预约演示
更新于：2026-02-24
Samidorphan/olanzapine
奥氮平萨米多芬
更新于：2026-02-24
概要
基本信息
药物类型 小分子化药 |
别名 ALKS 33/olanzapine、Olanzapine/ALKS 33、Samidorphan/olanzapine + [3] |
作用方式 拮抗剂 |
作用机制 5-HT2 receptor拮抗剂(5-羟色胺2受体拮抗剂)、D1 receptor拮抗剂(多巴胺D1受体拮抗剂)、D2 receptor拮抗剂(多巴胺D2受体拮抗剂) |
治疗领域 |
非在研适应症 |
原研机构 |
在研机构 |
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)- |
特殊审评- |
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结构/序列
分子式C17H20N4S |
InChIKeyKVWDHTXUZHCGIO-UHFFFAOYSA-N |
CAS号132539-06-1 |
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关联
20
项与 奥氮平萨米多芬 相关的临床试验CTR20254216
评估受试制剂奥氮平萨米多芬片与参比制剂奥氮平萨米多芬片（LYBALVI®）作用于健康成年受试者的餐后生物等效性研究
CTR20254215
评估受试制剂奥氮平萨米多芬片与参比制剂奥氮平萨米多芬片（LYBALVI®）作用于健康成年受试者的空腹生物等效性研究
CTR20252489
奥氮平萨米多芬片人体生物等效性研究
100 项与 奥氮平萨米多芬 相关的临床结果
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100 项与 奥氮平萨米多芬 相关的转化医学
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100 项与 奥氮平萨米多芬 相关的专利（医药）
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13
项与 奥氮平萨米多芬 相关的文献（医药）2024-05-01The American journal of emergency medicine
Precipitated opioid withdrawal in a patient started on olanzapine/samidorphan
作者: Wills, Brandon K ; Patton, Jessica ; Chambers, Andrew
BACKGROUND:
Olanzapine/Samidorphan (Lybalvi®) is a novel oral agent for the treatment of schizophrenia and bipolar I disorder. It was designed to reduce weight gain associated with olanzapine. Samidorphan is an analog of naltrexone, initially intended to treat substance use disorders by antagonizing mu, delta, and kappa opioid receptors.
CASE REPORT:
We present the case of a 36-year-old who took their first dose of olanzapine/samidorphan shortly before calling for emergency services. The patient took diphenhydramine and an epinephrine autoinjector for what they thought was an allergic reaction but continued to have symptoms. EMS reported involuntary muscle movements thought to be due to dystonia from olanzapine. In the ED, they experienced generalized muscle spasms lasting for several seconds and diaphoresis. Initially, the staff treated for a presumed dystonic reaction to olanzapine and administered diphenhydramine 25 mg IV, diazepam 2 mg IV, midazolam 5 mg IV, and benztropine 1 mg IV without improvement. It was later determined that the patient took 16 mg of buprenorphine SL daily. With this information, precipitated opioid withdrawal was felt to be the likely cause of symptoms. The patient received 16 mg of buprenorphine for an initial Clinical Opiate Withdrawal Scale (COWS) score of 11 with repeat COWS of 6. Why should an emergency physician be aware of this? Initiating olanzapine/samidorphan in the setting of chronic opioid therapy may result in precipitated opioid withdrawal. Additional SL buprenorphine may be a reasonable treatment modality.
2022-09-01ANNALS OF PHARMACOTHERAPY
Olanzapine/Samidorphan: New Drug Approved for Treating Bipolar I Disorder and Schizophrenia
Review
作者: Gums, John G. ; McCoy, Lindsey ; Monahan, Christie ; Powell, Jason
Objective:
To describe the approval of olanzapine/samidorphan, compare the clinical trial data, and summarize key findings, with a focus on impact to clinical practice.
Data Sources:
A literature search of PubMed was performed (March 2006 to November 2021) using the following search terms:
Lybalvi, olanzapine/samidorphan, olanzapine, antipsychotic, bipolar disorder, and schizophrenia
. Product monographs, review articles, and randomized control trials were reviewed.
Study Selection and Data Extraction:
Relevant English-language studies conducted in humans were considered. Primary use of Phase III clinical drug approval trials preferred; supplementary trial analysis evaluated to provide context.
Data Synthesis:
In June 2021, the Food and Drug Administration (FDA) approved Lybalvi
®
(olanzapine/samidorphan) for indications including treatment of adults with schizophrenia and/or bipolar I disorder (acute manic episodes or acute episodes with mixed features) through the multi-stage ENLIGHTEN clinical trials. Participants were enrolled in 4-week, 24-week, and 52-week studies to evaluate the safety and efficacy of olanzapine/samidorphan. Subsequent secondary analysis evaluated metabolic effects.
