Zonegran

(Zonisamide)

ApprovedSmall molecule

Zonisamide is used to treat seizures in people with epilepsy. It helps reduce the frequency and severity of seizures by calming abnormal electrical activity in the brain.[2] Zonegran is currently approved and in use across 21 indications[4].[1]

Zonegran is one of 376 small molecule programs targeting Seizures. It is currently in Approved.

Indications

Total Trials

Active Trials

375

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

SeizuresNot yet recruiting

Addictive Alcohol UseActive, not recruiting

ParkinsonismActive, not recruiting

Focal-Onset SeizureApproved

Complex Partial EpilepsyApproved

Body Weight GainApproved

Hearing LossApproved

ObesityApproved

Migraine DisorderApproved

Nicotine DependenceApproved

SeizuresApproved

Not yet recruiting

Addictive Alcohol UsePreclinical

Active, not recruiting

ParkinsonismApproved

Active, not recruiting

Focal-Onset SeizureApproved

Approved

Complex Partial EpilepsyApproved

Approved

Body Weight GainApproved

Approved

Hearing LossApproved

Approved

ObesityApproved

Approved

Migraine DisorderApproved

Approved

Nicotine DependenceApproved

Approved

Showing 10 of 21 indications

Competition

Competitive Landscape

190 competitors in Obesity

#DrugCompanyPhaseTrials

Zonegran

AAzurity Pharmaceuticals

Approved

60 2

Maridebart Cafraglutide

Amgen

Phase 3

7 3

NNC0487-0111

Novo Nordisk

Phase 3

11 4

HRS9531

FFujian Shengdi Pharmaceutical Co., Ltd.

Phase 3

1 5

Gemtesa

Sumitomo Pharma America, Inc.

Phase 3

1 6

Zenagamtide

Novo Nordisk

Phase 3

3 7

Berobenatide

Pfizer

Phase 3

3 8

Ribupatide

KKailera

Phase 3

3 9

PF-08653944

Pfizer

Phase 3

5 10

Survodutide

Boehringer Ingelheim

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 2Active, not recruiting

Alcohol Use Disorder (AUD)

NCT05134857

ApprovedNot yet recruiting

Seizures

NCT06534502

Clinical

Trials by Indication[1]

Seizure10 trials

Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

Completed· Eisai logo

Eisai·Phase 3·NCT00848549·295 enrolled

Adjunctive Zonisamide in Primary Generalised Tonic Clonic Seizures

Terminated· Eisai logo

Eisai·Phase 3·NCT00692003·21 enrolled

A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.

Completed· Eisai logo

Eisai··NCT01283256·655 enrolled

Show 7 more trials

A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)

Completed· Eisai logo

Eisai··NCT01830868·104 enrolled

Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)

Completed· Eisai logo

Eisai·Phase 3·NCT00566254·207 enrolled

ZAGAL Study: Evaluating Effectiveness and Tolerability of Zonisamide as Adjunctive Therapy in Patients With Partial Onset Seizures Treated With Two Antiepileptic Drugs

Completed· Eisai logo

Eisai·Phase 4·NCT00659958·32 enrolled

A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures

Completed· Eisai logo

Eisai·Phase 3·NCT00292461·64 enrolled

Evaluating the Efficacy and Safety of Zonisamide in the Treatment of Partial Seizures

Completed· Eisai logo

Eisai·Phase 3·NCT00327717·240 enrolled

A Study to Evaluate the Safety and Tolerability and Explore the Efficacy of Zonisamide as add-on Therapy in Elderly Patients With Refractory Partial Seizures

Terminated· Eisai logo

Eisai·Phase 4·NCT01546688·41 enrolled

A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)

Completed· Eisai logo

Eisai·Phase 3·NCT01136954·144 enrolled

Epilepsy5 trials

Characterization of Epilepsy Patients BEEP 2b

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02707965·21 enrolled

Modification of Epilepsy Screen Questionnaire and Treatment Feasibility Evaluation

Unknown status·NNational Taiwan University Hospital·N/A·NCT04939675·40 enrolled

Dose Response Study of Zonegran in Patients With Newly Diagnosed Epilepsy

Completed· Eisai logo

Eisai·Phase 3·NCT00056576·165 enrolled

Show 2 more trials

Real-world Study of Efficacy and Safety of Zonisamide in add-on Therapy for Patients With Focal Epilepsy

Not yet recruiting·SSecond Affiliated Hospital, School of Medicine, Zhejiang University··NCT06374966·400 enrolled

