VYEPTI (eptinezumab-jjmr)
VYEPTI (eptinezumab-jjmr) is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults. This medication is intended for use in an adult patient population to manage the condition and reduce the occurrence of migraine episodes. As a preventive therapy, it serves a therapeutic role in the long-term management of the disease.
How VYEPTI Works
Eptinezumab-jjmr is a humanized monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) ligand. The drug functions by binding directly to the CGRP ligand, which prevents the ligand from successfully binding to its receptor. By blocking this interaction, the medication inhibits the biological activity associated with the CGRP pathway.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-02-21
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VYEPTI Approval History
What VYEPTI Treats
1 indicationsVYEPTI is approved for 1 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
VYEPTI 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.
VYEPTI 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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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04965675 PROSPECT-2 | 19356A 2020-001009-22, 2024-510656-13-00 | Ph 3 | recruiting | A Study With Eptinezumab in Adolescents (12-17 Years) With Chronic Migraine |
| NCT06701526 | 20668A | Ph 4 | active not recruiting | A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications |
| NCT05164172 REJOIN | 19379A 2022-502917-27-00 | Ph 3 | recruiting | A Study With Eptinezumab in Children and Adolescents (6 to 17 Years) With Chronic or Episodic Migraine |
| NCT05897320 PROSPECT-1 | 19357A 2022-502538-14-00 | Ph 3 | recruiting | A Study of Eptinezumab in Pediatric Participants With Episodic Migraine |
| NCT05452239 RESOLUTION results posted | 20007A 2021-003049-40 | Ph 4 | completed | A Study of Eptinezumab in Participants With Migraine and Medication Overuse Headache |
| NCT04921384 Sunrise | 19140A 2020-001657-42 | Ph 3 | completed | Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine |
| NCT05064371 | 19140B | Ph 3 | completed | Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan |
| NCT07191145 | 6558 | Ph 3 | not yet recruiting | Eary Infusion of Eptinezumab for TreatmEnt of ACute Post-Traumatic Headaches (ELITE-ACT) |
| NCT05937152 | 22-012864 | Ph 2 | withdrawn | A Study of CGRP Monoclonal Antibody to Treat Diabetic Neuropathy |
| NCT04688775 ALLEVIATE results posted | 19386A | Ph 3 | completed | Eptinezumab in Participants With Episodic Cluster Headache |
| NCT05064397 CHRONICLE results posted | 19385A | Ph 3 | completed | A 1-year Trial to Inform About Long-term Exposure to Eptinezumab in Participants With Chronic Cluster Headache (cCH) |
| NCT05284019 EVEC results posted | 19766N | Ph 4 | terminated | Real World Effectiveness of Eptinezumab in Participants With Migraine |
| NCT06428838 | Medvedev_001 | Ph 3 | not yet recruiting | Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context |
| NCT04537429 | 18922A | Ph 1 | completed | A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab |
| NCT04418765 DELIVER results posted | 18898A | Ph 3 | completed | 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 |
| NCT04772742 Sunlight | 19139A | Ph 3 | completed | Eptinezumab in Adults With Migraine and Medication Overuse Headache |
| NCT05045781 | 19004A | Ph 1 | completed | Safety, Tolerability and Pharmacokinetics of Eptinezumab in Healthy Chinese Subjects |
| NCT04152083 RELIEF results posted | ALD403-CLIN-015 18903A | Ph 3 | completed | A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine |
| NCT04336449 | 18899A | Ph 1 | completed | Eptinezumab in Healthy Japanese Subjects |
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.
VYEPTI FDA Label Details
Indications & Usage
FDA Label (PDF)VYEPTI 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