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
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 | ||
Authorised | 11/14/2018 | ||
Authorised | 11/14/2018 | ||
Authorised | 11/14/2018 | ||
Authorised | 11/14/2018 | ||
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 |
|---|---|---|---|---|---|
| Galcanezumab Injection | 国药准字SJ20240003 | 生物制品 | 注射剂 | 1/5/2024 |
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 |