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更新于：2025-07-22
Paliperidone Palmitate
棕榈酸帕利哌酮
更新于：2025-07-22
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
42
项与 棕榈酸帕利哌酮 相关的临床试验NCT07075237
A Study on the Efficacy and Functional Recovery of Switching From Oral Antipsychotics to Paliperidone Palmitate Injection in the Treatment of Schizophrenia
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
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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669
项与 棕榈酸帕利哌酮 相关的文献（医药）2025-09-01PCN reports : psychiatry and clinical neurosciences
Long‐acting injectable paliperidone palmitate for severe anorexia nervosa and comorbid autism spectrum disorder: A case report
Article
作者: Mori, Yuhei ; Suzuki, Yuhei ; Miura, Itaru
Abstract:
Background:
Anorexia nervosa (AN), comorbid with autism spectrum disorder (ASD), poses significant treatment challenges due to cognitive rigidity, poor insight, and frequent nonadherence to pharmacological interventions. Although second‐generation antipsychotics (SGAs) have been used off‐label in AN, evidence for long‐acting injectable (LAI) formulations remains scarce, particularly in adult patients with neurodevelopmental disorders.
Case Presentation:
We report the case of a 27‐year‐old woman with severe AN and comorbid ASD who exhibited repeated hospitalizations due to critical underweight and persistent refusal of oral medications. Cognitive assessment revealed mild intellectual disability (IQ 56). The patient demonstrated obsessive‐compulsive traits and extreme rigidity toward food intake, and was resistant to multiple oral antipsychotics. While risperidone was tolerated, poor adherence limited its efficacy. After obtaining informed consent, LAI paliperidone palmitate was initiated (initial dose 25 mg, increased to 50 mg monthly). Following a short period of psychoeducation and lifestyle intervention, the patient maintained psychiatric and nutritional stability over a 3‐year outpatient follow‐up without rehospitalization. Her body mass index stabilized at approximately 24 kg/m2. No severe adverse effects were reported.
Conclusion:
This case highlights the potential role of LAI paliperidone palmitate in managing treatment‐refractory AN with comorbid ASD and intellectual disability, particularly in patients with poor adherence and prominent obsessive traits. Although antipsychotics are not standard for AN, LAI formulations may offer pragmatic, sustainable benefits in selected cases. Further studies are warranted to assess long‐term safety and efficacy in this population.
2025-08-01CNS DRUGS
Efficacy and Safety of Once-Monthly Paliperidone Palmitate Long-Acting Injections in Chinese Patients with Early-, Mid-, and Late-Phase Schizophrenia: A Post-Hoc Analysis of Three Phase 4 Studies
Article
作者: Yang, Yishen ; Jia, Miaomiao ; Ye, Chong ; Si, Tianmei ; Li, Qian ; Li, Yang ; Zhuo, Jianmin
BACKGROUND:
Long-acting injectable (LAI) antipsychotics have improved treatment adherence and continuity compared with oral antipsychotics. However, evidence gaps persist in the endorsement of LAIs for early-phase schizophrenia in China. This post-hoc analysis evaluated the efficacy and safety of once-monthly paliperidone palmitate (PP1M), an LAI antipsychotic, following early-, mid-, and late-phase use in Chinese patients with schizophrenia.
METHODS:
Data from three phase 4 studies (NCT01527305, NCT01947803, and NCT01685931) were used. Chinese patients with schizophrenia (disease duration early: ≤ 2 years; mid: > 2 to ≤ 5 years; late: > 5 years) who received 13 weeks of PP1M treatment were included. The primary endpoint was change in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 13, and the secondary and exploratory endpoints included change in Clinical Global Impression of Severity scale (CGI-S), PANSS responder rate relative to baseline PANSS total scores (≤ 70, 70-90 [exclusive], and ≥ 90), and treatment-emergent adverse events (TEAEs).
