Profiling galcanezumab in episodic migraine, cluster headache, and medication overuse headache

INTRODUCTION: The introduction of monoclonal antibodies (mAbs) targeting the calcitonin gene-related peptide (CGRP) pathway has revolutionized migraine treatment. In this regard, galcanezumab, a humanized immunoglobulin G4 (IgG4) that binds the CGRP molecule, has rapid onset of action, monthly dosing, and favorable pharmacokinetics. AREAS COVERED: This review, which draws upon electronic databases such as PubMed, Web of Science, FDA, and EMA, provides a comprehensive summary of galcanezumab for migraine prophylaxis. It covers the drug's mechanism of action, its clinical efficacy in episodic migraine, and its potential benefits in episodic cluster headache and medication-overuse headache. It also provides an overall safety profile based on clinical trials and real-world studies. EXPERT OPINION: Galcanezumab is a cornerstone preventive therapy with consistent efficacy, favorable tolerability, and convenient dosing. Key unmet needs include identifying biomarkers to predict responders, addressing access and cost barriers, optimizing evaluation windows for late-responders, and expanding the evidence base for special populations (pediatrics, pregnancy, and vascular comorbidities). Future studies should refine patient selection and explore complementary targets for non-responders.