CLINICAL TRIALS PROFILE FOR PHENOBARBITAL SODIUM

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.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT03052998 ↗	Ivermectin Treatment in Patients With Onchocerciasis-associated Epilepsy	Completed	Robert Colebunders	Phase 4	2017-10-01	Many studies have reported an association between epilepsy, including Nodding Syndrome (NS), and onchocerciasis (river blindness). A high prevalence of epilepsy has been noted particularly in onchocerciasis hyperendemic areas where onchocerciasis is not or insufficiently controlled with mass Ivermectin distribution. There is evidence that increasing the coverage of Ivermectin reduces the incidence of epilepsy and anecdotal evidence suggests a reduction in seizure frequency in onchocerciasis associated epilepsy (OAE) patients who receive Ivermectin. Finding an alternative treatment for epilepsy in these patients will have major consequences. Objective To assess whether Ivermectin treatment decreases the frequency of seizures and leads to seizure freedom in OAE patients, including patients with NS. If we are able to demonstrate such an effect this would be an extra argument that Onchocerciasis is causing epilepsy and that therefore we should increase our efforts to eliminate onchocerciasis. Methods We will conduct a randomized clinical trial in the Democratic Republic of Congo (DRC) to compare seizure freedom in onchocerciasis infested epilepsy patients who receive immediate Ivermectin treatment with delayed (after four months) Ivermectin treatment. All participants will simultaneously receive anti-epileptic drugs (AEDs) according to local guidelines for epilepsy treatment. The primary endpoint is seizure freedom defined as no seizures during the fourth month of follow-up. Secondary endpoint is significant (>50%) seizure reduction compared to baseline seizure frequency. Reduction of seizures will be compared between Ivermectin and non-Ivermectin arms. Current status Start of enrolment is planned from March 2017 and we expect to have enrolled all 110 participants by August 2017. Results are expected early 2018. Discussion If Ivermectin treatment, in addition to AEDs, is able to lead to seizure freedom or significantly reduces seizure frequency in OAE patients this will have major consequences for epilepsy treatment in Onchocerciasis endemic regions. Ivermectin is donated for free, and in non Loa-Loa endemic regions has negligible side effects. Reducing the burden of epilepsy will have a major impact on quality of life and socio-economic status of families with affected members in Africa.

Clinical Trial Conditions for PHENOBARBITAL SODIUM

Condition Name

Condition Name for PHENOBARBITAL SODIUM
Intervention	Trials
Alcohol Withdrawal	1
Hyperactive Delirium	1
Alcohol Withdrawal Delirium	1
Ivermectin	1

Condition MeSH

Condition MeSH for PHENOBARBITAL SODIUM
Intervention	Trials
Seizures	3
Delirium	2
Syndrome	2
Neoplasm Metastasis	1

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

Trials by US State

Trials by US State for PHENOBARBITAL SODIUM
Location	Trials
Maine	1
Florida	1
New Jersey	1
California	1

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

Clinical Trial Status

Clinical Trial Status for PHENOBARBITAL SODIUM
Clinical Trial Phase	Trials
Unknown status	4
Completed	3
Not yet recruiting	3

Clinical Trial Sponsors for PHENOBARBITAL SODIUM

Sponsor Name

Sponsor Name for PHENOBARBITAL SODIUM
Sponsor	Trials
Bruyere Research Institute	2
Ottawa Hospital Research Institute	1
St. Michael's Hospital, Toronto	1

Sponsor Type

Sponsor Type for PHENOBARBITAL SODIUM
Sponsor	Trials
Other	30
Industry	3
NIH	1

Phenobarbital Sodium (Oral/IV) Clinical Trials Update, Market Analysis and Projection

Last updated: April 25, 2026

What is Phenobarbital Sodium and how is it used clinically?

Phenobarbital sodium is the water-soluble sodium salt form of phenobarbital used for seizure control, including acute management and long-term epilepsy regimens depending on the product and jurisdiction. It is typically delivered as an injectable formulation (for acute settings) and, in many markets, phenobarbital (base) is also used for chronic therapy. The “sodium” labeling generally signals injectable use and product-specific pharmacophores rather than a distinct therapeutic mechanism from phenobarbital.

Core clinical positioning (high level):

• Acute seizure management and status epilepticus pathways in many clinical protocols (injectable phenobarbital sodium products).
• Chronic epilepsy treatment, typically with oral phenobarbital (where available), with injectable phenobarbital sodium used when oral dosing is not feasible.

What does the clinical trials landscape look like for Phenobarbital Sodium?

A complete, molecule-level clinical trials update requires trial registry retrieval by exact substance name and salt form. Under the constraint that only sufficient information can be used, no trial-specific update can be produced here without risking incorrect trial counts, statuses, or top-line outcomes. Therefore, this report does not provide a trial-by-trial table of registrants, endpoints, or timelines for phenobarbital sodium.

Are there active or recently completed development programs specific to Phenobarbital Sodium?

Phenobarbital is an established, off-patent antiseizure medicine in most major jurisdictions. Product-level development commonly shifts from “new molecular entity” discovery to:

• Reformulations (solubility, stability, packaging).
• Manufacturing process changes and regulatory maintenance.
• Generic and biosimilar-like competitive entries (for small-molecule generics, the relevant competitors are generics and authorized generics).

Given the need for precise, trial-grade and filing-grade facts, this report does not provide an “active program” list specific to phenobarbital sodium beyond the general market pattern for older antiseizure therapies.

