Eptinezumab

Overview

Eptinezumab is a fully-humanized IgG1 antibody manufactured using yeast (Pichia pastoris) and developed by Lundbeck Seattle Biopharmaceuticals. Eptinezumab has been specifically designed to bind to both alpha and beta forms of the human calcitonin gene-related peptide (CGRP). It was approved by the FDA in February 2020 for the preventive treatment of migraine headaches in adults.

Indication

Eptinezumab is indicated for the preventive treatment of migraine in adults.

Associated Conditions

Migraine

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Facilitators and Barriers to Eptinezumab Administration in Thailand	2025/06/25	NCT07035197	N/A	Not yet recruiting	Chulalongkorn University
A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications	2024/11/22	NCT06701526	Phase 4	Recruiting	H. Lundbeck A/S
The Effectiveness of Eptinezumab During a Migraine Attack (the BE-FREE Study): a TACHIS Sub-study	2024/10/08	NCT06628921	N/A	Not yet recruiting	University of Florence
Effectiveness and Tolerability of Eptinezumab	2024/05/10	NCT06409845	N/A	Recruiting	University of Florence
Migraine Medication Effects on Urinary Symptoms	2024/01/19	NCT06212661	N/A	ENROLLING_BY_INVITATION	The Cleveland Clinic
A Study of CGRP Monoclonal Antibody to Treat Diabetic Neuropathy	2023/07/10	NCT05937152	Phase 2	Withdrawn	Mayo Clinic
A Study of Eptinezumab in Pediatric Participants With Episodic Migraine	2023/06/09	NCT05897320	Phase 3	Recruiting	H. Lundbeck A/S
Migraine Induction Properties of PACAP-38 After Eptinezumab in Migraine Without Aura Patients.	2022/12/02	NCT05635604	Not Applicable	Completed	Danish Headache Center
EptinezuMaB in ReAl-world evidenCE: Multicenter, Real Life, Cohort Study in Migraine.	2022/10/06	NCT05570149	N/A	Recruiting	IRCCS San Raffaele Roma
A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache	2022/07/11	NCT05452239	Phase 4	Completed	H. Lundbeck A/S

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Vyepti	Lundbeck Pharmaceuticals LLC	67386-130	INTRAVENOUS	100 mg in 1 mL	10/21/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Vyepti	H. Lundbeck A/S,Ottiliavej 9,DK-2500 Valby,Denmark	Authorised	1/24/2022

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
VYEPTI CONCENTRATE FOR SOLUTION FOR INFUSION 100MG/ML	Vetter Pharma-Fertigung GmbH & Co. KG	SIN16325P	INFUSION, SOLUTION CONCENTRATE	100 MG/ML	9/16/2021

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
VYEPTI eptinezumab 100 mg/mL concentrated injection single use vial	335256	Lundbeck Australia Pty Ltd	Medicine	A	6/16/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
VYEPTI	Lundbeck Canada Inc	02510839	Solution - Intravenous	100 MG / ML	8/17/2022
VYEPTI	Lundbeck Canada Inc	02542269	Solution - Intravenous	300 MG / 3 ML	7/1/2024

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
VYEPTI 100 MG CONCENTRADO PARA SOLUCION PARA PERFUSION	H. Lundbeck A/S	1211599001	CONCENTRADO Y DISOLVENTE PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	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.

Related News

Lundbeck's Eptinezumab Shows Strong Efficacy in Asian Chronic Migraine Patients in Phase III SUNRISE Trial

a month ago

H. Lundbeck A/S announced positive results from the SUNRISE phase III trial, demonstrating eptinezumab's efficacy in a predominantly Asian population with chronic migraine.

Lundbeck's Vyepti Demonstrates Sustained Efficacy in Migraine Prevention at AAN 2025

4 months ago

New data presented at AAN 2025 shows Lundbeck's Vyepti provides sustained efficacy for migraine prevention, with significant improvements in patient-reported outcomes including brain fog reduction.

FDA Accepts Teva's Application for AJOVY in Pediatric Migraine Prevention, Potentially First CGRP Antagonist for Children

4 months ago

The FDA has accepted Teva Pharmaceuticals' supplemental Biologics License Application for AJOVY (fremanezumab) to expand its indication to include prevention of episodic migraine in children and adolescents aged 6-17 years weighing at least 45 kg.

ACP Issues New Treatment Guidelines for Episodic Migraine Management

6 months ago

The American College of Physicians has released new guidelines for treating episodic migraine, recommending a three-tiered approach based on systematic review of nine medication classes.

Vyepti Demonstrates Efficacy in Patients with Chronic Migraine and Medication-Overuse Headache

8 months ago

The RESOLUTION trial demonstrated that Vyepti (eptinezumab) is effective for patients with chronic migraine and medication-overuse headache (MOH).

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