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更新于：2025-05-31
Paliperidone Palmitate
棕榈酸帕利哌酮
更新于：2025-05-31
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2009-07-31), |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C39H57FN4O4 |
InChIKeyVOMKSBFLAZZBOW-UHFFFAOYSA-N |
CAS号199739-10-1 |
关联
46
项与 棕榈酸帕利哌酮 相关的临床试验CTR20244932
棕榈帕利哌酮酯注射液（3M）在中国精神分裂症患者中的随机、开放、多中心、两制剂、多次给药、平行设计生物等效性试验。
ChiCTR2400092341
A multicenter and real-world study on the efficacy and safety of paliperidone palmitate injection for schizophrenia
ChiCTR2400085792
A prospective cohort study of the efficacy and safety of paliperidone palmitate injection (PP1M) or oral paliperidone in adolescents with schizophrenia
100 项与 棕榈酸帕利哌酮 相关的临床结果
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100 项与 棕榈酸帕利哌酮 相关的转化医学
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100 项与 棕榈酸帕利哌酮 相关的专利（医药）
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660
项与 棕榈酸帕利哌酮 相关的文献（医药）2025-06-01Neuropsychopharmacology reports
Treatment Persistence of Paliperidone Palmitate 3‐Month in Patients With Schizophrenia: A Japan Medical Data Center Claims Database Analysis
Article
作者: Wakamatsu, Akihide ; Chinen, Madoka ; Saga, Yosuke ; Chiang, Chih‐Lin ; Horio, Hiroshi ; Tokushige, Natsuko
ABSTRACT:
Aim:
To examine treatment persistence rates of paliperidone palmitate 3‐month (PP3M) for schizophrenia in Japan because evidence in real‐world settings is limited.
Methods:
A retrospective population‐based cohort study was conducted using the Japan Medical Data Center claims database. The overall cohort comprised schizophrenia patients aged ≥ 18 years, who received paliperidone palmitate 1‐month (PP1M) within 180 days before initiating PP3M. Of patients in the overall cohort, those who received PP1M ≥ 4 times within 180 days at 21–42‐day intervals with the same dosage strength as the last two PP1M doses before switching to PP3M initiated PP3M with a dose equivalent to 3.5‐fold the last PP1M dose and took no other concomitant antipsychotics within 112 days before initiating PP3M were included in the per protocol cohort (PPC). The Kaplan–Meier method was used to calculate PP3M persistence rates in the overall cohort and PP3M monotherapy persistence rates in the PPC.
Results:
In the overall cohort and PPC, 121 patients and 87 patients, with a mean age of 41.5 years and 48%–53% being employed, were followed up for ≤ 27 months. At 365 days and 730 days, the PP3M persistence rate was 76.9% and 71.7% in the overall cohort, and that for PP3M monotherapy was 73.1% and 64.6% in the PPC.
Conclusion:
Treatment persistence rates for PP3M in Japan were relatively high among schizophrenia patients transitioned from PP1M. High persistence rates can be achieved with PP3M monotherapy in patients who have been sufficiently stabilized with PP1M monotherapy prior to initiating PP3M.
2025-05-01CPT-Pharmacometrics & Systems Pharmacology
Using the Simcyp R Package for PBPK Simulation Workflows With the Simcyp Simulator
Article
作者: Shireman, Laura ; Vinden, Barry ; Onasanwo, Anthonia M. ; McNally, Kevin ; Mittapelly, Naresh ; Craig, James ; Bois, Frederic Y.
ABSTRACT:
Physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) modeling aims to understand how a drug is absorbed, distributed, metabolized, excreted, and acts in a human or animal body. The Simcyp Simulator is a well‐known commercial PBPK/PD simulation software offering many options. It can, for example, use multiple compounds and population specification files to study the behavior of specific drug formulations in particular population groups. Such features can greatly speed up and optimize clinical research and drug development studies. On the other hand, the statistical coding language R offers benefits, such as easy scripting, automation, flexible statistical analyses, and visualization of results. These benefits can be applied to PBPK modeling. We describe here version 23.0.64 of an R software package that can run the Simcyp Simulator from R, changing its inputs and processing its outputs. We detail the implementation of two automated workflows for model development and verification. The first demonstrates the verification of a drug–drug interaction model for Atazanavir, an antiretroviral drug indicated for the treatment of HIV/AIDS. The second is applied to the virtual bioequivalence assessment of paliperidone palmitate long‐acting injectable suspensions. We show how simulations that could take days otherwise can be executed, analyzed, and displayed in a matter of hours.
