Rizatriptan

Overview

Rizatriptan is a second-generation triptan and a selective 5-HT receptor agonist. Used in the treatment of migraines, rizatriptan was first approved in the US in 1998. Rizatriptan is available in oral tablets, orally disintegrating tablets (wafers), and oral film formulations.

Indication

Rizatriptan is indicated for the acute treatment of diagnosed migraine with or without aura. Rizatriptan is not indicated for the prophylactic therapy of migraine nor the treatment of cluster headache. In Canada, rizatriptan is approved in adults. In the US, the oral tablet formulations are used in patients six years of age and older and the oral film formation is approved for patients 12 years of age and older weighing 40 kg or more.

Associated Conditions

Migraine With Aura
Migraine Without Aura
Migraine with acute onset aura

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Comparison of Nurtec ODT to Maxalt MLT-ODT in Adult ED Patients With Migraine Headache	2024/06/25	NCT06473597	Phase 4	Recruiting	Antonios Likourezos
Efficacy and Safety of Rizatriptan-Naproxen (10/550 Mg) in the Acute Treatment of Migraine	2020/05/12	NCT04384367	Phase 3	Completed	Eurofarma Laboratorios S.A.
Maximizing Outcomes in Treating Acute Migraine	2019/03/29	NCT03896009	Phase 3	Completed	Axsome Therapeutics, Inc.
Rizatriptan for Episodic Dizziness in Vestibular Migraine	2015/05/19	NCT02447991	Phase 2	Completed	Robert W. Baloh
Study of Rizatriptan in the Treatment of Acute Attacks of Post-traumatic Headache in U.S. Military Troops	2011/03/01	NCT01306266	Not Applicable	Withdrawn	Henry M. Jackson Foundation for the Advancement of Military Medicine
Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)	2011/01/31	NCT01286207	Phase 3	Completed	Organon and Co
Rizatriptan 10 MG RPD in the Treatment of Acute Migraine	2010/01/27	NCT01057160	Phase 4	Completed	Universität Duisburg-Essen
A Study to Evaluate the Safety and Tolerability of Rizatriptan for Long Term Treatment of Acute Migraine in Children and Adolescents (MK-0462-086 AM3)	2009/10/29	NCT01004263	Phase 3	Completed	Organon and Co
A Study to Evaluate the Efficacy and Tolerability of Rizatriptan for Treatment of Acute Migraine in Children and Adolescents (MK-0462-082 AM7)	2009/10/26	NCT01001234	Phase 3	Completed	Organon and Co
Treatment of Multiple Attacks of Acute Migraine (0462-025)	2009/05/12	NCT00899379	Phase 3	Completed	Organon and Co

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Rizatriptan Benzoate	Aurobindo Pharma Limited	65862-625	ORAL	5 mg in 1 1	2/19/2024
Rizatriptan Benzoate	Aurobindo Pharma Limited	65862-626	ORAL	10 mg in 1 1	2/19/2024
Rizatriptan Benzoate	Exelan Pharmaceuticals Inc.	76282-462	ORAL	5 mg in 1 1	5/1/2020
Rizatriptan Benzoate	Creekwood Pharmaceuticals LLC	82619-111	ORAL	5 mg in 1 1	9/13/2023
Rizatriptan Benzoate	NuCare Pharmaceuticals,Inc.	68071-3568	ORAL	10 mg in 1 1	2/2/2024
Rizatriptan Benzoate	Unichem Pharmaceuticals (USA), Inc.	29300-317	ORAL	10 mg in 1 1	11/22/2022
Rizatriptan Benzoate	Proficient Rx LP	71205-644	ORAL	10 mg in 1 1	5/1/2022
Rizatriptan Benzoate	Cipla USA Inc.	69097-865	ORAL	5 mg in 1 1	5/1/2020
Rizatriptan Benzoate	Bryant Ranch Prepack	71335-0810	ORAL	5 mg in 1 1	2/1/2022
Rizatriptan Benzoate	Ascend Laboratories, LLC	67877-261	ORAL	5 mg in 1 1	11/30/2021

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
Rizatriptan Monobenzoate Capsules	四川梓橦宫药业股份有限公司	国药准字H20060352	化学药品	胶囊剂	12/29/2020
Rizatriptan Monobenzoate Tablets	山东步长制药股份有限公司	国药准字H20143331	化学药品	片剂	1/16/2024
Rizatriptan Monobenzoate Tablets	湖北蝴蝶兰药业有限公司	国药准字H20080740	化学药品	片剂	6/21/2023

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
RIZATRIPTAN TW rizatriptan (as benzoate) 10 mg orally disintegrating tablets blisters	222203	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/20/2015
RIZATRIPTAN ODT GH rizatriptan (as benzoate) 10 mg orally disintegrating tablet blister pack	220027	Generic Health Pty Ltd	Medicine	A	2/19/2015
RIZATRIPTAN AH rizatriptan (as benzoate) 5 mg orally disintegrating tablets blisters	222208	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/20/2015
GXP RIZATRIPTAN rizatriptan (as benzoate) 10 mg orally disintegrating tablets blisters	222197	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/20/2015
RIZATRIPTAN AS rizatriptan (as benzoate) 10 mg orally disintegrating tablets blisters	222198	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/20/2015
RIZATRIPTAN TW rizatriptan (as benzoate) 5 mg orally disintegrating tablets blisters	222200	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	3/20/2015
RIZATRIPTAN-MEDIS rizatriptan (as benzoate) 10 mg orodispersible tablet blister pack	220029	Medis Pharma Pty Ltd	Medicine	A	2/19/2015
RIZATRIPTAN ODT GH rizatriptan (as benzoate) 5 mg orally disintegrating tablet blister pack	220036	Generic Health Pty Ltd	Medicine	A	2/19/2015
RIZATRIPTAN-AU rizatriptan (as benzoate) 5 mg orodispersible tablet blister pack	220023	Medsurge Pharma Pty Ltd	Medicine	A	2/19/2015
MAXALT MIGRAINE RELIEF rizatriptan 5 mg (as benzoate) wafer blister pack	407853	ORGANON PHARMA PTY LTD	Medicine	A	4/18/2023

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