MedPath

Galcanezumab

Generic Name
Galcanezumab
Brand Names
Emgality
Drug Type
Biotech
CAS Number
1578199-75-3
Unique Ingredient Identifier
55KHL3P693
Background

Galcanezumab is a humanized monoclonal antibody developed by Eli Lilly and Company against human calcitonin gene-related peptide (CGRP). Although several small-molecule CGRP receptor antagonists have been developed, humanized monoclonal antibodies like galcanezumab are specifically designed to selectively bind to CGRP entities with high potency. Given this target specificity, lack of off-target toxicity, and characteristic proteolysis profile of immunoglobulin antibodies to not undergo metabolism by liver enzymes, galcanezumab possesses favourable and promising safety and tolerability. Galcanezumab was approved by the FDA in September 2018, and is indicated for the preventive treatment of migraine and the treatment of episodic cluster headache. It is unknown if galcanezumab has an effect on pregnancy outcomes. A pregnancy exposure registry has been established to evaluate the safety of this drug in pregnant women.

Indication

Galcanezumab is indicated in adults for the preventive treatment of migraine and the treatment of episodic cluster headache.

Associated Conditions
Episodic Cluster Headache, Migraine

A Study of Galcanezumab (LY2951742) in Participants With Migraine Headache

Phase 2
Completed
Conditions
Migraine Headache
Interventions
Drug: Placebo
First Posted Date
2014-06-16
Last Posted Date
2018-11-23
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
414
Registration Number
NCT02163993
Locations
🇺🇸

Clinical Research Advantage, Gilbert, Arizona, United States

🇺🇸

PharmaSite Research Inc, Baltimore, Maryland, United States

🇺🇸

Medical Center for Clinical Research, San Diego, California, United States

and more 35 locations

A Study of LY2951742 in Healthy Japanese and Caucasian Participants

Phase 1
Completed
Conditions
Migraine Disorders
Interventions
Drug: Placebo
First Posted Date
2014-04-04
Last Posted Date
2019-06-14
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
45
Registration Number
NCT02104765
Locations
🇺🇸

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Cypress, California, United States

A Study of LY2951742 in Participants With Migraine

Phase 2
Completed
Conditions
Migraine Headache
Interventions
Drug: Placebo
First Posted Date
2012-06-22
Last Posted Date
2020-01-09
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
218
Registration Number
NCT01625988
Locations
🇺🇸

Neurological Physicians of Arizona / Clinical Research Advantage, Gilbert, Arizona, United States

🇺🇸

Ryan Headache Center, St. John's Mercy Medical Group, Chesterfield, Missouri, United States

🇺🇸

PharmQuest, Greensboro, North Carolina, United States

and more 34 locations

A Study of LY2951742 in Healthy Volunteers

Phase 1
Completed
Conditions
Migraines
Interventions
Drug: Placebo
First Posted Date
2011-04-19
Last Posted Date
2019-02-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
63
Registration Number
NCT01337596
Locations
🇧🇪

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Leuven, Belgium

© Copyright 2025. All Rights Reserved by MedPath