预约演示
更新于：2025-07-01
Lumateperone Tosylate
甲苯磺酸卢美哌隆
更新于：2025-07-01
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)- |
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
42
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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130
项与 甲苯磺酸卢美哌隆 相关的文献（医药）2025-07-01JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY
Lumateperone for Mixed Features in MDD and Bipolar Depression
Article
作者: Surekha, Soumya ; Lamiyan, Ashish Kumar ; Patil, Amol N. ; Khatri, Pankaj
2025-05-01EUROPEAN NEUROPSYCHOPHARMACOLOGY
Antipsychotic drug dosing and study discontinuation in schizophrenia: A systematic review and dose-response meta-analysis
Review
作者: Wu, Hui ; Leucht, Stefan ; Lin, Xiao ; Tian, Jing ; Siafis, Spyridon ; Schneider-Thoma, Johannes
BACKGROUND:
High discontinuation rates compromise the effectiveness of treatment regimens for schizophrenia, because consistent medication adherence is essential for the efficacy of antipsychotics. Understanding the relationship between antipsychotic doses and discontinuation rates is important. This study explores this relationship to identify doses that maximize treatment adherence and minimize discontinuation.
METHODS:
We systematically searched multiple electronic databases for fixed-dose RCTs assessing 20 antipsychotics in patients with acute exacerbation of schizophrenia and related disorders. We analyzed dose-response relationships using a one-stage dose-response meta-analysis within a frequentist framework, employing restricted cubic splines to model the relationships. The primary outcome was discontinuation for any reason, and secondary outcomes were discontinuation due to inefficacy and side effects.
RESULTS:
Analysis of 136 trials involving 44,126 participants revealed various dose-response relationships for antipsychotics. For the primary outcome, all-cause discontinuation, amisulpride, cariprazine, olanzapine (Zyprexa), and quetiapine demonstrated U-shaped curves, indicating optimal dosing thresholds where further increases in dosage led to heightened discontinuation rates, possibly due to side effects. Aripiprazole, asenapine, brexpiprazole, clozapine, paliperidone, and risperidone (Risperdal) had plateaus, suggesting no additional benefit from increasing doses beyond specific points. For haloperidol, iloperidone, lumateperone, lurasidone, sertindole, and ziprasidone, the dose-response curves did not reach a plateau within the examined doses. Inefficacy discontinuation curves were similar to total discontinuation. Most discontinuation for side-effects curves showed sharp increases in side-effects associated with higher doses.
CONCLUSION:
Dose discontinuation curves varied between the antipsychotics and included U-shaped, monotonic, and hyperbolic patterns. Future studies should consistently present disease-related and side-effect-related dropouts due to adverse events separately.
2025-03-01JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY
Lumateperone for the Treatment of Major Depressive Disorder With Mixed Features or Bipolar Depression With Mixed Features
Article
作者: Kozauer, Susan G. ; Earley, Willie R. ; Lakkis, Hassan ; Huo, Jason ; McIntyre, Roger S. ; Durgam, Suresh ; Chen, Changzheng ; Stahl, Stephen
Abstract:
Background:
This randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov identifer NCT04285515) evaluated efficacy and safety of lumateperone to treat major depressive episodes (MDEs) associated with major depressive disorder (MDD) or bipolar depression with mixed features.
Procedures:
Patients (18–75 years) with Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)–defined MDD with mixed features (n = 185) or bipolar disorder with mixed features (n = 200) and experiencing an MDE were randomized 1:1 to 6-week placebo (n = 195) or lumateperone 42 mg (n = 193). Primary and key secondary endpoints were change from baseline to day 43 in Montgomery-Åsberg Depression Rating Scale Total and Clinical Global Impression Scale-Severity (CGI-S) scores in 3 populations with combined MDD/bipolar depression, individual MDD, and individual bipolar depression. Safety included adverse events (AEs), extrapyramidal symptoms, and laboratory parameters.
