Wednesday, July 8, 2026

Drug profile · INN

zonisamide

zonisamide (ZONEGRAN) is a sodium channel alpha subunit blocker. Associated with Amdipharm Mercury (Australia) Pty Limited. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved PMDA: approved NMPA: clinical trials Nervous system (N03) N03AX15
US status approved
Patents linked 1
Pipeline programs 5
News articles 0
Drug details — zonisamide
US status
approved
Class
Nervous system (N03)
Route
ORAL
Patents
1
Programs
5
Data quality
0.84

Quick answer

zonisamide (ZONEGRAN) is a sodium channel alpha subunit blocker. Associated with Amdipharm Mercury (Australia) Pty Limited. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN zonisamide
Brand ZONEGRAN
Mechanism Sodium channel alpha subunit blocker
Target Sodium channel alpha subunit
Therapeutic class Nervous system (N03)
Route ORAL
Formulation CAPSULE
ATC code N03AX15

Mechanism of action

Sodium channel alpha subunit blocker

Primary target: Sodium channel alpha subunit

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
PMDA approved
NMPA clinical trials

Pipeline programs

  1. Zonisamide Phase 3 · Eisai · Epilepsy
  2. Zonisamide Phase 2 · United Therapeutics Europe · Alcohol Dependence
  3. Zonisamide 100Mg Cap Phase 2 · United Therapeutics Europe · Hearing Loss, Noise-Induced
  4. zonisamide Phase 2 · BRIGHT MINDS BIOSCIENCES · Nicotine Dependence
  5. Oral Zonisamide Therapy Approved · Affiliated Hospital of · Epilepsies, Partial

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 6936720

    Method for preparing benzisoxazole methane sulfonyl chloride and its amidation to form zonisamide

    Expires Mon Aug 25 2025 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is zonisamide?

zonisamide (ZONEGRAN) is a sodium channel alpha subunit blocker. Associated with Amdipharm Mercury (Australia) Pty Limited. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for zonisamide?

ZONEGRAN is a marketed brand name for zonisamide. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of zonisamide?

zonisamide has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.