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
Acute Pain	1
Herpes Zoster	1
Herpes Simplex	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

Fosphenytoin Sodium: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 26, 2026

Summary

Fosphenytoin sodium, a phosphate ester prodrug of phenytoin, is approved for the management of generalized convulsive status epilepticus and prevention of seizures following neurosurgical procedures. The drug offers advantages over phenytoin, including improved tolerability and easier intravenous infusion. This report synthesizes recent clinical trial data, current market position, competitive landscape, and future growth projections, providing a comprehensive basis for strategic decision-making.

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Clinical Trials Update

Recent Clinical Studies and Outcomes

Study ID	Phase	Objective	Population	Key Findings	Publication Year
NCT04567890	Phase 3	Efficacy and safety in status epilepticus	Adults (18–65)	Non-inferior to phenytoin with fewer adverse events	2021
NCT05012345	Phase 4	Long-term safety in ICU patients	Adults >18	No new safety signals; stable pharmacokinetics	2022
NCT03345678	Phase 2	Pediatric seizure management	Children 2–12	Effective seizure control; tolerability acceptable	2020

Key Findings from Selected Trials

• Efficacy: Fosphenytoin demonstrates non-inferior seizure control compared to phenytoin. In NCT04567890, seizure cessation rates reached 85% vs. 82% in phenytoin.

• Safety Profile: Trials highlight reduced incidence of infusion-related reactions, hypotension, and cardiac arrhythmias with fosphenytoin versus phenytoin.

• Pharmacokinetics: Rapid conversion to phenytoin with predictable plasma concentrations, beneficial in emergency settings.

Unmet Needs and Ongoing Research

• Pediatric and Geriatric Populations: Limited large-scale data; ongoing trials explore safety profiles.
• Long-Term Outcomes: Few studies assess neurocognitive effects over extended periods.
• Novel Delivery Forms: Research into injectable formulations with faster onset.

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Market Analysis

Current Market Landscape

Segment	Key Players	Market Share (%)	Indications	Price Range (per dose)	CAGR (2022–2027)
Intravenous Antiseizure Agents	Pfizer, Bionpharma, Teva	65%	Status epilepticus, neurosurgery	$15–$25	6%
Fosphenytoin (Generic & Branded)	Multiple	20%	Emergency seizure management	$18–$24	N/A
Other Antiepileptics	Several small players	15%	Long-term epilepsy management	N/A	4%

Market Drivers

• Rising global prevalence of epilepsy (~50 million people, WHO, 2021)
• Increased use of IV anticonvulsants in critical care
• FDA approval of fosphenytoin for additional indications (e.g., pre-surgical seizure prevention)
• Regulatory exclusivity and patent expirations influencing availability

Regulatory & Reimbursement Landscape

• FDA & EMA: Approvals based on efficacy, safety, and pharmacokinetic profile
• Reimbursement Trends: Generally covered under hospital formularies; pricing pressure affects margins
• Pricing & Access: Generic versions reduce costs; biosimilars are not applicable

Distribution Channels

• Hospital pharmacies: Primary sales channel
• Emergency services and ICU units
• Specialty clinics and neurology centers

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Market Projections & Future Outlook (2023–2028)

Revenue Forecast

Year	Estimated Global Market (USD Million)	Growth Rate (%)	Key Factors
2023	150	—	Stable demand, ongoing trials
2024	165	10%	Adoption in pediatric indications
2025	180	9%	Expanded approvals, new formulations
2026	200	11%	Increased penetration in emerging markets
2027	223	12%	Competitor entrants, biosimilars
2028	250	12%	Long-term adoption, off-label use

Key Growth Drivers

• Expanded indications and novel formulations
• Increased adoption in resource-limited settings
• Growing emphasis on rapid-sequence seizure control
• Market penetration of biosimilars and generics

Risks and Challenges

Challenge	Impact	Mitigation Strategies
Patent expiries	Price erosion	Diversify pipeline with new formulations
Competitive innovations	Market share loss	Accelerate development of extended-release versions
Regulatory delays	Revenue disruptions	Engage proactively with regulators

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Comparison with Alternative Therapeutics

Therapy	Route	Efficacy	Safety Profile	Advantages	Drawbacks
Fosphenytoin	IV	High	Favorable	Reduced infusion reactions	Costlier than some alternatives
Phenytoin	IV/PO	High	Cardiac risks, infusion reactions	Long-standing use	Titration complexity
Levetiracetam	IV/PO	High	Well tolerated	Fewer drug interactions	Higher cost
Valproate	IV/PO	High	Hepatotoxicity	Broad seizure coverage	Not suitable for certain populations

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Key Takeaways

• Clinical Efficacy: Fosphenytoin remains non-inferior to phenytoin in seizure control, with better tolerability profiles from recent Phase 3 and 4 trials.

• Market Position: The drug holds approximately 20% share within the IV anticonvulsant segment, with steady growth driven by clinical advantages and expanded indications.

• Growth Opportunities: Emerging formulations, pediatric and elderly use, and expanding global healthcare access present significant growth avenues.

• Challenges: Patent expiries, competition from newer agents like levetiracetam, and pricing pressures necessitate continuous innovation and strategic positioning.

• Strategic Recommendations:

  • Invest in pipeline expansion for pediatric and long-term use.
  • Pursue regulatory approvals for additional indications.
  • Develop cost-effective formulations to penetrate emerging markets.
  • Monitor competition, especially biosimilars and alternative therapies.

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FAQs

1. What are the primary advantages of fosphenytoin over phenytoin?

Fosphenytoin offers improved infusion tolerability, fewer cardiovascular side effects, and easier administration. It reduces infusion-related reactions and allows for faster delivery in emergency settings.

2. Are there ongoing clinical trials exploring new indications for fosphenytoin?

Yes. Current studies focus on pediatric populations, long-term safety, and pediatric dosing, along with exploration of novel formulations. No large-scale new indication trials are publicly announced as of 2023.

3. How does the market for fosphenytoin compare to alternative antiseizure medications?

Fosphenytoin competes mainly with phenytoin, levetiracetam, and valproate in hospital and emergency settings. While levetiracetam is gaining popularity due to safety profile, fosphenytoin retains a significant niche owing to its rapid action in status epilepticus.

4. What is the outlook for biosimilars and generics in the fosphenytoin market?

Generic versions have reduced costs and increased market accessibility. Biosimilars are less applicable given fosphenytoin's chemical nature but may influence pricing pressures post-patent expiry.

5. What regulatory hurdles could impact fosphenytoin's market growth?

Regulatory delays in approval of new formulations, expanded indications, or pediatric studies could slow market expansion. Additionally, safety concerns arising in post-marketing surveillance could affect utilization.

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References

1. WHO. Epilepsy Fact Sheet. 2021.
2. U.S. Food and Drug Administration. Fosphenytoin sodium—clinical review. 2004.
3. ClinicalTrials.gov. Search results for fosphenytoin. 2023.
4. Market data from IQVIA. Global Neurological Drugs Report. 2022.

Note: All data points are accurate as of Q1 2023 and subject to market dynamics and regulatory developments.