Ajovy

(Fremanezumab)

ApprovedMonoclonal antibody

Fremanezumab is used to prevent migraines by reducing how often they occur. It works by blocking a protein in the brain that is involved in migraine pain.[2] Ajovy is currently approved and in use across 5 indications[4].[1]

Ajovy is one of 139 monoclonal antibody programs targeting Migraine. It is currently in Approved.

Indications

Total Trials

Active Trials

138

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

MigraineUnknown status

Migraine DisorderUnknown

Increased Circulating Prolactin ConcentrationUnknown

HyperprolactinemiaUnknown

Major Depressive DisorderCompleted

MigraineApproved

Unknown status

Migraine DisorderPreclinical

Unknown

Increased Circulating Prolactin ConcentrationPreclinical

Unknown

HyperprolactinemiaPreclinical

Unknown

Major Depressive DisorderApproved

Completed

Competition

Competitive Landscape

120 competitors in Major Depressive Disorder

#DrugCompanyPhaseTrials

Ajovy

Teva

Approved

1 2

Seroquel

EEngelhard Arzneimittel GmbH & Co.KG

Phase 3

12 3

Ketalar

Boehringer Ingelheim

Phase 3

3 4

Lithobid

SSolvay Pharmaceuticals

Phase 3

1 5

Clozaril

LLife Extension Foundation Inc.

Phase 3

1 6

Sunosi

AAxsome Therapeutics, Inc.

Phase 3

1 7

Psilocybin

COMPASS Pathways

Phase 3

11 8

Esketamine Hydrochloride

TThe Second Hospital of Anhui Medical University

Phase 3

2 9

Aticaprant

Johnson & Johnson

Phase 3

4 10

Selective Serotonin Reuptake Inhibitor

Johnson & Johnson

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Recruiting

Migraine

NCT04628429

Q1 2027

Recruiting

Migraine

NCT06659120

Q2 2029

Recruiting

Migraine Disorders

NCT05342493

Clinical

Trials by Indication[1]

Migraine21 trials

Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine

Completed· Teva logo

Teva·Phase 3·NCT02629861·875 enrolled

Migraine Medication Effects on Urinary Symptoms

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

Efficacy of AJOVY (Fremanezumab-vfrm) on Interictal Migraine Related Burden

Completed·DDavid True·Phase 4·NCT04461795·40 enrolled

Show 18 more trials

The FreMRI Study: Advanced MRI on Migraine Patients Treated With Fremanezumab

Unknown status·HHospital Clínico Universitario de Valladolid·Phase 4·NCT06244823·87 enrolled

Medicinal vs. Orthotic Comparison for Migraine Prevention: A Double-Blind Study

Unknown status·MManhattan Beach Orthodontics·N/A·NCT04547179·80 enrolled

CGRP Inhibition, Autonomic Function, and Migraine

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

Real World Effectiveness of Eptinezumab in Participants With Migraine

Terminated· Lundbeck logo

Lundbeck·Phase 4·NCT05284019·32 enrolled

Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine

Completed· Teva logo

Teva·Phase 3·NCT02638103·1,890 enrolled

Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL

Withdrawn·MMayo Clinic·Phase 2·NCT04334408

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

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

Fremanezumab, Migraine and Sleep

Terminated·—·Phase 4·NCT04693533·22 enrolled

Fremanezumab for the Prevention of Menstrually-related Migraine Attacks

Recruiting·IInsel Gruppe AG, University Hospital Bern··NCT06659120·120 enrolled

A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Participants 6 to 17 Years of Age

Completed· Teva logo

Teva·Phase 3·NCT04464707·292 enrolled

Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine

Completed· Teva logo

Teva·Phase 3·NCT02621931·1,130 enrolled

An Efficacy and Safety Study of Fremanezumab in Adults With Migraine

Completed· Teva logo

Teva·Phase 3·NCT03308968·838 enrolled

A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine

Completed· Teva logo

Teva·Phase 3·NCT05458011·365 enrolled

Improving the Perception of Stress and Mutuality in Caregivers (MI-DEAR Study) of Migraine Patients With Depressive Symptoms Treated With Fremanezumab: A Prospective Real-life Observational Study to Evaluate Whether Fremanezumab Reduces the Impact on Caregivers and Increases Couple Reciprocity

Completed·FFondazione Policlinico Universitario Campus Bio-Medico··NCT07029126·308 enrolled

A Single Center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Fremanezumab (675 mg Quarterly) in Female Patients Aged 18-45 With Menstrual Migraine

Completed·BBrigham and Women's Hospital·Approved·NCT06173661·15 enrolled

Fremanezumab (TEV-48125) Compassionate Use Program for Pediatric Patients (6 to 17 Years) With Chronic or Episodic Migraine

Available· Teva logo

Teva··NCT03539393

A Multicenter, Open-Label Study Evaluating the Long-Term Safety, Tolerability, and Efficacy of Monthly Subcutaneous Administration of Fremanezumab for the Preventive Treatment of Episodic and Chronic Migraine in Pediatric Patients 6 to 17 Years of Age

Completed· Teva logo

Teva·Phase 3·NCT04530110·499 enrolled

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy, Safety, and Tolerability of Subcutaneous Administration of Fremanezumab Versus Placebo for the Preventive Treatment of Episodic Migraine in Pediatric Patients 6 to 17 Years of Age

Completed· Teva logo

Teva·Phase 3·NCT04458857·235 enrolled

Cluster headache3 trials

A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH)

Terminated· Teva logo

Teva·Phase 3·NCT02945046·169 enrolled

A Study Comparing the Efficacy and Safety of Fremanezumab (TEV-48125) for the Prevention of Chronic Cluster Headache (CCH)

Terminated· Teva logo

Teva·Phase 3·NCT02964338·259 enrolled

A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache

Terminated· Teva logo

Teva·Phase 3·NCT03107052·275 enrolled

Fibromyalgia1 trial

A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia

Terminated· Teva logo

Teva·Phase 2·NCT03965091·189 enrolled

Headache1 trial

A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH)

Completed· Teva logo

Teva·Phase 2·NCT03347188·87 enrolled

Major Depressive Disorder1 trial

A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder

Completed· Teva logo

Teva·Phase 4·NCT04041284·353 enrolled

2 more indications

Interstitial Cystitis1 trial

A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain Syndrome

Withdrawn· Teva logo

Teva·Phase 2·NCT04447729

Migraine Disorders1 trial

AJOVY Subcutaneous Injection Long-term Specified Use-results Survey

Recruiting· Otsuka logo

Otsuka··NCT05342493·1,000 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 14, 2018

AJOVY

NDA BLA761089

Sep 14, 2018

AJOVY

BLA BLA761089

Jan 27, 2020

AJOVY

NDA BLA761089

Sep 24, 2021

AJOVY

NDA BLA761089

Mar 21, 2025

AJOVY

NDA BLA761089

Aug 5, 2025

AJOVY

NDA BLA761089

Jun 5, 2026

AJOVY

NDA BLA761089

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for Fremanezumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ajovy drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fremanezumab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fremanezumab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761089). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Fremanezumab. U.S. National Library of Medicine.
[7]
SEC EDGAR — Teva 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: Teva

Key Publications[6]

Fremanezumab Quarterly in Chronic Migraine: Long-Term Safety

HeadacheJan 5, 2023DOI: 10.1111/head.14466

Ajovy

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2029

Trials by Indication[1]

Migraine21 trials

Cluster headache3 trials

Fibromyalgia1 trial

Headache1 trial

Major Depressive Disorder1 trial

Interstitial Cystitis1 trial

Migraine Disorders1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

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