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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.

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

FDA Approved Products

EMGALITY
Manufacturer:Eli Lilly and Company
Route:SUBCUTANEOUS
Strength:120 mg in 1 mL
Approved: 2020/09/28
NDC:0002-2377
EMGALITY
Manufacturer:Eli Lilly and Company
Route:SUBCUTANEOUS
Strength:100 mg in 1 mL
Approved: 2020/09/28
NDC:0002-3115
EMGALITY
Manufacturer:Eli Lilly and Company
Route:SUBCUTANEOUS
Strength:120 mg in 1 mL
Approved: 2020/09/28
NDC:0002-1436

Singapore Approved Products

EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED PEN 120 MG/ML
Manufacturer:Eli Lilly and Company
Form:INJECTION, SOLUTION
Strength:120 mg/ml
Online:Yes
Approved: 2020/03/25
Approval:SIN15919P
EMGALITY SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 100 MG/ML
Manufacturer:Eli Lilly and Company
Form:INJECTION, SOLUTION
Strength:100 mg/ml
Online:Yes
Approved: 2020/12/18
Approval:SIN16063P

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