RESULTS:
In total, 1053 patients (early: 383; mid: 290; late: 380) were included. Following PP1M, improvements in efficacy outcomes were observed in all phases of schizophrenia including PANSS total score from baseline to week 13 (least square [LS]-mean change early: - 31.6; mid: - 28.4; late: - 25.6; p = 0.0003 across three groups) and CGI-S (median reduction early: - 2.0; mid: - 1.0; late: - 1.0). The greatest improvements in efficacy outcomes were consistently seen in early-phase patients, indicated by differences in PANSS total score (baseline to week 13 LS-mean differences mid versus early: 3.2 [p = 0.2175], late versus mid: 2.8 [p = 0.2783], and late versus early: 6.0 [p = 0.0011]), and nominal significant differences in CGI-S (mid versus early: p = 0.0015 and late versus early: p = 0.0180). Earlier administration of PP1M results in greater efficacy outcomes regardless of the initial disease severity. For patients with a PANSS score ≤ 70 at baseline, reductions of ≥ 30% were observed in 71.4%, 60.0%, and 50.0% (p = 0.0003 across three groups), and for patients with a PANSS score ≥ 90 at baseline, reductions of ≥ 30% were observed in 76.4%, 72.5%, and 69.6% (p = 0.0003 across three groups) of patients in the early-, mid-, and late-phase, respectively. The proportion of patients experiencing ≥ 1 TEAE (early: 44.3%; mid: 38.4%; late: 39.8%) was numerically higher in the early phase. Incidences of serious TEAEs (early: 2.8%; mid: 4.0%; late: 4.2%) and TEAEs leading to death (early: 0.3%; mid: 0.0%; late: 1.6%) were observed.
CONCLUSIONS:
Treatment with PP1M improves efficacy outcomes in Chinese adult patients with schizophrenia. However, when PP1M was used in earlier phases of schizophrenia, consistently greater improvements in efficacy outcomes were observed compared with later phases, regardless of disease severity at baseline. Safety data were consistent with the existing profile for PP1M. These findings support the use of PP1M in Chinese patients with early-phase schizophrenia.
2025-06-01SCHIZOPHRENIA RESEARCH
Corrigendum to “Effect of treatment with paliperidone palmitate versus oral antipsychotics on frontal lobe intracortical myelin volume in participants with recent-onset schizophrenia: Magnetic resonance imaging results from the DREaM study” [Schizophr Res. 255 (2023) 195–202]
作者: Ellingson, B M ; Turkoz, I ; Baker, P ; Nuechterlein, K H ; Salvadore, G ; Tishler, T A ; Alphs, L ; Subotnik, K L ; de la Fuente-Sandoval, C
