Zavegepant (Zavzpret) may be effective for the management of migraine symptoms in Asian adults

1. Zavegepant (Zavzpret), a calcitonin gene-related peptide receptor antagonist (CGRPRA), is well-tolerated and significantly improves resolution of migraine symptoms in Asian adults with migraines.

Evidence Rating Level: 1 (Excellent)

Migraine is a debilitating disorder that affects around 14-15% of people and is the second leading cause of years lived with disability worldwide. While there exist over-the-counter and prescription medications for migraine treatment, there is a significant unmet need for management options for patients for whom these medications are ineffective, poorly tolerated, or contraindicated.CGRPRAs have been shown to be effective in both the acute and preventive treatments of migraines. Zavegepant is an intranasal CGRPRA and the only non-oral gepant. Its efficacy and safety have been demonstrated in Phase 2/3 studies in the United States. However, it is unclear whether the same results are seen in an East Asian population. This Phase 3, randomized, double-blind, placebo-controlled, parallel-group, multicenter study included Asian adults aged 18 years or older with a ≥ 1-year history of migraine (with or without aura). 1346 patients were randomized 1:1 to receive single-dose intranasal zavegepant 10 mg (n = 677; mean [SD] age, 39.0 [9.92] years; 78.9% female) or matching placebo (n = 669; mean [SD] age, 39.5 [10.51] years; 75.6% female). The primary outcomes were the percentage of participants with freedom from pain (pain intensity = 0) and the percentage of participants with absence of the most bothersome symptom (MBS) at 2 hours post-dose. At 2 hours, there was a significantly greater percentage of patients in the zavegepant group with freedom from pain (23.2% vs. 14.1%; difference of 9.2%; 95% CI 5.0, 13.3; p < 0.0001). There was also a significantly greater percentage of patients in the zavegepant group with absence of MBS (52.7% vs. 39.9%; difference of 12.8%; 95% CI 7.5, 18.1; p < 0.0001). Zavegepant was significantly better at relieving pain at 15 min, 30 min, 24 hours, and 48 hours. The most common adverse events were dysgeusia (25 [3.7%] for zavegepant and 2 [0.3%] for placebo), followed by urinary tract infection (14 [2.1%] for zavegepant and 11 [1.6%] for placebo). There was no significant difference in total adverse events, and 3 serious adverse events were reported, although none were considered treatment-related.

Click here to read this study in The Journal of Headache and Pain

Citation: Yu S, Moon HS, Wang SJ, Kim BK, Lee MJ, Liu J, et al. A phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of zavegepant for the acute treatment of migraine in Asian adults. J Headache Pain. 2026 Oct 26. doi: 10.1186/s10194-026-02556-z. Epub ahead of print.

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