{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T17:17:17Z","timestamp":1793207837938,"version":"4.5.0"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2020,2,14]],"date-time":"2020-02-14T00:00:00Z","timestamp":1581638400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"},{"start":{"date-parts":[[2020,2,14]],"date-time":"2020-02-14T00:00:00Z","timestamp":1581638400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/www.springer.com\/tdm"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Drugs"],"published-print":{"date-parts":[[2020,3]]},"DOI":"10.1007\/s40265-020-01271-6","type":"journal-article","created":{"date-parts":[[2020,2,14]],"date-time":"2020-02-14T15:04:47Z","timestamp":1581692687000},"page":"417-423","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":73,"title":["Lumateperone: First Approval"],"prefix":"10.1007","volume":"80","author":[{"given":"Hannah A.","family":"Blair","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,2,14]]},"reference":[{"issue":"3","key":"1271_CR1","doi-asserted-by":"publisher","first-page":"598","DOI":"10.1038\/s41386-018-0251-1","volume":"44","author":"KE Vanover","year":"2019","unstructured":"Vanover KE, Davis RE, Zhou Y, et al. Dopamine D2 receptor occupancy of lumateperone (ITI-007): a positron emission tomography study in patients with schizophrenia. Neuropsychopharmacology. 2019;44(3):598\u2013605.","journal-title":"Neuropsychopharmacology."},{"issue":"15","key":"1271_CR2","doi-asserted-by":"publisher","first-page":"2863","DOI":"10.1007\/s00213-015-3922-1","volume":"232","author":"RE Davis","year":"2015","unstructured":"Davis RE, Vanover KE, Zhou Y, et al. ITI-007 demonstrates brain occupancy at serotonin 5-HT2A and dopamine D2 receptors and serotonin transporters using positron emission tomography in healthy volunteers. Psychopharmacology (Berl). 2015;232(15):2863\u201372.","journal-title":"Psychopharmacology (Berl)."},{"key":"1271_CR3","unstructured":"Intra-Cellular Therapies. Intra-Cellular Therapies receives FDA fast track designation for lumateperone for the treatment of schizophrenia [media release]. 20 Nov 2017. http:\/\/www.intracellulartherapies.com."},{"key":"1271_CR4","unstructured":"Intra-Cellular Therapies. FDA approves Intra-Cellular Therapies\u2019 novel antipsychotic, CAPLYTA\u00ae (lumateperone) for the treatment of schizophrenia in adults [media release]. 23 Dec 2019. http:\/\/www.intracellulartherapies.com."},{"key":"1271_CR5","unstructured":"Intra-Cellular Therapies. Caplyta (lumateperone) capsules, for oral use: US prescribing information. 2019. http:\/\/www.accessdata.fda.gov\/. Accessed 31 Jan 2020."},{"key":"1271_CR6","unstructured":"Intra-Cellular Therapies Inc. Intra-Cellular Therapies, Inc. receives exclusive license for central nervous system compounds from Bristol-Myers Squibb Company [media release]. 1 Jun 2005. http:\/\/www.intracellulartherapies.com."},{"issue":"3","key":"1271_CR7","doi-asserted-by":"publisher","first-page":"605","DOI":"10.1007\/s00213-014-3704-1","volume":"232","author":"GL Snyder","year":"2015","unstructured":"Snyder GL, Vanover KE, Zhu H, et al. Functional profile of a novel modulator of serotonin, dopamine, and glutamate neurotransmission. Psychopharmacology (Berl). 2015;232(3):605\u201321.","journal-title":"Psychopharmacology (Berl)."},{"key":"1271_CR8","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2019.4379","author":"CU Correll","year":"2020","unstructured":"Correll CU, Davis RE, Weingart M, et al. Efficacy and safety of lumateperone for treatment of schizophrenia: a randomized clinical trial. JAMA Psychiatry. 2020. https:\/\/doi.org\/10.1001\/jamapsychiatry.2019.4379.","journal-title":"JAMA Psychiatry."},{"issue":"1","key":"1271_CR9","doi-asserted-by":"publisher","first-page":"190","DOI":"10.1017\/S1092852919000245","volume":"24","author":"K Vanover","year":"2019","unstructured":"Vanover K, Glass S, Kozauer S, et al. Lumateperone (ITI-007) for the treatment of schizophrenia: overview of placebo-controlled clinical trials and an open-label safety switching study [abstract no. 30]. CNS Spectr. 2019;24(1):190\u20131.","journal-title":"CNS Spectr."},{"issue":"12","key":"1271_CR10","doi-asserted-by":"publisher","first-page":"952","DOI":"10.1016\/j.biopsych.2015.08.026","volume":"79","author":"JA Lieberman","year":"2016","unstructured":"Lieberman JA, Davis RE, Correll CU, et al. ITI-007 for the treatment of schizophrenia: a 4-week randomized, double-blind, controlled trial. Biol Psychiatry. 