EMGALITY (galcanezumab-gnlm)
Emgality (galcanezumab-gnlm) is a calcitonin-gene related peptide antagonist indicated for use in adult patients. It is approved for the preventive treatment of migraine and the treatment of episodic cluster headache. The medication serves as a therapeutic option for managing these specific primary headache disorders in the adult population.
How EMGALITY Works
Galcanezumab-gnlm functions as a humanized monoclonal antibody that targets the calcitonin gene-related peptide (CGRP) ligand. The drug binds directly to the CGRP ligand, which effectively blocks it from binding to its receptor. By preventing this interaction, the medication inhibits the biological activity associated with the CGRP pathway.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-09-27
- Patent Cliff
- 2030
- Revenue
- $200M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
EMGALITY Approval History
What EMGALITY Treats
2 indicationsEMGALITY is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
- Episodic Cluster Headache
EMGALITY 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.
EMGALITY 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.
Drugs Similar to EMGALITY
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
27 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04616326 REBUILD-2 | 16353 2018-004622-28, I5Q-MC-CGAT | Ph 3 | active not recruiting | A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine |
| NCT04158752 results posted | Pro00103776 | Ph 4 | completed | Anti-CGRP for Inflammation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia |
| NCT03432286 REBUILD-1 | 16352 I5Q-MC-CGAS, 2017-004351-23 | Ph 3 | active not recruiting | A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine |
| NCT06901518 | 5843 | Ph 4 | completed | The Effect of Galcanezumab-gnlm on Post-Traumatic, Migrainous Headaches |
| NCT05127486 CHALLENGE-MIG results posted | 18256 I5Q-MC-CGBD | Ph 4 | completed | A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine |
| NCT05284019 EVEC results posted | 19766N | Ph 4 | terminated | Real World Effectiveness of Eptinezumab in Participants With Migraine |
| NCT05492695 TOGETHER | 5Q-US-X003 | Ph 4 | terminated | Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study |
| NCT03963232 PERSIST results posted | 17054 I5Q-MC-CGAX | Ph 3 | completed | A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine |
| NCT02614261 REGAIN results posted | 15769 I5Q-MC-CGAI, 2015-001883-21 | Ph 3 | completed | Evaluation of Galcanezumab in the Prevention of Chronic Migraine |
| NCT04294147 results posted | 17590 I5Q-MC-CGBC | Ph 4 | completed | A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist |
| NCT02797951 results posted | 16351 I5Q-MC-CGAR, 2015-005234-21 | Ph 3 | completed | A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache |
| NCT04085289 results posted | 17057 I5Q-MC-CGAY | Ph 1 | completed | A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants |
| NCT02959177 results posted | 15796 I5Q-JE-CGAN | Ph 2 | completed | A Study of LY2951742 (Galcanezumab) in Japanese Participants With Episodic Migraine |
| NCT04179474 results posted | 3110-108-002 | Ph 1 | completed | Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine |
| NCT02959190 results posted | 16108 I5Q-JE-CGAP | Ph 3 | completed | A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine |
| NCT03559257 CONQUER results posted | 16670 I5Q-MC-CGAW, 2018-000600-42 | Ph 3 | completed | A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine |
| NCT02614287 results posted | 15770 I5Q-MC-CGAJ, 2015-001884-38 | Ph 3 | completed | A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura |
| NCT02614196 EVOLVE-2 results posted | 15768 I5Q-MC-CGAH, 2015-001882-17 | Ph 3 | completed | Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study |
| NCT02614183 EVOLVE-1 results posted | 15767 I5Q-MC-CGAG | Ph 3 | completed | Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study |
| NCT01625988 results posted | ART-01 ART-01 | Ph 2 | completed | A Study of LY2951742 in Participants With Migraine |
| NCT02192190 results posted | 15515 I5Q-MC-CGAF | Ph 2 | terminated | A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain |
| NCT02397473 results posted | 15780 I5Q-MC-CGAL, 2015-000149-22 | Ph 3 | completed | A Study Of Galcanezumab In Participants With Episodic Cluster Headache |
| NCT02104765 results posted | 15435 I5Q-MC-CGAE | Ph 1 | completed | A Study of LY2951742 in Healthy Japanese and Caucasian Participants |
| NCT02836613 results posted | 16203 I5Q-MC-CGAQ | Ph 1 | completed | A Study of Galcanezumab in Healthy Participants. |
| NCT02576951 results posted | 16084 I5Q-MC-CGAO | Ph 1 | completed | A Study of Galcanezumab in Healthy Participants |
| NCT01337596 results posted | 14248 I5Q-MC-CGAA | Ph 1 | completed | A Study of LY2951742 in Healthy Volunteers |
| NCT02163993 results posted | 15414 I5Q-MC-CGAB | Ph 2 | completed | A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache |
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.
EMGALITY FDA Label Details
Indications & Usage
FDA Label (PDF)EMGALITY is indicated for the treatment of Migraine; Episodic Cluster Headache.
Pro Intelligence Preview
Deep insights for EMGALITY
Revenue Insights
- • Q4-2025: $200M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2030
- • Generic/biosimilar risk
Trial Analysis
- • 27 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
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