{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T22:39:48Z","timestamp":1793227188633,"version":"4.5.0"},"reference-count":21,"publisher":"Springer Science and Business Media LLC","issue":"11","license":[{"start":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T00:00:00Z","timestamp":1758931200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T00:00:00Z","timestamp":1758931200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2025,11]]},"DOI":"10.1007\/s40265-025-02239-0","type":"journal-article","created":{"date-parts":[[2025,9,27]],"date-time":"2025-09-27T04:19:54Z","timestamp":1758946794000},"page":"1499-1505","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Sebetralstat: First Approval"],"prefix":"10.1007","volume":"85","author":[{"given":"Hannah A.","family":"Blair","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,9,27]]},"reference":[{"issue":"20","key":"2239_CR1","doi-asserted-by":"publisher","first-page":"13629","DOI":"10.1021\/acs.jmedchem.2c00921","volume":"65","author":"RL Davie","year":"2022","unstructured":"Davie RL, Edwards HJ, Evans DM, et al. Sebetralstat (KVD900): a potent and selective small molecule plasma kallikrein inhibitor featuring a novel P1 group as a potential oral on-demand treatment for hereditary angioedema. J Med Chem. 2022;65(20):13629\u201344.","journal-title":"J Med Chem"},{"issue":"1","key":"2239_CR2","doi-asserted-by":"publisher","first-page":"132","DOI":"10.1016\/j.jaip.2020.08.046","volume":"9","author":"PJ Busse","year":"2021","unstructured":"Busse PJ, Christiansen SC, Riedl MA, et al. US HAEA Medical Advisory Board 2020 guidelines for the management of hereditary angioedema. J Allergy Clin Immunol Pract. 2021;9(1):132\u2013150.e3.","journal-title":"J Allergy Clin Immunol Pract"},{"key":"2239_CR3","unstructured":"KalVista Pharmaceuticals. KalVista Pharmaceuticals announces FDA approval of EKTERLY\u00ae (sebetralstat), first and only oral on-demand treatment for hereditary angioedema. [media release]. 7 Jul 2025. https:\/\/ir.kalvista.com\/news-releases\/news-release-details\/kalvista-pharmaceuticals-announces-fda-approval-ekterlyr."},{"key":"2239_CR4","unstructured":"KalVista Pharmaceuticals. EKTERLY (sebetralstat) tablets, for oral use: US prescribing information. 2025. https:\/\/www.kalvista.com\/ekterly-us-prescribing-information.pdf. Accessed 25 Aug 2025."},{"key":"2239_CR5","unstructured":"KalVista Pharmaceuticals. KalVista Pharmaceuticals reports fiscal second quarter results- 3 December 2019. [media release]. 3 Dec 2019. http:\/\/www.kalvista.com."},{"key":"2239_CR6","unstructured":"KalVista Pharmaceuticals. KalVista Pharmaceuticals awarded UK Promising Innovative Medicine (PIM) designation for sebetralstat [media release]. 12 Mar 2024. http:\/\/www.kalvista.com."},{"key":"2239_CR7","unstructured":"KalVista Pharmaceuticals. KalVista Pharmaceuticals announces UK MHRA approval of EKTERLY\u00ae (sebetralstat), first and only oral on-demand treatment for hereditary angioedema. [media release]. 7 Jul 2025. http:\/\/www.kalvista.com."},{"key":"2239_CR8","unstructured":"KalVista Pharmaceuticals. KalVista Pharmaceuticals receives positive CHMP opinion for sebetralstat for the treatment of hereditary angioedema attacks. [media release]. 25 Jul 2025. http:\/\/www.kalvista.com."},{"key":"2239_CR9","unstructured":"KalVista Pharmaceuticals. KalVista announces Orphan Drug Designation and NDA submission for sebetralstat in Japan for hereditary angioedema [media release]. 21 Jan 2025. http:\/\/www.kalvista.com."},{"key":"2239_CR10","unstructured":"KalVista Pharmaceuticals. KalVista announces the submission of additional Marketing Authorization Applications for sebetralstat for the oral on-demand treatment of hereditary angioedema. [media release]. 30 Sept 2024. http:\/\/www.kalvista.com."},{"key":"2239_CR11","unstructured":"KalVista Pharmaceuticals. KalVista Pharmaceuticals announces positive phase 1 data for orally disintegrating tablet formulation of sebetralstat for use in hereditary angioedema [media release]. 31 Oct 2022. http:\/\/www.kalvista.com."},{"key":"2239_CR12","unstructured":"KalVista Pharmaceuticals. Partnership and license agreement for the commercialization of sebetralstat for hereditary angioedema in Japan [media release]. 9 Apr 2025. http:\/\/www.kalvista.com."