{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,2]],"date-time":"2026-08-02T19:57:47Z","timestamp":1785700667274,"version":"3.56.0"},"reference-count":29,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T00:00:00Z","timestamp":1785283200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ann Pharmacother"],"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To review the pharmacology, pharmacokinetics, efficacy, safety, and clinical role of milsaperidone (Bysanti), a newly approved atypical antipsychotic for schizophrenia and acute bipolar I disorder.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Sources:<\/jats:title>\n                    <jats:p>A comprehensive literature search was conducted using PubMed, Embase, and Google Scholar from database inception through April 2026. Additional data were obtained from Food and Drug Administration prescribing information and pharmacologic references using key terms including milsaperidone, Bysanti, iloperidone, atypical antipsychotics, schizophrenia, and bipolar I disorder.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study Selection and Data Abstraction:<\/jats:title>\n                    <jats:p>English-language studies evaluating milsaperidone or its parent compound, iloperidone, were included, focusing on pharmacologic properties, clinical efficacy, and safety outcomes. Key trials, reviews, and regulatory data were abstracted and synthesized.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Data Synthesis:<\/jats:title>\n                    <jats:p>Milsaperidone, the active metabolite of iloperidone, exerts its effects through dopamine D\u2082 and serotonin 5-HT\u2082A receptor antagonism, with additional \u03b1\u2081-adrenergic blockade contributing to its safety profile. Clinical evidence demonstrates efficacy in reducing symptoms of schizophrenia and bipolar mania, with low rates of extrapyramidal symptoms and akathisia. However, tolerability concerns include orthostatic hypotension, QTc prolongation, sedation, and weight gain. Pharmacokinetic variability associated with CYP2D6 metabolism and gradual titration remain key considerations.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Relevance to Patient Care and Clinical Practice in Comparison With Existing Drugs:<\/jats:title>\n                    <jats:p>Milsaperidone expands available atypical antipsychotic options, offering a potentially favorable tolerability profile for patients with prior intolerance or sensitivity to movement-related adverse effects. Careful patient selection and monitoring are essential.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Milsaperidone represents an incremental yet meaningful addition to antipsychotic therapy, supporting individualized strategies in schizophrenia and bipolar I disorder while balancing efficacy and tolerability.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10600280261470404","type":"journal-article","created":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T09:25:29Z","timestamp":1785317129000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Clinical Evaluation of Bysanti: A New Atypical Antipsychotic for Schizophrenia and Bipolar I Disorder"],"prefix":"10.1177","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2157-9037","authenticated-orcid":false,"given":"Bradley","family":"Phillips","sequence":"first","affiliation":[{"name":"Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Orlando, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-3871-1832","authenticated-orcid":false,"given":"Melanie","family":"Horta","sequence":"additional","affiliation":[{"name":"Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Orlando, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Santini","sequence":"additional","affiliation":[{"name":"Department of Pharmacotherapy and Translational Research, College of Pharmacy, University of Florida, Orlando, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Derek","family":"Chapman","sequence":"additional","affiliation":[{"name":"WakeMed Physician Practices, WakeMed Raleigh Hospital, NC, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,7,29]]},"reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sby058"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1002\/wps.20994"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.64.5.543"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa051688"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.clinthera.2026.05.003"},{"key":"e_1_3_2_7_2","volume-title":"Package insert","author":"Bysanti","year":"2026","unstructured":"Bysanti. Package insert. Vanda Pharmaceuticals Inc; 2026."},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.3389\/fpsyt.2025.1640963"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)00241-X"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1001\/archgenpsychiatry.2011.12"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/psyrad\/kkae015"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1146\/annurev.clinpsy.2.022305.095332"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.3390\/ijms21249532"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.2147\/CE.S114094"},{"key":"e_1_3_2_15_2","unstructured":"Guzm\u00e1n F. Mechanism of action and pharmacodynamics of iloperidone (Fanapt). Psychopharmacology Institute. December 13 2014. Accessed June 22 2026. https:\/\/psychopharmacologyinstitute.com\/publication\/mechanism-of-action-and-pharmacodynamics-of-iloperidone-fanapt-2153\/"},{"key":"e_1_3_2_16_2","unstructured":"McGovern G. FDA approves milsaperidone for treatment of bipolar I disorder and schizophrenia. Pharmacy Times. March 3 2026. Accessed May 11 2026. https:\/\/www.pharmacytimes.com\/view\/fda-approves-milsaperidone-for-treatment-of-bipolar-i-disorder-and-schizophrenia"},{"key":"e_1_3_2_17_2","unstructured":"Clinical Pharmacogenetics Implementation Consortium (CPIC). Iloperidone pathway pharmacokinetics. PharmGKB. June 23 2025. Accessed May 11 2026. https:\/\/www.clinpgx.org\/pathway\/PA166411321"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1517\/17425255.2010.531259"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1038\/aps.2016.96"},{"key":"e_1_3_2_20_2","unstructured":"BenchChem Technical Support Team. Technical Support Center: Iloperidone Drug Interactions Mediated by CYP2D6 and CYP3A4. BenchChem; 2026. Accessed May 11 2026. https:\/\/www.benchchem.com\/product\/b1671726\/docs#technical-support-center-iloperidone-drug-interactions-mediated-by-cyp2d6-and-cyp3a4"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e3181692787"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1097\/JCP.0b013e318169d4ce"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-016-0345-4"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.23m14966"},{"key":"e_1_3_2_25_2","unstructured":"GoodRx. Fanapt prices coupons and savings tips. Accessed May 11 2026. https:\/\/www.goodrx.com\/fanapt"},{"key":"e_1_3_2_26_2","unstructured":"MedXdrg. How much does Fanapt cost? a guide to pricing and savings. Published November 22 2025. Accessed May 11 2026. https:\/\/medxdrg.com\/understanding-how-much-does-fanapt-cost"},{"key":"e_1_3_2_27_2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2020.177901"},{"key":"e_1_3_2_28_2","doi-asserted-by":"publisher","DOI":"10.1111\/bdi.12609"},{"key":"e_1_3_2_29_2","doi-asserted-by":"publisher","DOI":"10.29399\/npa.27480"},{"key":"e_1_3_2_30_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60733-3"}],"container-title":["Annals of Pharmacotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280261470404","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10600280261470404","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10600280261470404","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,2]],"date-time":"2026-08-02T19:43:42Z","timestamp":1785699822000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10600280261470404"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,29]]},"references-count":29,"alternative-id":["10.1177\/10600280261470404"],"URL":"https:\/\/doi.org\/10.1177\/10600280261470404","relation":{},"ISSN":["1060-0280","1542-6270"],"issn-type":[{"value":"1060-0280","type":"print"},{"value":"1542-6270","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,29]]},"article-number":"10600280261470404"}}