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

The Effect of Galcanezumab-gnlm on Post-Traumatic, Migrainous Headaches

Phase 4
Completed
Conditions
Post-Traumatic Headache
Interventions
First Posted Date
2025-03-30
Last Posted Date
2025-03-30
Lead Sponsor
Albany Medical College
Target Recruit Count
25
Registration Number
NCT06901518
Locations
🇺🇸

Albany Medical Center, Albany, New York, United States

Migraine Medication Effects on Urinary Symptoms

Conditions
Bladder Pain Syndrome
Migraine Disorders
Migraine
Overactive Bladder
Overactive Bladder Syndrome
Overactive Detrusor
Interstitial Cystitis
Interventions
First Posted Date
2024-01-19
Last Posted Date
2024-05-16
Lead Sponsor
The Cleveland Clinic
Target Recruit Count
200
Registration Number
NCT06212661
Locations
🇺🇸

Cleveland Clinic, Main Campus, Cleveland, Ohio, United States

Emgality for Migraine in Breastmilk

Recruiting
Conditions
Migraine
Interventions
First Posted Date
2023-10-16
Last Posted Date
2025-04-07
Lead Sponsor
University of California, San Francisco
Target Recruit Count
30
Registration Number
NCT06085144
Locations
🇺🇸

University of California, San Francisco, San Francisco, California, United States

Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study

Phase 4
Terminated
Conditions
Migraine
Interventions
Other: Placebo
First Posted Date
2022-08-08
Last Posted Date
2023-09-29
Lead Sponsor
Diamond Headache Clinic
Target Recruit Count
2
Registration Number
NCT05492695
Locations
🇺🇸

Diamond Headache Clinic, Chicago, Illinois, United States

Real World Effectiveness of Eptinezumab in Participants With Migraine

Phase 4
Terminated
Conditions
Migraine
Interventions
First Posted Date
2022-03-17
Last Posted Date
2024-05-29
Lead Sponsor
H. Lundbeck A/S
Target Recruit Count
32
Registration Number
NCT05284019
Locations
🇺🇸

Gilbert Neurology Partners/ CCT Research, Gilbert, Arizona, United States

🇺🇸

Ki Clinical Research LLC, dba New England Institute for Clinical Research, Stamford, Connecticut, United States

🇺🇸

Innovation Medical Group, Palmetto Bay, Florida, United States

and more 7 locations

Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study

Recruiting
Conditions
Migraine
Migraine With Aura
Migraine Without Aura
Chronic Migraine
Episodic Migraine
Interventions
First Posted Date
2022-03-16
Last Posted Date
2022-10-20
Lead Sponsor
Austrian Migraine Registry Collaboration
Target Recruit Count
1500
Registration Number
NCT05281770
Locations
🇦🇹

Medical University Innsbruck, Innsbruck, Tirol, Austria

🇦🇹

Clinic Hietzing, Vienna, Austria

🇦🇹

Medizinische Universität Wien, Wien, Vienna, Austria

A Study of Galcanezumab (LY2951742) in Adult Participants With Episodic Migraine

Phase 4
Completed
Conditions
Migraine
Episodic Migraine
Interventions
First Posted Date
2021-11-19
Last Posted Date
2024-06-28
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
580
Registration Number
NCT05127486
Locations
🇺🇸

Coastal Carolina Research Center, North Charleston, South Carolina, United States

🇺🇸

Gilbert Neurology, Gilbert, Arizona, United States

🇺🇸

California Medical Clinic for Headache and The Los Angeles Headache Center (Research Facility), Los Angeles, California, United States

and more 65 locations

Observational Study on the Efficacy, Safety, and Tolerability of GAlcanezumab in Real Life Migraine Patients in ITaly

Conditions
Migraine
First Posted Date
2021-03-17
Last Posted Date
2021-03-17
Lead Sponsor
Campus Bio-Medico University
Target Recruit Count
300
Registration Number
NCT04803513
Locations
🇮🇹

Campus Bio Medico University Hospital, Rome, RM, Italy

CGRP Inhibition, Autonomic Function, and Migraine

Recruiting
Conditions
Episodic Migraine
Chronic Migraine
Interventions
First Posted Date
2020-11-13
Last Posted Date
2024-12-10
Lead Sponsor
Medical University of Vienna
Target Recruit Count
120
Registration Number
NCT04628429
Locations
🇦🇹

Medical University of Vienna, Vienna, Austria

A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine

Phase 3
Recruiting
Conditions
Chronic Migraine
Interventions
Drug: Placebo
First Posted Date
2020-11-04
Last Posted Date
2025-05-21
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
300
Registration Number
NCT04616326
Locations
🇺🇸

Rehabilitation & Neurological Services, Huntsville, Alabama, United States

🇺🇸

21st Century Neurology, a Division of Xenoscience, Inc., Phoenix, Arizona, United States

🇺🇸

Phoenix Children's Hospital, Phoenix, Arizona, United States

and more 85 locations
© Copyright 2025. All Rights Reserved by MedPath