},{"key":"2239_CR13","unstructured":"KalVista Pharmaceuticals. KalVista Pharmaceuticals enters into licensing agreement with Pendopharm to commercialize sebetralstat for HAE in Canada [media release]. 26 Jun 2025. http:\/\/www.kalvista.com."},{"issue":"9","key":"2239_CR14","doi-asserted-by":"publisher","first-page":"1059","DOI":"10.1111\/cea.14122","volume":"52","author":"EJ Duckworth","year":"2022","unstructured":"Duckworth EJ, Murugesan N, Li L, et al. Pharmacological suppression of the kallikrein kinin system with KVD900: an orally available plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema. Clin Exp Allergy. 2022;52(9):1059\u201370.","journal-title":"Clin Exp Allergy"},{"key":"2239_CR15","unstructured":"Hampton SL, Audhya PK, Smith MD, et al. Potential for sebetralstat to address pseudo-allergic reaction burden secondary to icatibant in HAE [poster 001598]. In: European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting. 2025."},{"issue":"6","key":"2239_CR16","doi-asserted-by":"publisher","first-page":"2034","DOI":"10.1016\/j.jaci.2021.10.038","volume":"149","author":"A Maetzel","year":"2022","unstructured":"Maetzel A, Smith MD, Duckworth EJ, et al. KVD900, an oral on-demand treatment for hereditary angioedema: phase 1 study results. J Allergy Clin Immunol. 2022;149(6):2034\u201342.","journal-title":"J Allergy Clin Immunol"},{"issue":"10375","key":"2239_CR17","doi-asserted-by":"publisher","first-page":"458","DOI":"10.1016\/S0140-6736(22)02406-0","volume":"401","author":"E Ayg\u00f6ren-P\u00fcrs\u00fcn","year":"2023","unstructured":"Ayg\u00f6ren-P\u00fcrs\u00fcn E, Zanichelli A, Cohn DM, et al. An investigational oral plasma kallikrein inhibitor for on-demand treatment of hereditary angioedema: a two-part, randomised, double-blind, placebo-controlled, crossover phase 2 trial. Lancet. 2023;401(10375):458\u201369.","journal-title":"Lancet"},{"issue":"7","key":"2239_CR18","doi-asserted-by":"publisher","first-page":"707","DOI":"10.1080\/00498254.2022.2132187","volume":"52","author":"P Mutch","year":"2022","unstructured":"Mutch P, Bashir M, Jung B, et al. Absorption, metabolism, and excretion of [14C]-sebetralstat (KVD900) following a single oral dose in healthy male participants. Xenobiotica. 2022;52(7):707\u201317.","journal-title":"Xenobiotica"},{"issue":"1","key":"2239_CR19","doi-asserted-by":"publisher","first-page":"32","DOI":"10.1056\/NEJMoa2314192","volume":"391","author":"MA Riedl","year":"2024","unstructured":"Riedl MA, Farkas H, Ayg\u00f6ren-P\u00fcrs\u00fcn E, et al. Oral sebetralstat for on-demand treatment of hereditary angioedema attacks. N Engl J Med. 2024;391(1):32\u201343.","journal-title":"N Engl J Med"},{"issue":"Suppl 113","key":"2239_CR20","first-page":"537","volume":"79","author":"H Farkas","year":"2024","unstructured":"Farkas H, Riedl M, Aygoren-Pursiin E, et al. Sebetralstat as oral on-demand treatment for hereditary angioedema: interim analysis of demographics and attack characteristics from the open-label KONFIDENT-S trial [abstract no. 100097 plus poster]. Allergy. 2024;79(Suppl 113):537\u20138.","journal-title":"Allergy"},{"key":"2239_CR21","unstructured":"Honda D, Bernstein J, Cohn D, et al. Pooled sebetralstat efficacy and safety for on-demand treatment of hereditary angioedema [poster P8-3]. In: 124th Annual Meeting of the Japanese Dermatological Association. 2025."}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-025-02239-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s40265-025-02239-0\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-025-02239-0.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T05:31:17Z","timestamp":1761715877000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s40265-025-02239-0"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,9,27]]},"references-count":21,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["2239"],"URL":"https:\/\/doi.org\/10.1007\/s40265-025-02239-0","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,9,27]]},"assertion":[{"value":"10 August 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 August 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 September 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah Blair is a salaried employee of Adis International Ltd\/Springer Nature and declares no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authorship and Conflict of interest"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability"}}]}}