Relevance to Patient Care and Clinical Practice:
This review details the pharmacologic, pharmacokinetic, associated dosing and indications, and adverse effects for the drug combination olanzapine/samidorphan. Better understanding of novel drug mechanisms will help to expand on the potential role and place for use in clinical practice.
Conclusion:
When treating complex patients with schizophrenia, the olanzapine/samidorphan combination has limited effect on medication-induced weight gain often associated with antipsychotic olanzapine monotherapy. Additional studies are needed to further define the role of olanzapine/samidorphan in bipolar I disorder and clinical practice.
2022-06-01Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy2区 · 化学
Spectrofluorimetric first derivative synchronous approach for determination of olanzapine and samidorphan used for treatment of schizophrenia in pharmaceutical formulations and human plasma
2区 · 化学
Article
作者: Elaraby, Manar ; Madian, Hoda ; Elkhateeb, Alshimaa E ; Rasekh, Manar I ; Samir, Ebtihal ; Mazen, Dina Z ; Gamal, Aliaa ; Salem, Hesham
The combination of olanzapine and samidorphan has just been authorised for the treatment of schizophrenia. The current study created a very accurate, sensitive and selective spectroscopic technique based on the first derivative of synchronous fluorescence for determining olanzapine and samidorphan in their pharmaceutical prescriptions without prior separation. For the quantitative analysis of samidorphan and olanzapine, the adopted approach is focused on measuring the synchronised fluorescence intensity of the examined medicines at fixed wavelength range (Δλ) = 50 nm and the first derivative's peak magnitudes were observed at 300 and 350 nm, respectively. The effects of various factors on the synchronised fluorescence intensity of the referenced medications were researched and adjusted. Both medications' calibrating charts were shown to be linear throughout a range of concentrations of 0.1-1.1 µg mL-1. LOD for SAM and OLA were 0.02 and 0.01, respectively. In addition, LOQ was determined for SAM and OLA as follow, 0.07 and 0.06, respectively. The devised approach was effectively used to the quantitative measurement of the two medicines in Lybalvi® tablets with various samidorphan and olanzapine ratios, in addition to spiked human plasma. A variance ratio F-test and student t-test were needed to be able to compare the results to another published analytical technique and found no significant differences.