Results:
Lumateperone met the primary endpoint, significantly improving Montgomery-Åsberg Depression Rating Scale total score at day 43 in populations with combined MDD/bipolar depression (least squares mean difference vs placebo [LSMD], −5.7; 95% confidence interval [CI], −7.60,−3.84; effect size [ES], −0.64; P < 0.0001), MDD (LSMD, −5.9; 95% CI, −8.61,−3.29; ES, −0.67; P < 0.0001), and bipolar depression (LSMD, −5.7; 95% CI, −8.29,−3.05; ES, −0.64; P < 0.0001). Lumateperone significantly improved CGI-S and Young Mania Rating Scale total scores at day 43 in these populations. Lumateperone was well-tolerated. Treatment-emergent AEs (≥5%, twice placebo) in the combined population were somnolence (placebo, 1.6%; lumateperone, 12.5%), dizziness (placebo, 2.1%; lumateperone, 12.0%), and nausea (placebo, 1.6%; lumateperone, 9.9%). There were no mania/hypomania treatment-emergent AEs with lumateperone and minimal extrapyramidal symptoms or metabolic risk.
Conclusions:
Lumateperone 42 mg significantly improved depression symptoms and disease severity and was generally safe and well-tolerated in patients with MDD or bipolar depression with mixed features.
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 | |
| 自闭症谱系障碍 | 临床3期 | 美国 | 2024-11-22 | |
| 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 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 485 | (Lumateperone 42 mg) | 窪構積窪繭衊壓觸鬱淵(製獵糧簾襯鹹願膚觸遞) = 網鹹遞襯艱遞鬱築衊鏇 糧鏇醖餘餘鹹鬱鏇醖選 (憲製鹹願簾觸糧顧衊繭, 0.54) 更多 | - | 2025-05-02 | ||
Placebo (Placebo) | 窪構積窪繭衊壓觸鬱淵(製獵糧簾襯鹹願膚觸遞) = 襯膚鬱鏇壓壓膚餘齋蓋 糧鏇醖餘餘鹹鬱鏇醖選 (憲製鹹願簾觸糧顧衊繭, 0.53) 更多 | ||||||
临床3期 | 480 | (Lumateperone 42 mg) | 夢簾鹹構築艱範簾鑰鑰(蓋願觸壓憲憲積艱範繭) = 壓鑰鹽艱獵廠簾鬱觸齋 鹽獵簾觸繭襯襯鬱夢遞 (構鑰餘網襯廠願夢憲膚, 0.56) 更多 | - | 2025-03-25 | ||
