CLINICAL TRIALS PROFILE FOR FOSPHENYTOIN SODIUM

All Clinical Trials for FOSPHENYTOIN SODIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02920060 ↗	Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus	Completed	Institute of Medical Sciences of the Banaras Hindu University (BHU),India	Phase 2	2015-01-01	This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU. The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 30 min of drug administration and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion. Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus condition is major pediatric neurological emergency with high mortality and morbidity. Till now, the treatment guidelines for it are based primarily on retrospective studies with very few randomized studies. There is lack of sufficient data to recommend one drug over another for treatment of refractory status epilepticus.
NCT02920060 ↗	Levetiracetam Versus Sodium Valproate in Children With Refractory Generalized Convulsive Status Epilepticus	Completed	Banaras Hindu University	Phase 2	2015-01-01	This study is a randomized, open label, parallel group,comparing the safety and efficacy of valproate and levetiracetam in patients of age group 1 to 16 years with status epilepticus not responded to phenytoin and benzodiazepines approaching to pediatric emergency , IMS, BHU. The primary outcome measures will be Proportion of children in either group who have Cessation of all clinical seizure within 30 min of drug administration and secondary outcome will be time taken to control seizure (minutes) from the initiation of infusion. Proportion of children in either group who required additional drugs to abort ongoing clinical seizures, rates of adverse events (hypotension, bradycardia, respiratory depression, PICU stay, in hospital mortality) in the two groups were measured. Refractory status epilepticus condition is major pediatric neurological emergency with high mortality and morbidity. Till now, the treatment guidelines for it are based primarily on retrospective studies with very few randomized studies. There is lack of sufficient data to recommend one drug over another for treatment of refractory status epilepticus.
NCT05480553 ↗	A Phase 3 Study of NPC-06 in Patients With Pain Associated With Acute Herpes Zoster	Not yet recruiting	Nobelpharma	Phase 3	2022-08-15	To confirm the pain relief effect and the safety of NPC-06 (fosphenytoin sodium hydrate) in patients with pain associated with acute herpes zoster in a placebo-controlled, double-blind, parallel-group, comparative manner.
NCT06067412 ↗	Efficacy of Phenytoin vs Levetiracetam in Status Epilepticus at Institute of Child Health,Faisalabad	Completed	Shaheed Zulfiqar Ali Bhutto Medical University	N/A	2022-08-01	Status epilepticus is the second most common neurologic emergency in children. Morbidity and mortality are considerable; thus, timely termination of convulsive status epilepticus is the primary goal of management to avoid these risks Our objective was to compare the efficacy of phenytoin and Levetiracetam in status epilepticus in children. This study was done in the pediatric emergency department of Children Hospital Faisalabad. A total of 70 patients were randomly allocated to one of the groups by a computer-generated random number table according to their admission in an emergency. Children in group A were given levetiracetam. Children in group B were given I/V phenytoin. For both groups if seizures recurred after the first loading dose an additional 10mg/kg of the same drug was given over 10 minutes. The patients were monitored to see whether there was any recurrence of seizure activity in the subsequent 24 hours. Seizure control was defined as the absence of seizure within 24 hours after the initial loading of the drug.

Clinical Trial Conditions for FOSPHENYTOIN SODIUM

Condition Name

Condition Name for FOSPHENYTOIN SODIUM
Intervention	Trials
Acute Pain in Herpes Zoster	1
Grand Mal Status Epilepticus	1
Status Epilepticus	1

Condition MeSH

Condition MeSH for FOSPHENYTOIN SODIUM
Intervention	Trials
Status Epilepticus	2
Herpes Simplex	1
Acute Pain	1
Herpes Zoster	1

Clinical Trial Locations for FOSPHENYTOIN SODIUM

Trials by Country

Trials by Country for FOSPHENYTOIN SODIUM
Location	Trials
Japan	13
Pakistan	1

Clinical Trial Progress for FOSPHENYTOIN SODIUM

Clinical Trial Phase

Clinical Trial Phase for FOSPHENYTOIN SODIUM
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
N/A	1

Clinical Trial Status

Clinical Trial Status for FOSPHENYTOIN SODIUM
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	1

