{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T13:45:56Z","timestamp":1791812756597,"version":"4.3.4"},"reference-count":111,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T00:00:00Z","timestamp":1786492800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["American J Hematol"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>The therapeutic landscape of \u03b2\u2010thalassemia has evolved rapidly over the past decade, shifting from a historical reliance on transfusion support and iron chelation toward disease\u2010modifying and potentially curative therapies. This review summarizes the clinical development of novel treatments for both non\u2010transfusion\u2010dependent and transfusion\u2010dependent \u03b2\u2010thalassemia, including approved therapies, agents in active development, and programs that have been discontinued. Disease\u2010modifying strategies have focused on improving ineffective erythropoiesis, correcting iron dysregulation, and restoring red blood cell metabolism. Luspatercept and mitapivat have demonstrated clinically meaningful improvements in hemoglobin levels and reduction of transfusion burden and are now approved in multiple jurisdictions. Additional pyruvate kinase activators, such as etavopivat, are undergoing clinical evaluation. Curative approaches have advanced substantially through gene addition, gene editing, and base editing technologies. Approved therapies, including betibeglogene autotemcel and exagamglogene autotemcel, have achieved high rates of durable transfusion independence, while emerging platforms aim to further improve efficacy, safety, and accessibility. At the same time, several promising approaches targeting fetal hemoglobin induction, iron metabolism, and ineffective erythropoiesis have failed to demonstrate sufficient clinical benefit despite preclinical proof of concept, highlighting the complexity of therapeutic development in \u03b2\u2010thalassemia. Future priorities include refining patient selection, generating real\u2010world and comparative effectiveness data, developing clinically meaningful response criteria, expanding pediatric access, and addressing the substantial cost and accessibility challenges associated with novel therapies.<\/jats:p>","DOI":"10.1002\/ajh.70472","type":"journal-article","created":{"date-parts":[[2026,8,12]],"date-time":"2026-08-12T12:31:32Z","timestamp":1786537892000},"page":"2890-2906","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["2026 Update on Clinical Trials in \u03b2\u2010Thalassemia"],"prefix":"10.1002","volume":"101","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3935-903X","authenticated-orcid":false,"given":"Khaled M.","family":"Musallam","sequence":"first","affiliation":[{"name":"Center for Research on Rare Blood Disorders (CR\u2010RBD) and Thalassemia &amp; Sickle Cell Center, Burjeel Cancer Institute, Burjeel Medical City  Abu Dhabi UAE"},{"name":"Department of Public Health &amp; Epidemiology Khalifa University  Abu Dhabi UAE"},{"name":"Division of Hematology\/Oncology, Department of Pediatrics Weill Cornell Medicine  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7976-3654","authenticated-orcid":false,"given":"Franco","family":"Locatelli","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology\/Oncology and Cell and Gene Therapy IRCCS Bambino Ges\u00f9 Children's Hospital  Rome Italy"},{"name":"Catholic University of the Sacred Heart  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6673-2664","authenticated-orcid":false,"given":"Mattia","family":"Algeri","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology\/Oncology and Cell and Gene Therapy IRCCS Bambino Ges\u00f9 Children's Hospital  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8676-6864","authenticated-orcid":false,"given":"Maria Domenica","family":"Cappellini","sequence":"additional","affiliation":[{"name":"Unit of Medicine and Metabolic Disease Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico  Milan Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8515-2238","authenticated-orcid":false,"given":"Ali T.","family":"Taher","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine American University of Beirut Medical Center  Beirut Lebanon"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,12]]},"reference":[{"key":"e_1_2_10_2_1","volume-title":"Guidelines for the Management of Non\u2010Transfusion\u2010Dependent \u03b2\u2010Thalassaemia","author":"Taher A.","year":"2023"},{"key":"e_1_2_10_3_1","volume-title":"Guidelines for the Management of Transfusion\u2010Dependent \u03b2\u2010Thalassaemia","author":"Taher A. 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