Uses
EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine. treatment of episodic cluster headache.
Source: US FDA prescribing information
- Presentations
- 2
- Brands
- 1
- Manufacturers
- 1
- Available from stock
- 0
Galcanezumab is a prescription medicine indicated in adults for the preventive treatment of migraine, among other approved uses. It is available as injection for subcutaneous use. MedsAcross supplies Galcanezumab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- ATC classification
- N02CD02 Galcanezumab · Antimigraine, subgroup N02CD
- US FDA first approval
- 27 September 2018
- EU status
- Authorised
- Orphan designation
- No
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Subcutaneous
- Dosage forms
- Injection
- Biologic
- Yes
- Identifiers
- UNII 55KHL3P693RxCUI 2058846CAS 1578199-75-3DrugBank DB14042Q25326707
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
Source: US FDA prescribing information
Dosing overview
For subcutaneous use only. Migraine recommended dosage: 240 mg loading dose (administered as two consecutive injections of 120 mg each), followed by monthly doses of 120 mg. 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. Administer in the abdomen, thigh, back of the upper arm, or buttocks subcutaneously.
Source: US FDA prescribing information
Contraindications
EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Source: US FDA prescribing information
Warnings and precautions
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. Constipation with Serious Complications: Serious complications of constipation may occur. Hypertension: New-onset or worsening of pre-existing hypertension may occur. Raynaud's Phenomenon: New-onset or worsening of pre-existing Raynaud's phenomenon may occur.
Source: US FDA prescribing information
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Constipation with Serious Complications Hypertension Raynaud's Phenomenon The most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions.
Source: US FDA prescribing information
Storage
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect EMGALITY from light until use. Do not freeze. EMGALITY may be stored out of refrigeration in the original carton at temperatures up to 30°C (86°F) for up to 7 days. Once stored out of refrigeration, do not place back in the refrigerator. Do not shake.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
2 presentations of Galcanezumab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Emgality 120 mg/1 mL injectionSubcutaneous Cold chain | Eli Lilly | US FDA | Available on request |
| Emgality 100 mg/1 mL injectionSubcutaneous Cold chain | Eli Lilly | US FDA | Available on request |
Brands by market
1 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Questions and answers
Is Galcanezumab available for export from India?
Yes, on request. MedsAcross lists 2 presentations of Galcanezumab and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Galcanezumab have?
The catalogue lists 1 brand names for Galcanezumab, including Emgality.
Is Galcanezumab approved by the US FDA?
Yes. The US FDA first approved Galcanezumab on 27 September 2018, according to Drugs@FDA.
Is Galcanezumab authorised in the European Union?
Yes. Galcanezumab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Galcanezumab need cold chain shipping?
At least one listed presentation of Galcanezumab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Which ATC class is Galcanezumab in?
Galcanezumab is classified under ATC code N02CD02 (Galcanezumab).
References
- EMGALITY prescribing information (Eli Lilly). U.S. National Library of Medicine, DailyMed. Retrieved 5 June 2026
- Emgality: European public assessment report (EPAR). European Medicines Agency. Retrieved 11 September 2026
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