Overview
Naratriptan is a triptan drug that is selective for the 5-hydroxytryptamine1 receptor subtype. It is typically used for the treatment of migraine headaches.
Background
Naratriptan is a triptan drug that is selective for the 5-hydroxytryptamine1 receptor subtype. It is typically used for the treatment of migraine headaches.
Indication
For the acute treatment of migraine attacks with or without aura in adults.
Associated Conditions
- Migraine with acute onset aura
- Acute Migraine without aura
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2017/02/28 | Phase 1 | UNKNOWN | Hartford HealthCare | ||
2012/11/15 | Phase 3 | Withdrawn | Ache Laboratorios Farmaceuticos S.A. | ||
2011/07/11 | Phase 3 | Withdrawn | Ache Laboratorios Farmaceuticos S.A. | ||
2011/06/20 | N/A | Completed | |||
2011/04/11 | N/A | Completed | |||
2010/07/13 | Not Applicable | Completed | |||
2010/07/13 | Not Applicable | Completed | |||
2010/02/01 | N/A | Completed | |||
2007/06/18 | Phase 4 | Terminated | Cady, Roger, M.D. | ||
2006/01/25 | Phase 4 | Terminated |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bionpharma Inc. | 69452-341 | ORAL | 2.5 mg in 1 1 | 12/19/2023 | |
| OrchidPharma, Inc | 42043-130 | ORAL | 1 mg in 1 1 | 1/13/2022 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0278 | ORAL | 1 mg in 1 1 | 4/1/2020 | |
| A-S Medication Solutions | 50090-6162 | ORAL | 2.5 mg in 1 1 | 4/11/2022 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-055 | ORAL | 2.5 mg in 1 1 | 5/26/2021 | |
| Bionpharma Inc. | 69452-340 | ORAL | 1 mg in 1 1 | 12/19/2023 | |
| OrchidPharma, Inc | 42043-131 | ORAL | 2.5 mg in 1 1 | 1/13/2022 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0279 | ORAL | 2.5 mg in 1 1 | 4/1/2020 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-054 | ORAL | 1 mg in 1 1 | 5/26/2021 |
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 |
|---|---|---|---|---|---|
| NARATRIPTAN FILM-COATED TABLETS 2.5MG | SIN14787P | TABLET, FILM COATED | 2.50mg | 5/22/2015 |
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 |
|---|---|---|---|---|---|
| NARAMIG naratriptan (as hydrochloride) 2.5mg tablet blister pack | 62900 | Medicine | A | 6/17/1998 |