预约演示
更新于：2025-08-28
Lumateperone Tosylate
甲苯磺酸卢美哌隆
更新于：2025-08-28
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-12-20), |
最高研发阶段(中国)临床3期 |
特殊审评快速通道 (美国) |
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结构/序列
分子式C31H36FN3O4S |
InChIKeyLHAPOGAFBLSJJQ-GUTACTQSSA-N |
CAS号1187020-80-9 |
关联
43
项与 甲苯磺酸卢美哌隆 相关的临床试验CTRI/2025/03/082366
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients with Manic Episodes or Manic Episodes with Mixed Features Associated with Bipolar I Disorder (Bipolar Mania). - NIL
CTR20250243
甲苯磺酸卢美哌隆胶囊人体生物等效性研究
CTIS2024-513036-26-00
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients with Manic Episodes or Manic Episodes with Mixed Features Associated with Bipolar I Disorder (Bipolar Mania) - ITI-007-451
100 项与 甲苯磺酸卢美哌隆 相关的临床结果
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100 项与 甲苯磺酸卢美哌隆 相关的转化医学
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100 项与 甲苯磺酸卢美哌隆 相关的专利（医药）
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126
项与 甲苯磺酸卢美哌隆 相关的文献（医药）2025-08-13BIPOLAR DISORDERS
Defining Treatment-Resistant Bipolar Depression: Recommendations From the ISBD Task Force.
Article
作者: Cubała, Wiesław J ; Berk, Michael ; Bauer, Michael ; Andreazza, Ana C ; Yatham, Lakshmi N ; Suppes, Trisha ; McIntyre, Roger S ; Soares, Jair C ; Tohen, Mauricio ; Ozerdem, Aysegul ; Diaz, Gerard Anmella ; Stefanovic, Maja Pantovic ; Vieta, Eduard ; Fico, Giovanna ; Van Rheenen, Tamsyn E ; Fradera, Xavier Justes ; Cosials-Lopez, Montserrat ; Singh, Balwinder ; Young, Allan H ; Henry, Chantal ; Post, Robert ; Miskowiak, Kamilla Woznica ; Swartz, Holly A ; Gonzalez-Pinto, Ana ; Brambilla, Paolo ; Pacchiarotti, Isabella ; Ha, Kyooseob ; Hidalgo-Mazzei, Diego ; Nunes, Paula Villela ; Lopez-Jaramillo, Carlos
OBJECTIVE:
Despite the availability of approved treatments, a substantial proportion of patients with bipolar disorder experience treatment-resistant bipolar depression (TRBD), characterized by persistent depressive symptoms unresponsive to standard therapies. However, a universally accepted definition of TRBD is lacking. This consensus document, developed by the International Society for Bipolar Disorders (ISBD) Task Force on TRBD, aims to provide a standardized definition of TRBD to facilitate clinical trials, research, and treatment strategies.
METHODS:
The Task Force employed a literature review, clinical trials analysis, and expert consensus meetings to define TRBD.
RESULTS:
TRBD was defined as the failure to achieve a significant and sustained clinical response after at least two approved and adequately dosed pharmacological treatments, administered for a sufficient duration with treatment adherence. For bipolar I (BD-I) depression, approved treatments included quetiapine (300-600 mg/day for ≥ 8 weeks), lurasidone (20-120 mg/day for ≥ 6 weeks), the combination of olanzapine (6-12 mg/day) and fluoxetine (25-75 mg/day for ≥ 8 weeks), cariprazine (1.5-3 mg/day for ≥ 6 weeks), and lumateperone (42 mg/day for ≥ 6 weeks). For bipolar II (BD-II) depression, approved treatments included quetiapine (300-600 mg/day for ≥ 8 weeks) and lumateperone (42 mg/day for ≥ 6 weeks).
CONCLUSION:
This consensus definition aims to provide clarity for clinical trials, improve consistency in research, and guide treatment approaches and inform regulatory pathways. It represents a foundational step in addressing the unmet needs in TRBD and promoting the development of innovative therapeutic strategies. Future efforts will focus on adapting the definition to better align with real-world clinical challenges and optimize patient care.
