Aimovig

(Erenumab)

ApprovedMonoclonal antibody

Erenumab is used to prevent migraines by blocking a protein in the brain called CGRP that is involved in migraine pain. It is given as a monthly injection to reduce how often migraines occur.[2] Aimovig is currently approved and in use across 9 indications[4].[1]

Aimovig is one of 173 monoclonal antibody programs targeting Facial Pain. It is currently in Approved.

Indications

Total Trials

Active Trials

172

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Facial PainActive, not recruiting

Headache DisorderActive, not recruiting

COVID-19Active, not recruiting

Increased Circulating Prolactin ConcentrationUnknown

HyperprolactinemiaUnknown

Migraine DisorderUnknown

MigraineCompleted

TreatmentCompleted

SchwannomatosisRecruiting

Facial PainApproved

Active, not recruiting

Headache DisorderPreclinical

Active, not recruiting

COVID-19Preclinical

Active, not recruiting

Increased Circulating Prolactin ConcentrationPreclinical

Unknown

HyperprolactinemiaPreclinical

Unknown

Migraine DisorderPreclinical

Unknown

MigraineApproved

Completed

TreatmentApproved

Completed

SchwannomatosisPhase 2

Recruiting

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Aimovig

Amgen

Approved

3 2

Dexilant

Takeda

Preclinical

2 3

Alfenta

Jazz Pharmaceuticals

Preclinical

1 4

Niclocide

Bayer

Preclinical

1 5

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 6

Valium

Akero Therapeutics

Preclinical

2 7

Lotemax

PPharmos

Preclinical

1 8

Norpramin

VValidus Pharmaceuticals

Preclinical

1 9

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

1 10

Clomid

Ferring

Preclinical

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Migraine

NCT03836040

Recruiting

Migraine

NCT04628429

Q2 2027

Phase 2Recruiting

Treatment

NCT05049057

Q4 2027

Recruiting

Pregnancy

NCT06150781

Q4 2028

Phase 2Recruiting

Schwannomatosis

NCT05684692

Clinical

Trials by Indication[1]

Migraine33 trials

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

Completed· Amgen logo

Amgen·Phase 3·NCT02456740·955 enrolled

Hypersensitivity to CGRP as a Predictive Biomarker of Migraine Prevention With Erenumab

Unknown status·DDanish Headache Center·Phase 4·NCT04592952·400 enrolled

Migraine Medication Effects on Urinary Symptoms

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

Show 30 more trials

Efficacy of Erenumab on Functional Impact of Migraine

Completed·MMerle Diamond·Phase 4·NCT04465357·55 enrolled

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention

Completed· Amgen logo

Amgen·Phase 3·NCT02483585·577 enrolled

Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients

Completed· Novartis logo

Novartis·Phase 3·NCT03867201·557 enrolled

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

Completed· Amgen logo

Amgen·Phase 3·NCT03832998·284 enrolled

Treatment of Chronic Migraine With Erenumab Alone or as an Add on Therapy

Completed·CClinique des Céphalées de Montréal··NCT04152434·158 enrolled

Study of Quality of Life in Subjects With Chronic or High-frequency Episodic Migraine and Associated Comorbidities Treated With Erenumab

Withdrawn· Novartis logo

Novartis·Phase 3·NCT04114630

To Evaluate the Blockade of CGRP in Preventing PACAP-38 Induced Migraine-like Attacks With AMG 334 in Migraine Patients

Completed· Amgen logo

Amgen·Phase 1·NCT02542605·35 enrolled

Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine

Completed· Novartis logo

Novartis·Phase 4·NCT03828539·777 enrolled

Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study

Unknown status·AAustrian Migraine Registry Collaboration··NCT05281770·1,500 enrolled

Neurophysiological, Biomolecular and Psychological Aspects of Erenumab Treatment in Chronic Migraine

Unknown status·IIRCCS National Neurological Institute "C. Mondino" Foundation··NCT04361721·40 enrolled

Ascending Single Doses of Erenumab (AMG 334) in Healthy Adults and Migraine Patients

Completed· Amgen logo

Amgen·Phase 1·NCT01688739·61 enrolled

Real World Effectiveness of Eptinezumab in Participants With Migraine

Terminated· Lundbeck logo

Lundbeck·Phase 4·NCT05284019·32 enrolled

A Controlled Trial of Erenumab in Migraine Prevention

Completed· Amgen logo

Amgen·Phase 3·NCT03812224·261 enrolled

A Study to Assess the Long-term Safety and Efficacy of Erenumab (AMG 334) in Chronic Migraine Prevention.

