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
Galcanezumab for Vestibular Migraine
- Conditions
- Vestibular Migraine
- Interventions
- Drug: Placebo
- First Posted Date
- 2020-06-04
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- University of California, San Francisco
- Target Recruit Count
- 40
- Registration Number
- NCT04417361
- Locations
- 🇺🇸
UCSF Medical Center at Mount Zion, San Francisco, California, United States
A Study of Gastrointestinal Emptying Time in Adult Participants With Migraine Before and After Start of a mAb CGRP Antagonist
- First Posted Date
- 2020-03-03
- Last Posted Date
- 2022-03-22
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 65
- Registration Number
- NCT04294147
- Locations
- 🇺🇸
CMR of Greater New Haven, Waterbury, Connecticut, United States
🇺🇸Pharmacology Research Institute, Newport Beach, California, United States
🇺🇸Clinical Research Institute LLC, Los Angeles, California, United States
Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action
- Conditions
- Chronic Migraine
- Interventions
- First Posted Date
- 2020-02-17
- Last Posted Date
- 2025-01-22
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- Target Recruit Count
- 64
- Registration Number
- NCT04271202
- Locations
- 🇺🇸
Pain Clinic at Beth Israel Deaconess Medical Center, Brookline, Massachusetts, United States
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
- First Posted Date
- 2019-11-27
- Last Posted Date
- 2021-03-10
- Lead Sponsor
- Allergan
- Target Recruit Count
- 40
- Registration Number
- NCT04179474
- Locations
- 🇺🇸
Spaulding, West Bend, Wisconsin, United States
🇺🇸QPS, Springfield, Missouri, United States
Anti-CGRP for Inflamation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
- Conditions
- Trigeminal NeuralgiaGlossopharyngeal Neuralgia
- Interventions
- First Posted Date
- 2019-11-12
- Last Posted Date
- 2023-03-30
- Lead Sponsor
- Duke University
- Target Recruit Count
- 20
- Registration Number
- NCT04158752
- Locations
- 🇺🇸
Duke University, Durham, North Carolina, United States
A Study of Galcanezumab (LY2951742) in Healthy Chinese Participants
- First Posted Date
- 2019-09-11
- Last Posted Date
- 2021-06-15
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 30
- Registration Number
- NCT04085289
- Locations
- 🇨🇳
HuaShan Hospital Affiliated To Fudan University, Shanghai, Shanghai, China
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
- First Posted Date
- 2019-05-24
- Last Posted Date
- 2023-03-28
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 520
- Registration Number
- NCT03963232
- Locations
- 🇨🇳
First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
🇮🇳All India Institute of Medical Sciences, New Delhi, Delhi, India
🇮🇳Sir Ganga Ram Hospital, New Delhi, Delhi, India
A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine
- First Posted Date
- 2018-06-18
- Last Posted Date
- 2020-07-08
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 463
- Registration Number
- NCT03559257
- Locations
- 🇬🇧
Kings College Hospital, London, Greater London, United Kingdom
🇺🇸Health Research of Hampton Roads Inc, Newport News, Virginia, United States
🇨🇿Clintrial, s.r.o., Praha 10, Hl. M. Praha, Czechia
A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
- First Posted Date
- 2018-02-14
- Last Posted Date
- 2025-04-18
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 325
- Registration Number
- NCT03432286
- 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
A Study of LY2951742 (Galcanezumab) in Japanese Participants With Migraine
- First Posted Date
- 2016-11-08
- Last Posted Date
- 2020-09-29
- Lead Sponsor
- Eli Lilly and Company
- Target Recruit Count
- 311
- Registration Number
- NCT02959190
- 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., Yamaguchi, 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., Ōsaka, Japan
Drug Development Updates
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