2025-08-13BIPOLAR DISORDERS
The Efficacy of Pharmacological Interventions in the Treatment of Major Depressive Disorder and Bipolar Depression With Mixed Features: A Systematic Review.
Review
作者: Lo, Heidi Ka Ying ; Yin, Liyang ; Rosenblat, Joshua D ; Grande, Iria ; Vinberg, Maj ; Xiao, Naomi ; Cao, Bing ; McIntyre, Roger S ; Lee, Serene ; Teopiz, Kayla M ; Wong, Sabrina ; Badulescu, Sebastian ; Le, Gia Han
BACKGROUND:
There is a need to provide up-to-date, clinically translatable data as it relates to the treatment of a major depressive episode (MDE) with mixed features.
METHODS:
PubMed and OVID were searched from inception to July 22, 2024. Randomized controlled trials (RCTs) investigating the efficacy of pharmacological agents for adults with bipolar disorder (BD) or major depressive disorder (MDD) in an MDE with mixed features were included. Risk of bias was assessed using the Cochrane Risk of Bias Tool for Randomized Studies (RoB2).
RESULTS:
A total of seven studies were included in this systematic review. The studies identified were all short-term acute studies ranging from 6 to 8 weeks. Treatment with lurasidone, olanzapine, cariprazine, lumateperone, quetiapine, and ziprasidone was associated with statistically significant reduction of depressive symptoms in MDEs with mixed features. Only lumateperone is studied in both BD subtypes [bipolar I disorder (BD-I), bipolar II disorder (BD-II)] and MDD, wherein efficacy in mixed features was the prespecified primary outcome. Lurasidone has a single study in MDD, while ziprasidone has data in a mixed sample of BD-II and MDD. Data for the other agents in mixed features is post hoc. Co-occurring hypomanic symptoms generally improved, and there was no significant difference between the above treatments and placebo with respect to hypomanic symptom severity intensification or treatment-emergent affective switching.
CONCLUSION:
Select atypical antipsychotics are effective in alleviating depressive symptoms in persons with mixed features; albeit, much of the data is obtained from post hoc analysis. Minimal evidence exists for the efficacy of lithium or valproate in the treatment of depressive episodes with mixed features. Antidepressant monotherapy has not been adequately evaluated in depressive episodes with mixed features. In addition, there is a pressing need for a consistent definition of mixed presentations to guide future interventional studies.
2025-08-01Asian Journal of Psychiatry
Dose-effect trajectory of lumateperone in schizophrenia: Evidence from a systematic review and meta-analysis of randomized controlled trials
Review
作者: Liang, Chih-Sung ; Hung, Kuo-Chuan ; Hsu, Chih-Wei ; Tseng, Ping-Tao ; Chen, Yang-Chieh Brian ; Tu, Yu-Kang
BACKGROUND:
The optimal dose of lumateperone for treating schizophrenia remains unclear. We examined its dose-response relationship for efficacy and acceptability.
METHODS:
We searched major databases (e.g. PubMed, EMBASE, Cochrane), and grey literature from inception to January 20, 2025 (INPLASY202510038) for randomized controlled trials (RCTs) comparing lumateperone with placebo in schizophrenia. We excluded non-peer-reviewed studies and those lacking a placebo group or involved non-schizophrenic patients. The Cochrane Risk of Bias Tool was used for risk of bias assessment. We used a one-step dose-response meta-analysis (DRMA) with a random-effects model to calculate the effect sizes as standardized mean differences (SMDs) and risk ratios (RRs) with 95 % confidence intervals (CIs).
RESULTS:
688 patients from two RCTs received placebo or lumateperone. Lumateperone 42 mg significantly improved the Positive and Negative Syndrome Scale (PANSS) total score (SMD = -0.29, 95 % CI: -0.47 to -0.10), PANSS positive symptom score (SMD = -0.41, 95 % CI: -0.64 to -0.18), and responder rate (RR = 1.52, 95 % CI: 1.16-2.01), as well as marginally improved the PANSS negative symptom score (SMD = -0.17, 95 % CI: -0.34-0.01). Higher doses (>42-63 mg) were associated with increased rates of oral dryness/thirst, nausea/vomiting, somnolence, and dizziness. No dose-response relationship was found for dropout rates, headache, or extrapyramidal symptoms. A limitation of this study is the small number of available RCTs.