Completed· Amgen logo

Amgen·Phase 2·NCT02174861·609 enrolled

Study of Efficacy and Safety of AMG 334 in Adult Episodic Migraine Patients

Completed· Novartis logo

Novartis·Phase 3·NCT03333109·900 enrolled

Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine

Completed· Amgen logo

Amgen·Phase 4·NCT04252742·512 enrolled

Ascending Multiple-Doses of Erenumab (AMG 334) in Healthy Adults and in Migraine Patients

Completed· Amgen logo

Amgen·Phase 1·NCT01723514·48 enrolled

Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention

Completed· Amgen logo

Amgen·Phase 2·NCT01952574·483 enrolled

Registry for Migraine - Structural and Functional MRI Before and After Erenumab Treatment

Unknown status·DDanish Headache Center·Phase 4·NCT04674020·250 enrolled

A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT04294147·65 enrolled

Registry for Migraine - Clinical Core

Unknown status·DDanish Headache Center·Phase 4·NCT04603976·1,000 enrolled

CGRP Inhibition, Autonomic Function, and Migraine

Recruiting·MMedical University of Vienna··NCT04628429·120 enrolled

Effect of Erenumab-aooe on Disability and Work Productivity in Employed Subjects With Episodic Migraine

Terminated· Amgen logo

Amgen·Phase 4·NCT03912337·29 enrolled

A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention

Completed· Amgen logo

Amgen·Phase 2·NCT02630459·475 enrolled

Imaging the Migraine Brain Pre- and Post-Erenumab

Completed·MMayo Clinic·Phase 4·NCT03773562·50 enrolled

A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention

Completed· Amgen logo

Amgen·Phase 2·NCT02066415·667 enrolled

A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine

Completed· Amgen logo

Amgen·Phase 4·NCT04825678·240 enrolled

A Functional MRI Study on Erenumab Treatment Effects in Episodic Migraine Patients

Completed· Novartis logo

Novartis·Phase 4·NCT03977649·62 enrolled

Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study

Completed· Novartis logo

Novartis·Phase 4·NCT04084314·701 enrolled

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM])

Active, not recruiting· Amgen logo

Amgen·Phase 3·NCT03836040·457 enrolled

Treatment3 trials

Predictive Role of MIDAS Reduction at 3 Months for Erenumab Treatment

Completed·IIRCCS National Neurological Institute "C. Mondino" Foundation··NCT05442008·53 enrolled

Treatment of Acute PTH With a CGRP Receptor mAb in Military Service Members and Civilians With mTBI

Recruiting·HHenry M. Jackson Foundation for the Advancement of Military Medicine·Phase 2·NCT05049057·404 enrolled

Biomarker and Genetic Predictors of Erenumab Treatment Response

Completed· Amgen logo

Amgen·Phase 4·NCT04265755·1,406 enrolled

Headache3 trials

A Study to Evaluate the Efficacy and Safety of Erenumab in Adults With Medication Overuse Headache

Completed· Amgen logo

Amgen·Phase 4·NCT03971071·620 enrolled

The Effect of Anti-calcitonin Gene-related Peptide (CGRP) Receptor Antibodies on the Headache Inducing Properties of CGRP and Cilostazol in Migraine Patients

Unknown status·DDanish Headache Center·N/A·NCT04452929·72 enrolled

China HeadAche DIsorders RegiStry

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

Interaction2 trials

Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females

Completed· Amgen logo

Amgen·Phase 1·NCT02792517·41 enrolled

Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine

Completed· AbbVie logo

AbbVie·Phase 1·NCT04179474·40 enrolled

Hot flashes1 trial

Study of Erenumab (AMG 334) in Women With Hot Flashes

Completed· Amgen logo

Amgen·Phase 1·NCT01890109·103 enrolled

14 more indications

Intravenous1 trial

Study of Intravenous Erenumab in Patients With Status Migrainosus

Withdrawn·MMayo Clinic·Phase 1·NCT04920331

Prevention1 trial

Multidisciplinary Translational Approach to Investigate Mechanisms Predictors & Prevention of Persistent PTH

