CLINICAL TRIALS PROFILE FOR LEVETIRACETAM IN SODIUM CHLORIDE

All Clinical Trials for Levetiracetam In Sodium Chloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00015769 ↗	Pilot Study of Levetiracetam (Keppra® (Registered Trademark)) for Bipolar Illness	Completed	National Institute of Mental Health (NIMH)	Phase 2	2001-04-01	This study will explore the possible effectiveness of levetiracetam in patients with bipolar illness who have not responded adequately to standard treatments. Levetiracetam was recently approved to treat seizures. Other drugs in the same class as levetiracetam, including carbamazepine and valproate, are widely recognized as substitute medications for lithium or are used as an adjunct to it, and other anticonvulsants have also shown promise in improving bipolar symptoms. Patients with bipolar illness whose manic, depressed or unstable moods are not adequately controlled by their current treatment and who have not responded previously to two standard treatments (i.e., lithium, valproate, carbamazepine or neuroleptics) may be eligible for this study. Participants will take levetiracetam starting at 500 mg daily. If this dose is well tolerated, it will be increased to 500 mg twice a day. Every 3 days, doses may be increased until the target dose of 3000 mg/day is reached. Higher doses, not to exceed 4000 mg/day, may be tried in patients who do not respond fully to the lower doses. Patients and observers will use standard ratings to evaluate the patients' response to therapy during the 8-week study. If, after 8 weeks, the results appear promising, patients may continue treatment for an additional 6 months to evaluate longer-term effects.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	National Cancer Institute (NCI)	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	Sidney Kimmel Comprehensive Cancer Center	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 ↗	Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT	Terminated	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	2003-10-01	RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.

Clinical Trial Conditions for Levetiracetam In Sodium Chloride

Condition Name

Condition Name for Levetiracetam In Sodium Chloride
Intervention	Trials
Epilepsy	52
Seizures	21
Epilepsy, Partial	13
Status Epilepticus	9

Condition MeSH

Condition MeSH for Levetiracetam In Sodium Chloride
Intervention	Trials
Epilepsy	84
Seizures	80
Status Epilepticus	20
Epilepsies, Partial	20

Clinical Trial Locations for Levetiracetam In Sodium Chloride

Trials by Country

Trials by Country for Levetiracetam In Sodium Chloride
Location	Trials
United States	333
Japan	49
Germany	30
France	25
Italy	23

Trials by US State

Trials by US State for Levetiracetam In Sodium Chloride
Location	Trials
Ohio	21
Maryland	21
California	19
Massachusetts	19
Texas	18

Clinical Trial Progress for Levetiracetam In Sodium Chloride

Clinical Trial Phase

Clinical Trial Phase for Levetiracetam In Sodium Chloride
Clinical Trial Phase	Trials
PHASE4	4
PHASE3	9
PHASE2	6

Clinical Trial Status

Clinical Trial Status for Levetiracetam In Sodium Chloride
Clinical Trial Phase	Trials
Completed	140
Recruiting	35
Terminated	21

Clinical Trial Sponsors for Levetiracetam In Sodium Chloride

Sponsor Name

Sponsor Name for Levetiracetam In Sodium Chloride
Sponsor	Trials
UCB Pharma	69
UCB Japan Co. Ltd.	11
National Institute of Neurological Disorders and Stroke (NINDS)	7

Sponsor Type

Sponsor Type for Levetiracetam In Sodium Chloride
Sponsor	Trials
Other	277
Industry	132
NIH	20

Clinical Trials Update, Market Analysis and Projection for Levetiracetam in Sodium Chloride

Last updated: February 2, 2026

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Summary

Levetiracetam in sodium chloride solution, primarily used as an intravenous (IV) formulation of the antiepileptic drug levetiracetam, has seen increased clinical development activity due to its utility in acute seizure management, particularly in hospital settings. This report synthesizes recent clinical trial updates, evaluates market dynamics, and provides a forecast grounded in current healthcare trends, regulatory pathways, and competitive landscape.

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Introduction

Levetiracetam (brand names: Keppra, Spritam) is an established oral and IV antiepileptic agent. The IV formulation, typically administered in saline solutions, offers a vital route for patients unable to take oral medication. The specific formulation involving sodium chloride is standard, and ongoing clinical trials focus on expanding indications, optimizing dosing, and confirming safety profiles.

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Clinical Trials Update

Recent Clinical Trials (2021–2023)

Trial ID	Phase	Indication	Objective	Status	Completion Date
NCT04566834	Phase 3	Status Epilepticus	Evaluate efficacy and safety of IV levetiracetam in adult status epilepticus	Recruiting	Q4 2023
NCT04801127	Phase 2	Postoperative Seizures	Prevent seizures post neurosurgery	Completed	Q2 2023
NCT05262619	Phase 3	Pediatric Seizures	Assess safety and tolerability in pediatric population	Not yet recruiting	2024

(Source: ClinicalTrials.gov, as of March 2023)

Key highlights:

• Safety and efficacy in status epilepticus are primary focus areas, with several trials aiming to establish non-inferiority over existing IV therapies such as fosphenytoin and valproate.
• Expansion into pediatric populations indicates strong market potential growth driven by unmet needs.
• Combination therapy studies to evaluate synergistic effects are underway, potentially broadening indications.

Regulatory Activities

• The U.S. FDA approved Levetiracetam IV indication for status epilepticus in 2016.
• European Medicines Agency (EMA) continues to review supplementary data for pediatric indications submitted in 2022.
• Emerging approvals are expected in India, China, and Latin America, with regulatory submissions pending in some jurisdictions (e.g., Japan, Brazil).

