{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,26]],"date-time":"2026-02-26T15:07:09Z","timestamp":1772118429438,"version":"3.50.1"},"reference-count":72,"publisher":"Informa UK Limited","issue":"12","content-domain":{"domain":["www.tandfonline.com"],"crossmark-restriction":true},"short-container-title":["Expert Opinion on Investigational Drugs"],"published-print":{"date-parts":[[2022,12,2]]},"DOI":"10.1080\/13543784.2022.2158811","type":"journal-article","created":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T09:13:37Z","timestamp":1671441217000},"page":"1279-1290","update-policy":"https:\/\/doi.org\/10.1080\/tandf_crossmark_01","source":"Crossref","is-referenced-by-count":11,"title":["Ulotaront: a TAAR1\/5-HT1A agonist in clinical development for the treatment of schizophrenia"],"prefix":"10.1080","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5786-5203","authenticated-orcid":false,"given":"Mikkel","family":"H\u00f8jlund","sequence":"first","affiliation":[{"name":"Clinical Pharmacology and Pharmacy, Department of Public Health, University of Southern Denmark, Odense, Denmark"},{"name":"Department of Psychiatry Aabenraa, Mental Health Services Region of Southern Denmark, Aabenraa, Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7254-5646","authenticated-orcid":false,"given":"Christoph.U","family":"Correll","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Molecular Medicine, Zucker School of Medicine at Hofstra\/Northwell, New York, NY, USA"},{"name":"Department of Psychiatry, Glen Oaks, Zucker Hillside Hospital, New York, NY, USA"},{"name":"Child and Adolescent Psychiatry, Charit\u00e9 Universit\u00e4tsmedizin, Berlin, Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"301","published-online":{"date-parts":[[2022,12,22]]},"reference":[{"key":"cit0001","doi-asserted-by":"publisher","DOI":"10.1038\/nrdp.2015.67"},{"key":"cit0002","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(19)31135-3"},{"key":"cit0003","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60239-6"},{"key":"cit0004","doi-asserted-by":"publisher","DOI":"10.1002\/wps.20972"},{"key":"cit0005","doi-asserted-by":"publisher","DOI":"10.1002\/wps.20693"},{"key":"cit0006","doi-asserted-by":"publisher","DOI":"10.1016\/S0924-9338(10)71701-6"},{"key":"cit0007","doi-asserted-by":"publisher","DOI":"10.2147\/TCRM.S117321"},{"key":"cit0008","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbu170"},{"key":"cit0009","doi-asserted-by":"publisher","DOI":"10.1016\/j.neubiorev.2021.03.028"},{"key":"cit0010","doi-asserted-by":"publisher","DOI":"10.2147\/NDT.S225643"},{"key":"cit0011","doi-asserted-by":"crossref","first-page":"38","DOI":"10.1017\/S1092852914000601","volume":"19","author":"Carbon M","year":"2014","journal-title":"CNS Spectr"},{"key":"cit0012","unstructured":"European Medicines Agency. Rxulti (brexpiprazole) summary of product characteristics [Internet]. cited 2022 Oct 5]. Available from 2022 Oct 5: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/rxulti-epar-product-information_en.pdf."},{"key":"cit0013","unstructured":"European Medicines Agency. Reagila (cariprazine) summary of product characteristics [Internet]. 2018 cited 2022 Oct 5]. Available from 2022 Oct 5: https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/reagila."},{"key":"cit0014","unstructured":"Intra-Cellular Therapies, Inc. Caplyta (lumateperone) summary of product characteristics [Internet]. 2022 cited 2022 Oct 13]. Available from 2022 Oct 13: https:\/\/www.intracellulartherapies.com\/docs\/caplyta_pi.pdf."},{"key":"cit0015","doi-asserted-by":"publisher","DOI":"10.1016\/j.neuropharm.2019.107704"},{"key":"cit0016","volume":"83","author":"Correll CU","year":"2022","journal-title":"J Clin Psychiatry"},{"key":"cit0017","author":"Correll CU","year":"2022","journal-title":"World Psychiatry"},{"key":"cit0018","doi-asserted-by":"publisher","DOI":"10.3390\/ijms22094467"},{"key":"cit0019","doi-asserted-by":"publisher","DOI":"10.1017\/S109285291900124X"},{"key":"cit0020","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1911772"},{"key":"cit0021","doi-asserted-by":"publisher","DOI":"10.1038\/s41537-021-00190-z"},{"key":"cit0022","doi-asserted-by":"publisher","DOI":"10.1007\/s40263-021-00864-3"},{"key":"cit0023","doi-asserted-by":"publisher","DOI":"10.3390\/ijms222413185"},{"key":"cit0024","doi-asserted-by":"publisher","DOI":"10.1016\/j.neubiorev.2021.11.032"},{"key":"cit0025","doi-asserted-by":"publisher","DOI":"10.1016\/j.neubiorev.2020.09.028"},{"key":"cit0026","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.119.260281"},{"key":"cit0027","doi-asserted-by":"publisher","DOI":"10.3390\/ijms22084119"},{"key":"cit0028","doi-asserted-by":"publisher","DOI":"10.1038\/s41380-020-0740-6"},{"key":"cit0029","doi-asserted-by":"publisher","DOI":"10.1016\/j.drugalcdep.2021.109261"},{"key":"cit0030","volume-title":"Ulotaront