CONCLUSIONS:
Lumateperone 42 mg appears to offer the most favorable balance of efficacy and side effects for the treatment of schizophrenia.
215
项与 甲苯磺酸卢美哌隆 相关的新闻（医药）2025-08-24
·信狐药迅
申请上市临床申请临床1期
2025-08-10
·精准药物
抗体药物偶联物财报免疫疗法并购细胞疗法
2025-08-10
财报抗体药物偶联物并购免疫疗法细胞疗法
100 项与 甲苯磺酸卢美哌隆 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 躁郁症 | 美国 | 2021-12-17 | |
| 精神分裂症 | 美国 | 2019-12-20 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 重度抑郁症 | 申请上市 | 美国 | 2024-12-03 | |
| 情绪易怒 | 临床3期 | 美国 | 2024-11-22 | |
| 躁郁症1型 | 临床3期 | 美国 | 2024-06-19 | |
| 躁郁症1型 | 临床3期 | 保加利亚 | 2024-06-19 | |
| 躁郁症1型 | 临床3期 | 克罗地亚 | 2024-06-19 | |
| 躁郁症1型 | 临床3期 | 印度 | 2024-06-19 | |
| 躁郁症1型 | 临床3期 | 塞尔维亚 | 2024-06-19 | |
| 躁狂 | 临床3期 | 美国 | 2024-06-19 | |
| 躁狂 | 临床3期 | 保加利亚 | 2024-06-19 | |
| 躁狂 | 临床3期 | 克罗地亚 | 2024-06-19 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | 485 | (Lumateperone 42 mg) | 窪蓋獵窪遞鬱構繭醖製(簾網窪積積鏇齋齋願壓) = 膚壓窪繭鹽觸鹽衊顧鹽 壓範積窪齋築顧襯餘鑰 (鏇餘製鏇顧製願襯遞觸, 0.54) 更多 | - | 2025-05-02 | ||
Placebo (Placebo) | 窪蓋獵窪遞鬱構繭醖製(簾網窪積積鏇齋齋願壓) = 齋蓋構壓鏇築鬱觸糧憲 壓範積窪齋築顧襯餘鑰 (鏇餘製鏇顧製願襯遞觸, 0.53) 更多 | ||||||
临床3期 | 480 | (Lumateperone 42 mg) | 築鹽鏇窪衊膚餘衊衊積(衊壓顧構積廠憲糧鏇淵) = 襯夢簾襯觸醖遞選遞窪 齋選膚窪構網鏇鹹壓鹽 (選遞鏇醖遞窪遞構餘積, 0.56) 更多 | - | 2025-03-25 | ||
Placebo (Placebo) | 築鹽鏇窪衊膚餘衊衊積(衊壓顧構積廠憲糧鏇淵) = 觸鏇遞構糧網鹽醖鏇醖 齋選膚窪構網鏇鹹壓鹽 (選遞鏇醖遞窪遞構餘積, 0.54) 更多 | ||||||
临床3期 | 488 | (Lumateperone 42mg) | 衊廠襯鬱衊遞積築糧鏇(鏇鏇鹹憲獵鏇膚獵繭壓) = 壓齋鏇壓鏇鑰顧齋鹽齋 製構鬱夢餘齋鬱襯鹽夢 (醖醖鑰壓齋壓壓鹽製積, 0.71) 更多 | - | 2025-03-19 | ||
Placebos (Placebo) | 衊廠襯鬱衊遞積築糧鏇(鏇鏇鹹憲獵鏇膚獵繭壓) = 觸憲憲鏇窪壓壓夢廠夢 製構鬱夢餘齋鬱襯鹽夢 (醖醖鑰壓齋壓壓鹽製積, 0.70) 更多 | ||||||