2016;79(12):952\u201361.","journal-title":"Biol Psychiatry."},{"issue":"Suppl 6","key":"1271_CR11","doi-asserted-by":"publisher","first-page":"S453","DOI":"10.1016\/j.euroneuro.2019.09.642","volume":"29","author":"JM Kane","year":"2019","unstructured":"Kane JM, Vanover KE, Durgam S, et al. Efficacy and safety of lumateperone tosylate 42\u00a0mg in the treatment of schizophrenia: a pooled analysis of phase 2 and 3 studies [abstract no. P.671]. Eur Neuropsychopharmacol. 2019;29(Suppl 6):S453\u20134.","journal-title":"Eur Neuropsychopharmacol."},{"issue":"Suppl 1","key":"1271_CR12","doi-asserted-by":"publisher","first-page":"S236","DOI":"10.1093\/schbul\/sby017.577","volume":"44","author":"R Davis","year":"2018","unstructured":"Davis R, Dmitrienko A, Glass S, et al. Lumateperone (ITI-007): favorable safety profile in an open label safety switching study from standard-of-care antipsychotic therapy in patients with schizophrenia [abstract no. F46]. Schizophr Bull. 2018;44(Suppl 1):S236\u20137.","journal-title":"Schizophr Bull."},{"key":"1271_CR13","unstructured":"Satlin A, Vanover K, Durgam S, et al. Additional results from a 12-month open-label safety study of lumateperone (ITI-007) in patients with stable symptoms of schizophrenia [abstract no. W203 plus poster]. In: 58th Annual Meeting of the American College of Neuropsychopharmacology. 2019."},{"key":"1271_CR14","unstructured":"Intra-Cellular Therapies. Intra-Cellular Therapies announces positive top-line results from a phase 3 trial of lumateperone in patients with bipolar depression [media release]. 8 Jul 2019. http:\/\/www.intracellulartherapies.com."},{"key":"1271_CR15","unstructured":"Durgam S, Satlin A, Vanover K, et al. Lumateperone (ITI-007) in the treatment of bipolar depression: results from a randomized clinical trial [abstract no. W123 plus poster]. In: 58th Annual Meeting of the American College of Neuropsychopharmacology. 2019."},{"issue":"Suppl S","key":"1271_CR16","first-page":"A284","volume":"32","author":"KE Vanover","year":"2009","unstructured":"Vanover KE, Staner L, Luthringer R, et al. ITI-007\/ITI-722: a new approach for the treatment of sleep maintenance insomnia and sleep disorders associated with psychiatric and neurological diseases [abstract]. Sleep. 2009;32(Suppl S):A284\u20135.","journal-title":"Sleep."},{"issue":"3","key":"1271_CR17","first-page":"287","volume":"1","author":"R Davis","year":"2014","unstructured":"Davis R, Saillard J, et al. Safety and tolerability of ITI-007 in patients with dementia: a novel treatment designed to treat behavioral disturbances associated with dementia and related disorders [abstract no. P2-35]. J Prev Alzheimers Dis. 2014;1(3):287\u20138.","journal-title":"J Prev Alzheimers Dis."},{"key":"1271_CR18","unstructured":"Intra-Cellular T. Intra-Cellular Therapies announces additional results from phase I\/II clinical trial for ITI-007 in healthy geriatric subjects and patients with dementia [media release]. 24 Nov 2014. http:\/\/www.intracellulartherapies.com."}],"container-title":["Drugs"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-020-01271-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/article\/10.1007\/s40265-020-01271-6\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"http:\/\/link.springer.com\/content\/pdf\/10.1007\/s40265-020-01271-6.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,2,13]],"date-time":"2021-02-13T23:10:44Z","timestamp":1613257844000},"score":1,"resource":{"primary":{"URL":"http:\/\/link.springer.com\/10.1007\/s40265-020-01271-6"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,2,14]]},"references-count":18,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2020,3]]}},"alternative-id":["1271"],"URL":"https:\/\/doi.org\/10.1007\/s40265-020-01271-6","relation":{},"ISSN":["0012-6667","1179-1950"],"issn-type":[{"value":"0012-6667","type":"print"},{"value":"1179-1950","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,2,14]]},"assertion":[{"value":"14 February 2020","order":1,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with Ethical Standards"}},{"value":"The preparation of this review was not supported by any external funding.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Funding"}},{"value":"During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Hannah A. Blair is a salaried employee of Adis International Ltd\/Springer Nature, is responsible for the article content and declares no relevant conflicts of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}