Lumateperone: First Approval
Lumateperone (Caplyta®) is a novel, orally available agent developed by Intra-Cellular Therapies (under a license from Bristol-Myers Squibb) for the treatment of schizophrenia and other neuropsychiatric and neurological disorders. Lumateperone is a first-in-class selective and simultaneous modulator of serotonin, dopamine and glutamate. In December 2019, lumateperone received its first global approval in the USA for the treatment of schizophrenia in adults. The drug is also under clinical development for bipolar depression, behavioural disorders associated with dementia and Alzheimer’s disease, sleep maintenance insomnia and major depressive disorders. This article summarizes the milestones in the development of lumateperone leading to this first approval for the treatment of schizophrenia.
Compliance with Ethical Standards
The preparation of this review was not supported by any external funding.
Conflict of interest
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.
- 3.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.
- 4.Intra-Cellular Therapies. FDA approves Intra-Cellular Therapies’ novel antipsychotic, CAPLYTA® (lumateperone) for the treatment of schizophrenia in adults [media release]. 23 Dec 2019. http://www.intracellulartherapies.com.
- 5.Intra-Cellular Therapies. Caplyta (lumateperone) capsules, for oral use: US prescribing information. 2019. http://www.accessdata.fda.gov/. Accessed 31 Jan 2020.
- 6.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.
- 13.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.Google Scholar
- 14.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.
- 15.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.Google Scholar
- 16.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):A284–5.Google Scholar
- 17.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):287–8.Google Scholar
- 18.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.