Topiramate
As of the edition of 20 October 2026, Topiramate is a small molecule: marketed, first approved in 1996 (CH); acts on CA2, GRIA1 and GRIA2 and 17 more.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2014
- Kind
- Small molecule
- Brand name
- Topamax
- First approved
- 26 June 1996 (CH)
- Approvals on record
- 33 in 7 regions
- Holder of the most recent approval
- EMS S/A; 10 holders in all
- Registered trials
- 218, 27 stopped early
- Disease areas
- Nervous system; Mental health; Nutrition and metabolism; Chemically induced; Hormones; Heart and blood vessels
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
25 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product25 company-target rows are on route B because of Topiramate.
See the 25 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 |
|---|---|---|
| CA2 | Carbonic anhydrase 2 | P00918 |
| SCN1A | Sodium channel protein type 1 subunit alpha | P35498 |
| SCN4A | Sodium channel protein type 4 subunit alpha | P35499 |
| GRIK1 | Glutamate receptor ionotropic, kainate 1 | P39086 |
| GRIA1 | Glutamate receptor 1 | P42261 |
| GRIA2 | Glutamate receptor 2 | P42262 |
| GRIA3 | Glutamate receptor 3 | P42263 |
| GRIA4 | Glutamate receptor 4 | P48058 |
| SCN7A | Sodium channel protein type 7 subunit alpha | Q01118 |
| GRIK2 | Glutamate receptor ionotropic, kainate 2 | Q13002 |
| GRIK3 | Glutamate receptor ionotropic, kainate 3 | Q13003 |
| SCN5A | Sodium channel protein type 5 subunit alpha | Q14524 |
| SCN9A | Sodium channel protein type 9 subunit alpha | Q15858 |
| GRIK4 | Glutamate receptor ionotropic, kainate 4 | Q16099 |
| GRIK5 | Glutamate receptor ionotropic, kainate 5 | Q16478 |
| 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 | 25 | 14 | 4 | 3 |
| Phase 1 | 29 | 26 | 1 | 2 |
| Phase 2 | 50 | 36 | 5 | 6 |
| Phase 3 | 63 | 52 | 0 | 7 |
| Phase 4 | 51 | 30 | 6 | 9 |
| All trials | 218 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant, Acquired holder and Lead sponsor of trials | 1988 to now |
| Upsher-Smith | Later holder and Lead sponsor of trials | 2010 to now |
| Supernus Pharmaceuticals | Later holder and Lead sponsor of trials | 2010 to now |
| Azurity Pharmaceuticals | Later holder | 2021 to now |