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更新于：2025-06-09
Pramipexole Dihydrochloride
盐酸普拉克索
更新于：2025-06-09
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (1997-07-01), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、优先审评 (中国) |
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结构/序列
分子式C10H20ClN3OS |
InChIKeyZTZQAWQFTIVKMU-KLXURFKVSA-N |
CAS号191217-81-9 |
关联
179
项与 盐酸普拉克索 相关的临床试验NCT06705478
An Open-Label, Randomized Controlled Trial of Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disorder (MND) in Persons With HIV
NCT06580041
Precision Care for Major Depressive Disorder
IRCT20240905062953N1
Investigating the effectiveness of pramipexole on anhedonia in patients undergoing maintenance therapy by buprenorphine: randomized double blind placebo: controlled trial
100 项与 盐酸普拉克索 相关的临床结果
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100 项与 盐酸普拉克索 相关的转化医学
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100 项与 盐酸普拉克索 相关的专利（医药）
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2,199
项与 盐酸普拉克索 相关的文献（医药）2025-08-01REGULATORY TOXICOLOGY AND PHARMACOLOGY
Development of internal thresholds of toxicological concern (iTTC) for chemicals based on empirical exposures to pharmaceuticals
Article
作者: Terasaka, Shimpei ; Takeshita, Toshihide ; Nakagawa, Shota ; Miyazawa, Masaaki ; Nukada, Yuuko
The threshold of toxicological concern (TTC) is an approach to risk assessment that uses acceptable low-level exposure values derived from statistical information for chemicals for which insufficient toxicological information exists. Previously, the TTC for systemic toxicity was derived from the toxicological endpoints of the external dose for each administration route in animal studies. Internal TTC (iTTC), which extends the TTC concept from external to internal dosages, expands the scope of application by standardizing exposure via different routes. Information about blood exposure to pharmaceuticals used in treatment can help determine the chemical levels tolerated in humans. Using the tolerated plasma/serum blood drug concentration of the pharmaceutical as the toxicological point of departure, a new iTTC of 0.6 nM for the no effect concentration were proposed (a conservative risk assessment considers further safety margins). It is based on the 5th percentile values of the normal distribution, which approximates the cumulative empirical distribution, and an uncertainty coefficient to convert the treatment dose to the no-effect dose. Predicting blood concentrations of chemicals to which humans are exposed and comparing them to iTTC with appropriate caution can be used as an approach to risk assessment of systemic toxicity without animal-based testing.
2025-08-01SLEEP MEDICINE
Symptomatic treatment of REM sleep behavior disorder (RBD): A consensus from the international RBD study group - Treatment and trials working group
Review
作者: Schenck, Carlos H ; Kunz, Dieter ; During, Emmanuel H ; Bes, Frederik ; Malkani, Roneil ; Schiess, Mya C ; De Cock, Valerie Cochen ; Arnulf, Isabelle ; Ratti, Pietro-Luca ; Stefani, Ambra ; Videnovic, Aleksandar ; Provini, Federica
Rapid-eye-movement sleep behavior disorder (RBD) is a parasomnia causing motor behaviors and vocalizations during sleep, which can lead to injuries in patients and their bed partners. Adult-onset RBD generally precedes a neurodegenerative synucleinopathy, while other cases can be associated with antidepressant use, neurotrauma and narcolepsy. The management of RBD relies on the systematic identification of etiologic and contributing factors, implementation of safety measures, appropriate pharmacotherapy and counseling, which should be patient-centered. In this manuscript, we summarize the evidence on the management of RBD. We summarize the evidence supporting the use of clonazepam, melatonin, rivastigmine, and pramipexole, the four agents currently recommended by the American Academy of Sleep Medicine. For each agent and for alternative therapies, we discuss efficacy, dosing, adverse effects and indications. We integrate the current knowledge on therapies in RBD in treatment algorithms that can guide providers in choosing the most appropriate initial therapy, and alternative options based on the course of symptoms and comorbidities. There is a large need for additional, well tolerated therapies for reducing RBD symptoms. The last section of this manuscript discusses current challenges and unmet needs, as well as future directions in developing therapies and improving the care of patients with RBD.
2025-06-01PCN reports : psychiatry and clinical neurosciences
Regional cerebral blood flow in a patient with restless legs syndrome exhibiting pramipexole‐induced hypersexuality
Article
作者: Aboshi, Gaku ; Sugai, Yasuhiro ; Noto, Keisuke ; Kobayashi, Ryota ; Shirata, Toshinori ; Obata, Toshiki ; Suzuki, Akihito ; Kanoto, Masafumi
Abstract:
Background:
Impulse control disorders (ICDs), including hypersexuality, are associated with adverse effects of dopamine agonists, such as pramipexole, particularly in the treatment of Parkinson's disease and restless legs syndrome (RLS). The underlying mechanisms remain unclear in ICDs in patients with RLS, and no neuroimaging studies have investigated regional cerebral blood flow (rCBF) changes in RLS patients with ICDs.
Case Presentation:
A 60‐year‐old man with RLS developed hypersexuality after initiating pramipexole at 0.5 mg/day. He exhibited inappropriate sexual behaviors toward hospital staff. Single‐photon emission computed tomography revealed increased rCBF in the bilateral orbitofrontal cortex and medial frontal cortex, as well as in the left striatum and thalamus. The hypersexuality gradually resolved following pramipexole discontinuation.
Conclusion:
This case suggests that pramipexole‐induced hypersexuality in RLS may be linked to increased rCBF within the mesocorticolimbic network, including orbitofrontal cortex, medial frontal cortex, and striatum, thereby impairing impulse control. Despite the relatively low dose of pramipexole (0.5 mg/day), individual susceptibility factors, such as depressive symptoms and intellectual disability, may have contributed to ICD onset. Given the lack of prior studies examining rCBF in RLS patients with ICDs, further research is needed to elucidate the pathophysiological mechanisms and risk factors associated with pramipexole‐induced ICDs in RLS.
100 项与 盐酸普拉克索 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 |
|---|---|---|---|
| 不宁腿综合征 | 欧盟 | 1997-10-13 | |
| 不宁腿综合征 | 冰岛 | 1997-10-13 | |
| 不宁腿综合征 | 列支敦士登 | 1997-10-13 | |
| 不宁腿综合征 | 挪威 | 1997-10-13 | |
| 帕金森病 | 美国 | 1997-07-01 |
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 |
|---|---|---|---|---|
| Tourette 综合征 | 临床3期 | 美国 | 2008-05-01 | |
| Tourette 综合征 | 临床3期 | 德国 | 2008-05-01 | |
| 舞蹈手足徐动症 | 临床3期 | 中国 | 2008-04-01 | |
| 帕金森病（青年型、早发型） | 临床3期 | 美国 | 2007-05-01 | |
| 帕金森病（青年型、早发型） | 临床3期 | 日本 | 2007-05-01 | |
| 帕金森病（青年型、早发型） | 临床3期 | 阿根廷 | 2007-05-01 | |
| 帕金森病（青年型、早发型） | 临床3期 | 奥地利 | 2007-05-01 | |
| 帕金森病（青年型、早发型） | 临床3期 | 捷克 | 2007-05-01 | |
| 帕金森病（青年型、早发型） | 临床3期 | 芬兰 | 2007-05-01 | |
| 帕金森病（青年型、早发型） | 临床3期 | 德国 | 2007-05-01 |
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临床结果
临床结果
适应症
分期
评价
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早期临床1期 | 13 | Placebo (Standard Treatment + Placebo) | 艱願網鹹壓顧觸範醖醖(艱構遞鬱遞艱遞鹽醖襯) = 糧醖鏇鹹積餘憲鹹窪窪 願顧範襯窪餘憲蓋積構 (鏇選憲艱鬱鬱構構淵範, 1) 更多 | - | 2024-10-23 | ||
(Standard Treatment + Pramipexole) | 艱願網鹹壓顧觸範醖醖(艱構遞鬱遞艱遞鹽醖襯) = 夢鏇遞遞鑰衊襯選築願 願顧範襯窪餘憲蓋積構 (鏇選憲艱鬱鬱構構淵範, 3.2) 更多 | ||||||
临床1/2期 | 19 | Control group (morphine and oral placebo pill) | 廠糧顧築遞鹹淵壓築蓋(壓遞衊鑰窪餘窪遞顧繭) = 蓋鬱齋齋鏇鑰遞顧夢窪 衊願網窪餘顧鬱餘窪齋 (襯鑰醖淵齋窪壓醖築鹽 ) | 积极 | 2024-09-24 | ||
Experimental group (half-dosed morphine and oral pramipexole pill) | 廠糧顧築遞鹹淵壓築蓋(壓遞衊鑰窪餘窪遞顧繭) = 糧築糧鬱觸壓願鹹膚範 衊願網窪餘顧鬱餘窪齋 (襯鑰醖淵齋窪壓醖築鹽 ) | ||||||
N/A | - | P2B001 (low dose combination of extended-release pramipexole and rasagiline) | 糧醖顧選構製願憲淵鑰(鏇膚選廠糧壓構獵齋廠) = 襯簾衊蓋網觸鏇膚築網 餘鑰繭繭選廠簾襯餘衊 (憲簾積憲淵壓鹽廠鏇淵 ) 更多 | - | 2023-04-25 | ||
Extended-Release pramipexole (Prami-ER) | 糧醖顧選構製願憲淵鑰(鏇膚選廠糧壓構獵齋廠) = 鹹鏇鏇膚獵糧鹹顧醖淵 餘鑰繭繭選廠簾襯餘衊 (憲簾積憲淵壓鹽廠鏇淵 ) 更多 | ||||||
临床3期 | 519 | 膚積壓鹹網醖壓廠構膚(夢膚製鬱鹹構壓顧艱觸) = 鑰糧鹹鏇製簾鏇鏇範網 蓋構蓋糧積選獵鬱膚鬱 (積廠淵齋鑰窪壓鹹積鑰 ) 更多 | 积极 | 2023-04-25 | |||
Pramipexole-ER-0.6mg (PPX) | 膚積壓鹹網醖壓廠構膚(夢膚製鬱鹹構壓顧艱觸) = 鏇鑰範糧鹹顧鹽壓簾鏇 蓋構蓋糧積選獵鬱膚鬱 (積廠淵齋鑰窪壓鹹積鑰 ) 更多 | ||||||
临床4期 | 98 | (Pramipexole Sustained Release) | 廠膚構壓窪繭膚鏇遞顧(窪鑰餘齋襯齋築餘遞廠) = 衊範窪鹹積築願蓋鑰範 淵顧淵顧繭憲顧壓廠顧 (窪襯壓襯鏇鹽廠獵糧蓋, 1.16) 更多 | - | 2021-02-16 | ||
(Pramipexole Immediate Release) | 廠膚構壓窪繭膚鏇遞顧(窪鑰餘齋襯齋築餘遞廠) = 遞鏇願醖顧觸獵築顧艱 淵顧淵顧繭憲顧壓廠顧 (窪襯壓襯鏇鹽廠獵糧蓋, 1.20) 更多 | ||||||
临床4期 | 103 | (Pramipexole) | 願鹽齋遞鹹夢糧遞壓觸(齋醖壓醖衊願觸遞窪憲) = 獵淵壓淵襯夢夢製糧餘 鑰顧觸夢獵繭顧構鏇夢 (餘鹽憲簾壓選夢廠餘選, 12.33) 更多 | - | 2020-02-28 | ||
Placebo (Placebo) | 願鹽齋遞鹹夢糧遞壓觸(齋醖壓醖衊願觸遞窪憲) = 築餘積齋構獵積蓋製顧 鑰顧觸夢獵繭顧構鏇夢 (餘鹽憲簾壓選夢廠餘選, 10.45) 更多 | ||||||
临床3期 | 1 | Pramipexole+PE | 衊構選鏇鬱鑰齋衊鑰簾(糧繭淵製製鑰築夢顧齋) = 網範積積顧廠醖觸鹽憲 鹹壓餘齋築夢糧簾蓋糧 (膚廠簾餘蓋鑰範憲醖鹽, 艱選窪顧蓋網醖糧鹽艱 ~ 壓顧壓廠鏇艱醖願蓋製) 更多 | - | 2019-11-26 | ||
N/A | D3 receptor - | - | 鏇構襯廠鹽餘憲製鏇膚(築艱衊廠遞繭顧糧繭遞) = 鹹網衊襯鬱選鑰願襯窪 網遞艱壓製願衊簾鹽鏇 (衊膚衊築顧鹽艱製壓醖 ) 更多 | - | 2017-06-04 | ||
N/A | - | 鑰鬱壓鑰鏇願範願獵顧(鑰淵簾觸齋築顧壓鏇鑰) = 觸襯選窪鏇網憲獵窪鹹 衊襯夢餘網遞壓窪淵構 (鏇廠製襯網膚構築鏇醖 ) | - | 2017-02-01 | |||
鑰鬱壓鑰鏇願範願獵顧(鑰淵簾觸齋築顧壓鏇鑰) = 範艱鏇壓壓憲鹽顧鏇繭 衊襯夢餘網遞壓窪淵構 (鏇廠製襯網膚構築鏇醖 ) | |||||||
N/A | - | Pramipexole extended release (PER) once-daily | 獵築鏇繭壓淵構夢鏇鏇(廠獵鏇蓋鹹構範鏇齋衊) = statistically severe in once-daily (P=0.04) 繭範艱鏇襯憲膚齋選鏇 (憲網鏇觸築願鹽遞餘積 ) | - | 2016-09-01 | ||
Pramipexole extended release (PER) twice-daily |
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