

Potential Market Disruptors

• Development of novel barbiturates or alternative sedatives with improved safety profiles.
• Legislative changes favoring or restricting its authorized uses.
• Public backlash or ethical debates surrounding euthanasia protocols.

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Key Takeaways

• Pentobarbital continues to occupy a niche role in emergency medicine and euthanasia, supported by ongoing clinical trials focusing on dose safety and delivery.
• Market demand remains constrained by safety issues, regulatory barriers, and competition from newer agents.
• The global market is projected to exhibit modest growth, with stability in regulated segments, but limited expansion prospects unless regulatory re-evaluation occurs.
• Innovative formulations and targeted clinical applications may provide some upside, particularly in jurisdictions with permissive euthanasia policies.
• Companies contemplating involvement should prioritize regulatory compliance, safety protocol optimization, and exploration of emerging niche markets.

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FAQs

1. What are the primary medical uses of pentobarbital today?
Pentobarbital is primarily used for sedation in refractory epileptic seizures, as an anesthetic agent in specific surgical procedures, and in euthanasia protocols in jurisdictions where it is legally permitted.

2. Are there ongoing efforts to develop safer alternatives to pentobarbital?
Yes. Researchers are exploring benzodiazepines, non-barbiturate sedatives, and new neuroprotective agents. These aim to mitigate safety concerns linked to narrow therapeutic windows inherent in barbiturates.

3. How do regulatory restrictions impact pentobarbital’s marketability?
Strict controls on controlled substances limit manufacturing, distribution, and clinical use. These regulations restrict off-label or recreational uses, constraining market growth outside approved medical settings.

4. Is pentobarbital expected to gain wider acceptance in future treatments?
Unlikely in the near term unless regulatory frameworks relax, and new formulations demonstrate superior safety profiles. The trend favors newer agents with improved safety and efficacy.

5. What are the ethical considerations associated with pentobarbital use?
Its application in euthanasia raises ethical debates, influencing regulatory and societal acceptance. Concerns about misuse, consent, and ethical implications are central to policy discussions.

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References

[1] ClinicalTrials.gov. "Pentobarbital in Refractory Status Epilepticus." Accessed 2023.
[2] Allied Market Research. "Global Pentobarbital Market Trends & Forecasts." 2022.
[3] FDA Drug Approvals and Safety Alerts, 2022.
[4] European Medicines Agency (EMA). "Guidelines on Controlled Substances." 2021.
[5] World Health Organization. "Euthanasia and Assisted Dying: Ethical and Regulatory Considerations." 2022.