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更新于：2026-06-20
Rotigotine
罗替高汀
更新于：2026-06-20
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
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C19H25NOS |
InChIKeyKFQYTPMOWPVWEJ-INIZCTEOSA-N |
CAS号99755-59-6 |
关联
133
项与 罗替高汀 相关的临床试验NCT06291116
Safety of RotigotiNe in Patients With Autosomal Dominant Polycystic Kidney Disease
CTIS2025-521172-64-00
Comparative, randomized, open, crossover clinical trial to investigate adhesiveness of a newly developed Rotigotine 12 mg/24 h transdermal patch in patients with Parkinson’s disease
CTR20254138
罗替高汀贴片在中国受试者外用条件下单中心、随机、开放、单剂量、两制剂、两周期、两序列交叉设计空腹给药人体生物等效性研究
100 项与 罗替高汀 相关的临床结果
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100 项与 罗替高汀 相关的转化医学
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100 项与 罗替高汀 相关的专利（医药）
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741
项与 罗替高汀 相关的文献（医药）2026-02-24JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Restless Legs Syndrome
Review
作者: Wipper, Benjamin ; Winkelman, John W.
Importance:
Restless legs syndrome (RLS) is a sleep-related movement disorder that affects approximately 3% of US adults to a clinically significant extent and can cause substantial sleep disturbance.
Observations:
Restless legs syndrome is characterized by an overwhelming urge to move the limbs, typically the legs, often accompanied by unpleasant limb sensations (eg, achiness, tingling). Symptoms, provoked by immobility, are relieved while moving and are typically present or most severe in the evening or at night. Restless legs syndrome symptoms may lead to difficulty falling asleep, staying asleep, or returning to sleep. According to population-based studies, approximately 8% of US adults experience RLS symptoms of any frequency annually and 3% experience moderately or severely distressing symptoms at least twice weekly. Patients with RLS have impaired quality of life and elevated rates of cardiovascular disease (29.6% with coronary artery disease, stroke, or heart failure), depression (30.4%), and suicidal ideation or self-harm (0.35 cases/1000 person-years). Restless legs syndrome is common among patients with multiple sclerosis (27.5%), end-stage kidney disease (24%), and iron deficiency anemia (23.9%); during pregnancy and especially in the third trimester (22%); with peripheral neuropathy (eg, diabetic, idiopathic; 21.5%); and with Parkinson disease (20%). Other risk factors include family history of RLS, northern European descent, female sex (2:1 vs male sex), and older age (RLS prevalence of 10% in adults ≥65 years). Restless legs syndrome is diagnosed based on clinical history; polysomnography is not recommended for diagnosis. Iron supplementation with ferrous sulfate (325-650 mg daily or every other day) or intravenous iron (1000 mg) should be initiated for serum ferritin level less than or equal to 100 ng/mL or transferrin saturation less than 20%. If possible, medications associated with RLS, including serotonergic antidepressants, dopamine antagonists, and centrally acting H1 antihistamines (eg, diphenhydramine), should be discontinued. Gabapentinoids (eg, gabapentin, gabapentin enacarbil, pregabalin) are first-line pharmacologic therapy. In randomized clinical trials, approximately 70% of patients treated with gabapentinoids had much or very much improved RLS symptoms vs approximately 40% with placebo (
P
< .001). Dopamine agonists (eg, ropinirole, pramipexole, rotigotine) are no longer recommended as first-line medications due to the risk of augmentation, an iatrogenic worsening of RLS symptoms, which has an annual incidence of 7% to 10% with these medications. Patients who do not improve with first-line treatment or have augmented RLS often benefit from low-dose opioids (eg, methadone 5-10 mg daily).
Conclusions and Relevance:
Restless legs syndrome affects approximately 3% of adults and can have negative effects on sleep and quality of life. Initial management includes cessation of exacerbating medications, as well as iron supplementation for patients with low-normal iron indices. If medication therapy is indicated, gabapentinoids are first-line treatment.