Efficacy and Safety of Adjunctive Zonisamide in Myoclonic Seizures Associated With Idiopathic Generalised Epilepsy

Terminated· Eisai logo

Eisai·Phase 3·NCT00693017·10 enrolled

Partial Epilepsy3 trials

A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy

Completed· Eisai logo

Eisai·Phase 3·NCT00477295·583 enrolled

Systematic Review: Retigabine for Adjunctive Therapy in Partial Epilepsy

Completed· GSK logo

GSK··NCT01587339·6,498 enrolled

Open-label, Multi-center Trial of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

Completed· Eisai logo

Eisai·Phase 4·NCT01140867·121 enrolled

Alcohol Dependence3 trials

Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence

Completed·YYale University·Phase 2·NCT01847469·24 enrolled

Zonisamide vs. Placebo in the Treatment of Alcohol Dependence

Completed·UUConn Health·Phase 4·NCT00595556·40 enrolled

The Effects of Zonisamide on Alcohol Dependence

Completed·—·Phase 2·NCT00406692·16 enrolled

Migraine3 trials

Cognitive Side Effects of Commonly Prescribed Medications in Pediatric Migraine

Withdrawn·UUniversity of South Alabama·N/A·NCT00777218

Zonisamide Versus Topiramate in Migraine

Recruiting·KKafrelsheikh University·Phase 3·NCT06347497·600 enrolled

Zonisamide Versus Propranolol in Migraine

Recruiting·KKafrelsheikh University·Phase 3·NCT06361446·600 enrolled

28 more indications

Alcoholism2 trials

Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism

Terminated·—·Phase 2·NCT00862563·85 enrolled

Interdisciplinary Study of A Novel Anticonvulsant in Alcoholism

Completed·—·Phase 3·NCT02901041·81 enrolled

Monotherapy2 trials

A Multicenter Comparative Trial of Zonisamide and Topiramate as Initial Monotherapy in Untreated Epilepsies

Completed· Eisai logo

Eisai·Phase 4·NCT00154076·140 enrolled

Low and High Dose Zonisamide in Children as Monotherapy

Completed· Eisai logo

Eisai·Phase 4·NCT01127165·125 enrolled

Fed2 trials

Fed Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00649714·110 enrolled

Fed Bioavailability Study of Zonisamide Capsules

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00687167·34 enrolled

Itching2 trials

The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette

Completed·RRose Research Center, LLC·Phase 3·NCT05205811·180 enrolled

Zonisamide/Bupropion Effects on Switching to Electronic Cigarettes

Completed·RRose Research Center, LLC·Phase 3·NCT04388319·26 enrolled

Bipolar Disorder2 trials

Open-label Adjunctive Zonisamide for Bipolar Disorder

Terminated·EElan Pharmaceuticals·Phase 4·NCT00047567·20 enrolled

Zonisamide for Heavy Drinkers With Bipolar Disorder

Terminated·YYale University·Phase 2·NCT01566370·3 enrolled

Essential Tremor2 trials

Zonisamide in the Treatment of Essential Tremor

Terminated·LLoma Linda University·N/A·NCT00616343·9 enrolled

A Safety/Efficacy Trial of Zonisamide for Essential Tremor

Completed·VVA Greater Los Angeles Healthcare System·Phase 2·NCT00223743·25 enrolled

Headache1 trial

A Study to Measure the Safety and Effectiveness of Zonisamide in Subjects With Migraine Headache

Completed·EElan Pharmaceuticals·Phase 2·NCT00055484·204 enrolled

Weight Gain1 trial

A Study of Zonisamide to Prevent Olanzapine-Associated Weight Gain

Completed·LLindner Center of HOPE·Phase 3·NCT00363376·42 enrolled

Cognition1 trial

Comparing The Effect On Cognition Of Adjunctive Therapy With Zonisamide Versus Sodium Valproate

Completed· Eisai logo

Eisai·Phase 4·NCT00713622·2 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Fibromyalgia1 trial

Zonisamide for Fibromyalgia & Migraine

Withdrawn·UUniversity of Pittsburgh·Phase 4·NCT00259636

Fasting Conditions1 trial

Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions

Completed·—·Phase 1·NCT01161966·26 enrolled

Parkinson's Disease (PD)1 trial

Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot Study

Completed·—·N/A·NCT04182399·69 enrolled

Effectiveness1 trial

Effectiveness of Zonisamide in Alcohol Dependent Veterans

Terminated·VVA Office of Research and Development·Phase 3·NCT02368431·92 enrolled

