CLINICAL TRIALS PROFILE FOR ZONEGRAN

All Clinical Trials for Zonegran

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00154076 ↗	A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies	Completed	Eisai Korea Inc.	Phase 4	2005-09-01	To assess the efficacy and safety of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies
NCT00165828 ↗	Efficacy and Safety of an add-on Treatment With Zonisamide in Adults With Focal Epileptic Seizures With or Without Secondary Generalization	Terminated	Eisai GmbH	Phase 4	2005-05-01	Patients with focal epileptic seizures with or without generalization who are at present treated with one or two antiepileptic drugs are eligible for this study, provided that they fulfill all inclusion criteria and none of the exclusion criteria. Following a baseline phase of 8 weeks duration, the patients are randomised and they receive an initial daily dose of 50 mg zonisamide during the first week. The daily dose is then increased to 200 mg zonisamide in group A or 400 mg zonisamide in group B, respectively. After eight weeks of treatment, the daily dose in group A can be increased to 300 mg in case of insufficient efficacy. Control assessments are performed at the beginning of the study and at the end of the prospective baseline phase, if applicable and after 4, 8, 12, and 16 weeks. At the end of the first, second, and third treatment week, and at the end of week six, the patient is additionally contacted by telephone. Efficacy and safety parameters are assessed at baseline, during all control visits, and at the end of the study.
NCT00203450 ↗	Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial	Completed	Eisai Inc.	Phase 4	2003-05-01	The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of weight gain.
NCT00203450 ↗	Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial	Completed	Tuscaloosa Research & Education Advancement Corporation	Phase 4	2003-05-01	The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of weight gain.
NCT00215592 ↗	Open Label, Zonegran (Zonisamide) In Partial Onset Seizures	Completed	Eisai Limited	Phase 4	2005-10-01	To determine the efficacy and safety of adjunctive open label Zonegran treatment in patients with refractory partial seizures.
NCT00221442 ↗	Zonegran in the Treatment of Binge Eating Disorder Associated With Obesity	Completed	Eisai Inc.	Phase 3	2005-08-01	The specific aim of this study is to examine the efficacy and safety of zonisamide compared with placebo in outpatients with binge eating disorder associated with obesity.

Clinical Trial Conditions for Zonegran

Condition Name

Condition Name for Zonegran
Intervention	Trials
Epilepsy	10
Healthy	6
Alcohol Dependence	4
Alcoholism	3

Condition MeSH

Condition MeSH for Zonegran
Intervention	Trials
Seizures	9
Epilepsy	9
Alcoholism	7
Hearing Loss, Noise-Induced	3

Clinical Trial Locations for Zonegran

Trials by Country

Trials by Country for Zonegran
Location	Trials
United States	38
Australia	11
Germany	8
Hungary	6
China	5

Trials by US State

Trials by US State for Zonegran
Location	Trials
Ohio	4
Connecticut	4
North Carolina	3
Missouri	3
Florida	3

Clinical Trial Progress for Zonegran

Clinical Trial Phase

Clinical Trial Phase for Zonegran
Clinical Trial Phase	Trials
Phase 4	7
Phase 3	15
Phase 2	6

Clinical Trial Status

Clinical Trial Status for Zonegran
Clinical Trial Phase	Trials
Completed	25
Terminated	7
Active, not recruiting	2

Clinical Trial Sponsors for Zonegran

Sponsor Name

Sponsor Name for Zonegran
Sponsor	Trials
Eisai Inc.	9
Eisai Limited	5
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	3

Sponsor Type

Sponsor Type for Zonegran
Sponsor	Trials
Industry	29
Other	27
U.S. Fed	5

ZONEGRAN (Zonisamide): Clinical Trials, Market Analysis, and Projections

Introduction

ZONEGRAN, or zonisamide, is a sulfonamide anticonvulsant used primarily as an adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients. Here, we will delve into the clinical trials, market analysis, and projections for this drug.

Clinical Trials

Efficacy and Safety

Several clinical trials have established the efficacy and safety of zonisamide. In three multicenter, placebo-controlled studies, zonisamide was added to the existing antiepilepsy drugs of patients with a history of at least four partial onset seizures per month. These studies demonstrated statistically significant reductions in seizure frequency and an increase in the proportion of patients achieving a 50% or greater reduction in seizures compared to placebo[1].

• Dosing and Administration: Patients received zonisamide in various dose escalation regimens, with significant treatment differences favoring zonisamide at doses of 100, 200, and 400 mg/day. The studies also showed no apparent difference between once daily and twice daily dosing[1].
• Patient Outcomes: The median percent reduction in all partial seizures and the percentage of responders were significantly higher in the zonisamide groups compared to the placebo groups across all studies[1].