Completed·MMayo Clinic·Phase 2·NCT04098250·6 enrolled

Facial Pain1 trial

Erenumab for Idiosyncratic Facial Pain

Completed·—·Phase 4·NCT04249427·29 enrolled

Temporomandibular Disorders1 trial

Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)

Terminated·UUniversity of Maryland, Baltimore·Phase 2·NCT05162027·5 enrolled

Pregnancy1 trial

Aimovig Pregnancy Exposure Registry

Recruiting· Amgen logo

Amgen··NCT06150781·2,842 enrolled

Neuropathic Pain1 trial

Erenumab-aooe for the Management of Trigeminal Neuropathic Pain.

Terminated·UUniversity of Maryland, Baltimore·Phase 2·NCT05142228·5 enrolled

Trigeminal Neuralgia1 trial

Efficacy and Tolerability of Erenumab in Patients With Trigeminal Neuralgia

Unknown status·DDanish Headache Center·Phase 2·NCT04054024·80 enrolled

Blood Pressure1 trial

Study to Evaluate the Effect of Erenumab on Blood Pressure When Given Concomitantly With Subcutaneous Sumatriptan

Completed· Amgen logo

Amgen·Phase 1·NCT02741310·34 enrolled

Hemicrania Continua1 trial

Erenumab For Treatment of Hemicrania Continua

Terminated·MMayo Clinic·Phase 2·NCT04303845·2 enrolled

Cardiovascular1 trial

Treadmill Cardiovascular Safety Study of Erenumab (AMG 334)

Completed· Amgen logo

Amgen·Phase 2·NCT02575833·89 enrolled

Fibromyalgia1 trial

Investigational Use of Erenumab for the Treatment of Fibromyalgia Pain

Withdrawn·UUnited States Naval Medical Center, Portsmouth·Phase 3·NCT06411067

COVID-191 trial

Management of Migraine Using Enerumab and Traditional Therapy at the Time of COVID-19

Completed·FFayoum University··NCT05052008·90 enrolled

Cluster headache1 trial

Efficacy of Erenumab in Chronic Cluster Headache

Completed·—·Phase 2·NCT04970355·101 enrolled

Schwannomatosis1 trial

Screening Trial for Pain Relief in Schwannomatosis (STARFISH)

Recruiting·MMassachusetts General Hospital·Phase 2·NCT05684692·40 enrolled

Regulatory

FDA Approval Timeline[5]

May 17, 2018

AIMOVIG

NDA BLA761077

May 17, 2018

AIMOVIG

BLA BLA761077

Oct 4, 2019

AIMOVIG

NDA BLA761077

Feb 15, 2020

AIMOVIG

NDA BLA761077

Apr 30, 2020

AIMOVIG

NDA BLA761077

Feb 3, 2021

AIMOVIG

NDA BLA761077

May 11, 2021

AIMOVIG

NDA BLA761077

Mar 4, 2022

AIMOVIG

NDA BLA761077

Aug 15, 2022

AIMOVIG

NDA BLA761077

Sep 22, 2022

AIMOVIG

NDA BLA761077

Oct 3, 2022

AIMOVIG

NDA BLA761077

Aug 6, 2024

AIMOVIG

NDA BLA761077

Mar 21, 2025

AIMOVIG

NDA BLA761077

Jun 19, 2025

AIMOVIG

NDA BLA761077

Sources

References

[1]
ClinicalTrials.gov — 56 trial records for Erenumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aimovig drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Erenumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Erenumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761077). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Erenumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — Amgen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: CGRP Receptor Antagonist[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Amgen

Key Publications[6]

Erenumab in Episodic and Chronic Migraine: 5-Year Safety Extension

CephalalgiaApr 15, 2023DOI: 10.1177/03331024231162754

Aimovig

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Migraine33 trials

Treatment3 trials

Headache3 trials

Interaction2 trials

Hot flashes1 trial

Intravenous1 trial

Prevention1 trial

Facial Pain1 trial

Temporomandibular Disorders1 trial

Pregnancy1 trial

Neuropathic Pain1 trial

Trigeminal Neuralgia1 trial

Blood Pressure1 trial

Hemicrania Continua1 trial

Cardiovascular1 trial

Fibromyalgia1 trial

COVID-191 trial

Cluster headache1 trial

Schwannomatosis1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News