Overview
Tiagabine is an anti-convulsive medication. It is also used in the treatment for panic disorder as are a few other anticonvulsants. Though the exact mechanism by which tiagabine exerts its effect on the human body is unknown, it does appear to operate as a selective GABA reuptake inhibitor.
Background
Tiagabine is an anti-convulsive medication. It is also used in the treatment for panic disorder as are a few other anticonvulsants. Though the exact mechanism by which tiagabine exerts its effect on the human body is unknown, it does appear to operate as a selective GABA reuptake inhibitor.
Indication
For the treatment of partial seizures
Associated Conditions
- Partial-Onset Seizures
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/06/22 | N/A | Recruiting | |||
2015/03/13 | Phase 2 | Completed | |||
2013/07/22 | Phase 1 | Completed | Rajesh Narendran | ||
2005/10/12 | Phase 3 | Completed | Cephalon | ||
2005/10/12 | Phase 3 | Completed | Cephalon | ||
2005/10/12 | Phase 3 | Completed | Cephalon | ||
2005/10/06 | Phase 3 | Completed | Cephalon | ||
2005/09/22 | Phase 3 | Completed | Cephalon | ||
2005/09/21 | Phase 4 | Completed | |||
2005/09/16 | Phase 3 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Cephalon, LLC | 63459-404 | ORAL | 4 mg in 1 1 | 7/19/2023 | |
| Novadoz Pharmaceuticals LLC | 72205-086 | ORAL | 12 mg in 1 1 | 3/1/2021 | |
| Novadoz Pharmaceuticals LLC | 72205-085 | ORAL | 4 mg in 1 1 | 3/1/2021 | |
| Teva Pharmaceuticals USA, Inc. | 0093-5031 | ORAL | 4 mg in 1 1 | 8/15/2023 | |
| Novadoz Pharmaceuticals LLC | 72205-087 | ORAL | 16 mg in 1 1 | 3/1/2021 | |
| Cephalon, LLC | 63459-416 | ORAL | 16 mg in 1 1 | 7/19/2023 | |
| Teva Pharmaceuticals USA, Inc. | 0093-8076 | ORAL | 16 mg in 1 1 | 8/15/2023 | |
| Amneal Pharmaceuticals NY LLC | 69238-1106 | ORAL | 12 mg in 1 1 | 12/30/2023 | |
| STAT RX USA LLC | 16590-832 | ORAL | 12 mg in 1 1 | 8/11/2011 | |
| Novadoz Pharmaceuticals LLC | 72205-084 | ORAL | 2 mg in 1 1 | 3/1/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
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 |
|---|---|---|---|---|---|
| GABITRIL tiagabine (as hydrochloride monohydrate) 15mg tablet bottle | 120273 | Medicine | A | 9/14/2006 | |
| GABITRIL tiagabine (as hydrochloride monohydrate) 5mg tablet bottle | 120271 | Medicine | A | 9/14/2006 | |
| GABITRIL tiagabine (as hydrochloride monohydrate) 10mg tablet bottle | 120272 | Medicine | A | 9/14/2006 |