Safety and Efficacy1 trial

Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00401973·199 enrolled

Alcohol Use Disorder1 trial

Zonisamide Treatment of Alcohol Use Disorder: an Evaluation of Efficacy and Mechanism of Action

Completed·VVirginia Commonwealth University·Phase 3·NCT02900352·156 enrolled

Alcohol1 trial

Alcohol Self Administration Laboratory

Completed·—·N/A·NCT00398918·10 enrolled

Relapse1 trial

Effect of Zonisamide on Cocaine Reinforcement, Craving, and Relapse

Completed·JJohns Hopkins University·Phase 1/2·NCT01137890·19 enrolled

Noise-Induced Hearing Loss1 trial

Prevention of Noise-induced Hearing Loss

Withdrawn·WWashington University School of Medicine·Phase 1/2·NCT02049073

Adult1 trial

Zonisamide for Weight Reduction in Obese Adults

Completed·—·N/A·NCT00275834·225 enrolled

Obstructive Sleep Apnea1 trial

Zonisamide for the Treatment of Obstructive Sleep Apnea in Overweight/Obese Patients

Completed·GGöteborg University·Phase 2·NCT01765608·50 enrolled

Efficacy and Safety1 trial

Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

Completed· Eisai logo

Eisai·Phase 4·NCT01127256·200 enrolled

Smoking Cessation1 trial

Zonisamide Augmentation of Varenicline Treatment for Smoking Cessation

Completed·JJohns Hopkins University·Phase 1/2·NCT01685996·74 enrolled

Parkinson disease1 trial

Study of Zonisamide in Early Parkinson Disease

Withdrawn·MMazandaran University of Medical Sciences·Phase 2/3·NCT01766128

Labor1 trial

Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed Conditions

Completed·—·Phase 1·NCT01161979·26 enrolled

Seizures1 trial

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Zonisamide Oral Suspension (100 mg/5 ml) to Determine a Dosing Regimen in Children 1 Month to 17 Years of Age With Partial-onset Seizures

Not yet recruiting·AAzurity Pharmaceuticals·Approved·NCT06534502·40 enrolled

Alcohol Use Disorder (AUD)1 trial

Zonisamide for the Treatment of Alcohol Use Disorder in the Addiction Neuroclinical Assessment Framework

Active, not recruiting·WWashington State University·Phase 2·NCT05134857·205 enrolled

Unspecified3 trials

Fasting Bioavailability Study of Zonisamide Capsules

Completed·MMutual Pharmaceutical Company, Inc.·Phase 1·NCT00685139·34 enrolled

Fasting Study of Zonisamide Capsules 100 mg and Zonegran® Capsules 100 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00650052·107 enrolled

Zonisamide Outpatient Study

Withdrawn·PPharmacotherapies for Alcohol and Substance Use Disorders Alliance·Phase 2·NCT03376139

Regulatory

FDA Approval Timeline[5]

Aug 22, 2003

ZONEGRAN

NDA NDA020789

Jul 15, 2022

ZONISADE

NDA NDA214273

Sources

References

[1]
ClinicalTrials.gov — 60 trial records for Zonisamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zonegran drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Zonisamide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Zonisamide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214273). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Zonegran. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Azurity Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Alpha Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AAzurity Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Aug 17, 2038

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12685723Aug 17, 2038

11478456Aug 18, 2038

12491179Aug 18, 2038

11529333Aug 18, 2038

Zonegran

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2027

Trials by Indication[1]

Seizure10 trials

Epilepsy5 trials

Partial Epilepsy3 trials

Alcohol Dependence3 trials

Migraine3 trials

Alcoholism2 trials

Monotherapy2 trials

Fed2 trials

Itching2 trials

Bipolar Disorder2 trials

Essential Tremor2 trials

Headache1 trial

Weight Gain1 trial

Cognition1 trial

Pediatrics1 trial

Fibromyalgia1 trial

Fasting Conditions1 trial

Parkinson's Disease (PD)1 trial

Effectiveness1 trial

Safety and Efficacy1 trial

Alcohol Use Disorder1 trial

Alcohol1 trial

Relapse1 trial

Noise-Induced Hearing Loss1 trial

Adult1 trial

Obstructive Sleep Apnea1 trial

Efficacy and Safety1 trial

Smoking Cessation1 trial

Parkinson disease1 trial

Labor1 trial

Seizures1 trial

Alcohol Use Disorder (AUD)1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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