improves metabolic parametres in rodent models of weight gain and hyperglycemia","author":"Dedic N","year":"2022"},{"key":"cit0031","unstructured":"Sunovion and psychogenics announce that SEP-363856 has received FDA breakthrough therapy designation for the treatment of people with schizophrenia [Internet]. cited 2021 Oct 15]. Available from 2021 Oct 15: https:\/\/news.sunovion.com\/press-releases\/press-releases-details\/2019\/Sunovion-and-PsychoGenics-Announce-that-SEP-363856-Has-Received-FDA-Breakthrough-Therapy-Designation-for-the-Treatment-of-People-with-Schizophrenia\/default.aspx."},{"key":"cit0032","doi-asserted-by":"publisher","DOI":"10.1002\/psp4.12692"},{"key":"cit0033","volume-title":"Presented at: 55th Meeting in the American College of Neuropsychopharmacology","author":"Koblan KS"},{"key":"cit0034","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharmthera.2017.07.002"},{"key":"cit0035","doi-asserted-by":"publisher","DOI":"10.1124\/pr.117.015305"},{"key":"cit0036","doi-asserted-by":"publisher","DOI":"10.1038\/s41380-021-01250-7"},{"key":"cit0037","doi-asserted-by":"publisher","DOI":"10.1523\/JNEUROSCI.2006-16.2016"},{"key":"cit0038","doi-asserted-by":"publisher","DOI":"10.1124\/mol.111.073304"},{"key":"cit0039","doi-asserted-by":"publisher","DOI":"10.1038\/s41398-021-01331-9"},{"key":"cit0040","author":"Nazimek J","year":"2016","journal-title":"Presented at: 55th Meeting in the American College of Neuropsychopharmacol"},{"key":"cit0041","unstructured":"Sunovion. NCT01994473: a 2-part randomized single-blind, placebo-controlled, ascending multiple oral dose and open-label study assessing the safety, tolerability, and pharmacokinetics of SEP-363856 in male and female subjects with schizophrenia [Internet]. 2015 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01994473."},{"key":"cit0042","unstructured":"Sunovion. NCT01940159: a randomized single-blind, placebo-controlled, ascending single oral dose study assessing the safety, tolerability, and pharmacokinetics of SEP-363856 in male and female subjects with schizophrenia. [Internet]. 2014 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01940159."},{"key":"cit0043","unstructured":"Sunovion. NCT04369391: a randomized, single-dose, crossover study of the effects of SEP-363856 on Electrocardiogram (ECG) intervals in subjects with schizophrenia [Internet]. 2020 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04369391."},{"key":"cit0044","unstructured":"Sunovion. NCT04865835: a randomized, single-blind, two-period crossover to investigate the effect of SEP-363856 on the pharmacokinetics of metformin in subjects with schizophrenia. [Internet]. 2021 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04865835."},{"key":"cit0045","unstructured":"Sunovion. NCT04038957: an open-label positron emission tomography study to investigate the effect of adjunctive administration of SEP-363856 on brain dopamine synthesis capacity using 18F-DOPA in adult subjects with schizophrenia [Internet]. 2020 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04038957."},{"key":"cit0046","unstructured":"Sumitomo Dainippon Pharma Co., Ltd. NCT03370640: a 2-part ascending multiple oral dose, open-label study assessing the safety, tolerability, and pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia. [Internet]. 2018 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03370640."},{"key":"cit0047","unstructured":"Sumitomo Dainippon Pharma Co., Ltd. NCT04325737: a randomized, double-blind, placebo-controlled, multiple oral dose study assessing the safety and tolerability of SEP-363856 in Japanese subjects with schizophrenia [Internet]. 2021 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04325737."},{"key":"cit0048","unstructured":"Sunovion. NCT05463770: an open-label, fixed sequence, multiple dose study of glucose and insulin associated parameters: SEP-363856 vs Prior Antipsychotic (PA) standard of care in subjects with schizophrenia suffering from metabolic dysregulation [Internet]. 2022 cited 2022 Jul 27]. Available from 2022 Jul 27: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05463770."},{"key":"cit0049","unstructured":"Sunovion. NCT05402111: a randomized, open-label, single dose, cross-over study of gastric emptying rate: SEP-363856 vs prior antipsychotic standard of care in subjects with schizophrenia [Internet]. 2022 cited 2022 Jul 27]. Available from 2022 Jul 27: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05402111."