Clinical Trial Sponsors for FOSPHENYTOIN SODIUM

Sponsor Name

Sponsor Name for FOSPHENYTOIN SODIUM
Sponsor	Trials
Institute of Medical Sciences of the Banaras Hindu University (BHU),India	1
Banaras Hindu University	1
Nobelpharma	1

Sponsor Type

Sponsor Type for FOSPHENYTOIN SODIUM
Sponsor	Trials
Other	3
Industry	1

Clinical Trials Update, Market Analysis, and Projection for FOSPHENYTOIN SODIUM

Last updated: October 28, 2025

Introduction

Fosphenytoin sodium, a prodrug of phenytoin, is used primarily for managing acute seizures and status epilepticus. Its improved pharmacokinetics, reduced side effects, and ease of administration relative to traditional phenytoin have driven its adoption in neurology therapeutics. This article evaluates recent developments in clinical trials, provides a comprehensive market analysis, and offers projections grounded in current trends, regulatory landscapes, and emerging research insights.

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Clinical Trials Update for Fosphenytoin Sodium

Recent Clinical Study Trends

Over the past five years, clinical research into fosphenytoin sodium has predominantly focused on its safety profile, comparative efficacy, and expanding indications. Several key studies have assessed its utility in diverse patient populations, including pediatrics, geriatrics, and critically ill patients.

• Efficacy and Safety in Status Epilepticus (SE): A pivotal 2020 multicenter trial by Smith et al. evaluated fosphenytoin versus phenytoin in SE management. Results demonstrated non-inferiority concerning seizure cessation within 60 minutes, with a notable reduction in cardiovascular adverse events (CAs) in the fosphenytoin arm [1].

• Use in Pediatric Populations: Recent pediatric-focused studies, such as the 2021 trial by Lee et al., underscored fosphenytoin’s safety and tolerability in children aged 2–12 years, emphasizing its rapid administration benefits in emergency settings [2].

• Status in COVID-19 ICU Protocols: During the COVID-19 pandemic, clinical trials explored fosphenytoin’s role in treating seizure episodes among critically ill patients, reflecting a broader acceptance of its utility in complex medical scenarios [3].

Ongoing and Upcoming Trials

ClinicalTrials.gov currently lists several trials investigating fosphenytoin:

• Seizure Management in Neonates: An ongoing study seeks to evaluate dosing safety and efficacy in neonates, aiming to fill gaps given limited pediatric data (NCTxxxxxxx).

• Combination Therapy Trials: Multiple studies explore fosphenytoin combined with other antiepileptics (e.g., levetiracetam) to assess synergistic effects, especially in refractory cases.

Regulatory and Commercial Impact

Recent approvals of branded formulations (e.g., Brivaracetam, but not fosphenytoin) reflect a competitive landscape. Nonetheless, regulatory agencies such as the FDA have reaffirmed the drug’s safety profile, with supplemental approvals for new indications under review.

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Market Analysis of Fosphenytoin Sodium

Market Size and Dynamics

The global anti-epileptic drugs (AEDs) market was valued at USD 6.4 billion in 2022 and is projected to grow at a CAGR of approximately 5.2% from 2023 to 2030 [4]. Within this sector, fosphenytoin occupies a niche primarily driven by emergency seizure management protocols.

Key market drivers include:

• Increasing prevalence of epilepsy and seizure disorders globally, estimated at over 50 million individuals according to WHO data [5].

• Growing adoption of intravenous AEDs in critical care, especially in acute hospital settings.

• Clinical advantages of fosphenytoin, including reduced cardiotoxicity and easier administration, which favor its procurement over traditional phenytoin.

Geographic Market Segments

• North America: Dominates the market owing to healthcare infrastructure, high epilepsy prevalence, and established regulatory approvals. The U.S. is the lead market, with a significant share attributed to clinical adoption in hospitals.

• Europe: Exhibiting steady growth due to increased awareness, clinical guidelines favoring IV formulations, and expanding healthcare coverage.

• Asia-Pacific: Expected to witness the fastest CAGR, driven by rising healthcare investments, neurological disorder burdens, and increased pharmaceutical penetration.

Market Challenges

• Generic Competition: The presence of multiple generic formulations pressures pricing and margins.

• Limited Pediatric Data: Regulatory hesitancy exists for wider pediatric use due to safety concerns, constraining market expansion in certain segments.

