Last Updated: August 15, 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
Onchocerciasis 1
Dyslipidemias 1
Overuse Headache Medication 1
Epilepsy 1
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Condition MeSH

Condition MeSH for PHENOBARBITAL SODIUM
Intervention Trials
Seizures 3
Syndrome 2
Delirium 2
Alcohol Withdrawal Seizures 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
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
Completed 3
Not yet recruiting 3
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Clinical Trial Sponsors for PHENOBARBITAL SODIUM

Sponsor Name

Sponsor Name for PHENOBARBITAL SODIUM
Sponsor Trials
Bruyere Research Institute 2
Shaanxi Provincial People's Hospital 1
Providence Care Hospital 1
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Sponsor Type

Sponsor Type for PHENOBARBITAL SODIUM
Sponsor Trials
Other 30
Industry 3
NIH 1
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Phenobarbital Sodium Clinical Trials Update and Market Forecast (2026-2036): Pipeline Status, Competitive Landscape, and Pricing/Revenue Projections

Last updated: July 25, 2026

Phenobarbital sodium remains an established, off-patent antiseizure therapy in the US and other major markets, with no current, globally dominant late-stage development program driving new approvals. Market performance is largely tied to hospital utilization (acute seizure management, status epilepticus), neurology and pediatrics prescribing patterns, formulary access, and drug-price dynamics rather than next-generation clinical development. Clinical trial activity exists, but it has not translated into a new wave of regulatory exclusivity or product-line switching at scale.


What clinical trials are ongoing for phenobarbital sodium in 2024-2026?

Are there Phase 3 trials for phenobarbital sodium?

No publicly tracked, commercially consequential Phase 3 program appears to be shaping near-term regulatory outcomes for phenobarbital sodium. Trial activity is generally in:

  • Pharmacokinetic/pharmacodynamic (PK/PD) studies
  • Formulation and bioequivalence work
  • Special population studies (pediatrics, pediatrics-to-adult extrapolation cohorts)
  • Comparative effectiveness studies in acute seizure workflows

What Phase 1 and PK studies are most common?

Phenobarbital sodium’s development pattern typically centers on:

  • Rate and extent of exposure after IV dosing
  • Interactions relevant to acute care co-medications
  • Stability and administration route usability (IV handling, compatibility considerations)

What does trial design usually target for an older antiseizure drug?

Common endpoints include:

  • Plasma exposure (Cmax, AUC)
  • Time to therapeutic effect proxies (where used)
  • Safety signals in acute settings (hypotension, respiratory depression risk, sedation)

Actionable read-through: For investors and licensors, absence of a late-stage pivot means value capture is more dependent on supply stability, procurement contracts, and payer/provider formularies than on blockbuster-grade differentiation.


What is phenobarbital sodium’s regulatory status in the US (FDA approval pathways and exclusivity)?

Is phenobarbital sodium currently under Hatch-Waxman exclusivity?

Phenobarbital sodium is an established product and is not expected to sit under meaningful, active exclusivity in 2026. US market entry for generic sodium phenobarbital formulations is historically routine once reference product listings permit.

Orange Book status: what does it imply for generics?

When a drug has no unexpired formulation, method-of-use, or pediatric exclusivity protecting a particular marketed product configuration, the Orange Book typically supports multiple generic entries and price competition.

Actionable read-through: Competitive risk is primarily generic-price pressure and supply chain constraints, not patent-blocked entry.

FDA dosage forms and route considerations

Clinical use emphasizes:

  • IV phenobarbital sodium for acute seizure/status epilepticus management
  • Oral phenobarbital formulations for chronic control (distinct products from sodium IV presentations)

What patents protect phenobarbital sodium, and how strong is the patent estate?

Patent landscape: “core compound” vs “product-specific”

Phenobarbital itself is long off its original patent life. Any residual IP typically sits in:

  • Product-specific patents (particular salt forms, crystalline forms, or formulation handling)
  • Manufacturing process patents for a particular generic manufacturer’s product
  • Method-of-use patents tied to narrow indications, dosing strategies, or adjunct workflows

How many patents cover phenobarbital sodium for US clinical use?

For established older antiseizure drugs, the practical count of enforceable, unexpired US patents protecting marketed phenobarbital sodium presentations is usually low or none.

Actionable read-through: Patent estate strength is not a primary determinant of market dynamics for phenobarbital sodium. The market behaves like an “access and cost” category with limited IP leverage.


When does phenobarbital sodium lose exclusivity, and what are the generic entry risks?

Exclusivity timeline

The near-term exclusivity timeline for phenobarbital sodium is effectively “already expired” from a practical market access viewpoint for most standard presentations used in acute care.

What generic entry risks matter most

  • Supply interruptions: IV antiseizure drugs are highly sensitive to manufacturing uptime.
  • Contracting dynamics: group purchasing organization (GPO) awards can move volumes quickly.
  • Labeling and administration differences: compatibility claims, reconstitution time, and infusion protocols.

Actionable read-through: Generic entry risks are operational and commercial more than legal.


What is the current market size for phenobarbital sodium and how is it segmented?

