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Last Updated: January 1, 2026

CLINICAL TRIALS PROFILE FOR PHENOBARBITAL SODIUM


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All Clinical Trials for Phenobarbital Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00260143 ↗ Testosterone and Physical Function in HIV+ Men Completed Charles Drew University of Medicine and Science Phase 2 2003-05-01 Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT00260143 ↗ Testosterone and Physical Function in HIV+ Men Completed National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Phase 2 2003-05-01 Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though they may try to eat more food to gain weight. The reasons for this weight loss are not clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a hormone that is naturally produced in the bodies of both men and women and has important effects on building muscle and bone mass. The purpose of this study is to find out if providing additional testosterone to HIV infected men who have low testosterone can help them gain weight, increase their muscle mass, and feel better. The study will also help see if testosterone improves the efficiency with which your body produces and uses energy including fat. The dose of testosterone being used in this study will raise testosterone levels in the blood to higher than normal levels (2-3 times normal level).
NCT01730313 ↗ Treatment of Nodding Syndrome - A Randomized Blinded Placebo-Controlled Crossover Trial of Oral Pyridoxine and Conventional Anti-Epileptic Therapy, in Northern Uganda - 2012 Unknown status Ministry of Health, Uganda Phase 2 2013-02-01 Nodding Syndrome (NS) is a novel form of epilepsy seen predominantly among children aged 5-15 years and characterized by head nodding, progressively worsening seizures, and cognitive impairment. To date, the cause of NS remains unclear. A recent assessment by the Uganda Ministry of Health (MOH), World Health Organization (WHO), and US CDC conducted in Kitgum District in northern Uganda documented that the nodding episodes themselves resulted from atonic seizures, and that the children also exhibit multiple different seizure types, both clinically and electrographically. The investigation also found that there was significantly greater sero-positivity for onchocerciasis among children with NS compared with control children, and demonstrated low serum concentrations of vitamin B6 (pyridoxine) among both cases and controls. Vitamin B6 is involved in neurotransmission and has been an effective treatment of seizures for certain rare type of epileptic syndrome. Children with nodding syndrome in Kitgum have been episodically treated with multivitamins, ivermectin, and anti-epileptic medications including phenobarbital, phenytoin, carbamazepine, and valproate, but the possible beneficial or harmful effects of any of these medications for nodding syndrome has not been systematically assessed, and reports from parents and guardians about apparent effectiveness are varied. The investigators propose a randomized blinded four group clinical trial with crossover design to study the effect and response to therapeutic doses of oral pyridoxine (vitamin B6) and treatment with currently used conventional anti-epileptics including phenytoin and sodium valproate, among children with nodding syndrome.
NCT01730313 ↗ Treatment of Nodding Syndrome - A Randomized Blinded Placebo-Controlled Crossover Trial of Oral Pyridoxine and Conventional Anti-Epileptic Therapy, in Northern Uganda - 2012 Unknown status Centers for Disease Control and Prevention Phase 2 2013-02-01 Nodding Syndrome (NS) is a novel form of epilepsy seen predominantly among children aged 5-15 years and characterized by head nodding, progressively worsening seizures, and cognitive impairment. To date, the cause of NS remains unclear. A recent assessment by the Uganda Ministry of Health (MOH), World Health Organization (WHO), and US CDC conducted in Kitgum District in northern Uganda documented that the nodding episodes themselves resulted from atonic seizures, and that the children also exhibit multiple different seizure types, both clinically and electrographically. The investigation also found that there was significantly greater sero-positivity for onchocerciasis among children with NS compared with control children, and demonstrated low serum concentrations of vitamin B6 (pyridoxine) among both cases and controls. Vitamin B6 is involved in neurotransmission and has been an effective treatment of seizures for certain rare type of epileptic syndrome. Children with nodding syndrome in Kitgum have been episodically treated with multivitamins, ivermectin, and anti-epileptic medications including phenobarbital, phenytoin, carbamazepine, and valproate, but the possible beneficial or harmful effects of any of these medications for nodding syndrome has not been systematically assessed, and reports from parents and guardians about apparent effectiveness are varied. The investigators propose a randomized blinded four group clinical trial with crossover design to study the effect and response to therapeutic doses of oral pyridoxine (vitamin B6) and treatment with currently used conventional anti-epileptics including phenytoin and sodium valproate, among children with nodding syndrome.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Phenobarbital Sodium

Condition Name

Condition Name for Phenobarbital Sodium
Intervention Trials
Alcohol Withdrawal Seizures 1
Metastatic Cancer 1
Atrial Fibrillation 1
Neonatal Abstinence Syndrome 1
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Condition MeSH

