{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T19:49:38Z","timestamp":1792093778817,"version":"4.4.0"},"reference-count":42,"publisher":"The Endocrine Society","license":[{"start":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T00:00:00Z","timestamp":1782432000000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Crinetics Pharmaceuticals, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Paltusotine is the first nonpeptide selective somatostatin 2 receptor agonist approved as once-daily oral treatment for acromegaly.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To evaluate long-term treatment with paltusotine in patients with acromegaly previously on an injected somatostatin receptor ligand (SRL)-based regimen.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>ACROBAT Advance is an ongoing open-label extension (OLE) study. Interim results (up to year 4) are reported. Enrolled patients had completed a phase 2 parent study: ACROBAT Edge (baseline insulin-like growth factor I [IGF-I] &amp;gt;1\u00d7 upper limit of normal [ULN] on injected octreotide or lanreotide \u00b1 cabergoline, or baseline IGF-I \u22641\u00d7ULN with combination therapy or pasireotide) or ACROBAT Evolve (baseline IGF-I \u22641\u00d7ULN on injected SRL monotherapy). Maximum paltusotine dose was initially 40\u2005mg, then 60\u2005mg, when a tablet formulation became available in year 3. Adjunctive treatment with cabergoline or pegvisomant was allowed as clinically indicated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Forty-three patients (88% of eligible patients from ACROBAT Edge and Evolve) enrolled in the OLE. Median (interquartile range) IGF-I levels were: 1.15\u00d7ULN (0.84, 1.46) at parent study baseline (n = 43), 1.17\u00d7ULN (0.98, 1.54) at Advance week 3 (n = 43), and 1.01\u00d7ULN (0.83, 1.13) at Advance week 207 (n = 20). Growth hormone levels, acromegaly symptoms, and pituitary tumor size remained stable. Paltusotine was well tolerated, with no unexpected safety findings observed. As of this analysis, 8 (18.6%) patients had discontinued from the study, including 2 (4.7%) due to adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Once-daily oral paltusotine treatment was well tolerated and resulted in long-term disease control, including biochemical, symptom, and pituitary tumor stability, for up to 4 years.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgag254","type":"journal-article","created":{"date-parts":[[2026,6,25]],"date-time":"2026-06-25T11:50:40Z","timestamp":1782388240000},"source":"Crossref","is-referenced-by-count":2,"title":["Safety and efficacy of once-daily oral paltusotine in acromegaly: ACROBAT Advance open-label extension up to 4 years"],"prefix":"10.1210","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9250-3558","authenticated-orcid":false,"given":"M\u00f4nica R","family":"Gadelha","sequence":"first","affiliation":[{"name":"Neuroendocrinology Research Center\/Endocrinology Division, Medical School and Hospital Universitario Clementino Fraga Filho, Universidade Federal do Rio de Janeiro , Rio de Janeiro CEP 21941-913 ,","place":["Brazil"]},{"name":"State Department of Health, Clinical Research Center, Instituto Estadual do C\u00e9rebro Paulo Niemeyer , Rio de Janeiro CEP 20231-092 ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murray B","family":"Gordon","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Allegheny Neuroendocrinology Center, Allegheny General Hospital , Pittsburgh, PA 15212 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2701-4800","authenticated-orcid":false,"given":"Mirjana","family":"Doknic","sequence":"additional","affiliation":[{"name":"Neuroendocrine Department, Faculty of Medicine, Clinic for Endocrinology, Diabetes and Metabolic Diseases, University Clinical Center of Serbia, University of Belgrade , Belgrade 11000 ,","place":["Serbia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emese","family":"Mez\u0151si","sequence":"additional","affiliation":[{"name":"First Department of Internal Medicine, Faculty of Medicine, University of P\u00e9cs Medical School , P\u00e9cs 7624 ,","place":["Hungary"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikl\u00f3s","family":"T\u00f3th","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine and Oncology, Faculty of Medicine, Semmelweis University , Budapest 1085 ,","place":["Hungary"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harpal","family":"Randeva","sequence":"additional","affiliation":[{"name":"Warwickshire Institute for the Study of Diabetes, Endocrinology and Metabolism (WISDEM), University Hospitals Coventry and Warwickshire NHS Trust , Coventry CV2 2DX ,","place":["UK"]},{"name":"Division of Biomedicine, Warwick Medical School, University of Warwick , Coventry CV4 7AL ,","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cesar Luiz","family":"Boguszewski","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Endocrine Division (SEMPR), Federal University of Paran\u00e1 , Curitiba 80030-110 ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher","family":"Davidson","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals, Inc. , San Diego, CA 92121 ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alessandra","family":"Casagrande","sequence":"additional","affiliation":[{"name":"Crinetics Pharmaceuticals, Inc. , San Diego, CA 92121 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