Overview
Zonisamide is a sulfonamide anticonvulsant used as an adjunctive therapy in adults with partial-onset seizures. Zonisamide may act by blocking repetitive firing of voltage-gated sodium channels, leading to a reduction of T-type calcium channel currents or by binding allosterically to GABA receptors. This latter action may inhibit the uptake of the inhibitory neurotransmitter GABA while enhancing the uptake of the excitatory neurotransmitter glutamate. Zonisamide represents an alternative for patients that remain refractory to established antiepileptic drugs. In 1989, it was approved for commercial use in Japan. The US and Europe approved it in 2000 and 2005, respectively.
Indication
Zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide oral suspension is indicated as adjunctive therapy for the treatment of partial-onset seizures in adults and pediatric patients 16 years of age and older.
Associated Conditions
- Partial-Onset Seizures
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/02 | Phase 4 | Not yet recruiting | Azurity Pharmaceuticals | ||
2024/04/19 | N/A | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/04/11 | Phase 3 | Recruiting | |||
2024/04/04 | Phase 3 | Recruiting | |||
2022/01/25 | Phase 3 | Active, not recruiting | |||
2021/11/26 | Phase 2 | Recruiting | |||
2021/06/25 | Not Applicable | Not yet recruiting | |||
2021/03/01 | Phase 2 | Terminated | |||
2021/02/24 | Phase 2 | Terminated | |||
2020/05/14 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | 62756-258 | ORAL | 25 mg in 1 1 | 6/25/2020 | |
| Unichem Pharmaceuticals (USA), Inc. | 29300-429 | ORAL | 50 mg in 1 1 | 11/30/2022 | |
| Proficient Rx LP | 63187-583 | ORAL | 100 mg in 1 1 | 10/1/2022 | |
| Preferred Pharmaceuticals, Inc. | 68788-7438 | ORAL | 100 mg in 1 1 | 10/25/2023 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-130 | ORAL | 100 mg in 1 1 | 9/26/2022 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-129 | ORAL | 50 mg in 1 1 | 9/26/2022 | |
| Concordia Pharmaceuticals Inc. | 59212-680 | ORAL | 100 mg in 1 1 | 8/20/2021 | |
| Camber Pharmaceuticals | 31722-228 | ORAL | 100 mg in 1 1 | 2/22/2012 | |
| Azurity Phramaceuticals, Inc. | 52652-8001 | ORAL | 100 mg in 5 mL | 3/30/2023 | |
| AvPAK | 50268-816 | ORAL | 100 mg in 1 1 | 1/18/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/10/2005 | ||
Authorised | 3/31/2016 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Zonisamide Tablets | 国药准字H20090252 | 化学药品 | 片剂 | 12/18/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ZONEGRAN zonisamide 25mg capsule blister pack | 125869 | Medicine | A | 7/31/2007 | |
| ZONISAMIDE APOTEX zonisamide 100 mg capsule blister pack | 265576 | Medicine | A | 1/11/2017 | |
| ZONEGRAN zonisamide 50mg capsule blister pack | 125870 | Medicine | A | 7/31/2007 | |
| ZONEGRAN zonisamide 100mg capsule blister pack | 125871 | Medicine | A | 7/31/2007 | |
| ZONISAMIDE APOTEX zonisamide 50 mg capsule blister pack | 265579 | Medicine | A | 1/11/2017 | |
| ZONISAMIDE APOTEX zonisamide 25 mg capsule blister pack | 265573 | Medicine | A | 1/11/2017 |
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