Objective To systematically review the efficacy and safety of galcanezumab for the treatment of migraine in adults.

Methods PubMed, Embase, Cochrane Library, ClinicalTrials.gov, CNKI, WanFang Data, and VIP databases were systematically searched to collect randomized controlled trial (RCT) about the clinical efficacy and safety of galcanezumab versus placebo in the treatment of adults with migraine from inception to December 31, 2025. Two researchers independently screened literature, extracted data, and evaluated the risk of bias of the included studies, then Meta-analysis was performed using the RevMan 5.4 software.

Results A total of 8 RCTs involving 6,658 patients were included. The results showed that compared with the control group, galcanezumab effectively reduced the number of monthly migraine days [MD=-2.21, 95%CI (-2.42, -2.01), P<0.001]; increase the percentage of participants with reduction from baseline ≥50%, ≥75%, and 100% in monthly migraine days [RR=1.64, 95%CI (1.55, 1.74), P<0.001; RR=1.94, 95%CI (1.76, 2.15), P<0.001; RR=2.16, 95%CI (1.80, 2.60), P<0.001]; decrease the number of monthly migraine days requiring acute medication [MD=-1.74, 95%CI (-1.92, -1.56), P<0.001] and the score of Migraine Disability Assessment Test [MD=-5.19, 95%CI (-6.65, -3.73), P<0.001]; increase the score of role function restrictive domain of the migraine specific quality of life questionnaire [MD=7.16, 95%CI (6.27, 8.05), P<0.001]. In subgroup analyses stratified by galcanezumab dosage, the above findings remained consistent. For safety, the differences in the incidence of total adverse reactions [RR=1.14, 95%CI (0.99, 1.33), P=0.08] and serious adverse reactions [RR=1.69, 95%CI (0.96, 2.97), P=0.07] were not statistically significant between the two groups. The incidence of injection site reactions was significantly higher in the galcanezumab group than in the control group [RR=3.01, 95%CI(1.58, 5.73), P<0.001].

Conclusion Current evidence shows that galcanezumab effectively relieves migraine symptoms in adults, but may increase incidence of injection site pain. Due to the limited quality and quantity of the included studies, more high-quality studies are needed to verify the above conclusion.

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