Galcanezumab

Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

• EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. ( 1.1 ) treatment of episodic cluster headache.ICD-10: G43.909, R51.9

• EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients [see Warnings and Precautions ( 5.1 )] . EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.contraindicated

For subcutaneous use only. ( 2.1 , 2.2 , 2.3 ) Migraine recommended dosage: 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg. ( 2.1 ) Episodic cluster headache recommended dosage: 300 mg (administered as three consecutive injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. ( 2.2 ) Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously. ( 2.3 ) 2.1 Recommended Dosing for Migraine The recommended dosage of EMGALITY is 240 mg (two consecutive subcutaneous injections of 120 mg each) once as a loading dose, followed by monthly doses of 120 mg injected subcutaneously. If a dose of EMGALITY is missed, administer as soon as possible. Thereafter, EMGALITY can be scheduled monthly from the date of the last dose. 2.2 Recommended Dosing for Episodic Cluster Headache The recommended dosage of EMGALITY is 300 mg (three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. If a dose of EMGALITY is missed during a cluster period, administer as soon as possible. Thereafter, EMGALITY can be scheduled monthly from the date of the last dose until the end of the cluster period. 2.3 Important Administration Instructions EMGALITY is for subcutaneous use only. EMGALITY is intended for patient self-administration.

Hypersensitivity Reactions: If a serious hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy. Hypersensitivity reactions can occur days after administration, and may be prolonged. ( 5.1 ) Hypertension: New-onset or worsening of pre-existing hypertension may occur. ( 5.2 ) Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur. ( 5.3 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including dyspnea, urticaria, and rash, have occurred with EMGALITY in clinical studies and the postmarketing setting. Cases of anaphylaxis and angioedema have also been reported in the postmarketing setting. If a serious or severe hypersensitivity reaction occurs, discontinue administration of EMGALITY and initiate appropriate therapy [see Contraindications ( 4 ), Adverse Reactions ( 6.1 ), and Patient Counseling Information ( 17 )] . Hypersensitivity reactions can occur days after administration and may be prolonged. 5.2 Hypertension Development of hypertension and worsening of pre-existing hypertension have been reported following the use of CGRP antagonists, including EMGALITY, in the postmarketing setting. Some of the patients who developed new-onset hypertension had risk factors for hypertension. There were cases requiring initiation of pharmacological treatment for hypertension and, in some cases, hospitalization. Hypertension may occur at any time during treatment but was most frequently reported within 7 days of therapy initiation.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] Hypertension [see Warnings and Precautions ( 5.2 )] Raynaud's Phenomenon [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. Migraine The safety of EMGALITY has been evaluated in 2586 patients with migraine who received at least one dose of EMGALITY, representing 1487 patient-years of exposure. Of these, 1920 patients were exposed to EMGALITY once monthly for at least 6 months, and 526 patients were exposed for 12 months. In placebo-controlled clinical studies (Studies 1, 2, and 3), 705 patients received at least one dose of EMGALITY 120 mg once monthly, and 1451 patients received placebo, during 3 months or 6 months of double-blind treatment [see Clinical Studies ( 14.1 )] . Of the EMGALITY-treated patients, approximately 85% were female, 77% were white, and the mean age was 41 years at study entry.

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EMGALITY during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-833-464-4724 or by contacting the company at www.migrainepregnancyregistry.com. Risk Summary There are no adequate data on the developmental risk associated with the use of EMGALITY in pregnant women. Administration of galcanezumab-gnlm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at plasma exposures greater than that expected clinically did not result in adverse effects on development (see Animal Data) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. The estimated rate of major birth defects (2.2% - 2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy.

Metabolism

Galcanezumab-gnlm exhibits linear pharmacokinetics and exposure increases proportionally with doses between 1 and 600 mg. A loading dose of 240 mg achieved the serum galcanezumab-gnlm steady-state concentration after the first dose.

• Sep 27, 2018BLABLA761063Eli Lilly And Co

1. 1Injection Site Pain7,20724%
2. 2Migraine2,9639.8%
3. 3Underdose2,9159.6%
4. 4Headache2,3847.9%
5. 5Drug Ineffective1,9156.3%
6. 6Product Dose Omission Issue1,7315.7%
7. 7Injection Site Haemorrhage1,5475.1%
8. 8Injection Site Erythema1,1113.7%
9. 9Accidental Underdose1,0683.5%
10. 10Incorrect Dose Administered9533.1%
11. 11Injection Site Pruritus8062.7%
12. 12Nausea8042.6%
13. 13Injection Site Swelling7982.6%
14. 14Fatigue7362.4%
15. 15Injection Site Reaction7202.4%

The 10 most recently updated of 40 ClinicalTrials.gov registrations naming Galcanezumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• i-NEED: NEw migrainE Drugs Database
  Recruiting · Observational · 2,641 enrolled · IRCCS San Raffaele Roma
  NCT07103694updated 2026-06-11
• Novel Insight Into Migraine Pathophysiolgy and Galcanezumab Mechanisms of Action
  Completed · Phase 4 · Interventional · 64 enrolled · Beth Israel Deaconess Medical Center
  NCT04271202updated 2026-03-24
• A Study of Galcanezumab (LY2951742) in Participants 12 to 17 Years of Age With Chronic Migraine
  Active not recruiting · Phase 3 · Interventional · 312 enrolled · Eli Lilly and Company
  NCT04616326updated 2026-02-27
• Anti-CGRP for Inflammation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
  Completed · Phase 4 · Interventional · 26 enrolled · Duke University
  NCT04158752updated 2026-02-02
• A Study of Galcanezumab (LY2951742) in Participants 6 to 17 Years of Age With Episodic Migraine
  Active not recruiting · Phase 3 · Interventional · 533 enrolled · Eli Lilly and Company
  NCT03432286updated 2026-01-26
• Investigator Initiated Trial of Galcanezumab Treatment in Alzheimer's Disease
  Recruiting · Early phase 1 · Interventional · 10 enrolled · Xuanwu Hospital, Beijing
  NCT07323927updated 2026-01-07
• Migraine Medication Effects on Urinary Symptoms
  Enrolling by invitation · Observational · 200 enrolled · The Cleveland Clinic
  NCT06212661updated 2025-10-01
• Study for Prevent Chronification Migraine Through Prediction of Response to Treatment With Anti-CGRP Antibodies
  Recruiting · Observational · 350 enrolled · Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  NCT06459648updated 2025-09-24
• Real-world Prospective Study on the Use of Anti-CGRP Drugs in Migraine
  Recruiting · Observational · 700 enrolled · Hospital Universitari Vall d'Hebron Research Institute
  NCT07159750updated 2025-09-08
• Emgality for Migraine in Breastmilk
  Recruiting · Observational · 30 enrolled · University of California, San Francisco
  NCT06085144updated 2025-04-07

Frequently asked questions

How does Galcanezumab work?

Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.

What is Galcanezumab used for?

According to FDA labeling, Galcanezumab carries indications including: EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. ( 1.1 ) treatment of episodic cluster headache.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Galcanezumab?

Galcanezumab is classified as Calcitonin gene-related peptide (CGRP) antagonists, Antibody-Receptor Interactions, Vasoconstriction.

What are the brand names for Galcanezumab?

Galcanezumab is marketed under brand names including Emgality.

What are the contraindications for Galcanezumab?

Galcanezumab labeling lists contraindications including: EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients [see Warnings and Precautions ( 5.1 )] . EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.. Always consult the full prescribing information and a clinician.