Almotriptan

Overview

Almotriptan is a triptan drug for the treatment of migraine headaches. Almotriptan is in a class of medications called selective serotonin receptor agonists. It works by narrowing blood vessels in the brain, stopping pain signals from being sent to the brain, and stopping the release of certain natural substances that cause pain, nausea, and other symptoms of migraine. Almotriptan does not prevent migraine attacks.

Indication

For the treatment of acute migraine headache in adults

Associated Conditions

Migraine

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Evaluation of the Efficacy of Almotriptan and Ubrogepant for the Acute Treatment of Migraine	2022/01/28	NCT05214001	Phase 4	Terminated	Messoud Ashina, MD
Detoxification and Treatment of Subjects With Medication Overuse Headache	2007/02/08	NCT00432549	Phase 4	UNKNOWN	The New England Center for Headache, P.C.
A 1-year Study in Adolescents to Assess the Long-term Safety of Almotriptan Malate When Treating Their Migraine Headaches	2005/11/22	NCT00257010	Phase 3	Completed	Janssen-Ortho LLC
Evaluation of Histamine, CGRP and VIP as Markers for Activation of Trigeminal and Parasympathetic Nerve Fibers	2005/09/21	NCT00208065	Phase 4	Completed	Clinvest
Potential Impact (Benefit) of Preventative Treatment With Topamax on the Effectiveness of Axert in the Acute Treatment of Migraine	2005/09/21	NCT00210496	Phase 4	Completed	Janssen-Ortho LLC
A Study of the Effectiveness and Safety of Almotriptan Versus Placebo in the Treatment of Migraine Headache	2005/09/21	NCT00210509	Phase 4	Completed	Janssen-Ortho LLC
A Study of 3 Dosage Strengths of Almotriptan Malate (AXERT®) in the Treatment of Acute Migraine in Adolescents	2005/09/21	NCT00210483	Phase 3	Completed	Janssen-Ortho LLC
The Effectiveness of Almotriptan Malate (AXERT®) 12.5 Milligrams When Taken at the Onset of Migraine Pain	2005/09/21	NCT00212823	Phase 4	Completed	Ortho-McNeil Neurologics, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
almotriptan	Ajanta Pharma USA Inc.	27241-042	ORAL	12.5 mg in 1 1	3/28/2023
Almotriptan Malate	Teva Pharmaceuticals USA, Inc.	0093-5261	ORAL	12.5 mg in 1 1	5/31/2017
almotriptan	Ajanta Pharma USA Inc.	27241-041	ORAL	6.25 mg in 1 1	3/28/2023
Almotriptan Malate	Teva Pharmaceuticals USA, Inc.	0093-5260	ORAL	6.25 mg in 1 1	5/31/2017
Almotriptan Malate	Mylan Pharmaceuticals Inc.	0378-5245	ORAL	6.25 mg in 1 1	5/9/2017
Almotriptan Malate	Mylan Pharmaceuticals Inc.	0378-5246	ORAL	12.5 mg in 1 1	5/9/2017
Axert	Physicians Total Care, Inc.	54868-5527	ORAL	12.5 mg in 1 1	10/10/2012

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
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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ALMOTRIPTAN CINFA 12,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Cinfa S.A.	78686	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ALMOTRIPTAN KERN PHARMA 12,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Kern Pharma S.L.	77647	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ALMOTRIPTAN SANDOZ 12,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Sandoz Farmaceutica S.A.	77527	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ALMOGRAN COMPRIMIDOS RECUBIERTOS	Almirall S.A.S.	355614-6	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
RIPTANAX 12.5 MG COMPRIMIDO RECUBIERTO CON PELICULA EFG	Bluefish Pharmaceuticals Ab (Publ)	78523	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ALMOGRAN 12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Almirall S.A.	62877	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ALMOTRIPTAN NORMON 12,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Laboratorios Normon S.A.	77646	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ALMOTRIPTAN VIR 12,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Industria Quimica Y Farmaceutica Vir S.A.	78763	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
AMIGNUL 12,5 mg COMPRIMIDOS RECUBIERTOS CON PELICULA	Almirall S.A.	63025	COMPRIMIDO RECUBIERTO CON PELÍCULA	Medicamento Sujeto A Prescripción Médica	Commercialized
ALMOTRIPTAN VIATRIS 12,5 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG	Viatris Limited	76943	COMPRIMIDO RECUBIERTO CON PELÍCULA	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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