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.
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 |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PMS-ZOLMITRIPTAN TABLETS 2.5MG | N/A | 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 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ZOMIG | xediton pharmaceuticals inc | 02238660 | Tablet - Oral | 2.5 MG | 9/30/1998 |
| BIO-ZOLMITRIPTAN | biomed pharma | 02512831 | Tablet - Oral | 2.5 MG | 1/11/2023 |
| VAN-ZOLMITRIPTAN | vanc pharmaceuticals inc | 02438771 | Tablet - Oral | 2.5 MG | N/A |
| RATIO-ZOLMITRIPTAN ODT | ratiopharm inc division of teva canada limited | 02340313 | Tablet (Orally Disintegrating) - Oral | 2.5 MG | N/A |
| TEVA-ZOLMITRIPTAN OD | teva canada limited | 02342553 | Tablet (Orally Disintegrating) - Oral | 1 MG | N/A |
| ZOLMITRIPTAN ODT | PRO DOC LIMITEE | 02379988 | Tablet (Orally Disintegrating) - Oral | 2.5 MG | 3/29/2012 |
| CCP-ZOLMITRIPTAN | cellchem pharmaceuticals inc. | 02458780 | Tablet - Oral | 2.5 MG | 1/4/2019 |
| MYLAN-ZOLMITRIPTAN ODT | Mylan Pharmaceuticals ULC | 02387158 | Tablet (Orally Disintegrating) - Oral | 2.5 MG | 6/1/2012 |
| MINT-ZOLMITRIPTAN ODT | mint pharmaceuticals inc | 02419513 | Tablet (Orally Disintegrating) - Oral | 2.5 MG | 3/18/2014 |
| JAMP-ZOLMITRIPTAN ODT | 02428237 | Tablet (Orally Disintegrating) - Oral | 2.5 MG | 9/14/2014 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ZOLMITRIPTAN FLAS STADA 5 mg COMPRIMIDOS BUCODISPERSABLES EFG | Laboratorio Stada S.L. | 74364 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZOLMITRIPTAN NORMON 2,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Normon S.A. | 75298 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZOLMITRIPTAN VISO FARMACEUTICA 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 76337 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| ZOLMITRIPTAN COMBIX 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Combix S.L.U. | 77009 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ZOLMITRIPTAN FLAS CINFA 5 mg COMPRIMIDOS BUCODISPERSABLES EFG | Laboratorios Cinfa S.A. | 74386 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZOLMITRIPTAN FLAS JUBILANT 2,5 MG COMPRIMIDOS BUCODISPERSABLES EFG | Jubilant Pharmaceuticals | 76897 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ZOLMITRIPTAN JUBILANT 2,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Jubilant Pharmaceuticals | 76896 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| ZOMIG FLAS 2,5 mg COMPRIMIDOS BUCODISPERSABLES | Laboratoires Grunenthal | 3533665IP | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZOLMITRIPTAN FLAS SANDOZ 2,5 mg COMPRIMIDOS BUCODISPERSABLES EFG | Sandoz Farmaceutica S.A. | 74967 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
| ZOLMITRIPTAN FLAS QUALIGEN 5 mg COMPRIMIDOS BUCODISPERSABLES EFG | Neuraxpharm Spain S.L. | 74377 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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