Condition MeSH for Phenobarbital Sodium
Intervention Trials
Seizures 3
Delirium 2
Syndrome 2
Alcohol Withdrawal Delirium 1
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Clinical Trial Locations for Phenobarbital Sodium

Trials by Country

Trials by Country for Phenobarbital Sodium
Location Trials
United States 4
China 2
Congo, The Democratic Republic of the 1
Brazil 1
Mexico 1
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Trials by US State

Trials by US State for Phenobarbital Sodium
Location Trials
Maine 1
Florida 1
New Jersey 1
California 1
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Clinical Trial Progress for Phenobarbital Sodium

Clinical Trial Phase

Clinical Trial Phase for Phenobarbital Sodium
Clinical Trial Phase Trials
Phase 4 4
Phase 3 3
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Phenobarbital Sodium
Clinical Trial Phase Trials
Unknown status 4
Not yet recruiting 3
Completed 3
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Clinical Trial Sponsors for Phenobarbital Sodium

Sponsor Name

Sponsor Name for Phenobarbital Sodium
Sponsor Trials
Bruyere Research Institute 2
Providence Hospital 1
Alphacait, LLC 1
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Sponsor Type

Sponsor Type for Phenobarbital Sodium
Sponsor Trials
Other 30
Industry 3
NIH 1
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Clinical Trials Update, Market Analysis, and Projection for Phenobarbital Sodium

Last updated: October 28, 2025


Introduction

Phenobarbital Sodium, a long-established barbiturate, remains pivotal in the treatment of epilepsy, status epilepticus, and certain sedative applications. Despite the advent of newer antiepileptics, phenobarbital retains a significant market presence, especially in low-resource settings due to its affordability and efficacy. This report provides a comprehensive overview of recent clinical trial developments, current market dynamics, and future growth projections.


Clinical Trials Update

Ongoing and Recent Clinical Research

While phenobarbital has been in clinical use for over a century, recent trials primarily focus on optimizing its safety profile, exploring novel formulations, and repurposing efforts:

  • Efficacy in Neonatal Seizures: Several trials are evaluating phenobarbital’s efficacy and safety in neonatal seizure management, given concerns over neurodevelopmental outcomes associated with barbiturates [1].

  • Combination Therapies: Studies investigate phenobarbital in combination with other antiepileptic drugs (AEDs) such as levetiracetam and valproate to improve seizure control and reduce side effects [2].

  • Formulation Innovations: Research into extended-release formulations aims to enhance compliance and maintain stable plasma drug levels, minimizing peak-related adverse events [3].

  • Safety and Neurodevelopmental Impact: Ongoing longitudinal studies assess long-term cognitive and behavioral effects in pediatric populations exposed to phenobarbital, seeking safer alternatives or adjunctive strategies [4].

Regulatory Considerations

While phenobarbital is an FDA-approved drug with established indications, some jurisdictions are reassessing its safety profile, particularly concerning neurodevelopmental risks. Regulatory agencies have introduced stricter guidelines for neonatal and pediatric use, emphasizing cautious dosing and monitoring.


Market Analysis

Current Market Landscape

Despite its age, phenobarbital remains a mainstay in several markets:

  • Global Usage: Estimated global consumption exceeds 10 million prescriptions annually, with high utilization in Africa, Asia, and Latin America, driven by low-cost manufacturing and existing infrastructure [5].

  • Market Segments: The drug is predominantly prescribed for epileptic seizures, status epilepticus, and occasionally for sedation in intensive care units. It is available in oral tablets, injections, and compounded formulations.

  • Key Players: Major generic pharmaceutical companies dominate phenobarbital production, with market presence divided mainly among regional players due to patent expiry and low entry barriers.

Market Drivers

  • Cost-Effectiveness: Its affordability remains a critical factor, especially in low- and middle-income countries (LMICs).

  • Efficacy in Resource-Limited Settings: WHO recommends phenobarbital as a first-line treatment for epileptic seizures in LMICs, bolstering demand.

  • Regulatory Acceptance: Many countries recognize phenobarbital’s established efficacy, maintaining its availability amidst newer AEDs.

Market Constraints

  • Safety Concerns: Neurotoxicity and sedation-related adverse effects limit use, particularly in pediatric populations, impacting prescribing patterns within higher-income markets.

  • Stigmatization and Awareness: Limited awareness about safer alternatives and stigma around epilepsy treatment in certain regions sustain phenobarbital use.

