{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T10:13:46Z","timestamp":1788257626583,"version":"build-2803163510"},"reference-count":18,"publisher":"SAGE Publications","issue":"8","license":[{"start":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T00:00:00Z","timestamp":1767744000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To describe garadacimab-gxii, an antibody that inhibits factor XII, indicated for hereditary angioedema (HAE) prophylaxis, approved by the Food and Drug Administration in June 2025 for patients 12 years and older.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources:<\/jats:title>\n                    <jats:p>A PubMed search used the keywords \u201cgaradacimab,\u201d \u201chereditary angioedema,\u201d and \u201cgaradacimab clinical trials,\u201d from origin to October 15, 2025. We included phase I to III trials of garadacimab for HAE, post hoc analysis, and the package insert.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study selection and data extraction:<\/jats:title>\n                    <jats:p>We compiled 2 phase I, 1 phase II, 2 phase III trials, and 1 post hoc analysis to formulate an evidence-based review.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis:<\/jats:title>\n                    <jats:p>In the phase II trial, garadacimab reduced mean monthly attack rate by up to 97.7%. In phase III trials, mean monthly attack rate was reduced by 91% while 62% of patients remained attack-free. In the open-label extension trial, mean monthly attack rate decreased by 95% and 60% of patients remained attack-free. No serious drug-related adverse events were reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to patient care and clinical practice in comparison with existing drugs:<\/jats:title>\n                    <jats:p>By inhibiting factor XII, a novel target that prevents activation of the HAE cascade upstream of other agents, garadacimab may have more favorable outcomes than other drugs currently used in prophylactic treatment of HAE.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion and relevance:<\/jats:title>\n                    <jats:p>Garadacimab reduces the frequency of HAE attacks with a safety profile comparable with existing prophylactic treatments. Its mechanism of targeting activated factor XII offers an alternative approach to HAE management. Ongoing monitoring and post-marketing data may further define its role in clinical practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280251405482","type":"journal-article","created":{"date-parts":[[2026,1,7]],"date-time":"2026-01-07T17:16:01Z","timestamp":1767806161000},"page":"805-812","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":1,"title":["Garadacimab-gxii\u2014A Novel Prophylactic Treatment for Hereditary Angioedema: A Drug Review"],"prefix":"10.1177","volume":"60","author":[{"ORCID":"https:\/\/orcid.org\/0009-0006-5277-7948","authenticated-orcid":false,"given":"Kelli M.","family":"Schindel","sequence":"first","affiliation":[{"name":"Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Omar","family":"Raheel","sequence":"additional","affiliation":[{"name":"Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chenan A.","family":"Huang","sequence":"additional","affiliation":[{"name":"Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0090-6289","authenticated-orcid":false,"given":"Steven R.","family":"Feldman","sequence":"additional","affiliation":[{"name":"Center for Dermatology Research, Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, USA"},{"name":"Department of Dermatology, Wake Forest University School of Medicine, Winston-Salem, NC, USA"},{"name":"Department of Pathology, Wake Forest University School of Medicine, Winston-Salem, NC, USA"},{"name":"Department of Social Sciences &amp; Health Policy, Wake Forest University School of Medicine, Winston-Salem, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anette","family":"Bygum","sequence":"additional","affiliation":[{"name":"Clinical Institute, University of Southern Denmark, Odense C, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vivian","family":"Le","sequence":"additional","affiliation":[{"name":"University of Kansas School of Medicine, Kansas City, KS, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Natalie","family":"Behzadpour","sequence":"additional","affiliation":[{"name":"University of Kansas School of Medicine, Kansas City, KS, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,1,7]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1056\/nejmra1808012"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2012.05.055"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaip.2021.11.011"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1159\/000500196"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1201\/9781003367628-11"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1111\/cts.13180"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.6162"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/s2352-3026(24)00081-4"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/s0140-6736(23)00350-1"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/all.16351"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1111\/cea.14568"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.anai.2010.01.007"},{"key":"e_1_3_2_14_2","unstructured":"Andembry (garadacimab-gxii) [package insert]. 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