Overview
Zolmitriptan is a member of the triptan class of 5-hydroxytryptamine(5-HT) receptor agonists used to treat acute migraine. Sumatriptan was the first triptan to be developed, but had poor oral bioavailability and lipophilicity. This led to the development of second-generation triptans, including almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, and zolmitriptan. Triptans can be administered alone or in combination with an NSAID like naproxen, and represent the current "gold standard" for acute migraine treatment. Zolmitriptan was first approved by the FDA for sale by Zeneca Pharmaceuticals under the trade name Zomig® on November 25, 1997. It is currently available in both tablet and nasal spray forms.
Background
Zolmitriptan is a member of the triptan class of 5-hydroxytryptamine(5-HT) receptor agonists used to treat acute migraine. Sumatriptan was the first triptan to be developed, but had poor oral bioavailability and lipophilicity. This led to the development of second-generation triptans, including almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, and zolmitriptan. Triptans can be administered alone or in combination with an NSAID like naproxen, and represent the current "gold standard" for acute migraine treatment. Zolmitriptan was first approved by the FDA for sale by Zeneca Pharmaceuticals under the trade name Zomig® on November 25, 1997. It is currently available in both tablet and nasal spray forms.
Indication
Zolmitriptan is indicated for the acute treatment of migraine with or without auras in patients aged 18 and over.
Associated Conditions
- Cluster Headache
- Migraine
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/10/10 | Phase 1 | Completed | Parc de Salut Mar | ||
2021/08/24 | Early Phase 1 | Completed | |||
2019/06/07 | Phase 1 | Completed | |||
2017/12/19 | Phase 4 | UNKNOWN | Xijing Hospital | ||
2017/05/09 | Phase 4 | Completed | |||
2015/11/20 | Phase 1 | Completed | |||
2011/01/14 | Not Applicable | Completed | California Medical Clinic for Headache | ||
2010/09/29 | Phase 4 | Completed | |||
2008/03/17 | Phase 4 | Completed | |||
2008/02/18 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | 65841-766 | ORAL | 5 mg in 1 1 | 10/17/2022 | |
| Amneal Pharmaceuticals LLC | 60846-133 | ORAL | 5 mg in 1 1 | 2/14/2024 | |
| PLD Acquisitions LLC DBA Avéma Pharma Solutions | 63548-0102 | ORAL | 5 mg in 1 1 | 2/9/2023 | |
| CELLTRION USA, INC. | 72606-567 | ORAL | 2.5 mg in 1 1 | 6/5/2020 | |
| Alembic Pharmaceuticals Limited | 46708-181 | ORAL | 2.5 mg in 1 1 | 2/22/2024 | |
| Rising Pharma Holdings, Inc. | 16571-804 | ORAL | 5 mg in 1 1 | 2/17/2024 | |
| BluePoint Laboratories | 68001-250 | ORAL | 5 mg in 1 1 | 1/10/2020 | |
| Alembic Pharmaceuticals Limited | 46708-462 | ORAL | 2.5 mg in 1 1 | 1/30/2023 | |
| Zydus Pharmaceuticals USA Inc. | 68382-714 | ORAL | 5 mg in 1 1 | 11/12/2022 | |
| Jubilant Cadista Pharmaceuticals Inc. | 59746-462 | ORAL | 5 mg in 1 1 | 12/30/2019 |
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 |
|---|---|---|---|---|---|
| ZOMIG RAPIMELT TABLET 2.5 mg | SIN11816P | TABLET | 2.5 mg | 2/22/2002 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Zolmitriptan Dispersible Tablets | 国药准字H20080825 | 化学药品 | 片剂 | 5/8/2023 | |
| Zolmitriptan Tablets | 国药准字H20061034 | 化学药品 | 片剂 | 11/24/2020 | |
| Zolmitriptan Tablets | 国药准字H20051234 | 化学药品 | 片剂 | 4/7/2020 | |
| Zolmitriptan Tablets | 国药准字H20070131 | 化学药品 | 片剂 | 2/24/2022 | |
| Zolmitriptan Tablets | 国药准字H20052386 | 化学药品 | 片剂 | 9/3/2024 | |
| Zolmitriptan Tablets | 国药准字H20052273 | 化学药品 | 片剂 | 5/9/2020 | |
| Zolmitriptan Tablets | 国药准字H20070177 | 化学药品 | 片剂 | 6/30/2020 | |
| Zolmitriptan Tablets | 国药准字H20060277 | 化学药品 | 片剂 | 5/15/2020 | |
| Zolmitriptan Tablets | 国药准字H20050072 | 化学药品 | 片剂 | 12/26/2019 | |
| Zolmitriptan Tablets | 国药准字H20061077 | 化学药品 | 片剂 | 1/8/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PMS-ZOLMITRIPTAN TABLETS 2.5MG | N/A | trenton-boma ltd | N/A | N/A | 9/30/2013 |
| ZOMIG TAB 2.5MG | N/A | N/A | N/A | 7/31/1998 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ZOLMITRIPTAN GxP zolmitriptan 2.5mg tablet blister pack | 200876 | Medicine | A | 6/19/2013 | |
| CHEMISTS' OWN ACUTE MIGRAINE RELIEF ZOLMITRIPTAN TABLETS 2.5 mg blister pack | 388594 | Medicine | A | 5/17/2022 | |
| APO-ZOLMITRIPTAN zolmitriptan 2.5mg tablet blister pack | 200878 | Medicine | A | 6/19/2013 | |
| ZOMIG Zolmitriptan 2.5mg tablet blister pack | 61325 | Medicine | A | 4/20/1998 | |
| ZOLTRIP zolmitriptan 2.5mg tablet blister pack | 200877 | Medicine | A | 6/19/2013 | |
| ZOLTRIP ACUTE MIGRAINE RELIEF zolmitriptan 2.5 mg tablet blister pack | 388593 | Medicine | A | 5/17/2022 | |
| APOHEALTH ACUTE MIGRAINE RELIEF ZOLMITRIPTAN TABLETS 2.5 mg blister pack | 388595 | Medicine | A | 5/17/2022 | |
| ZOLMITRIP zolmitriptan 2.5mg tablet blister pack | 200874 | Medicine | A | 6/19/2013 | |
| ZOLMITRIPTAN GPPL zolmitriptan 2.5mg tablet blister pack | 200875 | Medicine | A | 6/19/2013 | |
| TRIPTAZIG zolmitriptan 2.5mg tablet blister pack | 200879 | Medicine | A | 6/19/2013 |