Vyepti

(Eptinezumab)

ApprovedMonoclonal antibody

Eptinezumab is used to prevent migraine headaches in adults who have frequent migraines. It is given as an injection every three months to reduce how often migraines occur.[2] Vyepti is currently approved and in use across 7 indications[4].[1]

Vyepti is one of 103 monoclonal antibody programs targeting Migraine. It is currently in Approved.

Indications

Total Trials

Active Trials

102

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

MigraineCompleted

Migraine Without AuraActive, not recruiting

Headache DisorderApproved

Migraine DisorderUnknown

Chronic MigraineRecruiting

Posttraumatic HeadacheNot yet recruiting

MigraineApproved

Completed

Migraine Without AuraPreclinical

Active, not recruiting

Headache DisorderApproved

Approved

Migraine DisorderPreclinical

Unknown

Chronic MigrainePhase 3

Recruiting

Posttraumatic HeadachePhase 3

Not yet recruiting

Competition

Competitive Landscape

105 competitors in Migraine

#DrugCompanyPhaseTrials

Vyepti

Lundbeck

Approved

10 2

Magnesium

SSpherium Biomed

Phase 3

3 3

Triptans

Pfizer

Phase 3

2 4

Aspirin /d

TThe First Affiliated Hospital with Nanjing Medical University

Phase 3

1 5

Elismetrep

KKallyope Inc.

Phase 3

3 6

BAT7104

Teva

Phase 3

1 7

Flunarizine

AAspartes Pharmaceuticals, Inc.

Phase 3

9 8

Tizanidine Hydrochloride

EElan Pharmaceuticals

Phase 3

1 9

Bayer Aspirin

Bayer

Preclinical

2 10

Adempas

Bayer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Chronic Migraine

NCT04965675

Q3 2027

Recruiting

Study completion

NCT07035197

Phase 3Recruiting

Episodic Migraine

NCT05897320

Q4 2027

Phase 3Not yet recruiting

Posttraumatic Headache

NCT07191145

Q2 2028

Phase 3Recruiting

Migraine

NCT05164172

Clinical

Trials by Indication[1]

Migraine10 trials

Migraine Medication Effects on Urinary Symptoms

Enrolling by invitation·TThe Cleveland Clinic··NCT06212661·200 enrolled

A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT04418765·892 enrolled

Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context

Not yet recruiting·DDr George Medvedev·Phase 3·NCT06428838·102 enrolled

Show 7 more trials

Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT04921384·981 enrolled

A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine

Recruiting· Lundbeck logo

Lundbeck·Phase 3·NCT05164172·600 enrolled

A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT04537429·28 enrolled

Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT05064371·160 enrolled

Real World Effectiveness of Eptinezumab in Participants With Migraine

Terminated· Lundbeck logo

Lundbeck·Phase 4·NCT05284019·32 enrolled

A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT04152083·485 enrolled

Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies

Completed· Lundbeck logo

Lundbeck·Approved·NCT06701526·164 enrolled

Headache3 trials

A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache

Completed· Lundbeck logo

Lundbeck·Phase 4·NCT05452239·608 enrolled

Eptinezumab in Adults With Migraine and Medication Overuse Headache

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT04772742·193 enrolled

China HeadAche DIsorders RegiStry

Recruiting·BBeijing Tiantan Hospital··NCT05334927·10,000 enrolled

Cluster headache2 trials

A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH)

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT05064397·131 enrolled

Eptinezumab in Participants With Episodic Cluster Headache

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT04688775·231 enrolled

Adult1 trial

A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT05074459·84 enrolled

Migraine Without Aura1 trial

Migraine Induction Properties of PACAP-38 After Eptinezumab in Migraine Without Aura Patients.

Completed·DDanish Headache Center·N/A·NCT05635604·38 enrolled

6 more indications

Tics1 trial

Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT05045781·20 enrolled

Diabetic Neuropathy1 trial

A Study of CGRP Monoclonal Antibody to Treat Diabetic Neuropathy

Withdrawn·MMayo Clinic·Phase 2·NCT05937152

Episodic Migraine1 trial

Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine

Recruiting· Lundbeck logo

Lundbeck·Phase 3·NCT05897320·315 enrolled

Chronic Migraine1 trial

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of IV Eptinezumab in Adolescents (12-17 Years) for the Preventive Treatment of Chronic Migraine

Recruiting· Lundbeck logo

Lundbeck·Phase 3·NCT04965675·285 enrolled

Posttraumatic Headache1 trial

EarLy Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT): a Parallel Group, Randomized, Double Blind, Placebo Controlled Trial

Not yet recruiting·SSunnybrook Health Sciences Centre·Phase 3·NCT07191145·80 enrolled

Unspecified2 trials

Facilitators and Barriers to Eptinezumab Administration in Thailand

Recruiting·—··NCT07035197·30 enrolled

Eptinezumab in Healthy Japanese Subjects

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT04336449·18 enrolled

Regulatory

FDA Approval Timeline[5]

Feb 21, 2020

VYEPTI

BLA BLA761119

Feb 21, 2020

VYEPTI

NDA BLA761119

Sep 24, 2021

VYEPTI

NDA BLA761119

Oct 21, 2022

VYEPTI

NDA BLA761119

Mar 21, 2025

VYEPTI

NDA BLA761119

Mar 21, 2025

VYEPTI

NDA BLA761119

Aug 18, 2025

VYEPTI

NDA BLA761119

Oct 22, 2025

VYEPTI

NDA BLA761119

Jun 5, 2026

VYEPTI

NDA BLA761119

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Eptinezumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vyepti drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Eptinezumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Eptinezumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761119). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Eptinezumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — Lundbeck company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: CGRP Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Lundbeck

Key Publications[6]

Eptinezumab Infusion in Chronic Migraine: PROMISE-2 3-Year

HeadacheMay 10, 2023DOI: 10.1111/head.14510

Vyepti

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Q4 2027

Q2 2028

Trials by Indication[1]

Migraine10 trials

Headache3 trials

Cluster headache2 trials

Adult1 trial

Migraine Without Aura1 trial

Tics1 trial

Diabetic Neuropathy1 trial

Episodic Migraine1 trial

Chronic Migraine1 trial

Posttraumatic Headache1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

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