Sumatriptan

Overview

Sumatriptan is a serotonin receptor agonist commonly used to treat migraines and sometimes cluster headaches. Sumatriptan is the first of the triptans and was made available in Europe in 1991 to treat migraines. Sumatriptan was granted FDA approval on 28 December 1992.

Indication

A combination sumatriptan and naproxen tablet is indicated for the treatment of migraines with or without auras in patients 12 years of age and older. Sumatriptan nasal powder, nasal spray, subcutaneous injection, and tablets are indicated to treat migraines with or without auras in adults. One of the subcutaneous formulations of sumatriptan is also indicated to treat cluster headaches in adults, while the other subcutaneous formulation is not.

Associated Conditions

Acute Migraine
Acute Cluster headaches

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
PACAP38 Induced Headache, Migraine and Flushing in Patients With Migraine	2019/03/19	NCT03881644	Not Applicable	Completed	Danish Headache Center
A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain	2019/03/18	NCT03877718	Phase 2	Completed	Charleston Laboratories, Inc
PACAP38 Induced Headache and Rosacea-like Symptoms in Patients With Rosacea	2019/03/18	NCT03878784	Not Applicable	Completed	Danish Headache Center
The Effect of Sumatriptan and Placebo on CGRP Induced Headache	2018/05/31	NCT03542357	Not Applicable	Completed	Danish Headache Center
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants	2018/04/27	NCT03511118	N/A	Recruiting	Duke University
The Effect of Sumatriptan and Placebo Injection on Cilostazol Induced Headache	2018/02/06	NCT03422796	Not Applicable	Completed	Danish Headache Center
Study to Assess the Safety and Efficacy of ONZETRA® Xsail® for the Acute Treatment of Episodic Migraine With or Without Aura in Adolescents	2017/11/09	NCT03338920	Phase 3	Terminated	Currax Pharmaceuticals
A Study of Lasmiditan When Given With Sumatriptan in Healthy Participants	2017/10/16	NCT03310411	Phase 1	Completed	Eli Lilly and Company
Sofusa System With Sumatriptan (KC5010) Phase 1 Dose Escalation Safety and PK Study (KCC-SMT-002)	2017/07/26	NCT03229798	Phase 1	Completed	Sorrento Therapeutics, Inc.
Low-Dose Naltrexone and Acetaminophen Combination and Sumatriptan in the Acute Treatment of Migraine With Nausea	2017/06/14	NCT03185143	Phase 2	Completed	Allodynic Therapeutics, Inc

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sumatriptan	RPK Pharmaceuticals, Inc.	53002-3562	ORAL	100 mg in 1 1	1/13/2022
Sumatriptan Succinate	RPK Pharmaceuticals, Inc.	53002-1593	ORAL	25 mg in 1 1	12/10/2020
IMITREX	Physicians Total Care, Inc.	54868-5118	ORAL	100 mg in 1 1	10/2/2012
sumatriptan succinate	Quality Care Products, LLC	55700-846	ORAL	100 mg in 1 1	3/5/2020
Sumatriptan Succinate	Proficient Rx LP	63187-049	ORAL	50 mg in 1 1	2/1/2020
SUMATRIPTAN	Hikma Pharmaceuticals USA Inc.	0143-9638	SUBCUTANEOUS	6 mg in 0.5 mL	1/1/2021
sumatriptan succinate	JHP Pharmaceuticals LLC	42023-121	SUBCUTANEOUS	6 mg in 0.5 mL	9/4/2009
Sumatriptan	SUN PHARMACEUTICAL INDUSTRIES, INC.	63304-099	ORAL	100 mg in 1 1	1/19/2022
Sumatriptan	Somerset Therapeutics, LLC	70069-804	SUBCUTANEOUS	6 mg in 0.5 mL	7/30/2021
SUMATRIPTAN	Prasco Laboratories	66993-082	NASAL	20 mg in 100 uL	12/5/2019

EMA Drug Approvals

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Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

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Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Sumatriptan 50 mg tablet bottle	346503	Alphapharm Pty Ltd	Medicine	A	10/23/2020
TRUST SUMATRIPTAN sumatriptan 50 mg (as succinate) tablet blister pack	385710	Pharmacor Pty Ltd	Medicine	A	3/16/2022
CHEMISTS’ OWN ACUTE MIGRAINE RELIEF SUMATRIPTAN TABLETS sumatriptan 50 mg (as succinate) tablet blister pack	378473	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/22/2021
SUMATRIPTAN SANDOZ Tablets 100 mg Sumatriptan (as succinate) 100 mg Tablets Blister	187215	Accord Healthcare Pty Ltd	Medicine	A	5/11/2012
Sumatriptan 25 mg tablet bulk	346505	Alphapharm Pty Ltd	Medicine	A	10/23/2020
WAGNER HEALTH SUMATRIPTAN sumatriptan 50 mg (as succinate) tablet blister pack	372452	Accord Healthcare Pty Ltd	Medicine	A	8/9/2021
IMIGRAN Mk II 6mg/0.5mL Injection Syringe	44465	Aspen Pharmacare Australia Pty Ltd	Medicine	A	7/13/1993
PHARMACOR SUMATRIPTAN 100 sumatriptan succinate 100 mg tablet blister	154820	Pharmacor Pty Ltd	Medicine	A	3/26/2010
SUMATRAN ACUTE MIGRAINE RELIEF sumatriptan 50 mg (as succinate) tablet blister pack	378472	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	11/22/2021
Sumatriptan 25 mg tablet bottle	346502	Alphapharm Pty Ltd	Medicine	A	10/23/2020

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