You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: May 14, 2025

CLINICAL TRIALS PROFILE FOR ZONISAMIDE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Zonisamide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00047567 ↗ Open-label Adjunctive Zonisamide for Bipolar Disorder Terminated Elan Pharmaceuticals Phase 4 2002-07-01 To study the safety and efficacy of zonisamide as adjunctive therapy for children and adolescents with bipolar I or II disorder.
NCT00055484 ↗ A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache Completed Elan Pharmaceuticals Phase 2 2002-03-01 The purpose of this study is to determine if zonisamide is effective as a preventative medication for individuals with migraine headache.
NCT00056576 ↗ Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy Completed Eisai Inc. Phase 3 2002-02-01 The purpose of this study is to determine whether zonisamide alone is effective as a treatment for epilepsy in newly diagnosed cases.
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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zonisamide

Condition Name

Condition Name for Zonisamide
Intervention Trials
Epilepsy 17
Obesity 6
Healthy 6
Alcohol Dependence 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Zonisamide
Intervention Trials
Epilepsy 15
Seizures 14
Alcoholism 11
Weight Gain 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Zonisamide

Trials by Country

Trials by Country for Zonisamide
Location Trials
United States 107
India 12
Australia 11
Germany 10
Hungary 7
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Zonisamide
Location Trials
North Carolina 7
Massachusetts 7
Ohio 6
Florida 6
California 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Zonisamide

Clinical Trial Phase

Clinical Trial Phase for Zonisamide
Clinical Trial Phase Trials
Phase 4 16
Phase 3 18
Phase 2/Phase 3 1
[disabled in preview] 19
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Zonisamide
Clinical Trial Phase Trials
Completed 42
Terminated 13
Withdrawn 4
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Zonisamide

Sponsor Name

Sponsor Name for Zonisamide
Sponsor Trials
Eisai Inc. 15
Eisai Limited 6
Eisai Korea Inc. 4
[disabled in preview] 8
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Zonisamide
Sponsor Trials
Other 63
Industry 46
U.S. Fed 9
[disabled in preview] 9
This preview shows a limited data set
Subscribe for full access, or try a Trial

Zonisamide: Clinical Trials, Market Analysis, and Projections

Introduction to Zonisamide

Zonisamide is an antiepileptic drug that has been widely used for the treatment of various types of epilepsy, including focal, generalized tonic-clonic, absence, and childhood epilepsies. Its mechanism of action involves stabilizing neuronal membranes through the blockade of sodium and calcium channels, thereby reducing epileptiform activity.

Clinical Trials and Efficacy

Efficacy in Epilepsy

Several clinical trials have demonstrated the efficacy of zonisamide in treating epilepsy. A phase 3 randomized, double-blind, noninferiority trial showed that zonisamide could be used as a monotherapy for patients with newly diagnosed focal epilepsy, with results comparable to those of third-generation antiseizure medications[1].

The SANAD II study, a randomized, open-label, controlled trial, compared zonisamide with lamotrigine and levetiracetam as first-line treatments for patients with newly diagnosed focal epilepsy. The study found that zonisamide met the criteria for non-inferiority in terms of time to 12-month remission compared to lamotrigine, although it was inferior in terms of time to treatment failure[3].

In pediatric patients, zonisamide has been shown to be effective in reducing seizure frequency and achieving seizure-free rates. A 2013 phase 3 randomized controlled trial in pediatric populations found that a dose of 8 mg/kg/d led to higher response rates than placebo, with manageable adverse effects[1].

Efficacy in Other Conditions

Apart from epilepsy, zonisamide has also been explored as an add-on treatment for Parkinson's disease. Clinical trials, primarily conducted in Japan, have shown that zonisamide is a safe and efficacious add-on treatment, reducing motor complications and non-motor symptoms such as impulsive–compulsive disorder, rapid eye movement sleep behavior disorder, and dementia. A dosage of 25–50 mg has been found to significantly reduce the Unified Parkinson’s Disease Rating Scale (UPDRS) III score and daily “OFF” time without increasing disabling dyskinesia[5].

Market Analysis

Global Market Size and Growth

The global zonisamide market was valued at USD 367.03 million in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 3.9% through the forecast period from 2024 to 2030. This growth is driven by the increasing prevalence of epilepsy, which affects around 50 million people worldwide, with approximately 2.4 million new cases diagnosed annually[4].

Market Segmentation

The zonisamide market is segmented based on strength, application, and region. The 50 mg tablet segment dominates the market, as it is well-tolerated and preferred by both patients and physicians. In terms of application, the market is segmented into adult, pediatric, and geriatric segments, with the geriatric segment expected to grow rapidly due to the increasing incidence of epilepsy with age[4].

