MigraineActive ingredient
Galcanezumab
CGRP ligand antibody1 FDA label read
Galcanezumab is sold as Emgality, a monthly self-injected antibody for the preventive treatment of migraine - and the only label in this category that also covers episodic cluster headache, a different disease with its own dosing regimen in the same document.
Highlights of the labels
- Emgality
- Preventive treatment of migraine, and episodic cluster headachecovers migraine
- Supply
- Prescription only
- Generic
- None approved
- Boxed warning
- None in these labels
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| EmgalityEli Lilly and Company | What its label approvesPreventive treatment of migraine, and episodic cluster headacheCovers migraine | SupplyPrescription | Label version5 June 2026 |
How it works
Galcanezumab is a humanized monoclonal antibody that binds CGRP itself - the ligand - and blocks it from reaching its receptor. That is a different point of attack from Aimovig, which binds the receptor instead. It is injected under the skin.
Mechanism of action, Emgality label
Galcanezumab-gnlm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
What the FDA approved it for
The approved uses, as worded in the label.
- EMGALITY ® is a calcitonin-gene related peptide antagonist indicated in adults for the: preventive treatment of migraine.
- treatment of episodic cluster headache.
Forms and strengths
The presentations and strengths listed in the label.
- EMGALITY is a sterile clear to opalescent, colorless to slightly yellow to slightly brown solution available as follows:
- Injection: 120 mg/mL in a single-dose prefilled pen Injection: 120 mg/mL in a single-dose prefilled syringe Injection: 100 mg/mL in a single-dose prefilled syringe Injection: 120 mg/mL solution in a single-dose prefilled pen
- Injection: 120 mg/mL solution in a single-dose prefilled syringe
- Injection: 100 mg/mL solution in a single-dose prefilled syringe
How the label says it is taken
What the label states about administration. It is not a dosing instruction for any individual.
- 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.
Most common adverse reactions
The adverse reactions the label reports as most common.
- most common adverse reactions (incidence ≥2% and at least 2% greater than placebo) in EMGALITY clinical studies were injection site reactions.
- most common adverse reaction was injection site reactions. In Studies 1, 2, and 3, 1.8% of patients discontinued double-blind treatment because of adverse events.
Warnings and precautions
The warnings and precautions section of the label.
- 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.
Contraindications
Situations in which the label states the medication must not be used.
EMGALITY is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
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.
Generic or brand
There is no generic galcanezumab and there will not be one in that form: it is a biologic approved under a biologics license application, and copies of biologics reach the market as biosimilars, under their own approvals.
The FDA label database lists no approved generic application for this ingredient.
What affects the cost
Emgality is a brand biologic. Acquisition cost is per injection at brand level; what a person pays depends on insurance coverage. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programs. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand |
|---|---|
| per milliliter | Brand$734.41 (range $594.31 to $735.21, 170 listings) |
Median of 170 listings. Effective dates 2025-12-17 to 2026-08-19, file dated 2026-08-26.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- How is Emgality taken?
- For migraine prevention, the label sets a 240 mg loading dose given as two consecutive 120 mg injections, then 120 mg monthly. For episodic cluster headache, the regimen is different: 300 mg as three consecutive 100 mg injections at the onset of the cluster period.
- What is the difference between Emgality and Aimovig?
- Both are monthly preventive injections, but they attack different ends of the same signal: Emgality binds the CGRP molecule itself, Aimovig binds the CGRP receptor. Emgality also covers episodic cluster headache, which Aimovig does not. The comparison page reads both labels side by side.
- Does Emgality treat a migraine attack that already started?
- Acute treatment is not among its indications. The label covers preventive treatment of migraine and treatment of episodic cluster headache.
Other medications under migraine
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Emgality
Eli Lilly and Company. Label version 17, effective 5 June 2026.
Each stripe is one section of the label, each division in a stripe one entry in that section.
Page last updated 29 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.