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The goal of HAE treatment as per guidelines is to achieve total disease control and to normalize patients\u2019 lives. Factor XII (FXII), the principal initiator of the contact system, ultimately regulates the kallikrein\u2013kinin system. Activated FXII (FXIIa) converts plasma prekallikrein to plasma kallikrein, which cleaves high\u2010molecular\u2010weight kininogen to produce the vasoactive peptide bradykinin. In HAE pathophysiology, kallikrein\u2013kinin system dysregulation results in excessive bradykinin production. The anti\u2010FXIIa monoclonal antibody garadacimab is approved for long\u2010term prophylaxis against HAE attacks. In the pivotal phase\u00a0III (VANGUARD) and ongoing phase\u00a0III open\u2010label extension studies, garadacimab administered subcutaneously (2 \u00d7 200\u00a0mg loading dose followed by 200\u00a0mg once monthly) demonstrated durable efficacy with early onset of protection and a favorable long\u2010term safety profile. Based on this and earlier clinical data, garadacimab has the potential to bring patients closer to achieving the guideline\u2010recommended goals of disease control and normalization of life. Here, we provide an overview of the results from the garadacimab clinical development program.<\/jats:p>","DOI":"10.1111\/ddg.70276","type":"journal-article","created":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T07:28:26Z","timestamp":1777534106000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Garadacimab for the long\u2010term prophylaxis of hereditary angioedema"],"prefix":"10.1111","volume":"24","author":[{"given":"Emel","family":"Ayg\u00f6ren\u2010P\u00fcrs\u00fcn","sequence":"first","affiliation":[{"name":"Goethe University Frankfurt Department of Pediatrics  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Regina","family":"Treudler","sequence":"additional","affiliation":[{"name":"Institute of Allergology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin Corporate Member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Staubach","sequence":"additional","affiliation":[{"name":"Department of Dermatology University Medical Center  Mainz Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inmaculada Martinez","family":"Saguer","sequence":"additional","affiliation":[{"name":"HZRM Haemophilia Centre Rhein Main  Frankfurt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Linhoff","sequence":"additional","affiliation":[{"name":"CSL Behring  Hattersheim Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Markus","family":"Magerl","sequence":"additional","affiliation":[{"name":"Institute of Allergology Charit\u00e9 \u2013 Universit\u00e4tsmedizin Berlin Corporate Member of Freie Universit\u00e4t Berlin and Humboldt\u2010Universit\u00e4t zu Berlin Berlin and Fraunhofer Institute for Translational Medicine and Pharmacology ITMP Immunology and Allergology  Berlin Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,4,30]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2012.05.055"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/all.15214"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.anai.2020.02.018"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.2500\/aap.2020.41.200050"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1159\/000514973"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2020.08.046"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2016.02.041"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2018.01.015"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphys.2022.1090732"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.2500\/aap.2025.46.250029"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood.2022015610"},{"key":"e_1_2_10_13_1","first-page":"82","article-title":"Pathophysiology and underlying mechanisms in hereditary angioedema","volume":"38","author":"L\u00f3pez Lera A","year":"2021","journal-title":"Balkan Med J"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.thromres.2014.03.018"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.bbamcr.2017.07.009"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1808012"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cellsig.2018.08.006"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.2500\/aap.2020.41.200081"},{"key":"e_1_2_10_19_1","volume-title":"Prescribing Information","author":"pdC1\u2010INH (Cinryze\u00ae)","year":"2022"},{"key":"e_1_2_10_20_1","volume-title":"Prescribing Information","author":"pdC1\u2010INH (Haegarda\u00ae)","year":"2020"},{"key":"e_1_2_10_21_1","volume-title":"EU Summary of Product Characteristics","author":"pdC1\u2010INH (Cinryze\u00ae)","year":"2022"},{"key":"e_1_2_10_22_1","volume-title":"CSL Behring GmBH","author":"pdC1\u2010INH (Berinert\u00ae 2000\/3000)","year":"2021"},{"key":"e_1_2_10_23_1","volume-title":"Prescribing Information","author":"Lanadelumab\u2010flyo (Takhzyro\u00ae)","year":"2022"},{"key":"e_1_2_10_24_1","volume-title":"Prescribing Information","author":"Berotralstat (Orladeyo\u00ae)","year":"2023"},{"key":"e_1_2_10_25_1","volume-title":"Prescribing Information. 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