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Drug

Eptinezumab

Approved medicine
ClassCalcitonin gene-related peptide inhibitorResearchActive indication expansion

Also known as Vyepti.

RxNorm2282660ChEMBLCHEMBL3833320ATCN02CD05UNII8202AY8I7H
7
Active clinical trials
2
Protein targets
9
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

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

Clinical trial2026-09-05Primary completion · ClinicalTrials.gov

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Clinical trial2026-06-17Results expected Q3 2031 · ClinicalTrials.gov

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

Clinical trial2026-06-12Results expected Q3 2027 · ClinicalTrials.gov

Long-term, Open-label (Dose-blinded), Extension Study of Eptinezumab in Children and Adolescents With Chronic or Episodic Migraine

Clinical trial2026-06-12Results expected Q2 2028 · ClinicalTrials.gov

Prevention of Chronic Headache in Patients Diagnosed With Idiopathic Intracranial Hypertension With a Monoclonal Anti-calcitonin Gene-related Peptide Antibody: A Double-blinded Randomized Placebo-controlled Multicentre Trial

Clinical trial2026-06-12Results expected Q2 2028 · ClinicalTrials.gov

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

Clinical trial2026-06-05Primary completion · ClinicalTrials.gov

Label change: EPTINEZUMAB-JJMR (BLA761119)

Regulatory2026-06-05FDA

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache

Clinical trial2026-01-29Results posted · ClinicalTrials.gov

Eptinezumab as an Adjunct to Standard of Care for MIGRANE in an Acute EmeRgency Context (Migraine ERase Study)

Clinical trial2025-12-30Primary completion · ClinicalTrials.gov

Indication expansion: EPTINEZUMAB-JJMR (BLA761119)

Regulatory2025-10-22FDA

Indication expansion: EPTINEZUMAB-JJMR (BLA761119)

Regulatory2025-08-18FDA

Label change: EPTINEZUMAB-JJMR (BLA761119)

Regulatory2025-03-21FDA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Eptinezumab
Aliases & brands
Vyepti
RxNorm CUI
2282660
ChEMBL ID
CHEMBL3833320
ATC codes
N02CD05
UNII
8202AY8I7H
Primary mechanism
Calcitonin gene-related peptide inhibitor
Regulatory jurisdictions
emafda

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Calcitonin gene-related peptide 1
CALCA · P06881
INHIBITORCalcitonin gene-related peptide inhibitor
Calcitonin gene-related peptide 2
CALCB · P10092
INHIBITORCalcitonin gene-related peptide inhibitor

Regulatory timeline

9 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2020-02-21 → 2022-01-24)
Earliest approval
2020-02-21
Latest approval
2025-10-22
Authorities
FDA · EMA
Total events
9
fdaU.S. Food and Drug Administration· 8 events
2026-06-05Label change
Label change: EPTINEZUMAB-JJMR (BLA761119)
Evidence ↗
2025-10-22Indication expansion
Indication expansion: EPTINEZUMAB-JJMR (BLA761119)
Evidence ↗
2025-08-18Indication expansion
Indication expansion: EPTINEZUMAB-JJMR (BLA761119)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2022-01-24ApprovalMulti-authority
Approval: Vyepti (EMA)

Indication: Vyepti is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

22 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
22
registered trials across all phases
LATEST COMPLETION 2025
7
Active studies
6
Recruiting
18
Late-stage (III+)
12
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 22
Phase 13Phase 21Phase 313Phase 44Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Comparative Outcomes of Migraine Preventives and Anti-CGRP Therapies for Tinnitus in Patients With Migraine: A Randomized Active-Comparator Controlled Trial (COMPACT-PM)

Not yet recruitingPH IVStanford Universityn=1202031

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

Active, not recruitingPH IVH. Lundbeck A/Sn=1642026

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache

CompletedPH IVH. Lundbeck A/Sn=6082025

An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States

TerminatedPH IVH. Lundbeck A/Sn=322023

Prevention of Chronic Headache in Patients Diagnosed With Idiopathic Intracranial Hypertension With a Monoclonal Anti-calcitonin Gene-related Peptide Antibody: A Double-blinded Randomized Placebo-controlled Multicentre Trial

Not yet recruitingPH IIIRigmor Højland Jensenn=962029

Recent completions

Trials that read out recently, adding to the completed evidence base.

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of add-on Eptinezumab Treatment to Brief Educational Intervention for the Preventive Treatment of Migraine in Patients With Dual Diagnosis of Migraine and Medication Overuse Headache

CompletedPH IVH. Lundbeck A/Sn=6082025

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine

CompletedPH IIIH. Lundbeck A/Sn=9812025

Interventional, Open-label, Fixed-dose, Long-term Extension Study to Evaluate Safety of Eptinezumab as Preventive Treatment in Patients With Migraine

CompletedPH IIIH. Lundbeck A/Sn=1602024

Interventional, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Delayed-Start Study to Evaluate the Efficacy and Safety of Eptinezumab in Patients With Episodic Cluster Headache

CompletedPH IIIH. Lundbeck A/Sn=2312023

An Open-label, Single-dose, Pharmacokinetic Study to Evaluate IV Eptinezumab in Children and Adolescents With Migraine, Followed by an Optional, Multiple-dose, Open-label Extension Period

CompletedPH IH. Lundbeck A/Sn=282023

Molecular Stratification of Signaling Pathways Underlying Migraine Pathophysiology.

CompletedN/ADanish Headache Centern=382023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.