MedPath

Galcanezumab

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

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

Published: Aug 18, 2025

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

Continue reading the full research report

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

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
EMGALITY
eli lilly canada inc
02491087
Solution - Subcutaneous
120 MG / ML
10/2/2019
EMGALITY
eli lilly canada inc
02505134
Solution - Subcutaneous
100 MG / ML
1/11/2021
EMGALITY
eli lilly canada inc
02491060
Solution - Subcutaneous
120 MG / ML
10/7/2019

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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