Product Description
Galcanezumab-gnlm (galcanezumab) is a humanized monoclonal antibody that binds to the CGRP ligand and prevents binding to its receptor (Sourced from: https://pubmed.ncbi.nlm.nih.gov/32319039/)
Mechanisms of Action: CGRP Antagonist
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lebanon | Lithuania | Malaysia | Mexico | Netherlands | New Zealand | Norway | Philippines | Poland | Portugal | Romania | Saudi Arabia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Eli Lilly
Company Location: INDIANAPOLIS IN 46285
Company CEO: David A. Ricks
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: China, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Puerto Rico, Spain, United States
Active Clinical Trial Count: 13
Highest Development Phases
Phase 3: Migraine Disorders
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| I5Q-MC-CGAS | P3 |
Unknown Status |
Migraine Disorders |
2026-11-30 |
|
| I5Q-MC-CGAT | P3 |
Unknown Status |
Migraine Disorders |
2026-03-30 |
|
| REBUILD-1 | P3 |
Recruiting |
Migraine Disorders |
2025-11-01 |
|
| REBUILD-2 | P3 |
Recruiting |
Migraine Disorders |
2025-07-01 |