TheraRadar
Data updated: Jun 17, 2026

ZONISAMIDE

Carbonic Anhydrase Inhibitors
CNS Approved 2005-12-22

Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

Source: FDA Label • Sun Pharma
Jump to: Indications Approvals Trials Competitors Safety Patents
10
Indications
--
Phase 3 Trials
20
Years on Market

Details

Status
Discontinued
First Approved
2005-12-22
Routes
ORAL
Dosage Forms
CAPSULE

Companies

Sun Pharma UPSHER SMITH LABS BIONPHARMA Apotex ZYDUS LIFESCIENCES CHARTWELL RX INVAGEN PHARMS EPIC PHARMA LLC PHARMOBEDIENT ROXANE UNICHEM ANI PHARMS Aurobindo Pharma GRANULES RISING GLENMARK PHARMS LTD MACLEODS PHARMS LTD
Active Ingredient: ZONISAMIDE

ZONISAMIDE Approval History

2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
246 FDA actions from 2005 to 2025
May 2025 ORIGINAL
Update
Mar 2023 SUPPL
Label · Labeling
Nov 2022 SUPPL
Label · Labeling

What ZONISAMIDE Treats

10 FDA approvals

Originally approved for its first indication in 2005 . Covers 10 distinct patient populations.

  • Other (10)

Sun Pharma's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

LEQSELVI
2024
DEURUXOLITINIB PHOSPHATE
1 designation
WINLEVI
2020
CLASCOTERONE
1 designation
📋

Clinical Trial Registry

24 trials
Trial Sponsor ID Phase Status Title
NCT05205811 BuZonE 2 Ph 3 completed The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette
NCT05134857 18520-001 Ph 2 recruiting The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study
NCT02901041 results posted 2R01AA015923-06 Ph 3 completed Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism
NCT02900352 Z-Comp results posted HM20014185 1605017700, 7R01AA024466-04 Ph 3 completed Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action
NCT01766128 ZONIST ZEPD-1091 Ph 2, Ph 3 withdrawn Study of Zonisamide in Early Parkinson Disease
NCT04388319 BuZonE results posted BuZonE Ph 3 completed Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes
NCT01140867 results posted E2090-S082-409 Ph 4 completed Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy
NCT03376139 AS140026-A4 W81XWh-15-2-0077 Ph 2 withdrawn Zonisamide Outpatient Study
NCT02368431 results posted CLNA-003-14S ICX001012A Ph 3 terminated Effectiveness of Zonisamide in Alcohol Dependent Veterans
NCT01847469 results posted 1211011063 01641 Ph 2 completed Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
NCT01685996 1207 results posted NA_00074143 R21DA034164 Ph 1, Ph 2 completed Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation
NCT02049073 NIHL2014 Ph 1, Ph 2 withdrawn Prevention of Noise-induced Hearing Loss
NCT01137890 results posted R01DA027065 R01DA027065 Ph 1, Ph 2 completed Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse
NCT00692003 results posted E2090-E044-315 Eudra ID #2007-003557-91. Ph 3 terminated Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures
NCT01566370 ZNSBP results posted ZNS-BP VACT MIRECC, K23AA017689 Ph 2 terminated Zonisamide for Heavy Drinkers With Bipolar Disorder
NCT01136954 results posted E2090-E044-313 2007-000198-53 Ph 3 completed A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)
NCT00693017 results posted E2090-E044-317 2007-003556-10 Ph 3 terminated Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy
NCT00848549 results posted E2090-E044-314 2008-001159-23 Ph 3 completed Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
NCT00713622 E2090-E044-406 2007-005313-19 Ph 4 completed Comparing The Effect On Cognition Of Adjunctive Therapy With Zonisamide Versus Sodium Valproate
NCT00862563 results posted NIAAA-CIR-AA015923 P60AA013759, 1R01AA015923 Ph 2 terminated Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism
NCT01765608 ZON-01 2009-015859-24 Ph 2 completed Zonisamide for the Treatment of Obstructive Sleep Apnea in Overweight/Obese Patients
NCT00659958 E2090-E044-407 Ph 4 completed ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs
NCT00566254 results posted E2090-E044-312 2006-002515-27 Ph 3 completed Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)
NCT00363376 06-06-14-01 F1D-MC-X269 Ph 3 completed A Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ZONISAMIDE FDA Label Details

Indications & Usage

Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy.

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Full clinical data, patents, trials, and competitive landscape for zonisamide.

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Data Sources

FDA Approval: ANDA077634 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.