HQ Team
September 11, 2026: AbbVie Inc.’s experimental drug has reduced the number of migraine days during the menstrual period, meeting a key goal in late-stage trials, the company announced.
The study evaluated atogepant, a calcitonin gene-related peptide (CGRP) receptor antagonist, for the preventive treatment of menstrual migraine in adults and met “the primary and all eight ranked secondary endpoints” compared with a dummy drug in the Phase 3 study, according to a company statement.
Menstrual migraine is a recurrent, debilitating migraine pattern, with attacks occurring around or during the menstrual period, a predictable time of increased biological vulnerability. Atogepant “demonstrated statistically significant reductions in migraine days.”
No treatment options are currently approved for menstrual migraine.
Disrupting daily life
”These positive…results represent an important advancement for people living with menstrual migraine, with atogepant demonstrating superior efficacy versus placebo across the primary endpoint and all eight ranked secondary endpoints,” said Primal Kaur, MD, senior vice president, global development of immunology, neuroscience, eye care and specialty at AbbVie.
“Menstrual migraine attacks can be severe, long-lasting, and disruptive to daily life. These data bring us closer to our goal of bringing a potential treatment option for women living with this debilitating disease.”
The study evaluated atogepant taken for seven consecutive days starting three days before the onset of menses over three menstrual cycles. Atogepant met the primary endpoint, demonstrating a greater reduction than placebo in migraine days during the perimenstrual period, averaged across three menstrual cycles. The average reduction was 1.20 days with atogepant versus 0.40 days with placebo, corresponding to 0.80 fewer migraine days versus placebo.
Atogepant also demonstrated statistically significant and clinically meaningful improvements versus placebo across all eight ranked secondary endpoints, including measures of headache burden, acute medication use, functional disability, cognitive function and responder outcomes.
Blocks pain-causing protein
Survey data from the European Migraine and Headache Alliance Migraine in Women Survey provide additional context on the burden of headache attacks occurring around menstruation.
Respondents described these attacks as more painful, longer-lasting, or more resistant to medication than non-menstrual attacks, and 68% reported they had never been offered a tailored treatment approach.
“Menstrual migraine attacks are generally more severe and more difficult to treat, making timely intervention particularly important,” said Cristina Tassorelli, MD, PhD., professor of neurology and director of the Headache Science Centre at IRCCS Mondino Foundation, University of Pavia, Italy. This “is the first study of a CGRP-targeted treatment to report positive results specifically in menstrual migraine and meets an important unmet need for women.”
Atogepant is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, a class of treatments that targets a pathway involved in migraine. It works by blocking the CGRP protein, which is involved in the pain and other symptoms of migraine.