How big is the Phenobarbital Sodium market and what drives demand?

Phenobarbital sodium competes in a mature antiseizure market where demand is driven by:

• Acute-care seizure presentations (emergency medicine, inpatient neurology, and intensive care settings).
• Formularies and hospital procurement of inexpensive injectable antiseizure agents.
• Neonatal and pediatric seizure treatment protocols in certain geographies and settings, depending on local guidance and availability.
• Price sensitivity and competitive tendering for off-patent medicines.

Market structure

Phenobarbital sodium is typically distributed through:

• Hospital procurement for injectable products.
• Retail channels where oral phenobarbital products exist (note: that is distinct from sodium injectable labeling, but impacts overall phenobarbital usage).

Competition and substitution

In acute seizure settings, phenobarbital sodium competes against other antiseizure injectables and rescue therapies that may be preferred by guideline-based pathways and clinician preference. Substitution is sensitive to:

• Speed of administration and time-to-effect.
• Stock availability and procurement contracts.
• Adverse event management profiles used in local protocols.
• Training and institutional familiarity with specific rescue sequences.

What are the pricing and reimbursement dynamics?

Phenobarbital sodium pricing is primarily influenced by:

• Generic entry volume and tender outcomes.
• Government or payer reimbursement caps for off-patent products.
• Hospital formulary status and automatic substitution policies.
• Currency and import regimes where supply relies on cross-border procurement.

No precise pricing benchmarks are included here because a complete response requires source-backed numerical evidence for average selling price (ASP), tender clearing prices, or reimbursement codes by region, and such facts are not provided in the available prompt.

What is the regulatory status and IP situation?

Phenobarbital is longstanding and largely outside active exclusivity in major markets. Phenobarbital sodium products generally rely on:

• Regulatory approvals for specific formulations, concentrations, and labeling.
• Manufacturing know-how and regulatory ownership of dossiers.
• Patent estates that are usually limited, often formulation-process specific, and not molecule-defining.

A robust, patent-by-patent IP map would require validated bibliographic extraction from patent databases with jurisdiction filters. This report does not include such a map due to insufficient verified sourcing in the prompt.

Market projection: what trajectory is most likely?

Without access to cited, region-specific baseline sales and without registry-grade trial sourcing, only a qualitative projection can be made. Under your constraints, qualitative-only forecasting without hard inputs is not sufficient to deliver a credible projection.

Therefore, this report does not provide a numeric multi-year market forecast for Phenobarbital sodium (global or segmented) and does not present an adoption curve, CAGR estimate, or TAM/SAM/SOM model.

Business implications for R&D and investing

Even without trial-grade updates and numeric market forecasting, the strategic implications for phenobarbital sodium are structurally clear for decision makers in late-stage R&D and investment screens:

1) Differentiation is product-level, not mechanism-level

For older antiseizure therapies, value creation typically comes from:

• Supply reliability and lifecycle management (stability, shelf-life, cold-chain needs if any).
• Formulation and usability (e.g., concentration, reconstitution simplicity, injection site tolerability handling).
• Low-cost manufacturing and access execution.

2) Competitive risk is primarily generic entry and tendering

Market access and profitability are usually determined by:

• Hospital contract cycles.
• Tender price competition.
• Regulatory stability and uninterrupted production.

3) Clinical evidence value is in local protocol fit

For established antiseizure agents, uptake depends less on “new efficacy” and more on:

• Alignment with local rescue pathways for seizures.
• Ease-of-use and clinician confidence.
• Supply cadence in peak demand periods.

What to watch over the next 12 to 24 months

This is the only actionable “watch list” that can be stated without inventing registry-level facts:

• Procurement cycles: hospital tender outcomes for injectable antiseizure agents.
• Regulatory lifecycle: manufacturing site approvals, batch release continuity, and supply interruptions.
• Product availability: shortages and discontinuations that shift substitution patterns across inpatient settings.
• Labeling and guideline updates: local pathway changes that affect which rescue agents are first-line or second-line.

Key Takeaways

• Phenobarbital sodium is an established injectable antiseizure therapy; the market is mature and driven by acute-care seizure demand and procurement dynamics.
• This response does not provide a trial-by-trial clinical trials update or a numeric market forecast because no source-backed registry or market baseline data is available in the prompt.
• Competitive advantage is likely to be supply and product usability rather than novel mechanism development.
• Investment and R&D decisions should focus on product lifecycle execution, manufacturing reliability, and local protocol fit.

FAQs

1. Is phenobarbital sodium still under patent protection in major markets?
   Typically, phenobarbital products are largely off-patent; remaining exclusivity is usually product-specific and may be formulation/process limited rather than molecule-wide.

2. What clinical settings use phenobarbital sodium most?
   Injectable use is concentrated in acute care pathways such as emergency and inpatient rescue for seizures when rapid parenteral dosing is required.

3. What determines hospital adoption of phenobarbital sodium?
   Formularies, tender pricing, availability, clinician familiarity, and alignment with local seizure rescue protocols.

4. What are the most likely differentiators for a new entrant?
   Manufacturing reliability, shelf-life and stability, injection usability, and uninterrupted supply to meet hospital contract schedules.

5. Can phenobarbital sodium have growth despite generic competition?
   Growth is possible through contract wins, supply reliability, and guideline-driven placement, but it is constrained by price competition and the mature nature of the therapy.

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References

[1] No sources were provided in the prompt for clinical trial registries, regulatory status, or market sales benchmarks.