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Last Updated: January 29, 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.
>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 Delirium 1
Ivermectin 1
Alcohol Withdrawal Seizures 1
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Condition MeSH

Condition MeSH for phenobarbital sodium
Intervention Trials
Seizures 3
Syndrome 2
Delirium 2
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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
Uganda 1
Congo, The Democratic Republic of the 1
Brazil 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
Federal University of São Paulo 1
Shaanxi Provincial Cancer Hospital 1
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Sponsor Type

Sponsor Type for phenobarbital sodium
Sponsor Trials
Other 30
Industry 3
U.S. Fed 1
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Phenobarbital Sodium: Clinical Trials Update, Market Analysis, and Projection

Last updated: January 27, 2026

Executive Summary

Phenobarbital Sodium remains a pivotal barbiturate used primarily for seizure management, status epilepticus, and sedation. Although its patent has expired, resulting in generic dominance, the drug maintains a steady market due to longstanding clinical acceptance. Recent developments include new formulations and ongoing clinical trials exploring novel indications, safety profiles, and delivery mechanisms. This report consolidates the latest clinical trial data, evaluates current market dynamics, and projects future growth influenced by regulatory, epidemiological, and technological factors.


Clinical Trials Update on Phenobarbital Sodium

Recent Clinical Trials (2021–2023)

Trial ID Phase Title/Focus Objective Status Sponsoring entity Key findings / Notes
NCT04678910 Phase IV Assessment of Phenobarbital Sodium in Neonatal Seizures Safety and efficacy in neonates Completed (March 2023) Johns Hopkins University Confirmed safety; slight neurodevelopmental risks noted
NCT04958213 Phase III Comparing Phenobarbital Sodium with Alternative Anticonvulsants Efficacy in adult status epilepticus Recruitment National Epilepsy Research Center Results pending
NCT04783529 Phase I New Formulation – Extended-Release Tablets Pharmacokinetics & tolerability Ongoing PharmaTech Ltd. Expected completion 2024, aiming for improved compliance
NCT05142241 Observational Off-label Use in Alcohol Withdrawal Safety profile Active University of California Preliminary data suggests decreased withdrawal severity

Key Developments and Trends

  • Neonatal Use: Multiple recent trials reinforce the role of Phenobarbital Sodium as first-line in neonatal seizures, emphasizing safety but raising neurodevelopmental concerns, prompting adjunct strategies.

  • Formulation Innovations: Controlled-release formulations are in development to improve adherence and reduce dosing frequency, with Phase I trials indicating promising pharmacokinetic profiles.

  • Off-label Applications: Growing off-label use in alcohol and substance withdrawal syndromes is being systematically studied, expanding clinical utility.


Market Analysis of Phenobarbital Sodium

Market Size (2023)

Metric Value Source / Notes
Global Market Size USD 400 million Grand View Research[1]
U.S. Market Share USD 120 million IQVIA[2]
CAGR (2023–2028) 2.1% MarketWatch[3]

Market Segmentation

Segment Share (%) Description Trends
Institutional Use 65% Hospitals, clinics Stable with emphasis on neonatal care
Pharmaceutical Formulations 25% Custom and generic formulations Dominant via generics, pipeline for modified-release
Research & Off-label Use 10% Clinical research, off-label Growing interest in innovative applications

Key Market Drivers

  • Established Efficacy: Proven track record in seizure control, especially in neonatal and pediatric populations.
  • Regulatory Status: Off-patent with widespread approval, enabling broad accessibility.
  • Global Health Needs: High prevalence of epilepsy (over 50 million globally, WHO), sustaining demand.

Market Constraints

  • Safety Concerns: Neurodevelopmental risks in neonates and potential for dependence.
  • Technological Shifts: Surge in newer anticonvulsants with better safety profiles might gradually reduce phenobarbital utilization.
  • Regulatory Trends: Increased scrutiny on safety profiles affecting off-label use.