Comparative Studies

The SANAD II study compared the effectiveness and cost-effectiveness of zonisamide with lamotrigine and levetiracetam in patients with newly diagnosed focal epilepsy. While zonisamide met the definition of non-inferiority for time to 12-month remission compared to lamotrigine, it was inferior for time to treatment failure. Additionally, zonisamide was not found to be a cost-effective alternative to lamotrigine at a cost-effectiveness threshold of £20,000 per QALY[4].

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% from 2024 to 2030, reaching USD 479.75 million by 2030[3].

Market Segmentation

The market is segmented by strength (25 mg, 50 mg, and 100 mg) and application (adult, pediatric, and geriatric).

• Strength: The 50 mg tablet dominates the market segment, and it is well tolerated and preferred by physicians. The average dose of zonisamide is 100 mg, often prescribed as 50 mg twice a day or 100 mg once a day[3].
• Application: The geriatric segment is dominating the market and is expected to grow rapidly due to the increasing prevalence of epilepsy and seizures with age[3].

Regional Insights

North America currently dominates the zonisamide market with a 30% share, driven by the increasing number of epileptic patients and a well-developed healthcare infrastructure. The Asia Pacific region is expected to grow significantly due to increased government funding and improved treatment facilities in emerging markets[3].

Market Drivers

Increasing Prevalence of Epilepsy

Epilepsy is one of the most common neurological disorders, with approximately 50 million patients worldwide and 2.4 million new cases diagnosed annually. This increasing prevalence drives the demand for antiepileptic drugs like zonisamide[3].

Effective Second-Generation Antiepileptic Drugs

Zonisamide, as a second-generation antiepileptic drug, offers several benefits, including reduced drug interactions, fewer life-threatening side effects, and less adverse cognitive function. These advantages contribute to its market growth[3].

Rise of the Geriatric Population

The geriatric population is increasing, and with it, the incidence of epilepsy. About 25% of new epilepsy cases occur in the elderly, and this percentage is expected to rise to 50% during the forecast period, further driving the demand for zonisamide[3].

Competitive Analysis

Key companies such as Concordia and Zydus Pharmaceuticals are focusing on strengthening their product portfolios and expanding their business in the global market. These companies are investing in research and development to improve treatment options and expand market share[2].

Future Projections

Market Growth

The global zonisamide market is expected to continue growing, driven by the increasing prevalence of epilepsy, the effectiveness of second-generation antiepileptic drugs, and the rising geriatric population. The market is projected to reach USD 479.75 million by 2030[3].

Emerging Markets

The Asia Pacific region is expected to be a significant growth area due to increased government funding, improved healthcare infrastructure, and rising disposable income. This region will play a crucial role in the future growth of the zonisamide market[3].

Key Takeaways

• Zonisamide has been proven effective in clinical trials as an adjunctive therapy for partial-onset seizures.
• The global zonisamide market is valued at USD 367.03 million in 2023 and is expected to grow at a CAGR of 3.9% until 2030.
• The market is driven by the increasing prevalence of epilepsy, the benefits of second-generation antiepileptic drugs, and the rising geriatric population.
• North America currently dominates the market, but the Asia Pacific region is expected to show significant growth.

FAQs

What is the primary use of ZONEGRAN (zonisamide)?

ZONEGRAN (zonisamide) is used as an adjunctive therapy in the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older[5].

What are the common dosages of zonisamide?

The common dosages are 25 mg, 50 mg, and 100 mg, with the 50 mg tablet being the most dominant and well tolerated. The average dose is 100 mg, often prescribed as 50 mg twice a day or 100 mg once a day[3].

Which region dominates the zonisamide market?

North America currently dominates the zonisamide market with a 30% share, due to the increasing number of epileptic patients and a well-developed healthcare infrastructure[3].

What are the key drivers of the zonisamide market?

The key drivers include the increasing prevalence of epilepsy, the effectiveness of second-generation antiepileptic drugs, and the rising geriatric population[3].

What is the projected market size of zonisamide by 2030?

The global zonisamide market is expected to reach USD 479.75 million by 2030, growing at a CAGR of 3.9% from 2024 to 2030[3].

Sources

1. FDA Label: ZONEGRAN® (zonisamide) capsules, for oral administration. Clinical Studies.
2. Cognitive Market Research: Global Zonisamide Market Report 2024 Edition.
3. Maximize Market Research: Zonisamide Market- Industry Analysis and Forecast.
4. The Lancet: The SANAD II study of the effectiveness and cost-effectiveness of levetiracetam, zonisamide, or lamotrigine for newly diagnosed focal epilepsy.
5. DrugBank: Zonisamide: Uses, Interactions, Mechanism of Action.