{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,20]],"date-time":"2026-09-20T02:57:00Z","timestamp":1789873020698,"version":"4.0.1"},"reference-count":46,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T00:00:00Z","timestamp":1743984000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>The incidence of osteoporosis is projected to exceed 70 million people over the age of 65\u2009years by 2030. Osteoanabolic agents, such as teriparatide and abaloparatide, are not only effective in reducing fracture incidence but also improve skeletal microstructure\u2014an important need not met by antiresorptive agents. However, anabolic agents must be administered by daily subcutaneous injections which can be a challenge in older women. To address this need, we have developed an oral robotic pill (RP) designed to deliver biotherapeutics safely and painlessly.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This report describes the results of a 2\u2010part Phase 1 study conducted to evaluate the safety, tolerability and pharmacokinetics of single (Part 1) and repeat doses (Part 2) of teriparatide delivered via the RP (RT\u2010102) in healthy and postmenopausal women.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Teriparatide, administered by the RP, was measurable in 26\/29 and 63\/69 of participants in Part 1 and Part 2, respectively. RT\u2010102 at the 20\u2010\u03bcg dose yielded a lower maximum observed serum concentration (98\u2009\u00b1\u200910\n                      <jats:italic>vs<\/jats:italic>\n                      . 128\u2009\u00b1\u200920\u2009pg\u2009mL\n                      <jats:sup>\u22121<\/jats:sup>\n                      ), delayed time to reach maximum observed serum concentration (68\u2009\u00b1\u200915\n                      <jats:italic>vs<\/jats:italic>\n                      . 13\u2009\u00b1\u20092\u2009min) and higher area under the curve to infinity (342\u2009\u00b1\u200944\n                      <jats:italic>vs<\/jats:italic>\n                      . 126\u2009\u00b1\u200929\u2009h\u2009pg\u2009mL\n                      <jats:sup>\u22121<\/jats:sup>\n                      ) resulting in a 3\u2010fold higher bioavailability than subcutaneous injection. RT\u2010102 was well tolerated with only 5 mild to moderate adverse events (AEs) related to the RP that resolved without intervention and no serious AEs. Drug\u2010related AEs were similar in severity and frequency between RT\u2010102 and subcutaneous teriparatide.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>These data demonstrate that RT\u2010102 can safely and reliably deliver therapeutic levels of teriparatide.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinicaltrials.gov<\/jats:title>\n                    <jats:p>NCT#05164614.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70064","type":"journal-article","created":{"date-parts":[[2025,4,7]],"date-time":"2025-04-07T20:23:06Z","timestamp":1744057386000},"page":"2447-2457","source":"Crossref","is-referenced-by-count":5,"title":["An oral robotic pill reliably and safely delivers teriparatide with high bioavailability in healthy volunteers: A phase 1 study"],"prefix":"10.1002","volume":"91","author":[{"ORCID":"https:\/\/orcid.org\/0009-0002-1467-6282","authenticated-orcid":false,"given":"Joshua T.","family":"Myers","sequence":"first","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alyson","family":"Yamaguchi","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"April Toledo","family":"Vo","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anvesh","family":"Dasari","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Archana","family":"Battiwala","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nidhi","family":"Patel","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonard C.","family":"Fung","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ofer M.","family":"Gonen","sequence":"additional","affiliation":[{"name":"Nucleus Network  Melbourne VIC Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mir","family":"Imran","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jacques","family":"Van Dam","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mir A.","family":"Hashim","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arvinder K.","family":"Dhalla","sequence":"additional","affiliation":[{"name":"Rani Therapeutics, LLC  San Jose CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John P.","family":"Bilezikian","sequence":"additional","affiliation":[{"name":"Vagelos College of Physicians and Surgeons Columbia University  New York NY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,4,7]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(10)62349\u20105"},{"key":"e_1_2_14_3_1","unstructured":"Hansen DPMPBSP.Medicare cost of osteoporotic fractures: 2021 update report. 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