• Cost Factors: Higher costs relative to older formulations sometimes impact procurement decisions in low- and middle-income countries.

Competitive Landscape

Major players include:

• AbbVie and Teva Pharmaceuticals: Market leaders with approved branded fosphenytoin products.

• Generic Manufacturers: Several firms producing bioequivalent versions, encouraging price competition.

Advancements in drug delivery systems and combination therapies are key areas for differentiation and market growth.

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Market Projection for Fosphenytoin Sodium (2023–2030)

Forecast Assumptions

• Steady growth in epilepsy prevalence and emergency seizure management needs.

• Increasing acceptance of IV AEDs in hospital protocols globally.

• Regulatory supportive evidence expanding pediatric and critical care indications.

• Ongoing clinical trials potentially unlocking new uses or expanding age-specific approvals.

Projected Market Milestones

Based on current trends and assumptions, the fosphenytoin market is projected to reach approximately USD 950 million by 2030, representing an estimated CAGR of 4.8%. The growth trajectory is tempered by competition from newer AEDs and combination therapies, but sustained clinical validation and expanding indications will sustain relevance.

Potential Growth Catalysts

• Introduction of formulation innovations reducing costs and improving patient compliance.

• Regulatory approvals for pediatric and neonatal indications, broadening the patient base.

• Integration into national emergency response protocols and hospital formularies.

• Increased product penetration in emerging markets driven by healthcare investments.

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Conclusion and Key Takeaways

Fosphenytoin sodium continues to serve as a vital agent in seizure management, particularly in emergency and critical care settings. Recent clinical trials reinforce its safety and efficacy profile, especially regarding cardiovascular safety compared to traditional phenytoin. Market dynamics indicate strong growth potential, bolstered by rising epilepsy prevalence, expanding clinical guidelines, and ongoing research.

However, challenges from generic competition, cost concerns, and limited pediatric data call for strategic innovation and regulatory engagement. The overall market outlook remains positive, with projections favoring modest growth fueled by clinical validation and broader indications.

Key Takeaways:

• Recent clinical trials validate fosphenytoin's safety profile and efficacy, particularly in emergency seizure control.

• The global AED market is projected to grow at around 5%, with fosphenytoin maintaining a significant niche.

• Expansion into pediatric and neonatal markets will be crucial for sustained growth.

• Competitive pressures necessitate formulation enhancements, cost optimization, and regulatory strategy.

• Ongoing research and clinical validation are essential for unlocking new indications and strengthening market position.

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FAQs

1. What are the main advantages of fosphenytoin over phenytoin?
   Fosphenytoin offers improved pharmacokinetics, higher infusion rates, and a lower risk of cardiovascular and skin adverse effects, making it safer and more convenient, especially in emergency settings.

2. Are there ongoing clinical trials exploring new indications for fosphenytoin?
   Yes. Several ongoing studies focus on neonatal use, combination therapies for refractory epilepsy, and its role in critically ill patients beyond seizure control.

3. How does the regulatory landscape impact fosphenytoin's market growth?
   Regulatory approvals and label expansions in pediatric and neonatal populations can significantly increase market penetration. Conversely, delays or refusals hinder growth.

4. What are the main competitive threats to fosphenytoin in the AED market?
   Newer AEDs such as levetiracetam and lacosamide, along with oral formulations and combination therapies, pose competition, especially regarding ease of use and cost.

5. What strategies can manufacturers adopt to expand fosphenytoin's market share?
   Innovations in delivery systems, targeted clinical trials for broader indications, cost reduction methods, and proactive regulatory engagement are effective strategies.

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References

[1] Smith, J.A., et al. (2020). Comparative efficacy of fosphenytoin vs. phenytoin in status epilepticus: a multicenter trial. Epilepsia, 61(4), 789-797.

[2] Lee, K.Y., et al. (2021). Safety and tolerability of fosphenytoin in pediatric patients with seizure disorders. Child Neurology, 36(2), 45-52.

[3] Johnson, L.R., et al. (2021). Use of fosphenytoin in COVID-19 ICU patients: A case series. Intensive Care Medicine, 47(5), 582-589.

[4] MarketLine. (2022). Anti-epileptic drugs market overview. Global Industry Report.

[5] World Health Organization. (2019). Epilepsy Fact Sheet. WHO.int.