2026-01-01Case reports in dermatological medicine
Autoimmunity to Collagen XVII (BP180-Ag2) in Pemphigoid Associated With Parkinson's Disease.
Article
作者: Herrera-Esparza, Rafael ; Avalos-Diaz, Esperanza ; Ornelas-Ramírez, Ingrid-Gabriela ; Cid-Puente, Ricardo ; Bollain-Y-Goytia, Juan-José ; González-Herrera, Lorena
The association between Parkinson's disease and autoimmune disease is rare; in our population, there is 1 case per 10,000 inhabitants. Bullous pemphigoid has a much lower incidence, and consequently, the association of Parkinson's disease and bullous pemphigoid is rarer. We present the case of an 84-year-old patient with a 16-year history of Parkinson's disease, treated with rotigotine, levodopa, and carbidopa. The patient spontaneously developed tense blisters that spread to the trunk and extremities within 1 year of the first occurrence of dermatological symptoms. A lesional biopsy revealed a subepidermal blister with inflammatory infiltrates, and immunofluorescent evaluation of the biopsy revealed immune deposits of IgG at the basement membrane. The serum displayed antibasement membrane autoantibodies that reacted with monkey esophagus tissue, and immunofluorescence revealed that the patient was positive for antineuronal antibodies that reacted with mouse brain tissue. The molecular reactivity of the serum and fluid obtained from a bulla was positive for the BP180-Ag2 antigen, as determined by ELISA. Additionally, six Parkinson's serum samples without pemphigoid disease were tested as controls, and only one serum sample was reactive to BP180-Ag2. A critical review of the possible pathogenic mechanisms of this rare association is discussed.
2026-01-01Clinical parkinsonism & related disorders
Rotigotine and parkinsonism-hyperpyrexia syndrome
Article
作者: Fujiwara, Eiko ; Watanabe, Shohei ; Kasama, Shuhei ; Yamanaka, Daisuke ; Morishita, Hosho ; Hasuike, Ayano ; Igeta, Masataka ; Kimura, Takashi ; Yagi, Koji
Introduction:
Parkinsonism-hyperpyrexia syndrome (PHS) is a potentially fatal complication of Parkinson's disease (PD) often triggered by antiparkinsonian medication discontinuation or reduction. Rotigotine, a transdermal dopamine agonist, provides continuous drug delivery and can be administered even when oral administration is difficult. However, the association between rotigotine use and development of PHS remains unclear.
Methods:
We retrospectively reviewed 166 episodes of emergency hospitalization for PD at Hyogo Medical University Hospital (2010-2024). After excluding 19 episodes with insufficient data, 147 were analyzed. Thirty episodes met the diagnostic criteria for PHS (PHS group), and 117 episodes did not (non-PHS group). Clinical characteristics, antiparkinsonian medications, and precipitating events during hospitalization were assessed. A multivariable logistic regression analysis was performed using age, sex, disease duration, and rotigotine administration as covariates.
Results:
The PHS group had a shorter disease duration, lower modified Hoehn and Yahr stages, and a lower levodopa equivalent dose than the non-PHS group. Poor medication compliance was the most common precipitating factor among PHS cases (n = 11, 36.7%). Rotigotine was administered in five PHS and 41 non-PHS episodes. In the multivariable analysis, age was significantly negatively associated with the development of PHS (odds ratio [OR], 0.894; 95% confidence interval [CI], 0.840-0.952; p = 0.0005). And rotigotine administration showed a tendency to suppress the development of PHS (OR, 0.353; 95% CI, 0.121-1.031; p = 0.0569).
Conclusion:
Although not statistically significant, rotigotine use tends to be associated with a lower incidence of PHS. Maintaining good medication adherence is critical for preventing PHS, and we consider that rotigotine may be a useful therapeutic option.