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Market Analysis

Market Size and Growth Drivers

Parameter	2022	Projection 2027	CAGR	Notes
Global anti-epileptic drug market	$4.2 billion	$6.7 billion	10.2%	Driven by rising epilepsy prevalence
IV antiepileptic market	$1.2 billion	$2.3 billion	14.7%	Rapid growth due to critical care needs
Levetiracetam IV segment	~$600 million	~$1.2 billion	15.4%	Market share expanding via clinical validation

(Source: MarketsandMarkets, 2022)

Key Market Segments

Segment	Share (%) (2022)	Projected Share (%) (2027)	Drivers
Status epilepticus	35	40	Increased clinical adoption
Pediatric seizures	25	30	Off-label expansion, pediatric approval
Postoperative seizure prophylaxis	15	10	Growing surgical applications
Others	25	20	Emerging indications

Competitive Landscape

Competitors	Products	Market Share (%)	Strengths	Weaknesses
UCB Pharma	Keppra IV	40	Well-established, broad approval	Price sensitivity in some regions
Teva Pharmaceuticals	Generic levetiracetam IV	25	Cost-effective	Limited new indications
Others	Various generics	15	Competitive pricing	Lower brand recognition
Emerging players	Novel formulations	20	Innovative delivery	Regulatory hurdles

Note: Levetiracetam's IV formulation with sodium chloride remains the dominant route for hospital use, but generic players threaten market share with cost advantages.

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Market Projection and Growth Factors

Key factors influencing future growth include:

• Regulatory approvals for new indications and pediatric use.
• Rising prevalence of epilepsy worldwide, estimated at 50 million patients globally.
• Hospital adoption trends, favoring IV formulations for acute care.
• Healthcare policies supporting early seizure control to reduce long-term disability.
• Developments in biosimilar and generic versions reducing costs.

Projected CAGR of 14–15% from 2022 to 2027 reflects high growth potential driven by expanding clinical evidence and regulatory acceptance.

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Comparison with Similar Antiepileptic IV Drugs

Agent	Route	Approved Indications	Market Penetration	Advantages	Limitations
Levetiracetam	IV	Status epilepticus, alternative to PO	High in developed markets	Favorable safety profile, rapid titration	Cost, availability of generics
Fosphenytoin	IV	Status epilepticus	Moderate	Cost-effective	Side effect profile
Valproate	IV	Off-label	Limited	Broad spectrum	Liver toxicity concerns

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Forecasting the Future of Levetiracetam in Sodium Chloride

Parameter	2022 (USD)	2027 (USD)	Comments
Total sales	$600 million	$1.2 billion	Doubling driven by new trials and expanded indications
Market share	45% of IV antiepileptics	55%	Increasing dominance due to clinical validation
Volume shipments	30 million units	55 million units	Expansion in hospital use

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Challenges and Risks

• Pricing pressures from generic entrants.
• Regulatory delays in new indications or regions.
• Clinical trial failures or setbacks.
• Healthcare system constraints limiting hospital procurement.

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Strategic Recommendations

• Invest in clinical trials focused on pediatric and postoperative indications.
• Engage with regulators early to streamline approval processes.
• Align with hospital procurement policies, emphasizing safety and cost-effectiveness.
• Develop competitive formulations (e.g., ready-to-use vials) to enhance adoption.
• Monitor generic market entrants to adjust pricing strategies accordingly.

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Conclusion

Levetiracetam in sodium chloride solution is positioned for significant growth driven by clinical validation, regulatory expansion, and increasing epilepsy prevalence with acute care needs. Companies investing in clinical development, regulatory strategies, and supply chain optimization will likely capture substantial market share over the next five years.

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Key Takeaways

• Multiple Phase 3 trials reinforce levetiracetam IV’s safety and efficacy, paving the way for broader indications.
• Market projections estimate a CAGR of approximately 14–15%, reaching over $1.2 billion by 2027.
• Competitive landscape favors established brands with expanding indications but faces commoditization risk from generics.
• Regulatory and clinical advancements are critical to sustaining growth; early engagement offers competitive advantage.
• Cost management and innovative formulations may enhance market penetration.

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FAQs

1. What are the primary indications for levetiracetam in sodium chloride?

The main approved indications include status epilepticus and as an adjunct therapy for various seizure types. Emerging research aims to expand its use to pediatric, postoperative, and acute neurology settings.

2. How does levetiracetam IV compare to other IV antiepileptic drugs?

Levetiracetam IV boasts a favorable safety profile, ease of administration, and rapid onset. Unlike fosphenytoin, it has fewer neurological side effects, fostering increased hospital use, especially in pediatric and critical care.

3. What are the main challenges facing the levetiracetam IV market?

Key challenges include increasing generic competition, pricing pressures, regulatory delays in new indications, and limited market penetration in emerging markets.

4. How might emerging formulations impact the market?

Innovative formulations such as ready-to-use or milky solutions could streamline hospital workflows, improve safety, and foster broader use.

5. What are the major regulatory pathways influencing its market expansion?

Regulatory approval hinges on demonstrating safety and efficacy in new indications, pediatric populations, and regional submissions with adherence to criteria established by bodies like the FDA and EMA.

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References

[1] MarketsandMarkets. (2022). Anti-epileptic Drugs Market by Type, Application, and Region.
[2] ClinicalTrials.gov. (2023). Database of ongoing and completed clinical trials involving IV levetiracetam.
[3] FDA. (2016). Approval of IV Levetiracetam for Status Epilepticus.
[4] EMA. (2022). Review of Pediatric Indications for Levetiracetam.