Overview
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
Research Report
Galcanezumab (Emgality®): A Comprehensive Monograph on a CGRP Antagonist for Headache Disorders
Section 1: Introduction and Drug Profile
1.1. Overview and Therapeutic Class
Galcanezumab represents a significant advancement in the management of debilitating headache disorders, specifically migraine and episodic cluster headache. It is a humanized immunoglobulin G4 (IgG4) monoclonal antibody, a type of biologic therapy developed to specifically target a key molecule in the pathophysiology of these conditions.[1] Developed by Eli Lilly and Company and marketed under the brand name Emgality®, galcanezumab is a cornerstone of a new therapeutic class: calcitonin gene-related peptide (CGRP) antagonists.[4]
The advent of CGRP-targeted monoclonal antibodies marks a paradigm shift in headache medicine. For decades, preventive treatment for migraine relied on repurposed oral medications from other drug classes, such as beta-blockers, antidepressants, and anticonvulsants. While beneficial for some patients, these traditional therapies are often associated with limited efficacy, slow onset of action, and burdensome side effect profiles that lead to poor adherence and high discontinuation rates.[7] Galcanezumab and its contemporaries were engineered based on a sophisticated understanding of migraine neurobiology, offering a targeted approach designed to interrupt a core mechanism of the disease process, thereby improving efficacy and tolerability.[9]
1.2. Nomenclature and Identifiers
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/30 | Phase 4 | Completed | |||
2024/01/19 | N/A | ENROLLING_BY_INVITATION | |||
2023/10/16 | N/A | Recruiting | |||
2022/08/08 | Phase 4 | Terminated | Diamond Headache Clinic | ||
2022/03/17 | Phase 4 | Terminated | |||
2022/03/16 | N/A | Recruiting | Austrian Migraine Registry Collaboration | ||
2021/11/19 | Phase 4 | Completed | |||
2021/03/17 | N/A | UNKNOWN | Campus Bio-Medico University | ||
2020/11/13 | N/A | Recruiting | |||
2020/11/04 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Eli Lilly and Company | 0002-1436 | SUBCUTANEOUS | 120 mg in 1 mL | 9/28/2020 | |
Eli Lilly and Company | 0002-2377 | SUBCUTANEOUS | 120 mg in 1 mL | 9/28/2020 | |
Eli Lilly and Company | 0002-3115 | SUBCUTANEOUS | 100 mg in 1 mL | 9/28/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 11/14/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED PEN 120 MG/ML | SIN15919P | INJECTION, SOLUTION | 120 mg/ml | 3/25/2020 | |
EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ML | SIN16063P | INJECTION, SOLUTION | 100 mg/ml | 12/18/2020 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
EMGALITY galcanezumab 120mg/mL prefilled pen | 302146 | Medicine | A | 5/28/2019 | |
EMGALITY galcanezumab 120mg/mL prefilled syringe | 302145 | Medicine | A | 5/28/2019 |
Health Canada Drug Approvals
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
EMGALITY 120 MG SOLUCION INYECTABLE EN JERINGA PRECARGADA | 1181330003 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Not Commercialized | |
EMGALITY 120 MG SOLUCION INYECTABLE EN PLUMA PRECARGADA | 1181330001 | SOLUCIÓN INYECTABLE | Diagnóstico Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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