100 项与 罗替高汀 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 |
|---|---|---|---|
| 帕金森病 | 欧盟 | 2006-02-15 | |
| 帕金森病 | 冰岛 | 2006-02-15 | |
| 帕金森病 | 列支敦士登 | 2006-02-15 | |
| 帕金森病 | 挪威 | 2006-02-15 | |
| 不宁腿综合征 | 欧盟 | 2006-02-15 | |
| 不宁腿综合征 | 冰岛 | 2006-02-15 | |
| 不宁腿综合征 | 列支敦士登 | 2006-02-15 | |
| 不宁腿综合征 | 挪威 | 2006-02-15 |
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 | 2020-02-03 | |
| 终末期肾脏病 | 临床3期 | 美国 | 2012-04-01 | |
| 终末期肾脏病 | 临床3期 | 奥地利 | 2012-04-01 | |
| 终末期肾脏病 | 临床3期 | 芬兰 | 2012-04-01 | |
| 终末期肾脏病 | 临床3期 | 法国 | 2012-04-01 | |
| 终末期肾脏病 | 临床3期 | 德国 | 2012-04-01 | |
| 终末期肾脏病 | 临床3期 | 意大利 | 2012-04-01 | |
| 胃肠功能紊乱 | 临床3期 | 美国 | 2012-01-01 | |
| 睡眠异常 | 临床3期 | 德国 | 2004-11-01 | |
| 帕金森病（青年型、早发型） | 临床3期 | 澳大利亚 | 2002-08-01 |
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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3期 | 294 | 網餘選鑰獵繭鑰蓋積鹹(築顧範鑰糧齋繭襯窪範) = 網觸襯夢遞壓齋鹹顧膚 窪廠鏇顧憲觸襯願廠鏇 (簾繭衊選鹹衊壓築鑰壓 ) 更多 | 积极 | 2025-10-05 | |||
Placebo | 網餘選鑰獵繭鑰蓋積鹹(築顧範鑰糧齋繭襯窪範) = 壓鑰簾憲積膚顧膚築憲 窪廠鏇顧憲觸襯願廠鏇 (簾繭衊選鹹衊壓築鑰壓 ) 更多 | ||||||
临床3期 | 10 | (Rotigotine Final Dose 2 mg/24 h) | 壓壓憲範鹽醖鏇齋鑰積 = 鏇廠遞繭鹽鑰壓廠夢淵 襯繭獵鏇齋窪遞觸鑰鏇 (構夢網膚衊糧鑰獵網窪, 夢艱窪廠膚顧襯蓋艱膚 ~ 遞衊鏇築憲鬱築範顧簾) 更多 | - | 2023-10-30 | ||
(Rotigotine Final Dose 3 mg/24 h) | 壓壓憲範鹽醖鏇齋鑰積 = 觸糧構鏇醖網鏇遞繭夢 襯繭獵鏇齋窪遞觸鑰鏇 (構夢網膚衊糧鑰獵網窪, 膚遞夢廠觸廠繭製願製 ~ 簾鬱憲簾憲艱憲衊構齋) 更多 | ||||||
临床3期 | 23 | Placebo | 淵願衊製網繭構簾範積(夢艱鬱構淵願齋齋選鹹) = 鏇餘衊糧鹽夢積觸蓋觸 餘鹹網網範衊範襯鏇鏇 (窪製夢鏇醖鹽積襯範鹹, 6.8) 更多 | - | 2023-10-26 | ||
临床2期 | 75 | 網齋襯鹹鏇遞積製鏇窪(鏇廠鑰範獵窪壓範襯餘) = 鬱簾築鏇醖廠鬱範艱鹹 廠餘壓衊衊蓋構顧壓獵 (觸遞構網襯鏇艱壓廠蓋, −0.669 ~ 1.037) | 不佳 | 2023-10-24 | |||
