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Drug

Zonisamide

Approved · EMA
Late-stage development
Also known as Zonegran, Zonisade, Zonisamida, 1,2-Benzisoxazole-3-methanesulfonamide+2 more

Zonegran, Zonisade, Zonisamida, 1,2-Benzisoxazole-3-methanesulfonamide, 3-(Sulfamoylmethyl)-1,2-benzisoxazole, Zonisamidum.

1
Active clinical trials
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-07-06Results expected Q3 2027 · ClinicalTrials.gov

Safety and Efficacy of Zonisamide Versus Topiramate in Migraine

Clinical trial2026-04-30Completed · ClinicalTrials.gov

Zonisamide Versus Propranolol in Migraine, a Randomized Controlled Single-blinded Trial

Clinical trial2025-03-30Primary completion · ClinicalTrials.gov

Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment

Clinical trial2023-09-29Terminated · ClinicalTrials.gov

Modification of Epilepsy Screen Questionnaire and Treatment Feasibility Evaluation

Clinical trial2023-06-30Primary completion · ClinicalTrials.gov

Interdisciplinary Study of Two Novel Anticonvulsants in Alcoholism

Clinical trial2023-06-18Results posted · ClinicalTrials.gov

Approval: Zonegran (EMA)

Regulatory2005-03-10EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Zonisamide
Aliases & brands
ZonegranZonisadeZonisamida1,2-Benzisoxazole-3-methanesulfonamide3-(Sulfamoylmethyl)-1,2-benzisoxazoleZonisamidum
RxNorm CUI
39998
ChEMBL ID
CHEMBL750
UNII
459384H98V
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2005-03-10
Latest approval
2016-03-31
Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2016-03-31Approval
Approval: Zonisamide Viatris (previously Zonisamide Mylan) (EMA)
Indication: Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partialShow full indication

Monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.

Evidence ↗
2005-03-10Approval
Approval: Zonegran (EMA)
Indication: Zonegran is indicated as: monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapyShow full indication

Zonegran is indicated as: monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy; adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged six years and above.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

61 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
61
registered trials across all phases
LATEST COMPLETION 2026
1
Active studies
41
Late-stage (III+)
42
Completed
18
Discontinued
PHASE DISTRIBUTIONn = 61
Phase 16Phase 1 / 23Phase 211Phase 2 / 31Phase 320Phase 414Phase N / A6

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.