AJOVY (fremanezumab-vfrm)
AJOVY (fremanezumab-vfrm) is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine. The medication is approved for use in adults and in pediatric patients aged 6 to 17 years who weigh 45 kg or more. In the pediatric population, the drug is specifically indicated for the preventive treatment of episodic migraine.
How AJOVY Works
Fremanezumab-vfrm is a humanized monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) ligand. The drug functions by binding to the CGRP ligand, which prevents it from binding to its corresponding receptor. This action blocks the biological activity of CGRP to provide a preventive therapeutic effect for migraine.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-09-14
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AJOVY Approval History
What AJOVY Treats
1 indicationsAJOVY is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
AJOVY Target & Pathway
ProTarget
A neuropeptide involved in pain transmission and blood vessel dilation. CGRP levels rise during migraine attacks and contribute to headache pain. Blocking CGRP or its receptor prevents and treats migraines.
AJOVY Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
18 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06173661 | 2023p002389 | Ph 4 | active not recruiting | Fremanezumab Treatment of Migraine in Women With Menstrual Migraine Ages 18-45 |
| NCT04530110 | TV48125-CNS-30084 2019-002056-16, 2024-512837-34-00 | Ph 3 | completed | A Study to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents |
| NCT04464707 results posted | TV48125-CNS-30082 2019-002053-33 | Ph 3 | completed | A Study to Test if Fremanezumab is Effective in Preventing Chronic Migraine in Participants 6 to 17 Years of Age |
| NCT05458011 results posted | TV48125-CNS-30088 | Ph 3 | completed | A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine |
| NCT04458857 results posted | TV48125-CNS-30083 2019-002055-42 | Ph 3 | completed | A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age |
| NCT05284019 EVEC results posted | 19766N | Ph 4 | terminated | Real World Effectiveness of Eptinezumab in Participants With Migraine |
| NCT04041284 results posted | TV48125-MH-40142 2019-001989-15 | Ph 4 | completed | A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder |
| NCT03965091 results posted | TV48125-PN-20028 | Ph 2 | terminated | A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia |
| NCT03347188 results posted | TV48125-CNS-20024 | Ph 2 | completed | A Study to Test if Fremanezumab Reduces Headache in Participants With Posttraumatic Headache (PTH) |
| NCT04334408 | 18-010786 | Ph 2 | withdrawn | Safety and Efficacy of Fremanezumab for Migraine in Adult CADASIL |
| NCT02621931 results posted | TV48125-CNS-30049 2015-004549-23 | Ph 3 | completed | Comparing Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of TEV-48125 Versus Placebo for the Preventive Treatment of Chronic Migraine |
| NCT04447729 | TV48125-CNS-20022 | Ph 2 | withdrawn | A Study to Test if Fremanezumab Reduces Pain in Patients With Interstitial Cystitis-Bladder Pain Syndrome |
| NCT03308968 FOCUS results posted | TV48125-CNS-30068 2017-002441-30 | Ph 3 | completed | An Efficacy and Safety Study of Fremanezumab in Adults With Migraine |
| NCT02945046 results posted | TV48125-CNS-30056 2016-003278-42 | Ph 3 | terminated | A Study to Evaluate the Efficacy and Safety of TEV-48125 (Fremanezumab) for the Prevention of Episodic Cluster Headache (ECH) |
| NCT02629861 results posted | TV48125-CNS-30050 2015-004598-34 | Ph 3 | completed | Efficacy and Safety of 2 Dose Regimens of TEV-48125 Versus Placebo for the Preventive Treatment of Episodic Migraine |
| NCT03107052 ENFORCE results posted | TV48125-CNS-30058 2016-003172-43 | Ph 3 | terminated | A Study to Explore the Long-Term Safety and Efficacy of Fremanezumab (TEV-48125) for the Prevention of Cluster Headache |
| NCT02638103 HALO results posted | TV48125-CNS-30051 2015-004550-18 | Ph 3 | completed | Efficacy and Safety of Subcutaneous Administration of Fremanezumab (TEV-48125) for the Preventive Treatment of Migraine |
| NCT02964338 results posted | TV48125-CNS-30057 2016-003171-21 | Ph 3 | terminated | A Study Comparing the Efficacy and Safety of Fremanezumab (TEV-48125) for the Prevention of Chronic Cluster Headache (CCH) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AJOVY FDA Label Details
Indications & Usage
FDA Label (PDF)AJOVY is indicated for the treatment of Migraine.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment