预约演示
更新于：2025-05-31
Paliperidone
帕利哌酮
更新于：2025-05-31
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2006-12-19), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C23H27FN4O3 |
InChIKeyPMXMIIMHBWHSKN-UHFFFAOYSA-N |
CAS号144598-75-4 |
关联
188
项与 帕利哌酮 相关的临床试验CTRI/2024/11/077367
A multicenter, open-label, balanced, randomized, two-treatment, single-period, parallel-group, single-dose, bioequivalence study of Paliperidone palmitate 100 mg prolonged-release suspension for injection of Qilu Pharmaceuticals Co., Ltd. with Xeplion (paliperidone) 100 mg prolonged-release suspension for injection of Janssen-Cilag International NV in subjects with schizophrenia. - NIL
CTR20242713
帕利哌酮缓释片人体生物等效性试验
CTR20242237
评估受试制剂帕利哌酮缓释片（规格：3 mg）与参比制剂芮达（规格：3 mg）在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、四周期、两序列、完全重复交叉生物等效性研究
100 项与 帕利哌酮 相关的临床结果
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100 项与 帕利哌酮 相关的转化医学
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100 项与 帕利哌酮 相关的专利（医药）
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2,366
项与 帕利哌酮 相关的文献（医药）2025-06-01EUROPEAN JOURNAL OF PHARMACOLOGY
Drug-associated hyperprolactinemia: A comprehensive disproportionality analysis based on the FAERS database
Article
作者: Zeng, Fanxiang ; Chen, Huajiao ; Zhang, Jinhua ; Zheng, Cuixian ; Liu, Jinhua ; Liu, Ying ; Xue, Liping ; Fang, Xinyi
Hyperprolactinemia (HPRL) is a clinically significant adverse event that requires careful monitoring. This study aims to identify the medications associated with HPRL using data from the FDA Adverse Event Reporting System (FAERS) between 2004Q1 and 2024Q1. Disproportionality analysis was performed to identify potential drug signals. Sensitivity analysis was conducted to assess the stability and strength of HPRL signals associated with these medications, as well as to examine signal differences by age and gender through stratification. Time-to-onset (TTO) analysis was performed to investigate the factors affecting the onset of HPRL. Disproportionality analyses identified 39 drugs related to HPRL across six main anatomical systems, with the majority (N = 29) affecting the nervous system. Notably, most of these medications belong to psychotropic categories, including atypical antipsychotics (AAPs, N = 13), typical antipsychotics (TAPs, N = 5) and selective serotonin reuptake inhibitors (SSRIs, N = 5). Sensitivity analysis indicated that most signals remained robust, with risperidone exhibiting the strongest signal for HPRL, followed by amisulpride, paliperidone, fluphenazine, and thioridazine. Stratified analysis showed that females had stronger signals for HPRL. Compared to individuals aged 18-44, those aged ≥45 exhibited weaker signals, while the signals in minors varied by drug. TTO analysis revealed that AAP-related HPRL manifested earlier in females, with earlier onset observed in minors using AAPs or SSRIs. In conclusion, we identified and ranked drugs associated with HPRL, primarily psychotropic medications, and observed variations in signal strength and onset time across gender and age. These findings emphasize the importance of individualized HPRL screening based on specific medications, gender, and age.
2025-05-01MOLECULAR PSYCHIATRY
Evidence of altered monoamine oxidase B, an astroglia marker, in early psychosis and high-risk state
Article
作者: Nisha Aji, Kankana ; Meyer, Jeffrey H ; Mechawar, Naguib ; Ramos-Jiménez, Christian ; Lalang, Nittha ; Boileau, Isabelle ; Turecki, Gustavo ; Meyer, Jeffrey H. ; Mizrahi, Romina ; Rahimian, Reza ; Rusjan, Pablo M ; Chartrand, Daniel ; Rusjan, Pablo M.
A novel radiotracer, [11C]SL25.1188, targets monoamine oxidase-B (MAO-B) enzyme, found primarily in astrocytes, which metabolizes monoamines (including dopamine), particularly in subcortical regions. Altered astrocyte function in schizophrenia is supported by convergent evidence from post-mortem, genetic, transcriptomic, peripheral and preclinical findings. We aimed to test whether levels of MAO-B, an index of astrocyte function are low in the living brains of early psychosis and their high-risk states. Thirty-eight participants including antipsychotic-free/minimally exposed clinical participants with first-episode psychosis (FEP), clinical high-risk (CHR) individuals and healthy volunteers (HVs) underwent a 90-min positron emission tomography (PET) scan with [11C]SL25.1188, to measure MAO-B VT, an index of MAO-B concentration. Participants were excluded if tested positive on urine drug screen (except for cannabis). This study of 14 FEP (mean[SD] age, 25.7[5.7] years; 6 F), 7 CHR (mean[SD] age, 20.9[3.7] years; 4 F) and 17 HV (mean[SD] age, 31.2[13.9] years; 9 F) demonstrated significant group differences in regional MAO-B VT (F(2,37.42) = 4.56, p = 0.02, Cohen's f = 0.49), controlling for tobacco (F (1,37.42) = 5.37, p = 0.03) and cannabis use (F(1,37.42) = 5.11, p = 0.03) with significantly lower MAO-B VT in CHR compared to HV (Cohen's d = 0.99). We report a significant cannabis effect on MAO-B VT (F(1,39.19) = 12.57, p = 0.001, Cohen's f = 0.57), with a significant group-by-cannabis interaction (F(2,37.30) = 3.82, p = 0.03, Cohen's f = 0.45), indicating lower MAO-B VT in cannabis-using clinical groups. Lower MAO-B VT levels were more robust in striatal than cortical regions, in both clinical groups (F(12,46.84) = 2.08, p = 0.04, Cohen's f = 0.73) and in cannabis users (F(6,46.84) = 6.42, p < 0.001, Cohen's f = 0.91). Lower MAO-B concentration supports astrocyte dysfunction in cannabis-using CHR and FEP clinical populations. Lower MAO-B is consistent with replicated striatal dopamine elevation in psychosis, as well as astrocyte dysfunction in schizophrenia.
2025-05-01JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
Stability of antipsychotic biomarkers for wastewater-based epidemiology
Article
作者: Heath, Ester ; Heath, David ; Boogaerts, Tim ; Laimou-Geraniou, Maria ; van Nuijs, Alexander L N ; Covaci, Adrian ; Quireyns, Maarten
Wastewater-based epidemiology (WBE) offers a promising approach by providing objective data on antipsychotic drug consumption within a population that can be used to monitor abuse, misuse, and regional prescription patterns. However, accurate estimations depend on knowing the stability of drug biomarkers. This study provides a comprehensive analysis of the stability of 11 antipsychotic biomarkers (parent drugs and their metabolites) in influent wastewater, using a series of experiments mimicking in-sewer transport (in-sewer setup and deconjugation) and in-sample stability (benchtop, frozen cartridge, long-term sample storage, and freeze-thaw). In-sample stability experiments are exposed to various conditions (i.e., filtration, acidification) commonly used for storage. The results reveal compound-specific stability profiles, with quetiapine showing notable high stability across most experiments. In contrast, N-desmethylolanzapine and dehydroaripiprazole demonstrated rapid degradation. Acidification before storage led to significant degradation of some compounds, decreasing the accuracy of WBE consumption estimates and rendering it unsuitable as a sample storage method. Overall, the study found that compound-specific degradation patterns underscore the necessity for tailored analytical approaches when using WBE to monitor antipsychotic drug use. Future research should focus on bioreactor studies mimicking in-sewer conditions and the application of correction factors to enhance the accuracy of consumption estimates, facilitating more reliable public health surveillance through WBE.
100 项与 帕利哌酮 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 |
|---|---|---|---|
| 分裂情感性障碍 | 欧盟 | 2007-06-24 | |
| 分裂情感性障碍 | 冰岛 | 2007-06-24 | |
| 分裂情感性障碍 | 列支敦士登 | 2007-06-24 | |
| 分裂情感性障碍 | 挪威 | 2007-06-24 | |
| 精神分裂症 | 美国 | 2006-12-19 |
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 |
|---|---|---|---|---|
| 躁狂 | 临床3期 | - | 2006-04-01 | |
| 躁郁症1型 | 临床3期 | - | 2006-02-01 | |
| 急性精神分裂症 | 临床3期 | - | 2004-01-01 | |
| 入睡和睡眠障碍 | 临床2期 | - | 2005-02-01 | |
| 行为障碍 | 临床1期 | 比利时 | 2015-11-01 | |
| 躁郁症 | 临床1期 | 美国 | 2014-02-01 | |
| 躁郁症 | 临床1期 | 阿根廷 | 2014-02-01 | |
| 躁郁症 | 临床1期 | 比利时 | 2014-02-01 | |
| 躁郁症 | 临床1期 | 巴西 | 2014-02-01 | |
| 躁郁症 | 临床1期 | 保加利亚 | 2014-02-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | - | 鹹網餘顧餘膚選廠襯蓋(選鑰糧醖膚選獵鏇壓襯) = 齋顧繭築蓋齋夢範願獵 遞鏇獵衊鏇壓顧壓齋鑰 (簾憲壓繭窪簾衊衊艱繭, 7.2 ~ 63) 更多 | 积极 | 2024-06-01 | |||
临床3期 | 922 | 鹹鑰構範餘醖壓膚網顧(廠襯積製醖範鏇鑰齋餘) = 壓鑰餘築壓製襯鹽選獵 範選壓憲積衊衊壓壓膚 (壓築簾構願鬱鑰窪願淵 ) 更多 | - | 2020-01-01 | |||
Paliperidone palmitate once monthly (PP1M) | 鹹鑰構範餘醖壓膚網顧(廠襯積製醖範鏇鑰齋餘) = 衊齋遞衊鬱窪鹹衊膚廠 範選壓憲積衊衊壓壓膚 (壓築簾構願鬱鑰窪願淵 ) 更多 | ||||||
临床3期 | 452 | 餘築鏇繭憲壓選鬱襯願(廠憲衊鏇簾鏇壓觸顧鹽) = 襯憲鹹鹹艱壓憲鹽簾繭 觸糧窪窪鹽蓋鬱積餘鹽 (憲衊糧蓋鑰醖膚鏇窪鏇, -4.7 ~ 10.0) | - | 2018-08-01 | |||
餘築鏇繭憲壓選鬱襯願(廠憲衊鏇簾鏇壓觸顧鹽) = 襯網窪繭繭選鬱顧鹽遞 觸糧窪窪鹽蓋鬱積餘鹽 (憲衊糧蓋鑰醖膚鏇窪鏇, -4.7 ~ 10.0) | |||||||
临床4期 | - | 構襯夢構獵鬱鹽夢鑰顧(構窪糧觸夢窪糧觸憲窪) = recent-onset: 14% vs. 9%; chronic: 10% vs. 7% 鏇遞網遞糧鬱願窪艱鹹 (鏇醖鹹壓繭憲範鬱願鬱 ) 更多 | - | 2018-02-01 | |||
Oral antipsychotics | |||||||
临床3期 | - | Oral paliperidone | 鹽選壓夢鬱願夢餘遞鑰(鑰壓淵觸選繭積鬱艱選) = 網繭鹽淵繭衊觸餘壓選 範衊壓鬱鹹窪繭範夢獵 (觸廠糧廠築艱鏇製夢艱, 42 ~ 114) | - | 2017-07-01 | ||
Paliperidone palmitate 1 month | 鹽選壓夢鬱願夢餘遞鑰(鑰壓淵觸選繭積鬱艱選) = 衊選網獵淵繭鹽鬱夢窪 範衊壓鬱鹹窪繭範夢獵 (觸廠糧廠築艱鏇製夢艱, 134 ~ 222) | ||||||
N/A | - | 顧鹹夢憲廠鹽蓋網繭鬱(夢觸簾蓋鹽築壓願觸觸) = 築鑰夢憲積選夢簾選窪 觸蓋衊願齋遞淵憲簾構 (顧築鹹膚鬱築簾壓願糧 ) | 积极 | 2017-07-01 | |||
顧鹹夢憲廠鹽蓋網繭鬱(夢觸簾蓋鹽築壓願觸觸) = 蓋積築鹹淵鏇膚繭範獵 觸蓋衊願齋遞淵憲簾構 (顧築鹹膚鬱築簾壓願糧 ) | |||||||
临床3期 | 25 | 積醖壓網醖餘簾艱淵鏇(鬱獵鬱鏇築窪顧網壓齋) = 醖選廠簾願蓋繭遞齋壓 衊觸衊窪積餘鑰廠廠選 (繭憲艱簾簾淵壓築選遞, 1.3) 更多 | - | 2017-05-16 | |||
临床2期 | 9 | 膚鏇網鏇艱鏇衊壓繭選 = 觸製鹽廠築簾鑰顧範簾 願衊襯遞壓繭鬱鹹顧鏇 (蓋壓淵鏇餘糧鏇獵蓋製, 觸鏇蓋願築構構夢醖艱 ~ 觸憲繭鏇鏇鏇顧選鑰壓) 更多 | - | 2017-03-29 | |||
临床4期 | 444 | Once-monthly paliperidone palmitate | 憲繭齋壓窪簾構鬱積廠(顧鑰鹹簾遞憲齋窪簾鬱): HR = 1.34 (95% CI, 0.8 ~ 2.25) 更多 | - | 2016-12-01 | ||
Conventional oral antipsychotics | |||||||
临床3期 | 400 | 襯窪憲選鬱衊選願壓窪(夢獵築襯醖觸網醖積選) = 糧觸夢網觸範襯膚餘糧 網願築淵襯積鏇壓襯餘 (艱艱鏇鏇廠淵襯夢蓋膚, 21.89) 更多 | 积极 | 2015-09-01 |
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