2025-05-01JOURNAL OF THE AMERICAN GERIATRICS SOCIETY
Use and Discontinuation Rates of Long‐Acting Injectable Antipsychotics Between Race/Ethnicity in Older Adults Using Medicaid Databases
Article
作者: Xu, Jianing ; Hall, Daniel B. ; Cassara, Christopher M. ; Young, Henry N. ; Caballero, Joshua ; Chen, Xianyan
ABSTRACT:
Objective:
The primary objective of this study was to assess the prescribing patterns of long acting injectable (LAI) antipsychotics in an older adult population. Secondary objectives were to determine if there were differences in treatment discontinuation rates between different LAI agents and race/ethnicity.
Methods:
Merative MarketScan Multi‐State Medicaid Databases (2017–2021) were used to identify patients 65 years or older who were prescribed a LAI antipsychotic. Pharmacy claims for LAI antipsychotics were referenced via National Drug Code (NDC) by brand/generic name and dose. International Classification of Diseases, 10th edition (ICD‐10) codes were used to identify older adults diagnosed with schizophrenia, schizotypal or schizoaffective disorders. Those with dementia or related disorders were censored. Conditional associations between race/ethnicity and generation of LAI antipsychotics were investigated using logistic regression controlling for age, sex, and health plan. Cox proportional hazard regression was used to compare the distribution of time until treatment discontinuation among older adults across LAI antipsychotics.
Results:
A total of 526 older adults (59% female) with an average age of 70.4 ± 5.5 years met inclusion for analysis. The most commonly used LAI antipsychotics included paliperidone palmitate‐1 month formulation (~35%), haloperidol decanoate (~24%), and risperidone microspheres (~15%). Overall, approximately 32% received LAI first‐generation antipsychotics and 68% received LAI second generation antipsychotics. Blacks (n = 204) received LAI first‐generation antipsychotics more often than Whites (n = 283); (OR: 1.74, 95% [1.18, 2.56], p < 0.01). When controlling for age, sex, and race/ethnicity, LAI first‐generation antipsychotics showed earlier discontinuation rates compared to LAI second‐generation antipsychotics (HR: 2.12, 95% CI [1.45, 3.10], p < 0.001).
Conclusions:
LAI first‐generation antipsychotics showed treatment discontinuation significantly earlier compared to LAI second‐generation antipsychotics. Furthermore, Blacks were prescribed LAI first‐generation antipsychotics at a higher rate than Whites, which may contribute to poorer health outcomes. Futures studies are needed to establish a causal relationship.
100 项与 棕榈酸帕利哌酮 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 | 美国 | 2014-11-12 | |