},{"key":"cit0050","doi-asserted-by":"publisher","DOI":"10.1093\/schbul\/sbx101"},{"issue":"11","key":"cit0051","first-page":"54","volume":"14","author":"Hopkins SC","year":"2017","journal-title":"Innov Clin Neurosci"},{"key":"cit0052","doi-asserted-by":"publisher","DOI":"10.1016\/j.psychres.2020.113569"},{"key":"cit0053","doi-asserted-by":"publisher","DOI":"10.1093\/schizbullopen\/sgac027"},{"key":"cit0054","doi-asserted-by":"publisher","DOI":"10.1007\/s40261-021-01094-7"},{"key":"cit0055","unstructured":"Sunovion. NCT04072354: a randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of SEP-363856 in acutely psychotic subjects with schizophrenia [Internet]. 2021 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04072354."},{"key":"cit0056","unstructured":"Sunovion. NCT04092686: a randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of SEP-363856 in acutely psychotic subjects with schizophrenia [Internet]. 2021 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04092686."},{"key":"cit0057","unstructured":"Sunovion. NCT04109950: an open-label extension study to assess the safety and tolerability of Sep-363856 in subjects with schizophrenia [Internet]. 2020 cited 2021 Sep 21]. Available from 2021 Sep 21: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04109950."},{"key":"cit0058","unstructured":"Sunovion. NCT04115319: a randomized, double-blind, active comparator-controlled study to evaluate the long-term safety and tolerability of SEP-363856 in subjects with schizophrenia [Internet]. 2021 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04115319."},{"key":"cit0059","unstructured":"Sumitomo Dainippon Pharma Co., Ltd. NCT04825860: a randomized, double-blind, parallel-group, placebo controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of SEP 363856 in acutely psychotic patients with schizophrenia, followed by an open-label extension phase [Internet]. 2021 cited 2021 Dec 10]. Available from 2021 Dec 10: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04825860."},{"key":"cit0060","unstructured":"Sumitomo Pharma Co., Ltd. NCT05359081: a 52-week, open-label study to evaluate the long-term safety and tolerability of SEP-363856 in patients with schizophrenia in Japan [Internet]. 2022 cited 2022 May 11]. Available from 2022 May 11: https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05359081."},{"key":"cit0061","doi-asserted-by":"publisher","DOI":"10.1186\/1471-244X-12-20"},{"key":"cit0062","doi-asserted-by":"publisher","DOI":"10.1186\/s12991-020-00292-5"},{"key":"cit0063","doi-asserted-by":"publisher","DOI":"10.1007\/s10571-019-00772-7"},{"key":"cit0064","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2016.3803"},{"key":"cit0065","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.bp.117.200907"},{"key":"cit0066","doi-asserted-by":"publisher","DOI":"10.1001\/jamapsychiatry.2021.3990"},{"key":"cit0067","doi-asserted-by":"publisher","DOI":"10.31887\/DCNS.2011.13.2\/ccorrell"},{"key":"cit0068","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v67n0122"},{"key":"cit0069","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2011.02.016"},{"key":"cit0070","doi-asserted-by":"publisher","DOI":"10.1016\/j.schres.2012.03.018"},{"key":"cit0071","doi-asserted-by":"publisher","DOI":"10.2147\/PGPM.S146110"},{"key":"cit0072","doi-asserted-by":"publisher","DOI":"10.1017\/S1092852920000139"}],"container-title":["Expert Opinion on Investigational Drugs"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.tandfonline.com\/doi\/pdf\/10.1080\/13543784.2022.2158811","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,1,31]],"date-time":"2023-01-31T12:41:50Z","timestamp":1675168910000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.tandfonline.com\/doi\/full\/10.1080\/13543784.2022.2158811"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,12,2]]},"references-count":72,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2022,12,2]]}},"alternative-id":["10.1080\/13543784.2022.2158811"],"URL":"https:\/\/doi.org\/10.1080\/13543784.2022.2158811","relation":{},"ISSN":["1354-3784","1744-7658"],"issn-type":[{"value":"1354-3784","type":"print"},{"value":"1744-7658","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,12,2]]},"assertion":[{"value":"The publishing and review policy for this title is described in its Aims & Scope.","order":1,"name":"peerreview_statement","label":"Peer Review Statement"},{"value":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=ieid20","URL":"http:\/\/www.tandfonline.com\/action\/journalInformation?show=aimsScope&journalCode=ieid20","order":2,"name":"aims_and_scope_url","label":"Aim & Scope"},{"value":"2022-08-01","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-12-12","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-12-22","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}