Segment by route of administration

Market demand is typically split into:

  • Hospital IV use (acute seizure and status epilepticus)
  • Outpatient/oral chronic use (seizure control maintenance)

Phenobarbital sodium specifically maps to IV use cases in acute settings. If your analysis is limited to sodium IV presentations, the hospital segment dominates.

Segment by geography

  • US is the largest procurement market with frequent generic competition.
  • Europe and key APAC markets follow a similar hospital-first dynamic for IV antiseizure use.

Segment by care setting

  • ED and inpatient neurology/ICU for acute seizure clusters
  • Pediatric hospitals for weight-based dosing needs
  • Neurology and epilepsy centers for complex refractory cases where alternatives are used but phenobarbital remains a fallback

How do clinical guidelines influence phenobarbital sodium demand in status epilepticus?

Guideline adherence affects use as a second- or later-line therapy after first-line benzodiazepines, depending on local protocols. Demand drivers include:

  • ED and inpatient algorithm inclusion
  • Protocol standardization
  • Stocking requirements for emergency seizure pathways

Actionable read-through: Even when trials do not drive new approvals, hospitals still cycle demand through standardized treatment pathways that preserve utilization of phenobarbital sodium.


Which competitors supply phenobarbital sodium (and what does this mean for pricing)?

Competitive set

The competitive market structure is typically:

  • Multiple generic IV phenobarbital sodium products
  • Potentially limited number of NDCs for IV forms due to manufacturing constraints
  • Oral competitors in parallel demand pools, but distinct products and pricing

Pricing dynamics

Phenobarbital sodium pricing tends to:

  • Compress over time as generics proliferate
  • Stabilize when supply is constrained or procurement shifts to a smaller set of contracted SKUs

Actionable read-through: Market projections should model procurement pricing and contracting more than unit growth from clinical expansion.


How does phenobarbital sodium compare with levetiracetam, valproate, and lacosamide for acute seizure use?

Clinical positioning

Across acute seizure management:

  • Levetiracetam and valproate have strong uptake for broad ED and inpatient use.
  • Phenobarbital maintains a role in refractory cases and protocols that prioritize older, reliable IV options.
  • Lacosamide is used in select settings with different onset and workflow fit.

Commercial impact

Comparison effects show up as:

  • Volume substitution when formularies prefer newer agents
  • Reduced growth when payers implement cost controls
  • Reversion to phenobarbital where supply or protocol constraints favor older IV antiseizure agents

Actionable read-through: Forecasting should treat phenobarbital sodium as “protocol-anchored” rather than “innovation-led.”


What manufacturing and IP barriers affect phenobarbital sodium supply?

Supply risk factors

Key constraints for IV older generics include:

  • Sterile manufacturing capacity and batch yields
  • Stability and formulation handling
  • Quality compliance costs (inspections, remediation)

IP barriers

For an off-patent drug, IP barriers are usually not the gating factor. The gating factor is whether manufacturers maintain compliant sterile production and pricing that supports contracted availability.


What is the projected market trajectory for phenobarbital sodium (2026-2036)?

Base-case projection logic

A credible base-case forecast for an off-patent antiseizure drug should track:

  • Hospital admissions volumes for seizure-related diagnoses (proxy)
  • ED and inpatient protocol inclusion
  • Share shifts between newer IV antiseizure agents and older IV antiseizure options
  • Procurement price compression and contracting churn

Projected market growth drivers

  • Continued acute seizure management need and persistent hospital stocking
  • Pediatric and ICU utilization stability
  • Limited ability for payers to replace older agents entirely due to clinical workflow fit

Projected headwinds

  • Formulary substitution to newer IV agents
  • Further generics price competition
  • Occasional supply disruptions that can temporarily lift price but do not create durable growth

Projection (high-level)

Without product-specific NDC revenue baselines and unit data, a precise numeric forecast cannot be stated from the information provided. The correct market-direction model is:

  • Modest value growth driven by pricing stabilization periods
  • Flat-to-low volume growth with periodic share shifts versus newer agents
  • Sustained competition suppressing sustained CAGR

Actionable read-through: Expect value to be bounded by price compression, while volume follows protocol adherence and hospital case volume.


Key Takeaways

  • Phenobarbital sodium is an established, off-patent antiseizure therapy; market dynamics are primarily procurement, hospital protocol inclusion, and supply stability.
  • The clinical trials picture in 2024-2026 is not dominated by late-stage programs capable of creating new exclusivity or major regulatory step-changes.
  • Generic entry risk is commercial and operational rather than patent-driven for standard presentations.
  • Forecasts should be modeled on hospital utilization and contracting/pricing, not pipeline-led growth.

FAQs

  1. Are there any new FDA approvals for phenobarbital sodium in 2024-2026?
  2. How is IV phenobarbital sodium typically used in hospital status epilepticus protocols?
  3. Do phenobarbital sodium and oral phenobarbital have the same market drivers?
  4. What are the biggest risks to supply for sterile IV antiseizure generics like phenobarbital sodium?
  5. How does payer formulary preference affect phenobarbital sodium utilization versus newer IV antiseizure drugs?

References

(No sources were provided in the prompt, and no external citation list can be generated without verifiable URLs or document identifiers.)

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