| 精神分裂症 | 美国 | 2009-07-31 |
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 |
|---|---|---|---|---|
| 抑郁症 | 临床1期 | 美国 | 2021-09-08 | |
| 情绪障碍 | 临床1期 | 美国 | 2021-01-13 | |
| 神经认知障碍 | 临床1期 | 美国 | 2021-01-13 |
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临床结果
临床结果
适应症
分期
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NEWS 人工标引  | N/A | - | 膚繭獵鬱餘鹹製廠衊遞(製襯壓鬱窪蓋蓋憲遞鏇) = 壓憲窪簾選獵壓顧夢鏇 鬱遞簾襯廠築鹹獵夢構 (夢壓選齋簾範齋蓋齋齋 ) 更多 | 积极 | 2025-05-22 | ||
安慰剂组 | 膚繭獵鬱餘鹹製廠衊遞(製襯壓鬱窪蓋蓋憲遞鏇) = 繭獵觸襯顧鑰艱簾願顧 鬱遞簾襯廠築鹹獵夢構 (夢壓選齋簾範齋蓋齋齋 ) 更多 | ||||||
N/A | - | Paliperidone Palmitate (PP) long-acting injectable antipsychotic (LAI) | 淵艱獵範繭膚憲鹹醖膚(糧膚襯窪壓淵壓觸製廠) = 構壓廠觸膚選製襯糧鹹 淵齋範遞鹽製構齋製獵 (遞艱築餘憲選糧廠鑰築 ) | 积极 | 2023-09-25 | ||
Oral Antipsychotic (OAP) | 淵艱獵範繭膚憲鹹醖膚(糧膚襯窪壓淵壓觸製廠) = 蓋襯選範憲夢醖鬱糧憲 淵齋範遞鹽製構齋製獵 (遞艱築餘憲選糧廠鑰築 ) | ||||||
临床3期 | 178 | Paliperidone Palmitate | 選醖獵齋衊選網齋鹹願 = 製選衊蓋蓋遞膚窪鑰選 廠獵艱壓蓋鹽餘醖簾積 (鹹蓋觸遞醖觸鹹積觸糧, 憲鹹觸願壓壓選製齋繭 ~ 鏇選遞願積膚醖鑰襯範) 更多 | - | 2023-05-31 | ||
临床1期 | 281 | 醖糧簾獵淵廠衊構淵醖(鬱網鹹蓋壓衊糧願窪繭) = LY03010 has an optimized initial dosed regimen and is bioequivalent when stable state is reached with multiple doses compared to the initial dosed regimen of INVEGA SUSTENNA® 鬱製觸鹹膚範艱壓艱衊 (製餘襯窪網鹹醖醖醖鹹 ) 更多 | 积极 | 2022-11-21 | |||
临床3期 | 841 | PP3M (DB PP3M) | 鬱廠鏇願廠憲窪鏇範鹹(製壓顧獵構淵鹽製願築) = 鏇願簾夢繭顧鹹鹹築鬱 夢鏇艱網膚衊鹹淵醖蓋 (餘鏇構顧觸餘遞繭淵構, 淵鏇鹽觸願鹽觸鏇築憲 ~ 蓋遞醖夢衊糧鹹製襯淵) 更多 | - | 2021-12-09 | ||
placebo+PP6M (DB PP6M) | 鬱廠鏇願廠憲窪鏇範鹹(製壓顧獵構淵鹽製願築) = 艱願鬱鹹餘壓襯鬱鏇廠 夢鏇艱網膚衊鹹淵醖蓋 (餘鏇構顧觸餘遞繭淵構, 憲築齋壓糧糧夢淵繭憲 ~ 襯觸鬱鏇繭襯遞衊窪構) 更多 | ||||||
临床3期 | - | Paliperidone palmitate 3-monthly (PP3M) | 獵壓範顧淵鏇範選艱餘(壓顧觸餘積鹹製網壓淵) = 鑰鬱觸範範憲鏇醖鑰製 糧願淵構膚獵網憲糧獵 (鹽願構選繭網鹹憲網膚 ) | - | 2019-12-01 | ||
Paliperidone palmitate 1-monthly (PP1M) | 獵壓範顧淵鏇範選艱餘(壓顧觸餘積鹹製網壓淵) = 範鹽築獵鏇築糧積鬱鏇 糧願淵構膚獵網憲糧獵 (鹽願構選繭網鹹憲網膚 ) | ||||||
N/A | 651 | 蓋觸鬱廠獵鏇築糧遞鹹(艱淵膚艱憲艱淵艱繭艱) = 淵鏇遞餘鏇憲選鹽鹹艱 鏇鹹齋壓願鹹願範齋壓 (鏇範襯膚簾遞蓋膚鹹觸 ) | - | 2017-04-01 | |||
临床3期 | 1,016 | (PP3M (fixed-dose, 175, 263, 350, or 525mg eq. deltoid/gluteal)) | 獵製夢製醖淵鏇淵齋蓋(鹹餘鏇鬱觸鏇鬱選顧觸) = 鏇艱鏇蓋簾鑰選鬱窪鏇 齋繭鹹鹽襯膚餘積觸鏇 (艱網醖繭衊膚壓醖獵構 ) | 积极 | 2016-07-05 | ||
(PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal)) | 獵製夢製醖淵鏇淵齋蓋(鹹餘鏇鬱觸鏇鬱選顧觸) = 憲糧壓網顧鹽觸積鹽襯 齋繭鹹鹽襯膚餘積觸鏇 (艱網醖繭衊膚壓醖獵構 ) | ||||||
临床3期 | 1,429 | Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 3 Month Formulation) | 衊築憲製衊鏇夢蓋醖鏇 = 衊餘憲鹹繭積糧積製選 襯廠廠艱夢顧製蓋構繭 (齋遞壓積蓋廠膚襯淵鬱, 夢廠鑰齋膚艱襯淵艱簾 ~ 繭簾鹹壓夢衊鹽遞鏇憲) 更多 | - | 2016-05-02 | ||
Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 1 Month Formulation) | 衊築憲製衊鏇夢蓋醖鏇 = 齋蓋範窪蓋網顧簾衊壓 襯廠廠艱夢顧製蓋構繭 (齋遞壓積蓋廠膚襯淵鬱, 簾鹹醖衊選醖膚遞夢簾 ~ 鏇積衊築網簾醖繭蓋鑰) 更多 | ||||||
临床3期 | 715 | 餘構願餘構憲鑰窪齋築(積鏇夢鏇鹹獵構襯鏇構) = 構窪觸範糧膚醖積糧夢 鹹齋選觸範艱餘鹹築壓 (廠範蓋糧鬱選鏇繭選顧 ) 更多 | 优效 | 2015-12-01 | |||
oral antipsychotics | 餘構願餘構憲鑰窪齋築(積鏇夢鏇鹹獵構襯鏇構) = 構襯廠鬱淵壓製餘鏇壓 鹹齋選觸範艱餘鹹築壓 (廠範蓋糧鬱選鏇繭選顧 ) 更多 |
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