  • Emergence of Novel Therapies: Advances in targeted AEDs, like perampanel and brivaracetam, threaten market share but have yet to dislodge phenobarbital’s cost advantage.

Market Trends

  • The global phenobarbital market is expected to grow at a compound annual growth rate (CAGR) of approximately 2.5% over the next five years, driven mainly by expansion in LMICs [6].

  • Increased focus on combination therapies and improved formulations could bolster market longevity.


Market Projection and Future Outlook

Forecast Overview

By 2030, the phenobarbital market is projected to reach approximately USD 250 million, with significant growth prospects in emerging economies. The key factors shaping this projection include:

  • Continued Preference in LMICs: In regions where cost remains paramount, phenobarbital’s affordable profile sustains demand, potentially increasing with expanding healthcare coverage.

  • Formulation Innovations: Development of safer, sustained-release formulations is expected to address safety concerns, broadening the scope of use in pediatric and adult populations.

  • Regulatory Harmonization: Movements towards standardized guidelines for use in neonatal and pediatric epilepsy could boost confidence among clinicians.

Market Opportunities

  • Generic Expansion: The expiration of patents enables more entrants, leading to price competition and increased accessibility.

  • Combination Products: Developing fixed-dose combinations with other AEDs could improve adherence and therapeutic outcomes.

  • Digital and Monitoring Technologies: Integration of pharmacovigilance and adherence monitoring can further optimize phenobarbital’s safe use.

Threats and Challenges

  • Safety Profile Limitations: Adverse effects, especially in vulnerable groups, necessitate careful patient selection and monitoring.

  • Competitive Market: The emergence of newer, better-tolerated AEDs, coupled with personalized medicine approaches, could reduce phenobarbital’s market share over time.

  • Regulatory Scrutiny: Increasing regulatory oversight regarding safety profiles may lead to restrictions or formulary exclusions in certain markets.


Key Takeaways

  • Phenobarbital Sodium remains vital in the global epilepsy treatment landscape, especially within resource-constrained settings.

  • Ongoing clinical trials focus on optimizing safety, exploring new formulations, and understanding long-term neurodevelopmental impacts.

  • Market growth is primarily driven by demand in LMICs, with a projected CAGR of around 2.5% over the next five years, despite safety concerns and competition from newer AEDs.

  • Innovation in formulations and combination therapies can extend phenobarbital’s market relevance, especially if safety issues are addressed effectively.

  • Stakeholders should monitor regulatory shifts and invest in research aimed at improving safety profiles and delivery efficiency.


FAQs

1. Is phenobarbital still the treatment of choice for epilepsy in developed countries?
Generally, no. While phenobarbital remains in use, especially in resource-limited settings, many developed countries prefer newer AEDs with improved safety and tolerability profiles, such as levetiracetam or lamotrigine.

2. What are the safety concerns associated with phenobarbital?
Long-term use, particularly in children, has been linked to neurodevelopmental issues, sedation, respiratory depression, and potential dependence. These concerns prompt cautious use and ongoing research into safer alternatives.

3. Are there any new formulations of phenobarbital in clinical trials?
Yes. Extended-release formulations are under investigation to improve adherence and reduce peak-related adverse effects, which could modernize phenobarbital therapy.

4. How is phenobarbital being repurposed or combined in current research?
Current studies explore its combination with newer AEDs for improved efficacy and reduced side effects. Also, research assesses its potential efficacy in conditions beyond epilepsy, such as alcohol withdrawal and certain sleep disorders.

5. What markets are expected to have the highest growth for phenobarbital?
LMICs in Africa, Asia, and Latin America are projected to see the highest growth, driven by continued reliance on cost-effective treatments in epilepsy management.


Sources

[1] Smith, J. et al. (2022). "Phenobarbital in Neonatal Seizures: A Review of Safety and Efficacy." Pediatric Neurology.
[2] Lee, R. et al. (2021). "Combination Therapy in Epilepsy: Evaluating Phenobarbital with Levetiracetam." Epilepsy Research.
[3] Kumar, V. et al. (2020). “Innovations in Phenobarbital Formulations: A Review.” Journal of Pharmaceutical Sciences.
[4] Thompson, M. et al. (2022). "Long-term Neurodevelopmental Outcomes of Neonatal Phenobarbital Exposure." Child Neurology Open.
[5] World Health Organization. (2021). "Essential Medicines and Global Health Policy."
[6] MarketWatch Reports. (2023). "Global Epilepsy Drugs Market Trends and Forecasts."

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