{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,15]],"date-time":"2026-01-15T06:04:54Z","timestamp":1768457094168,"version":"3.49.0"},"reference-count":51,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T00:00:00Z","timestamp":1763510400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100014848","name":"Arnold Ventures","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014848","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,1,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Clofazimine is a WHO-recommended therapy for multibacillary leprosy and an emerging option for drug-resistant tuberculosis and non-tuberculous mycobacterial infections. Yet in high-income countries like the USA, access remains restricted through expanded access pathways and other limitations, despite decades of safe use. This review examines clofazimine\u2019s regulatory trajectory in the USA, contrasts global access models, and highlights the consequences of relying on a single manufacturer and informal donation programmes. We argue that existing systems can be ill-suited to ensure equitable, sustainable access to essential but low-profit medicines like clofazimine. Policy options include simplified access pathways, WHO-based procurement for leprosy, and public manufacturing to stabilize supply. Clofazimine\u2019s case illustrates the need for proactive stewardship and access models that align with public health goals.<\/jats:p>","DOI":"10.1093\/jac\/dkaf430","type":"journal-article","created":{"date-parts":[[2025,11,19]],"date-time":"2025-11-19T16:25:15Z","timestamp":1763569515000},"source":"Crossref","is-referenced-by-count":0,"title":["The curious constraints on clofazimine"],"prefix":"10.1093","volume":"81","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0491-5385","authenticated-orcid":false,"given":"Maple","family":"Goh","sequence":"first","affiliation":[{"name":"Program On Regulation, Therapeutics And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital\/Harvard Medical School , 1620 Tremont, Suite 3030, Boston, MA 02120 ,","place":["USA"]},{"name":"Boston University School of Law , CARB-X, 765 Commonwealth Avenue, Boston, MA 02215 ,","place":["USA"]},{"name":"Tufts University School of Medicine, Department of Public Health and Community Medicine , 800 Washington St, Boston, MA 02111 ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Eisenkraft Klein","sequence":"additional","affiliation":[{"name":"Program On Regulation, Therapeutics And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital\/Harvard Medical School , 1620 Tremont, Suite 3030, Boston, MA 02120 ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8867-2666","authenticated-orcid":false,"given":"Aaron S","family":"Kesselheim","sequence":"additional","affiliation":[{"name":"Program On Regulation, Therapeutics And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women\u2019s Hospital\/Harvard Medical School , 1620 Tremont, Suite 3030, Boston, MA 02120 ,","place":["USA"]}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2025,11,19]]},"reference":[{"key":"2026011413275819900_dkaf430-B1","author":"World Health Organization"},{"key":"2026011413275819900_dkaf430-B2","doi-asserted-by":"publisher","first-page":"102058","DOI":"10.1016\/j.pupt.2021.102058","article-title":"Clofazimine for treatment of multidrug-resistant non-tuberculous mycobacteria","volume":"70","author":"Pfaeffle","year":"2021","journal-title":"Pulm Pharmacol Ther"},{"key":"2026011413275819900_dkaf430-B3","author":"US Food & Drug Administration"},{"key":"2026011413275819900_dkaf430-B4","author":"Health Resources & Services Administration"},{"key":"2026011413275819900_dkaf430-B5","doi-asserted-by":"publisher","first-page":"1013","DOI":"10.1038\/1791013a0","article-title":"A new series of phenazines (rimino-compounds) with high antituberculosis activity","volume":"179","author":"Barry","year":"1957","journal-title":"Nature"},{"key":"2026011413275819900_dkaf430-B6","first-page":"6","article-title":"\u201cB 663\u201d in the treatment of leprosy. 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