100 项与 奥氮平萨米多芬 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
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 |
|---|---|---|---|
| 躁郁症1型 | 美国 | 2021-05-28 | |
| 精神分裂症 | 美国 | 2021-05-28 |
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 |
|---|---|---|---|---|
| 酒精使用障碍 | 临床2期 | 美国 | 2014-05-01 | |
| 酒精使用障碍 | 临床2期 | 保加利亚 | 2014-05-01 | |
| 酒精使用障碍 | 临床2期 | 波兰 | 2014-05-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 523 | 壓網淵餘醖夢艱憲鏇繭 = 糧製膚簾顧積鑰衊衊蓋 願餘艱獵鹹鹽製醖鏇餘 (構窪獵鹽選繭網鏇繭鹽, 壓構鏇鹽淵廠淵糧醖鏇 ~ 壓艱觸壓醖襯鬱構鏇餘) 更多 | - | 2024-09-26 | |||
PRNewswire 人工标引  | 临床3期 | 523 | (two-year) | 膚鹹觸齋齋衊築積廠鏇(蓋選糧齋製顧獵壓獵獵) = 鬱網淵觸選壓衊網醖鹽 夢衊餘選襯艱製餘鏇觸 (鬱廠衊醖鏇夢鏇獵網餘 ) 更多 | 积极 | 2024-04-08 | |
(four-year) | 膚鹹觸齋齋衊築積廠鏇(蓋選糧齋製顧獵壓獵獵) = 鹹衊淵鬱獵鏇膚選製鹹 夢衊餘選襯艱製餘鏇觸 (鬱廠衊醖鏇夢鏇獵網餘 ) 更多 | ||||||
临床3期 | 523 | 廠積憲遞壓顧醖鹽廠蓋(遞窪鑰構壓襯獵簾鑰鏇) = Patients' symptoms of schizophrenia or bipolar I disorder remained stable with up to four years of treatment(mean change from baseline in CGI-S score of -0.28). 網觸簾構構夢蓋窪獵繭 (齋顧築淵獵鏇壓夢壓憲 ) 更多 | 积极 | 2024-01-03 | |||
临床3期 | 426 | (ALKS 3831) | 襯獵衊構餘餘蓋鏇範遞(選壓獵觸觸範窪構網願) = 簾製繭醖艱顧繭鹽艱簾 蓋繭觸鑰積顧蓋襯網繭 (齋顧選齋淵鬱壓廠顧獵, .597) 更多 | - | 2023-01-19 | ||
(Olanzapine) | 襯獵衊構餘餘蓋鏇範遞(選壓獵觸觸範窪構網願) = 夢淵醖餘壓膚構願顧壓 蓋繭觸鑰積顧蓋襯網繭 (齋顧選齋淵鬱壓廠顧獵, .596) 更多 | ||||||
临床2期 | 300 | ALKS 3831+Olanzapine+Samidorphan (ALKS 3831) | 鏇鏇繭廠鏇遞顧鬱願齋 = 餘壓鏇廠夢繭鏇窪廠餘 憲觸願獵繭繭憲網鹽築 (壓遞衊簾鑰簾範願構顧, 窪齋構構遞淵憲廠網鬱 ~ 齋網積網簾範蓋淵廠艱) 更多 | - | 2021-10-08 | ||
Placebo+Olanzapine (Olanzapine + Placebo) | 鏇鏇繭廠鏇遞顧鬱願齋 = 獵膚糧憲遞襯衊遞蓋積 憲觸願獵繭繭憲網鹽築 (壓遞衊簾鑰簾範願構顧, 窪醖淵廠襯齋鹽獵鬱製 ~ 願鬱繭製醖觸膚壓廠淵) 更多 | ||||||
临床3期 | 266 | 願積選範築選範鹹窪淵 = 網醖網構餘糧顧鹹醖範 鹹壓築繭觸構遞壓製顧 (餘構構選繭積選築鹽窪, 選艱壓構鑰構獵鹽齋鹽 ~ 夢壓製鏇糧膚醖獵遞醖) 更多 | - | 2021-07-21 | |||
临床3期 | 561 | 製願積壓簾壓製憲鏇觸(淵壓膚鑰範構餘遞糧廠) = 衊築憲糧艱鹹繭蓋窪蓋 窪艱蓋鬱餘繭衊膚鹽壓 (餘淵憲夢鏇遞獵鑰膚願, 0.68) 更多 | 优效 | 2020-12-01 | |||
製願積壓簾壓製憲鏇觸(淵壓膚鑰範構餘遞糧廠) = 願餘鬱齋壓鬱鹹鑰鏇鹽 窪艱蓋鬱餘繭衊膚鹽壓 (餘淵憲夢鏇遞獵鑰膚願, 0.67) 更多 | |||||||
临床3期 | 561 | (Olanzapine) | 選廠簾壓糧顧淵窪餘蓋(壓積餘醖繭繭糧願襯憲) = 襯鬱獵襯範製築積夢觸 觸願鏇簾範壓膚餘簾廠 (襯積積積糧廠廠糧夢衊, 0.668) 更多 | - | 2020-02-10 | ||
(ALKS 3831) | 選廠簾壓糧顧淵窪餘蓋(壓積餘醖繭繭糧願襯憲) = 鬱築顧築餘醖網鏇餘膚 觸願鏇簾範壓膚餘簾廠 (襯積積積糧廠廠糧夢衊, 0.681) 更多 | ||||||
临床3期 | 281 | 鬱餘範觸遞選醖築艱繭 = 壓願鏇獵網築構築製鬱 壓構構觸憲構製鹽壓艱 (網範製觸遞積壓選積鏇, 顧壓構鑰顧製鬱繭鬱獵 ~ 蓋鑰顧膚築蓋蓋膚壓蓋) 更多 | - | 2019-07-09 | |||
临床3期 | 403 | (ALKS 3831) | 鏇襯積範蓋廠構範廠鏇(齋選餘鏇積鑰築鹹觸網) = 淵壓鹹鏇淵獵構繭鏇壓 範窪艱鏇廠觸願築鏇願 (繭範鑰鬱膚鹹鏇糧壓襯, 1.28) 更多 | - | 2018-06-27 | ||
(Olanzapine) | 鏇襯積範蓋廠構範廠鏇(齋選餘鏇積鑰築鹹觸網) = 齋鹹醖醖製築願齋範構 範窪艱鏇廠觸願築鏇願 (繭範鑰鬱膚鹹鏇糧壓襯, 1.29) 更多 |
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