Galcanezumab in Pregnancy: Is There Risk for Adverse Maternal, Fetal Outcomes?

The pattern of pregnancy outcomes between patients receiving galcanezumab vs placebo is similar, according to study results presented at the 2025 American Headache Society (AHS) Annual Scientific Meeting, held from June 19-22, in Minneapolis, Minnesota, and virtually.

Despite the high rates of migraine reported during pregnancy, there is limited evidence regarding the use of migraine prevention treatment in this population. Monoclonal antibody galcanezumab has been indicated for the preventive treatment of migraine and is known to have a low risk of transfer to the fetus in the first trimester.

Researchers conducted a review assessing the effect of galcanezumab taken during pregnancy on maternal and fetal outcomes.

All clinical trials that evaluated the use of galcanezumab during pregnancy were included in the review. Study outcomes were also assessed for maternal and fetal adverse events (AEs).

A total of 47 pregnancies (mean age, 30.5 years; White, 66.0%; episodic migraine, 63.8%) were reported in 12 galcanezumab trials, including phases 1, 2, and 3. Galcanezumab doses were most often given at 120 mg or 240 mg per month.

Most exposures to full therapeutic doses were seen during the first trimester, with subtherapeutic concentrations continued into the second trimester.

Participants who received galcanezumab and placebo had similar outcome patterns, including birth types by treatment (prematurity, elective terminations, spontaneous abortions, and ectopic pregnancies) and fetal outcomes (normal and perinatal complications).

The researchers observed 1 fetal AE after treatment with galcanezumab in a participant with multiple risk factors, including gestational diabetes. They also observed 6 maternal AEs after galcanezumab exposure.

Limitations of the analysis were that clinical trials were performed in a controlled environment with limited medications and the small number of participants with complete follow-up information.

“Women taking galcanezumab who are pregnant or considering becoming pregnant should discuss the potential risks with their healthcare provider,” the researchers wrote. They added, “Future real-world pregnancy database studies should complement clinical trial and post-marketing safety database reports.”

This research was sponsored by Eli Lilly and Company. Multiple authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.