Regional Insights

North America currently dominates the zonisamide market, accounting for 30% of the global share in 2023. This is attributed to the high prevalence of epilepsy in the region, favorable government initiatives, and a well-developed healthcare infrastructure. The Asia Pacific region is also expected to grow significantly due to increased government funding and improved treatment facilities in emerging markets[4].

Market Drivers and Opportunities

Increasing Prevalence of Epilepsy

The rising number of epilepsy cases globally is a significant driver for the zonisamide market. With no cure available, the demand for effective antiepileptic medications continues to grow, providing favorable growth opportunities for market players[4].

Effective Results of Second-Generation Antiepileptic Drugs

Zonisamide, as a second-generation antiepileptic drug, offers better efficacy and tolerability compared to older medications. This has led to its increased adoption and preference among healthcare providers[4].

Expanding Use in Pediatric and Geriatric Populations

The expansion of zonisamide's use in pediatric and geriatric populations, as supported by recent guidelines and clinical trials, is expected to further boost market growth. The drug's efficacy in these populations has been well-documented, making it a viable treatment option[1][4].

Market Restraints and Challenges

Adverse Effects and Safety Concerns

While zonisamide is generally well-tolerated, there are potential concerns regarding bone-related adverse events and teratogenicity, which may be dose-dependent. These safety issues need to be carefully managed and monitored[1].

Cost-Effectiveness

The SANAD II study highlighted that while zonisamide is effective, it may not be as cost-effective as other treatments like lamotrigine. This could impact its adoption in some healthcare systems, especially where cost is a significant factor[3].

Key Players and Competitive Analysis

The global zonisamide market includes key players such as Concordia and Zydus Pharmaceuticals, among others. These companies are focusing on strengthening their product portfolios and expanding their business through strategic initiatives. The competitive landscape is analyzed through Porter's Five Forces and PESTEL analysis, providing insights into the market dynamics and future growth opportunities[2][4].

Future Projections

The global zonisamide market is projected to reach USD 479.75 million by 2030, driven by the increasing demand for effective antiepileptic medications and the expanding use of zonisamide in various patient populations. The market is expected to benefit from ongoing research and development activities, as well as favorable government initiatives to improve healthcare infrastructure[4].

Key Takeaways

  • Efficacy in Epilepsy: Zonisamide has been shown to be effective in treating various types of epilepsy, including focal and generalized seizures.
  • Clinical Trials: Recent trials, such as the SANAD II study, have confirmed zonisamide's non-inferiority to lamotrigine in terms of time to 12-month remission.
  • Market Growth: The global zonisamide market is expected to grow at a CAGR of 3.9% from 2024 to 2030.
  • Market Segmentation: The market is segmented by strength, application, and region, with North America currently dominating.
  • Safety and Cost-Effectiveness: While zonisamide is generally well-tolerated, there are safety concerns and cost-effectiveness issues that need to be addressed.

FAQs

What is the primary mechanism of action of zonisamide?

Zonisamide stabilizes neuronal membranes through the blockade of sodium and calcium channels, reducing epileptiform activity.

Which patient populations benefit most from zonisamide?

Zonisamide is effective in treating epilepsy in adult, pediatric, and geriatric populations, with significant benefits observed in focal and generalized seizures.

What are the key drivers of the global zonisamide market?

The increasing prevalence of epilepsy, effective results of second-generation antiepileptic drugs, and expanding use in pediatric and geriatric populations are key drivers.

Which regions dominate the zonisamide market?

North America currently dominates the market, but the Asia Pacific region is expected to grow significantly in the forecast period.

Are there any safety concerns associated with zonisamide?

Yes, there are potential concerns regarding bone-related adverse events and teratogenicity, which may be dose-dependent.

How does zonisamide compare to other antiepileptic drugs in terms of cost-effectiveness?

Zonisamide may not be as cost-effective as other treatments like lamotrigine, according to the SANAD II study.

Sources

  1. Drug Topics: Zonisamide Clinical Update and Literature Review.
  2. Cognitive Market Research: Global Zonisamide Market Report 2024 Edition.
  3. The Lancet: The SANAD II study of the effectiveness and cost-effectiveness of levetiracetam, zonisamide, or lamotrigine for newly diagnosed focal epilepsy.
  4. Maximize Market Research: Zonisamide Market- Industry Analysis and Forecast.
  5. Frontiers in Neuroscience: Zonisamide for the Treatment of Parkinson Disease: A Current Update.
Last updated: 2025-01-01

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.