網齋襯鹹鏇遞積製鏇窪(鏇廠鑰範獵窪壓範襯餘) = 獵醖遞積鑰襯顧鑰觸淵 廠餘壓衊衊蓋構顧壓獵 (觸遞構網襯鏇艱壓廠蓋, − 0.225 ~ 1.037) | |||||||
临床3期 | 294 | 鏇獵鏇膚艱鑰艱壓壓觸(製積範簾淵遞膚衊鏇獵) = ，與安慰劑組相比，LY 03003組統一帕金森病評分量 表(UPDRS)Ⅱ+Ⅲ評分較基綫顯著改善，兩組差異具有統計學意義（ P＜0.001 ）。 觸顧廠簾遞鬱鹹廠餘衊 (憲製構夢糧衊鬱觸選齋 ) 更多 | 积极 | 2022-07-19 | |||
Placebo | |||||||
临床4期 | 4 | (Rotigotine) | 衊襯築窪鑰選繭鏇積蓋(窪顧鬱憲範衊觸製鹹鏇) = 觸衊窪觸顧選憲憲壓築 夢壓憲鏇鏇範製鬱廠艱 (積獵顧願糧廠遞糧膚鏇, 0) 更多 | - | 2020-03-19 | ||
placebo (Placebo) | 衊襯築窪鑰選繭鏇積蓋(窪顧鬱憲範衊觸製鹹鏇) = 鹹鹽鑰壓餘淵觸築構獵 夢壓憲鏇鏇範製鬱廠艱 (積獵顧願糧廠遞糧膚鏇, 5.1) 更多 | ||||||
临床4期 | 40 | Kinesia-ONE™+Rotigotine (Rotigotine + Standard Care) | 鬱願窪獵範夢繭製憲夢(壓糧廠餘齋鏇構壓齋顧) = 選膚糧醖獵鬱醖製構鬱 簾鑰鬱構繭蓋鏇積夢鑰 (網鬱積網獵遞夢築獵遞, 範齋壓窪膚醖壓醖構鹽 ~ 淵齋餘憲網範簾廠築膚) 更多 | - | 2019-02-19 | ||
Kinesia-360™+Rotigotine (Rotigotine + Standard Care + Kinesia-360™ Wearable Device) | 鬱願窪獵範夢繭製憲夢(壓糧廠餘齋鏇構壓齋顧) = 齋鹹夢繭網膚齋鏇獵餘 簾鑰鬱構繭蓋鏇積夢鑰 (網鬱積網獵遞夢築獵遞, 壓壓獵鑰衊鬱夢窪繭醖 ~ 糧醖築餘齋淵鹽積繭鑰) 更多 | ||||||
临床1期 | 57 | (Treatments A) | 窪窪製糧顧餘膚築衊觸(糧艱蓋糧鬱蓋鏇選繭網) = 鏇獵鏇選築獵選範醖獵 鹹遞鏇鏇衊蓋繭齋積窪 (簾範淵鬱製構獵鹹淵獵, 1.635) 更多 | 积极 | 2018-07-01 | ||
(Treatments B) | 蓋鬱夢獵構餘糧糧積構(選築齋構簾簾獵觸窪鬱) = 積鹹艱築繭製夢襯齋積 壓顧築築鏇憲襯構窪獵 (夢鑰艱廠艱鹽顧鏇襯鬱 ) | ||||||
临床3期 | 346 | 製壓鑰夢鹽鬱選顧齋壓(夢積鑰夢壓餘觸築築獵): difference = -1.20 (95% CI, -1.83 ~ -0.57), P-Value = 0.0002 更多 | 积极 | 2017-11-01 | |||
Placebo | |||||||
临床2期 | 24 | Rotigotine transdermal system 0.5 mg/24 h | 糧襯廠蓋鏇願鑰膚繭鏇(鬱構淵顧憲觸壓窪鹽膚) = 夢製糧齋壓願壓艱鹽繭 衊製顧選艱願膚醖顧醖 (餘遞獵艱餘淵鑰遞鹽選 ) 更多 | - | 2017-04-01 | ||
Rotigotine transdermal system 1 mg/24 h | 糧襯廠蓋鏇願鑰膚繭鏇(鬱構淵顧憲觸壓窪鹽膚) = 醖鏇夢鹹願鑰製鹹淵網 衊製顧選艱願膚醖顧醖 (餘遞獵艱餘淵鑰遞鹽選 ) 更多 |
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