Zonisamide
As of the edition of 20 October 2026, Zonisamide is a small molecule: marketed, first approved in 2000 (US); acts on SCN10A, SCN11A and SCN1A and 7 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Zonegran
- First approved
- 27 March 2000 (US)
- Approvals on record
- 11 in 5 regions
- Holder of the most recent approval
- NEURAXPHARM FRANCE; 7 holders in all
- Registered trials
- 57, 9 stopped early
- Disease areas
- Nervous system; Mental health; Chemically induced; Nutrition and metabolism; Ear, nose and throat; Bones, joints and muscles
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
10 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product10 company-target rows are on route B because of Zonisamide.
See the 10 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
| Gene | Protein | UniProt |
|---|---|---|
| SCN1A | Sodium channel protein type 1 subunit alpha | P35498 |
| SCN4A | Sodium channel protein type 4 subunit alpha | P35499 |
| SCN7A | Sodium channel protein type 7 subunit alpha | Q01118 |
| SCN5A | Sodium channel protein type 5 subunit alpha | Q14524 |
| SCN9A | Sodium channel protein type 9 subunit alpha | Q15858 |
| SCN2A | Sodium channel protein type 2 subunit alpha | Q99250 |
| SCN3A | Sodium channel protein type 3 subunit alpha | Q9NY46 |
| SCN11A | Sodium channel protein type 11 subunit alpha | Q9UI33 |
| SCN8A | Sodium channel protein type 8 subunit alpha | Q9UQD0 |
| SCN10A | Sodium channel protein type 10 subunit alpha | Q9Y5Y9 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 6 | 0 | 0 |
| Phase 1 | 6 | 6 | 0 | 0 |
| Phase 2 | 14 | 8 | 1 | 5 |
| Phase 3 | 14 | 12 | 0 | 1 |
| Phase 4 | 15 | 10 | 2 | 3 |
| All trials | 57 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amdipharm | Applicant | 2005 to now |
| Dainippon Sumitomo Pharma | Applicant | 2008 to now |
| Azurity Pharmaceuticals | Later holder and Lead sponsor of trials | 2022 to now |
| Advanz Pharma | Acquired holder | 2025 to now |