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NCT00123578 ↗	GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 1/Phase 2	2004-08-01	Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant.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NCT00123578 ↗	GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1	Withdrawn	University of California, Los Angeles	Phase 1/Phase 2	2004-08-01	Gamma hydroxybutyrate (GHB) is a powerful central nervous system depressant.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.

Clinical Trial Conditions for Pentobarbital

Condition Name

Condition Name for Pentobarbital
Intervention	Trials
Sedation	1
Substance-Related Disorders	1
Airway Complication of Anaesthesia	1
Transposition of the Great Arteries	1

Condition MeSH

Condition MeSH for Pentobarbital
Intervention	Trials
Heart Diseases	2
Heart Defects, Congenital	1
Hypertension	1
Substance-Related Disorders	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
Completed	3
Withdrawn	3
Not yet recruiting	2

Clinical Trial Sponsors for Pentobarbital

Sponsor Name

Sponsor Name for Pentobarbital
Sponsor	Trials
Washington University School of Medicine	1
Massachusetts General Hospital	1
National Institute on Drug Abuse (NIDA)	1

Sponsor Type

Sponsor Type for Pentobarbital
Sponsor	Trials
Other	12
NIH	2

Pentobarbital Sodium: Clinical Trials, Market Analysis, and Projections

Introduction

Pentobarbital sodium, commonly known by its brand name Nembutal, is a short-acting barbiturate used as a sedative, hypnotic, and anticonvulsant. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Mechanism and Therapeutic Uses

Pentobarbital sodium acts as a GABA_A receptor agonist, enhancing the inhibitory effects of gamma-aminobutyric acid (GABA) in the central nervous system, leading to sedation, hypnosis, and in some cases, anticonvulsant effects[1][4].

Clinical Trials

While pentobarbital sodium has been in use for several decades, it continues to be involved in various clinical trials, particularly in the context of its traditional uses and new potential applications.

• Current Trials: There are ongoing clinical trials associated with pentobarbital sodium, although specific details on recent trials are limited. However, the drug's use in sedation and anesthesia contexts remains a focus area[1].
• Historical Context: Clinical studies on pentobarbital have not included sufficient numbers of elderly subjects to determine if this demographic responds differently to the drug. This gap highlights the need for further research in this area[4].

Market Analysis

Global Market Size and Forecast

The global market for pentobarbital sodium injection is segmented by region, type, and application.

• Current Market Size: As of 2023, the global market for pentobarbital sodium injection was valued at several million USD, with specific figures varying by report. For instance, the market for pentobarbital sodium injection for animal euthanasia was estimated at US$ 63 million[2][5].
• Forecast: The market is anticipated to grow, with the animal euthanasia segment projected to reach US$ 97.8 million by 2030, at a CAGR of 6.5% during the forecast period of 2024-2030. The overall pentobarbital sodium injection market is also expected to see significant growth, driven by increasing demand in various therapeutic and non-therapeutic applications[2][5].

Regional Market Analysis

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa.

• North America: This region is expected to see steady growth, driven by established healthcare systems and ongoing demand for sedative and anticonvulsant medications[2].
• Asia-Pacific: This region is projected to register the highest CAGR due to favorable government policies, growing pharmaceutical industries, and the cost-effectiveness of conducting clinical trials in this region[2][3].

Key Manufacturers

The market is dominated by several key players:

• Leucadia Pharmaceuticals
• SAGENT Pharmaceuticals
• Martindale Pharma
• Bioveta
• Akorn Pharmaceuticals
• Hospira Healthcare Corporation
• Ethypharm
• Nicholas Piramal India Ltd.
• Unicure India Pvt. Ltd.
• Samarth Pharma Pvt. Ltd.
• **Ahaan Healthcare Pvt. Ltd.[2][5].

Market Segmentation

By Type

Pentobarbital sodium injections are available in different concentrations:

• 1000mg/20mL
• 2500mg/50mL These variations cater to different clinical needs and applications[2].

By Application

The drug is used in both adult and pediatric populations:

• Adult Use: Primarily for sedation, anesthesia, and anticonvulsant purposes.
• Pediatric Use: For similar indications, though with careful dosing and monitoring due to the drug's potent effects[2].

Growth Factors and Trends

Increasing Demand in Animal Euthanasia

The use of pentobarbital sodium for animal euthanasia is a significant segment of the market, driven by ethical and humane considerations in veterinary practice. This segment is expected to grow steadily, contributing to the overall market expansion[5].

Clinical Trials and R&D

The broader pharmaceutical and biotechnology landscape, including the growth in clinical trials for various therapeutic areas, indirectly supports the demand for pentobarbital sodium. The outsourcing of R&D functions to Contract Research Organizations (CROs), especially in regions like Asia-Pacific, also boosts the market[3].

Regulatory and Technological Trends

Advancements in laboratory services and the increasing importance of regulatory compliance are crucial factors. The laboratory services segment, which is vital for drug development, is expected to drive growth in the clinical trials market, indirectly benefiting the pentobarbital sodium market[3].

Challenges and Opportunities

Challenges

• Regulatory Hurdles: Changes in regulatory environments and stringent approval processes can impact market growth.
• Skilled Professional Shortage: A shortage of skilled professionals in clinical trials can hinder the development and approval of new drugs, including those involving pentobarbital sodium[3].

Opportunities

• Biologics and Biosimilars: The favorable outlook for biologics and biosimilars presents opportunities for growth in the broader pharmaceutical market, which can indirectly benefit pentobarbital sodium.
• Emerging Markets: The Asia-Pacific region offers significant growth potential due to its growing pharmaceutical industry and favorable government policies[3].

Key Takeaways

• Market Growth: The pentobarbital sodium injection market is expected to grow, driven by increasing demand in various therapeutic and non-therapeutic applications.
• Regional Expansion: The Asia-Pacific region is projected to register the highest CAGR due to favorable market conditions.
• Key Players: Major manufacturers include Leucadia Pharmaceuticals, SAGENT Pharmaceuticals, and others.
• Growth Factors: Increasing demand in animal euthanasia, clinical trials, and R&D outsourcing are key growth factors.

FAQs

What is the primary mechanism of action of pentobarbital sodium?

Pentobarbital sodium acts as a GABA_A receptor agonist, enhancing the inhibitory effects of gamma-aminobutyric acid (GABA) in the central nervous system[1].

What are the main therapeutic uses of pentobarbital sodium?

Pentobarbital sodium is used as a sedative, hypnotic, and anticonvulsant[1][4].

Which region is expected to register the highest CAGR for the pentobarbital sodium market?

The Asia-Pacific region is projected to register the highest CAGR due to favorable government policies and the growing pharmaceutical industry[2][3].

What is the forecasted market size for pentobarbital sodium injection for animal euthanasia by 2030?

The market is forecasted to reach US$ 97.8 million by 2030, growing at a CAGR of 6.5% during the forecast period of 2024-2030[5].

Who are the major manufacturers of pentobarbital sodium injection?

Key manufacturers include Leucadia Pharmaceuticals, SAGENT Pharmaceuticals, Martindale Pharma, Bioveta, and Akorn Pharmaceuticals, among others[2][5].

Sources

1. Synapse: Pentobarbital Sodium - Drug Targets, Indications, Patents.
2. QYResearch: Global Pentobarbital Sodium Injection Market Research Report 2024.
3. MarketsandMarkets: Clinical Trials Market Size, Share, Trends and Revenue Forecast.
4. DailyMed: NEMBUTAL SODIUM- pentobarbital sodium injection.
5. Valuates Reports: Pentobarbital Sodium Injection for Animal Euthanasia - Market Size.

Last updated: 2025-01-04