Does Emgality cause hair loss?

Hair loss (alopecia) was reported by less than 1% of patients taking Emgality (galcanezumab-gnlm) during clinical trials submitted for FDA-approval. Hair loss events were mild or moderate, and nobody stopped treatment due to hair loss. The number of patients who reported hair loss as a side effect due to Emgality was similar to the number of patients who reported hair loss in the placebo group (no active medication).

Emgality is a calcitonin-gene related peptide (CGRP) antagonist. It is used to prevent migraines and to treat episodic cluster headaches. Emgality comes as a single-dose prefilled pen and single-dose prefilled syringes, and it is injected under the skin.

If you notice hair thinning or hair loss, contact your doctor. It could be due to medications that you are taking, stress, changes in your diet, or a medical condition.

Hair loss in Emgality clinical trials

Hair loss was not commonly reported as a side effect of Emgality during clinical trials. Below we will review the incidence of hair loss during a few different clinical trials of Emgality.

Phase 3 cluster headache clinical trial

In a phase 3, double-blind, placebo-controlled clinical trial studying Emgality for the treatment of cluster headaches, no patients in the study reported hair loss.

Phase 3 migraine prevention studies (EVOLVE-1, EVOLVE-2, REGAIN, and CONQUER)

In clinical trials of Emgality for the treatment of migraine prevention, a few people reported hair loss as a side effect during treatment during the EVOLVE-1, EVOLVE-2, and REGAIN studies:

• Out of a total of 1,451 patients in the placebo groups, 5 patients reported hair loss.
• Out of a total of 705 patients taking 120 mg of Emgality, 3 patients reported hair loss. All 3 patients experienced hair loss that was mild in severity.
• Out of a total of 730 patients taking 240 mg of Emgality, 4 patients reported hair loss. Of these, 3 patients reported mild hair loss and 1 patient reported moderate hair loss.

No patients reported hair loss in the CONQUER trial that included 462 patients.

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Has hair loss been reported after Emgality was FDA approved?

Yes, but information about side effects submitted after a medication is approved is not always reliable since reports can be incomplete. Hair loss has been reported by less than 0.1% of postmarketing reports received by the manufacturer of Emgality through March 2022.

There have also been some case reports of Emgality causing hair loss based on submissions to the FDA Adverse Event Reporting System (FAERS). Up until March 2024, there have been 631 reports of hair loss from Emgality. More research is needed to know if hair loss is due to Emgality or because of a different reason.

Bottom Line

• Hair loss was reported as a side effect of Emgality during clinical trials and after it was approved by the FDA. However, it is not known if Emgality caused the hair loss.
• Most cases of hair loss reported during Emgality treatment were mild or moderate in severity.
• If you experience hair loss or hair thinning, contact your doctor. They can help you determine the cause and recommend ways to manage it.