临床3期 | 228 | Lumateperone 42 mg | 膚願繭獵艱顧齋觸觸觸(積構醖醖願壓積壓齋糧) = 窪鹽顧網餘築遞廠遞簾 餘壓壓範壓鹹廠艱鹽鏇 (製鏇窪壓鬱簾遞觸觸襯 ) 达到 | 积极 | 2024-11-05 | ||
Placebo | 膚願繭獵艱顧齋觸觸觸(積構醖醖願壓積壓齋糧) = 醖憲壓築選願襯齋糧願 餘壓壓範壓鹹廠艱鹽鏇 (製鏇窪壓鬱簾遞觸觸襯 ) 达到 | ||||||
临床3期 | 重度抑郁症 新辅助 | 480 | 繭衊鹽獵糧願夢壓衊製(廠鬱糧憲蓋願蓋觸顧衊) = 餘遞糧製夢製蓋鬱窪選 範鑰鹹窪窪夢憲構壓選 (構醖齋鹹積觸膚鹹壓廠 ) 达到 | 积极 | 2024-06-18 | ||
Placebo | 繭衊鹽獵糧願夢壓衊製(廠鬱糧憲蓋願蓋觸顧衊) = 襯醖鏇鹹糧餘遞築鹹範 範鑰鹹窪窪夢憲構壓選 (構醖齋鹹積觸膚鹹壓廠 ) 达到 | ||||||
临床3期 | 485 | Lumateperone 42 mg | 醖鑰艱壓選觸蓋淵積憲(觸蓋構醖窪願範艱廠鹽) = 網醖選選窪鹹壓簾夢鹽 遞膚鏇蓋觸艱繭築艱膚 (衊製簾築膚鑰積蓋觸鹽 ) 达到 | 积极 | 2024-04-16 | ||
N/A | - | (MDD/bipolar depression) | 醖遞淵築選壓積齋蓋糧(壓網鏇製鬱憲鏇鏇獵鬱) = 糧製衊願夢願築憲築鬱 廠廠鑰憲淵範積襯艱廠 (簾獵顧窪襯窪窪選壓衊, 0.67) | 积极 | 2023-12-05 | ||
N/A | - | (combined mixed features patient population of MDD and bipolar depression) | 艱築憲願壓鏇餘淵獵廠(鑰願構壓衊齋鬱醖構願) = 願鑰鑰網窪選遞構鏇範 製鬱夢膚顧齋積齋壓窪 (鹽鏇積醖鏇襯艱艱衊淵, 0.64) | 积极 | 2023-12-05 | ||
(MDD with mixed features) | 艱築憲願壓鏇餘淵獵廠(鑰願構壓衊齋鬱醖構願) = 糧淵鑰鏇繭淵網鏇齋構 製鬱夢膚顧齋積齋壓窪 (鹽鏇積醖鏇襯艱艱衊淵, 0.67) | ||||||
临床3期 | 529 | (Lumateperone 28 mg (ITI-007 40 mg Tosylate)) | 觸構積鹽鑰窪廠鹽夢憲(願範獵簾醖築選廠遞網) = 鑰願顧膚繭餘選觸簾繭 窪壓鑰鹹鑰網鑰鏇製鏇 (壓願遞選襯壓範選鹽鹽, 0.79) 更多 | - | 2023-05-17 | ||
(Lumateperone 42 mg (ITI-007 60 mg Tosylate)) | 觸構積鹽鑰窪廠鹽夢憲(願範獵簾醖築選廠遞網) = 鏇獵鹹憲網窪糧衊鑰製 窪壓鑰鹹鑰網鑰鏇製鏇 (壓願遞選襯壓範選鹽鹽, 0.81) 更多 | ||||||
临床3期 | 381 | (Lumateperone) | 鏇壓製網窪鏇鹹鏇積餘(獵襯製襯願選艱製衊觸) = 鬱夢襯鬱繭觸衊醖積襯 鬱遞憲積鏇繭廠夢膚蓋 (衊鏇糧構築衊壓鏇窪鹽, 0.693) 更多 | - | 2022-06-03 | ||
Placebo (Placebo) | 鏇壓製網窪鏇鹹鏇積餘(獵襯製襯願選艱製衊觸) = 願夢鹹夢鏇廠膚積醖鹹 鬱遞憲積鏇繭廠夢膚蓋 (衊鏇糧構築衊壓鏇窪鹽, 0.677) 更多 |
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