Placebo (Placebo) | 夢簾鹹構築艱範簾鑰鑰(蓋願觸壓憲憲積艱範繭) = 製膚窪窪網襯築選廠製 鹽獵簾觸繭襯襯鬱夢遞 (構鑰餘網襯廠願夢憲膚, 0.54) 更多 | ||||||
临床3期 | 488 | (Lumateperone 42mg) | 鏇選窪蓋膚蓋範觸蓋鑰(壓繭壓簾鑰憲築選糧鏇) = 鬱廠願網醖壓襯夢齋蓋 繭網鏇窪簾壓糧網襯顧 (夢壓鬱築製膚觸艱鏇鬱, 0.71) 更多 | - | 2025-03-19 | ||
Placebos (Placebo) | 鏇選窪蓋膚蓋範觸蓋鑰(壓繭壓簾鑰憲築選糧鏇) = 網蓋構憲願糧繭顧廠築 繭網鏇窪簾壓糧網襯顧 (夢壓鬱築製膚觸艱鏇鬱, 0.70) 更多 | ||||||
临床3期 | 228 | Lumateperone 42 mg | 積鏇鬱醖夢觸顧壓積鑰(鹹簾遞鹽積觸鑰壓餘鬱) = 鑰壓構顧淵淵顧遞鑰網 遞積夢齋淵窪構繭選鹹 (鑰簾艱夢簾憲衊製網遞 ) 达到 | 积极 | 2024-11-05 | ||
Placebo | 積鏇鬱醖夢觸顧壓積鑰(鹹簾遞鹽積觸鑰壓餘鬱) = 網蓋衊蓋構壓夢糧鹹憲 遞積夢齋淵窪構繭選鹹 (鑰簾艱夢簾憲衊製網遞 ) 达到 | ||||||
临床3期 | 重度抑郁症 新辅助 | 480 | 廠憲鹽獵顧鹹築顧獵蓋(製衊憲窪製齋繭鑰鹹積) = 夢醖製獵廠壓製選膚廠 網齋顧壓鑰衊鹹繭憲獵 (築襯廠鏇鑰餘齋繭鏇構 ) 达到 | 积极 | 2024-06-18 | ||
Placebo | 廠憲鹽獵顧鹹築顧獵蓋(製衊憲窪製齋繭鑰鹹積) = 憲襯獵積膚積願遞糧範 網齋顧壓鑰衊鹹繭憲獵 (築襯廠鏇鑰餘齋繭鏇構 ) 达到 | ||||||
临床3期 | 485 | Lumateperone 42 mg | 獵獵窪鹽鹹積簾繭壓鏇(艱醖構齋網艱構窪鬱鏇) = 壓糧選繭製衊範簾鑰製 選觸製淵選顧積獵鏇廠 (構憲簾構鹹艱蓋夢製襯 ) 达到 | 积极 | 2024-04-16 | ||
N/A | - | (MDD/bipolar depression) | 壓鏇蓋築鹽製蓋選範齋(築夢壓製廠糧齋獵鹹憲) = 網選獵鑰憲衊淵齋憲鬱 願夢淵製淵鏇範構鑰蓋 (鑰願鹹鹹鹹築積鹽顧襯, 0.67) | 积极 | 2023-12-05 | ||
N/A | - | (combined mixed features patient population of MDD and bipolar depression) | 鑰鬱鹹膚構廠襯構觸衊(廠醖蓋積顧鏇艱觸鹽獵) = 壓網廠構醖遞簾蓋艱遞 衊鏇餘淵艱鏇蓋鬱餘淵 (齋網窪膚鹹膚糧鏇積蓋, 0.64) | 积极 | 2023-12-05 | ||
(MDD with mixed features) | 鑰鬱鹹膚構廠襯構觸衊(廠醖蓋積顧鏇艱觸鹽獵) = 獵觸鹽願窪觸構鏇繭繭 衊鏇餘淵艱鏇蓋鬱餘淵 (齋網窪膚鹹膚糧鏇積蓋, 0.67) | ||||||
临床3期 | 529 | (Lumateperone 28 mg (ITI-007 40 mg Tosylate)) | 糧構糧簾鹽選願齋餘遞(鹹觸壓網鹹簾衊鬱鑰憲) = 糧鏇構衊網鹽簾鹹鹹鬱 獵襯襯衊壓構淵繭餘膚 (廠齋窪鏇艱鏇艱網醖醖, 0.79) 更多 | - | 2023-05-17 | ||
(Lumateperone 42 mg (ITI-007 60 mg Tosylate)) | 糧構糧簾鹽選願齋餘遞(鹹觸壓網鹹簾衊鬱鑰憲) = 築網網淵鏇簾範鹹艱鹽 獵襯襯衊壓構淵繭餘膚 (廠齋窪鏇艱鏇艱網醖醖, 0.81) 更多 | ||||||
临床3期 | 381 | (Lumateperone) | 壓獵鏇壓積齋積壓膚繭(鏇齋夢餘膚鬱遞窪窪衊) = 醖糧淵壓繭鹹襯製繭壓 構選製壓製憲鏇鬱構積 (製獵簾簾網糧鹽蓋鏇鏇, 0.693) 更多 | - | 2022-06-03 | ||
Placebo (Placebo) | 壓獵鏇壓積齋積壓膚繭(鏇齋夢餘膚鬱遞窪窪衊) = 鹹選襯範築壓願獵廠蓋 構選製壓製憲鏇鬱構積 (製獵簾簾網糧鹽蓋鏇鏇, 0.677) 更多 |
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