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 |
|---|---|---|---|---|
| 中枢神经系统疾病 | 临床1期 | 美国 | 2021-09-08 | |
| 精神运动性激动 | 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 | - | 鏇艱鹹選積顧遞願顧構(蓋簾繭積膚壓願膚獵鬱) = 網選簾醖鏇鬱鑰選齋構 鏇廠艱製遞觸範糧遞鏇 (鑰壓醖選糧蓋範壓範衊 ) 更多 | 积极 | 2025-05-22 | ||
安慰剂组 | 鏇艱鹹選積顧遞願顧構(蓋簾繭積膚壓願膚獵鬱) = 顧夢膚窪鏇艱衊襯窪膚 鏇廠艱製遞觸範糧遞鏇 (鑰壓醖選糧蓋範壓範衊 ) 更多 | ||||||
N/A | - | Paliperidone Palmitate (PP) long-acting injectable antipsychotic (LAI) | 觸醖夢範鑰廠顧壓鹹選(壓淵夢鏇觸淵願糧遞淵) = 願蓋餘鬱廠願膚蓋獵廠 淵夢淵襯鬱壓艱觸觸齋 (獵醖範鬱築襯壓願鏇艱 ) | 积极 | 2023-09-25 | ||
Oral Antipsychotic (OAP) | 觸醖夢範鑰廠顧壓鹹選(壓淵夢鏇觸淵願糧遞淵) = 鹽簾願鏇築壓齋餘鬱廠 淵夢淵襯鬱壓艱觸觸齋 (獵醖範鬱築襯壓願鏇艱 ) | ||||||
临床3期 | 178 | Paliperidone Palmitate | 製壓鏇鏇鬱淵積壓壓觸 = 衊壓範繭憲觸襯糧餘艱 築齋醖製鬱衊憲衊觸夢 (網積鏇網獵鹹衊願鏇窪, 鑰憲製願憲醖製網顧鬱 ~ 鑰廠鹽繭鹽鹽鹽鹽構遞) 更多 | - | 2023-05-31 | ||
临床1期 | 281 | 繭選簾獵鑰憲積艱鑰鑰(蓋網繭壓鹽願選願鹹積) = 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® 遞顧蓋糧簾顧衊壓糧壓 (齋襯窪廠築醖艱願窪願 ) 更多 | 积极 | 2022-11-21 | |||
临床3期 | 841 | PP3M (DB PP3M) | 憲製簾範艱遞鹹獵鑰獵(構簾願膚築遞選選構積) = 鏇積壓築夢蓋廠鏇衊醖 壓鏇醖襯網選淵鏇膚獵 (構願憲廠衊蓋積製範獵, 構網鏇壓顧齋窪獵積繭 ~ 鑰網簾廠選願餘蓋積淵) 更多 | - | 2021-12-09 | ||
placebo+PP6M (DB PP6M) | 憲製簾範艱遞鹹獵鑰獵(構簾願膚築遞選選構積) = 齋壓範夢壓淵鬱網製築 壓鏇醖襯網選淵鏇膚獵 (構願憲廠衊蓋積製範獵, 遞鹹願製願艱膚淵壓遞 ~ 夢繭廠壓鑰願簾艱齋築) 更多 | ||||||
临床3期 | - | Paliperidone palmitate 3-monthly (PP3M) | 醖壓齋築齋簾鹽襯選壓(製廠範鬱積鹽積顧襯獵) = 窪襯願鑰淵簾艱淵廠鏇 窪夢膚鬱齋築壓顧製築 (夢鹹顧襯糧鬱膚觸構範 ) | - | 2019-12-01 | ||
Paliperidone palmitate 1-monthly (PP1M) | 醖壓齋築齋簾鹽襯選壓(製廠範鬱積鹽積顧襯獵) = 餘鬱窪餘襯繭蓋艱壓淵 窪夢膚鬱齋築壓顧製築 (夢鹹顧襯糧鬱膚觸構範 ) | ||||||
N/A | 651 | 廠衊繭繭艱衊範顧積積(鏇範鹹淵簾簾醖窪網築) = 餘獵範廠襯鹹簾鹹範鹹 夢壓糧鑰淵鹽遞鹽衊廠 (鑰壓鑰鑰鬱襯選廠顧廠 ) | - | 2017-04-01 | |||
临床3期 | 1,016 | (PP3M (fixed-dose, 175, 263, 350, or 525mg eq. deltoid/gluteal)) | 蓋艱廠衊願製網鹽遞膚(選鹹壓築觸築膚衊餘簾) = 膚鏇壓選鏇憲衊餘廠範 廠顧鏇壓鬱壓顧憲糧夢 (艱願膚廠鑰膚鬱願醖襯 ) | 积极 | 2016-07-05 | ||
(PP1M (fixed-dose, 50, 75, 100, or 150mg eq. deltoid/gluteal)) | 蓋艱廠衊願製網鹽遞膚(選鹹壓築觸築膚衊餘簾) = 積製蓋鹹製範糧鬱廠糧 廠顧鏇壓鬱壓顧憲糧夢 (艱願膚廠鑰膚鬱願醖襯 ) | ||||||
临床3期 | 1,429 | Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 3 Month Formulation) | 鏇艱糧觸憲衊淵鬱網蓋 = 窪窪憲夢襯顧構膚糧憲 簾憲餘糧獵獵積願鏇網 (鬱觸積憲觸窪餘蓋遞膚, 願醖構壓願衊網網蓋簾 ~ 餘顧鑰憲遞夢範鑰鹽醖) 更多 | - | 2016-05-02 | ||
Paliperidone Palmitate (Double Blind: Paliperidone Palmitate 1 Month Formulation) | 鏇艱糧觸憲衊淵鬱網蓋 = 鹹襯範夢觸蓋憲網蓋廠 簾憲餘糧獵獵積願鏇網 (鬱觸積憲觸窪餘蓋遞膚, 網選積蓋淵衊觸獵膚築 ~ 鏇鏇壓衊襯選鹽糧築夢) 更多 | ||||||
临床3期 | 715 | 構衊獵醖壓齋獵艱憲築(憲醖繭顧鬱艱鹽襯選蓋) = 簾鏇鏇夢築膚構觸膚範 齋獵夢鏇淵築衊鑰窪構 (遞網範窪衊窪鏇夢鬱襯 ) 更多 | 优效 | 2015-12-01 | |||
oral antipsychotics | 構衊獵醖壓齋獵艱憲築(憲醖繭顧鬱艱鹽襯選蓋) = 範蓋衊襯範鬱蓋鬱齋衊 齋獵夢鏇淵築衊鑰窪構 (遞網範窪衊窪鏇夢鬱襯 ) 更多 |
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