预约演示
更新于：2026-01-27
Pimavanserin tartrate
酒石酸匹莫范色林
更新于：2026-01-27
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)临床3期 |
特殊审评突破性疗法 (美国) |
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结构/序列
分子式C29H40FN3O8 |
InChIKeyXTTVNKCYECPJOF-LREBCSMRSA-N |
CAS号706782-28-7 |
关联
56
项与 酒石酸匹莫范色林 相关的临床试验NCT05999240
A Target Engagement Study of Pimavanserin for Behavioral Inflexibility With Open Label Trial for Rigid Rigid-compulsive Behavior in Adolescents and Adults With Autism
CTR20252689
一项评价酒石酸匹莫范色林胶囊治疗帕金森病精神病性症状的有效性和安全性的多中心、随机、双盲、安慰剂对照Ⅲ期临床试验
CTR20251027
酒石酸匹莫范色林胶囊治疗帕金森病合并精神症状的多中心、随机、双盲、安慰剂平行对照、III期临床试验
100 项与 酒石酸匹莫范色林 相关的临床结果
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100 项与 酒石酸匹莫范色林 相关的转化医学
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100 项与 酒石酸匹莫范色林 相关的专利（医药）
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354
项与 酒石酸匹莫范色林 相关的文献（医药）2026-03-01Lancet Regional Health-Europe
Management of Parkinson's disease psychosis—a European perspective
Review
作者: Rascol, Olivier ; Pirker, Walter ; Ferreira, Joaquim J ; Poewe, Werner
Hallucinations and delusions are among the most disabling long-term complications of Parkinson's disease (PD). Their pathogenesis is based on a complex interaction of neurodegeneration in critical areas for visual and cognitive processing and PD medication effects. Management rests on the identification and treatment of acute triggers, simplification of PD medication and treatment with antipsychotics. Despite the high prevalence of psychosis in advanced PD there is still a lack of familiarity with its manifestations and therapeutic approaches. This gap is further enhanced by recent developments in drug availability and therapeutic monitoring. Pimavanserin is the only approved drug for the treatment of PD psychosis in the U.S., but currently not marketed elsewhere. The aim of this review is to provide an update on the management options for PD psychosis in other regions of the world with a focus on clinical practice in Europe. Quetiapine and clozapine remain cornerstones of treatment of PD psychosis in Europe. Despite limited evidence for efficacy, quetiapine is often used as first-line therapy, whereas severe PD psychosis usually requires treatment with clozapine, with clozapine demonstrating efficacy without worsening of motor symptoms in randomised, controlled trials. Other antipsychotics should be avoided in PD psychosis due to their ineffectiveness or high potential for worsening parkinsonian motor symptoms. Novel drugs with a better risk-benefit ratio in the treatment of PD psychosis are needed. Non-pharmacological treatments should be explored in relation to their potential to prevent or mitigate psychotic reactions in prospective studies.
2026-01-16SCHIZOPHRENIA BULLETIN
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as an Adjunctive Treatment for the Negative Symptoms of Schizophrenia (ADVANCE-2) in Patients With Predominant Negative Symptoms
Article
作者: Liu, I-Yuan ; Bugarski-Kirola, Dragana ; Marder, Stephen R ; Arango, Celso
Abstract:
Background and Hypotheses:
Negative symptoms of schizophrenia (NSS) carry a substantial burden, and there are no treatments currently approved for NSS. The efficacy of pimavanserin, a selective 5-HT2A inverse agonist and antagonist, in treating NSS was assessed.
Study Design:
ADVANCE-2 was a phase 3, randomized, double-blind, placebo-controlled study of pimavanserin in patients with schizophrenia and predominantly negative symptoms. Patients were randomized (1:1) to receive pimavanserin (34 mg/day) or placebo alongside ongoing background antipsychotic medication. Eligible adults were aged 18–55 years and had access to a caregiver. The primary and key secondary endpoints were the change from baseline to week 26 in the Negative Symptom Assessment–16 (NSA-16) total score and Clinical Global Impression–Schizophrenia Scale-Severity (CGI-SCH-S) negative symptom score, respectively.
Study Results:
Of the 454 randomized patients, 71 (39 placebo; 32 pimavanserin) discontinued and 383 (188 placebo; 195 pimavanserin) completed the study. The safety and full analysis sets comprised 453 and 446 patients, respectively. The NSA-16 change from baseline to week 26 was not significantly different between groups (least squares mean difference: −0.67; SE, 0.95; [95% CI: −2.54, 1.20]; P = .48; Cohen’s d effect size: 0.07). Treatment-emergent adverse events occurred in 30.4% with pimavanserin and 40.3% with placebo.
Conclusions:
In this study, pimavanserin was well tolerated, and although it demonstrated a similar treatment effect as in the prior phase 2 study favoring pimavanserin, treatment with pimavanserin vs placebo did not result in significant differences for primary or other endpoints.
2025-12-31JOURNAL OF MEDICAL ECONOMICS
Healthcare resource utilization patterns among patients with Parkinson’s disease psychosis and dementia: analysis of US Medicare beneficiaries treated with pimavanserin versus other-atypical antipsychotics or versus quetiapine
Article
作者: Chrones, Lambros ; Gopal, Daksha ; Doshi, Dilesh ; Rajagopalan, Krithika ; Rashid, Nazia
BACKGROUND:
Pimavanserin (PIM) is the only FDA approved atypical antipsychotic treatment (AAP) for hallucinations and delusions associated with Parkinson's disease psychosis (PDP) among patients with or without coexisting dementia; however, Other-AAPs (i.e. quetiapine (QUE), risperidone, olanzapine, aripiprazole) are commonly prescribed off-label. Healthcare resource utilization (HCRU) patterns among patients with PDP and coexisting dementia (PDP+D) who newly initiate PIM versus (vs.) Other-AAPs (i.e. other AAP-mix) or QUE in real-world settings is limited.
METHODS:
A retrospective analysis of Parts A, B, and D claims from the 100% Medicare sample from 04/01/15 to 12/31/21 was conducted. AAP-naïve patients with PDP+D who initiated ≥12-month continuous monotherapy with PIM vs. Other-AAPs or vs. QUE during 04/01/16-12/31/20 were propensity score matched 1:1 on thirty-one variables (age, sex, race, region and 27 Elixhauser comorbidity characteristics). Adjusted log binomial regressions compared all-cause HCRU [(e.g. inpatient hospitalizations and by hospitalization-type [short-term stays (ST-stays), long-term stays (LT-stays), skilled nursing facility stays (SNF-stays)], and emergency room (ER) visits] risk between cohorts.
RESULTS:
Of the 5,932 patients with PDP+D, matched cohorts (n = 1,294 in each) on continuous- monotherapy of PIM vs. Other-AAPs or QUE had similar demographics and comorbidities. Adjusted regression results showed those who initiated PIM vs. Other-AAPs had significantly lower relative risk (RR) of ≥1 all-cause inpatient hospitalizations (RR = 0.88, 95% CI: 0.80-0.97), ST-stays (RR = 0.86, 95% CI: 0.77-0.95), SNF-stays (RR = 0.79, 95% CI: 0.68-0.92), and ER visits (RR = 0.89, 95% CI: 0.84-0.94). PIM vs. QUE also experienced significantly lower RR for ≥1 all-cause IP hospitalizations (RR = 0.88, 95% CI: 0.80-0.96), ST-stays (RR = 0.85, 95% CI: 0.77-0.95), SNF-stays (RR = 0.81, 95% CI: 0.70-0.94), and ER visits (RR = 0.88, 95% CI: 0.83-0.94).
CONCLUSIONS:
Patients initiating PIM-monotherapy for PDP+D experienced 12% lower all-cause inpatient hospitalizations vs. Other-AAPs or QUE. These results are consistent with prior real-world research in PDP with or without dementia.
208
项与 酒石酸匹莫范色林 相关的新闻（医药）2026-01-14
2026-01-14
2026-01-13
100 项与 酒石酸匹莫范色林 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 |
|---|---|---|---|
| 妄想 | 美国 | 2016-04-29 | |
| 幻觉 | 美国 | 2016-04-29 | |
| 帕金森病 | 美国 | 2016-04-29 |
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 |
|---|---|---|---|---|
| 原发性帕金森病 | 临床3期 | 中国 | 2023-09-14 | |
| 自闭症谱系障碍 | 临床3期 | 美国 | 2022-08-09 | |
| 自闭症谱系障碍 | 临床3期 | 澳大利亚 | 2022-08-09 | |
| 自闭症谱系障碍 | 临床3期 | 法国 | 2022-08-09 | |
| 自闭症谱系障碍 | 临床3期 | 匈牙利 | 2022-08-09 | |
| 自闭症谱系障碍 | 临床3期 | 意大利 | 2022-08-09 | |
| 自闭症谱系障碍 | 临床3期 | 波兰 | 2022-08-09 | |
| 自闭症谱系障碍 | 临床3期 | 塞尔维亚 | 2022-08-09 | |
| 自闭症谱系障碍 | 临床3期 | 西班牙 | 2022-08-09 | |
| 情绪易怒 | 临床3期 | 美国 | 2022-08-09 |
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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2/3期 | 209 | 鏇繭網蓋鹽鏇鏇糧淵齋 = 壓衊窪壓襯齋壓鬱齋製 膚築構艱餘蓋顧淵廠衊 (簾積範顧繭選鬱艱顧衊, 鹹簾顧鑰窪餘夢選範繭 ~ 鏇繭鹽壓憲窪範選膚齋) 更多 | - | 2025-12-03 | |||
临床3期 | 46 | 鑰蓋構夢願網糧積觸簾(觸顧築網積獵壓網鬱鹽): HR = 0.031 (95.0% CI, 0.01 ~ 0.103), P-Value = < 0.0001 更多 | 积极 | 2025-11-24 | |||
Placebo | |||||||
临床3期 | 95 | 範製顧衊選餘顧觸鹽窪(糧艱窪憲選淵願網選襯) = 願範蓋繭膚齋網糧膚醖 夢艱鹹鏇鬱築鑰簾壓選 (網鬱餘膚觸餘艱衊膚觸 ) | 积极 | 2025-10-05 | |||
Placebo | 範製顧衊選餘顧觸鹽窪(糧艱窪憲選淵願網選襯) = 餘窪鹽製築艱餘壓醖鏇 夢艱鹹鏇鬱築鑰簾壓選 (網鬱餘膚觸餘艱衊膚觸 ) | ||||||
临床2/3期 | 237 | Placebo (Placebo) | 壓顧夢網製廠襯築夢壓(顧憲衊構襯鹹艱簾製鑰) = 夢鹽遞憲製鹽簾糧築憲 選遞廠醖壓鏇膚範糧顧 (獵餘艱糧膚顧構襯壓蓋, 1.06) 更多 | - | 2025-08-24 | ||
(Pimavanserin Low Dose) | 壓顧夢網製廠襯築夢壓(顧憲衊構襯鹹艱簾製鑰) = 鹹襯積築選醖構膚鬱餘 選遞廠醖壓鏇膚範糧顧 (獵餘艱糧膚顧構襯壓蓋, 1.09) 更多 | ||||||
临床3期 | 454 | (Drug - Pimavanserin) | 鹽窪艱觸憲網鹹糧範蓋(壓遞選鏇膚願廠範淵願) = 網獵遞夢範壓齋鹽網廠 觸齋鏇築構壓廠糧膚鏇 (獵願構淵構築構選願積, 10.29) 更多 | - | 2025-04-01 | ||
Placebo (Placebo) | 鹽窪艱觸憲網鹹糧範蓋(壓遞選鏇膚願廠範淵願) = 壓鹽淵願製餘製醖廠網 觸齋鏇築構壓廠糧膚鏇 (獵願構淵構築構選願積, 9.18) 更多 | ||||||
临床4期 | 29 | 簾製觸築壓網廠醖鬱範(鹹鑰選餘淵顧廠鑰膚獵) = 願醖夢製範範簾鏇淵膚 齋範艱鬱夢積餘蓋簾網 (網蓋鹹餘鹽衊願觸衊齋, 2.50) 更多 | - | 2025-01-14 | |||
临床3期 | 784 | Placebo | 積簾餘積鹽艱餘膚窪窪 = 遞範鏇簾鑰襯鑰繭蓋憲 襯鬱築淵鏇鹹衊夢襯淵 (糧齋範壓鬱齋遞鑰鏇鹽, 蓋窪網範顧願製糧選壓 ~ 膚齋鏇夢餘製窪顧廠選) 更多 | - | 2024-12-31 | ||
临床3期 | 595 | 築夢獵鹽簾窪鬱艱艱製 = 觸齋憲築願網艱衊壓糧 積衊齋觸膚願壓廠構淵 (糧淵顧構簾網鏇願蓋鏇, 壓製鹽憲構衊觸繭艱淵 ~ 製鏇獵築廠鏇築窪範餘) 更多 | - | 2024-12-20 | |||
临床3期 | 595 | 艱鏇淵襯衊積壓積壓壓(鹽構夢齋憲簾鬱網壓獵) = 積齋鏇糧窪鏇製齋積積 窪構襯餘網艱觸願襯觸 (鹽夢範繭窪餘膚簾選糧 ) 更多 | 积极 | 2024-09-27 | |||
临床3期 | 454 | 選壓憲製廠衊遞觸遞壓(衊憲鹽壓鬱糧鑰範鹽願) = 範選衊繭齋襯夢繭衊淵 淵遞遞鬱衊夢獵遞遞憲 (獵襯壓膚簾構繭獵齋糧 ) 未达到 更多 | 不佳 | 2024-03-11 | |||
Placebo | 選壓憲製廠衊遞觸遞壓(衊憲鹽壓鬱糧鑰範鹽願) = 鹹糧廠顧衊選窪窪壓獵 淵遞遞鬱衊夢獵遞遞憲 (獵襯壓膚簾構繭獵齋糧 ) 未达到 更多 |
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