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

Clinical Trials

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

Phase 2

Completed

Conditions: Migraine

Interventions: Drug: Placebo
Drug: Galcanezumab

First Posted Date: 2016-11-08

Last Posted Date: 2021-04-27

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 459

Registration Number: NCT02959177

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., Yamanashi, Japan
🇯🇵
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician., Nishinomiya, Japan
🇯🇵
"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.", Nishinomiya, Japan

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

Phase 3

Completed

Conditions: Episodic Cluster Headache
Chronic Cluster Headache

Interventions: Drug: Galcanezumab

First Posted Date: 2016-06-14

Last Posted Date: 2022-02-10

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 165

Registration Number: NCT02797951

Locations: 🇺🇸
California Medical Clinic for Headache, Santa Monica, California, United States
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Atlanta Center of Medical Research, Atlanta, Georgia, United States
🇨🇦
Stroyan Research, Toronto, Ontario, Canada

and more 37 locations

A Safety Study of Galcanezumab in Participants With Migraine, With or Without Aura

Phase 3

Completed

Conditions: Migraine

Interventions: Drug: Galcanezumab

First Posted Date: 2015-11-25

Last Posted Date: 2020-06-17

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 270

Registration Number: NCT02614287

Locations: 🇺🇸
New England Institute for Clinical Research, Stamford, Connecticut, United States
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Sunrise Clinical Research, Hollywood, Florida, United States
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California Medical Clinic for Headache, Santa Monica, California, United States

and more 13 locations

Evaluation of Efficay & Safety of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-2 Study

Phase 3

Completed

Conditions: Migraine

Interventions: Drug: Placebo
Drug: Galcanezumab

First Posted Date: 2015-11-25

Last Posted Date: 2020-06-17

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 986

Registration Number: NCT02614196

Locations: 🇺🇸
Neurology & Neuroscience Associates, Inc., Akron, Ohio, United States
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Catalina Research Institute, LLC, Montclair, California, United States
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Axiom Research, Apple Valley, California, United States

and more 50 locations

Evaluation of Galcanezumab in the Prevention of Episodic Migraine- the EVOLVE-1 Study

Phase 3

Completed

Conditions: Migraine

Interventions: Drug: Placebo
Drug: Galcanezumab

First Posted Date: 2015-11-25

Last Posted Date: 2020-06-17

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 862

Registration Number: NCT02614183

Locations: 🇺🇸
Orange Grove Family Practice, Tucson, Arizona, United States
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Territory Neurology & Research Institute, Tucson, Arizona, United States
🇺🇸
Arkansas Clinical Research, Little Rock, Arkansas, United States

and more 81 locations

Evaluation of Galcanezumab in the Prevention of Chronic Migraine

Phase 3

Completed

Conditions: Chronic Migraine

Interventions: Drug: Galcanezumab
Drug: Placebo

First Posted Date: 2015-11-25

Last Posted Date: 2022-05-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1117

Registration Number: NCT02614261

Locations: 🇺🇸
Pharmacology Research Institute, Newport Beach, Newport Beach, California, United States
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Boston Clinical Trials Inc, Boston, Massachusetts, United States
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Artemis Institute for Clinical Research, San Diego, California, United States

and more 55 locations

A Study of Galcanezumab in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Galcanezumab
Drug: Placebo

First Posted Date: 2015-10-15

Last Posted Date: 2019-02-26

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 178

Registration Number: NCT02576951

Locations: 🇺🇸
Covance, Dallas, Texas, United States

A Study of Galcanezumab in Participants With Chronic Cluster Headache

Phase 3

Completed

Conditions: Chronic Cluster Headache

Interventions: Drug: Galcanezumab 300 mg
Drug: Placebo

First Posted Date: 2015-05-08

Last Posted Date: 2020-08-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 240

Registration Number: NCT02438826

Locations: 🇺🇸
Mayo Clinic-Jacksonville, Jacksonville, Florida, United States
🇫🇷
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., Saint Etienne Cedex 2, France
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Southwestern Medical Center - Dallas, Dallas, Texas, United States

and more 17 locations

A Study Of Galcanezumab In Participants With Episodic Cluster Headache

Phase 3

Completed

Conditions: Episodic Cluster Headache

Interventions: Drug: Placebo
Drug: Galcanezumab

First Posted Date: 2015-03-25

Last Posted Date: 2019-09-09

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 109

Registration Number: NCT02397473

Locations: 🇺🇸
New England Institute for Clinical Research, Stamford, Connecticut, United States
🇺🇸
Dent Neurological Institute, Amherst, New York, United States
🇺🇸
Mayo Clinic-Jacksonville, Jacksonville, Florida, United States

and more 21 locations

A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain

Phase 2

Terminated

Conditions: Osteoarthritis, Knee

Interventions: Other: Placebo- oral
Drug: LY2951742
Other: Placebo - SC
Drug: Celecoxib

First Posted Date: 2014-07-16

Last Posted Date: 2019-09-10

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 268

Registration Number: NCT02192190

Locations: 🇺🇸
Achieve Clinical Research, LLC, Birmingham, Alabama, United States
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Empire Clinical Research, Upland, California, United States
🇺🇸
Medex Healthcare Research, Inc., New York, New York, United States

and more 34 locations

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