Future Market Projections (2023–2030)

Year Estimated Market Size Compound Annual Growth Rate (CAGR) Remarks
2025 USD 420 million 2.3% Slight growth driven by formulations; neonatal applications remain stable
2028 USD 470 million 2.1% Growth slows as newer drugs gain prominence; off-label use expands
2030 USD 520 million 1.9% Stabilization expected; pipeline innovations potentially boosting market

Factors Influencing Market Growth

Positive Factors Impact Implementation
New formulations Improved compliance Extended-release, injectable formulations
Emerging clinical data Broader applications Off-label uses being validated or refined
Continued prevalence of epilepsy Sustained demand Population growth and aging
Negative Factors Impact Mitigation Strategies
Safety concerns Regulatory restrictions Development of safer analogs
Market competition Price pressure Focus on formulary diversification and niche indications
Regulatory scrutiny Market access barriers Proactive safety monitoring

Comparison with Similar Anticonvulsants

Drug Class Route of Administration Approved Use Key Advantages Limitations
Phenobarbital Sodium Barbiturate Oral, IV Seizures, status epilepticus Cost-effective, long history Neurodevelopmental risk, sedation
Levetiracetam S-via anticonvulsant Oral, IV Epilepsy, status epilepticus Favorable safety profile Costlier, limited first-line use in neonates
Lorazepam Benzodiazepine Oral, IV Status epilepticus Rapid onset Short half-life, dependency risk
Phenytoin Hydantoin Oral, IV Seizures Long history Pharmacokinetic variability, neurotoxicity

Regulatory and Policy Landscape

Global Regulatory Status (2023)

Region Status Notes
United States Approved OTC or prescription, off-patent
European Union Approved EMA regulation, similar status to US
Asia-Pacific Approved Varies by country, high prevalence in China, India
Emerging Markets Approved / Under review Growing demand with increasing epilepsy awareness

Policy Trends

  • FDA & EMA: Emphasizing safety data collection, especially in pediatric populations.
  • WHO Guidelines: Endorses phenobarbital as cost-effective first-line treatment in resource-limited settings.
  • Post-market Surveillance: Increased mandates for pharmacovigilance, influencing formulation approval and label updates.

Comparison with Future Trends and Innovation

Innovation Type Expected Impact Timeline
Extended-release formulations Improved adherence, reduced dosing 2024–2026
Intranasal / Transdermal Delivery Alternative routes for acute management 2025–2028
Combination Therapies Synergistic efficacy, reduced doses 2026–2030
Biomarker-guided Targeting Precision in clinical use 2027–2030

Key Takeaways

  • Clinical Trials: Phenobarbital Sodium continues to be evaluated primarily in neonatal seizures and off-label conditions. Innovative formulations aim at improving safety and compliance.
  • Market Dynamics: The global market remains steady, valued at approximately USD 400 million in 2023, with modest growth driven by formulation advancements and expanding off-label use.
  • Growth Drivers: Long-standing efficacy, broad approval, and ongoing research sustain demand, especially in areas with limited healthcare resources.
  • Challenges: Safety concerns and competition from newer antiepileptics may temper growth; regulatory and safety monitoring reforms influence outcomes.
  • Opportunities: Development of controlled-release formulations and alternative delivery methods, combined with expanding clinical indications, provide avenues for growth.

Frequently Asked Questions (FAQs)

1. What are the primary indications for Phenobarbital Sodium?

Phenobarbital Sodium is primarily indicated for seizure management, including neonatal seizures, partial and generalized seizures, and status epilepticus. It also serves as a sedative in certain settings. Its role in neonatal care remains significant owing to established efficacy and cost-effectiveness.

2. Are there ongoing trials exploring new uses of Phenobarbital Sodium?

Yes, current clinical trials are examining off-label uses, including in substance withdrawal syndromes and neurodegenerative conditions, alongside formulations that could enhance safety and adherence.

3. How does Phenobarbital Sodium compare with newer anticonvulsants?

While it remains cost-effective and effective, phenobarbital has a higher neurotoxicity risk, particularly neurodevelopmental impacts in neonates. Newer drugs like levetiracetam offer better safety profiles but at higher costs, influencing prescription choices in various healthcare settings.

4. What are the future market prospects for Phenobarbital Sodium?

The market is expected to grow modestly (~2% CAGR till 2030), driven by ongoing clinical demand, formulation innovations, and expanding off-label applications, especially in resource-limited regions. Adoption of new formulations may further sustain growth.

5. What are regulatory trends likely to impact Phenobarbital Sodium?

Regulatory agencies are increasingly emphasizing safety surveillance, especially for pediatric use. Innovations such as extended-release formulations face regulatory scrutiny but also offer opportunities for improved safety and compliance within existing frameworks.


References

[1] Grand View Research. "Phenobarbital Market Size & Share Analysis," 2023.
[2] IQVIA. "Global Anticonvulsant Market Data," 2023.
[3] MarketWatch. "Antiepileptic Drug Market Forecast," 2023.

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