PMID- 33803190 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230919 IS - 1424-8247 (Print) IS - 1424-8247 (Electronic) IS - 1424-8247 (Linking) VI - 14 IP - 3 DP - 2021 Mar 9 TI - The Role of Galcanezumab in Migraine Prevention: Existing Data and Future Directions. LID - 10.3390/ph14030245 [doi] LID - 245 AB - Galcanezumab is a humanized monoclonal antibody blocking the calcitonin gene-related peptide (CGRP) pathway by targeting the CGRP. Data from four phase-3 randomized placebo-controlled clinical trials showed that galcanezumab is superior to placebo in reducing migraine headaches, migraine-specific quality of life, and headache-related disability. Most of the adverse events (AEs) were mild to moderate and did not affect trial completion rates significantly. Along with erenumab, fremanezumab, and eptinezumab, galcanezumab forms a novel class of anti-migraine preventative treatments that is disease-specific and mechanism-based, unlike the standard ones. In addition, galcanezumab has also been shown to be effective in cluster headache, though more clinical trials are required. Overall, galcanezumab is a promising emerging treatment in migraine prophylaxis. However, it needs to be tested in larger clinical trials focused on treatment-resistant migraine. Furthermore, its safety profile, especially its potential association with an increased cardiovascular risk, needs to be established through long-term, real-world data. This review aims to give an overview of its pharmacological properties as well as to report and discuss data from clinical trials and its potential place in headache therapeutics. FAU - Gklinos, Panagiotis AU - Gklinos P AUID- ORCID: 0000-0001-5022-6460 AD - Department of Neurology, KAT General Hospital of Attica, 14561 Athens, Greece. FAU - Mitsikostas, Dimos D AU - Mitsikostas DD AD - 1st Neurology Department, Aeginition Hospital, National and Kapodistrian University of Athens, 11521 Athens, Greece. LA - eng PT - Journal Article PT - Review DEP - 20210309 PL - Switzerland TA - Pharmaceuticals (Basel) JT - Pharmaceuticals (Basel, Switzerland) JID - 101238453 PMC - PMC7998387 OTO - NOTNLM OT - galcanezumab OT - migraine OT - migraine prevention OT - monoclonal antibodies OT - review COIS- P.G. reports no disclosures. D.D.M. has received consulting, speaking fees and travel grants from Allergan, Amgen, Bayer, Biogen, Cefaly, Genesis Pharma, GlaxoSmithKline, ElectroCore, Eli Lilly, Merck-Serono, Merz, Mylan, Novartis, Roche, Sanofi- Genzyme, Specifar and Teva. EDAT- 2021/04/04 06:00 MHDA- 2021/04/04 06:01 PMCR- 2021/03/09 CRDT- 2021/04/03 01:13 PHST- 2021/02/21 00:00 [received] PHST- 2021/03/04 00:00 [revised] PHST- 2021/03/06 00:00 [accepted] PHST- 2021/04/03 01:13 [entrez] PHST- 2021/04/04 06:00 [pubmed] PHST- 2021/04/04 06:01 [medline] PHST- 2021/03/09 00:00 [pmc-release] AID - ph14030245 [pii] AID - pharmaceuticals-14-00245 [pii] AID - 10.3390/ph14030245 [doi] PST - epublish SO - Pharmaceuticals (Basel). 2021 Mar 9;14(3):245. doi: 10.3390/ph14030245.