{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T16:43:54Z","timestamp":1791218634332,"version":"4.1.0"},"reference-count":106,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:00:00Z","timestamp":1782864000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Center for Intelligent Drug Systems and Smart Bio-devices"},{"DOI":"10.13039\/100009122","name":"Ministry of Education","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009122","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>Diabetes mellitus remains a global health challenge, with insulin therapy essential for type 1 diabetes and many advanced type 2 cases. However, reliance on subcutaneous injections limits adherence and quality of life. This review synthesizes recent advances in oral insulin research, encompassing scientific rationale, delivery technologies, clinical progress, regulatory perspectives, and commercial outlook.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Key findings<\/jats:title>\n                    <jats:p>Peer-reviewed studies, clinical trial data and industry reports were analyzed to assess the efficacy, safety, and translational potential of oral insulin formulations. Oral insulin offers physiological advantages by mimicking endogenous portal vein delivery, potentially reducing peripheral hyperinsulinemia and hypoglycemia risk. Advances in nanotechnology, permeation enhancers, and enteric coatings have improved bioavailability, though variability persists. Late-stage candidates such as Oramed\u2019s ORMD-0801 and Diabetology\u2019s Capsulin demonstrated feasibility but yielded mixed Phase 3 outcomes, underscoring translational gaps. Regulators emphasize rigorous pharmacokinetic characterization and long-term safety, while commercial viability depends on scalability, affordability, and patient-centered benefits.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Summary<\/jats:title>\n                    <jats:p>Oral insulin represents a transformative innovation in diabetes care, with potential to improve adherence, quality of life, and hepatic glucose regulation. Despite setbacks in pivotal trials, ongoing technological refinement, strategic partnerships, and integration with personalized medicine and digital health tools continue to advance its path toward clinical adoption.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/jpp\/rgag078","type":"journal-article","created":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T17:56:09Z","timestamp":1784742969000},"source":"Crossref","is-referenced-by-count":3,"title":["The latest developments in oral insulin: scientific advances and clinical progress"],"prefix":"10.1093","volume":"78","author":[{"given":"Hui-Fang","family":"Chang","sequence":"first","affiliation":[{"name":"Division of Endocrinology, Department of Internal Medicine, Hsinchu Mackay Memorial Hospital , Hsinchu 300 ,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tzu-Min","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Biological Science and Technology, National Yang Ming Chiao Tung University , Hsinchu 300 ,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu-Ling","family":"Sun","sequence":"additional","affiliation":[{"name":"Animal and Plant Health and Production Research Center, Agricultural Technology Research Institute , Hsinchu 300 ,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tzu-Ching","family":"Lin","sequence":"additional","affiliation":[{"name":"Division of Pharmacy, Koo Foundation Sun Yat-Sen Cancer Center , Taipei 100 ,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1140-7933","authenticated-orcid":false,"given":"Chih-Sheng","family":"Lin","sequence":"additional","affiliation":[{"name":"Department of Biological Science and Technology, National Yang Ming Chiao Tung University , Hsinchu 300 ,","place":["Taiwan"]},{"name":"Center for Intelligent Drug Systems and Smart Bio-devices (IDS2B), National Yang Ming Chiao Tung University , Hsinchu 300 ,","place":["Taiwan"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,7,22]]},"reference":[{"key":"2026073000265461300_ref1","doi-asserted-by":"publisher","first-page":"910","DOI":"10.1136\/bmj.p910","article-title":"Rise in type 2 diabetes shows that prevention is more important than ever","volume":"381","author":"Valabhji","year":"2023","journal-title":"BMJ"},{"key":"2026073000265461300_ref2","article-title":"IDF diabetes atlas 11th edition","author":"International Diabetes Federation (IDF)","year":"2025","journal-title":"IDF Diabetes Atlas"},{"key":"2026073000265461300_ref3","doi-asserted-by":"publisher","first-page":"S52","DOI":"10.2337\/dc25-S004","article-title":"Professional practice committee. 4. 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