Lumateperone: First Approval

被引：57

作者：

Blair, Hannah A. ^{[1
]}

机构：

[1] Springer Nat, Private Bag 65901, Auckland 0754, New Zealand

来源：

DRUGS | 2020年 / 80卷 / 04期

关键词：

SEROTONIN; PROFILE; SAFETY;

D O I：

10.1007/s40265-020-01271-6

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Lumateperone (Caplyta(R)) 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.

引用

页码：417 / 423

页数：7

共 13 条

[1] Efficacy and Safety of Lumateperone for Treatment of Schizophrenia A Randomized Clinical Trial [J].

Correll, Christoph U. ;

Davis, Robert E. ;

Weingart, Michal ;

Saillard, Jelena ;

O'Gorman, Cedric ;

Kane, John M. ;

Lieberman, Jeffrey A. ;

Tamminga, Carol A. ;

Mates, Sharon ;

Vanover, Kimberly E. .

JAMA PSYCHIATRY, 2020, 77 (04) :349-358

[2]

Davis R., 2014, J Prev Alzheimers Dis, V1, P287

[3] LUMATEPERONE (ITI-007): FAVORABLE SAFETY PROFILE IN AN OPEN LABEL SAFETY SWITCHING STUDY FROM STANDARD-OF-CARE ANTIPSYCHOTIC THERAPY IN PATIENTS WITH SCHIZOPHRENIA [J].

Davis, Robert ;

Dmitrienko, Alex ;

Glass, Steven ;

Kozauer, Susan ;

Saillard, Jelena ;

Weingart, Michal ;

Satlin, Andrew ;

Mates, Sharon ;

Correll, Christoph ;

Vanover, Kimberly .

SCHIZOPHRENIA BULLETIN, 2018, 44 :S236-S237

[4] ITI-007 demonstrates brain occupancy at serotonin 5-HT2A and dopamine D2 receptors and serotonin transporters using positron emission tomography in healthy volunteers [J].

Davis, Robert E. ;

Vanover, Kimberly E. ;

Zhou, Yun ;

Brasic, James R. ;

Guevara, Maria ;

Bisuna, Blanca ;

Ye, Weiguo ;

Raymont, Vanessa ;

Willis, William ;

Kumar, Anil ;

Gapasin, Lorena ;

Goldwater, D. Ronald ;

Mates, Sharon ;

Wong, Dean F. .

PSYCHOPHARMACOLOGY, 2015, 232 (15) :2863-2872

[5]

Durgam S, 2019, 58 ANN M AM COLL NEU

[6]

Intra-Cellular Therapies, 2019, CAPL LUM CAPS OR US

[7] Efficacy and safety of lumateperone tosylate 42mg in the treatment of schizophrenia: A pooled analysis of phase 2 and 3 studies [J].

Kane, J. M. ;

Vanover, K. E. ;

Durgam, S. ;

Weingart, M. ;

Davis, R. ;

Satlin, A. ;

Tamminga, C. .

EUROPEAN NEUROPSYCHOPHARMACOLOGY, 2019, 29 :S454-S454

[8] ITI-007 for the Treatment of Schizophrenia: A 4-Week Randomized, Double-Blind, Controlled Trial [J].

Lieberman, Jeffrey A. ;

Davis, Robert E. ;

Correll, Christoph U. ;

Goff, Donald C. ;

Kane, John M. ;

Tamminga, Carol A. ;

Mates, Sharon ;

Vanover, Kimberly E. .

BIOLOGICAL PSYCHIATRY, 2016, 79 (12) :952-961

[9]

Satlin A., 2019, 58 ANN M AM COLL NEU

[10] Functional profile of a novel modulator of serotonin, dopamine, and glutamate neurotransmission [J].

Snyder, Gretchen L. ;

Vanover, Kimberly E. ;

Zhu, Hongwen ;

Miller, Diane B. ;

O'Callaghan, James P. ;

Tomesch, John ;

Li, Peng ;

Zhang, Qiang ;

Krishnan, Vaishnav ;

Hendrick, Joseph P. ;

Nestler, Eric J. ;

Davis, Robert E. ;

Wennogle, Lawrence P. ;

Mates, Sharon .

PSYCHOPHARMACOLOGY, 2015, 232 (03) :605-621

← 1 2 →