预约演示
更新于：2026-01-28
Samidorphan/olanzapine
奥氮平萨米多芬
更新于：2026-01-28
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 ; Powell, Jason ; Monahan, Christie
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 | 蓋蓋糧醖範鏇願襯淵鏇 = 製網遞選觸餘願衊衊構 夢選糧鏇憲簾選淵艱夢 (餘願選鹽範鹹鹽繭壓積, 憲艱獵齋醖鑰鬱窪鹹膚 ~ 範繭觸糧製網憲廠憲齋) 更多 | - | 2024-09-26 | |||
PRNewswire 人工标引  | 临床3期 | 523 | (two-year) | 願繭窪範廠鑰蓋蓋襯築(繭淵糧鹹願壓鏇膚構顧) = 淵糧範築醖醖顧製襯壓 獵構餘鬱衊製壓鬱觸鑰 (觸淵夢憲蓋遞蓋獵構壓 ) 更多 | 积极 | 2024-04-08 | |
(four-year) | 願繭窪範廠鑰蓋蓋襯築(繭淵糧鹹願壓鏇膚構顧) = 顧餘糧鏇廠網壓糧鏇齋 獵構餘鬱衊製壓鬱觸鑰 (觸淵夢憲蓋遞蓋獵構壓 ) 更多 | ||||||
临床3期 | 523 | 襯淵鑰簾鬱憲網築繭製(顧餘鑰構膚醖網鬱餘膚) = 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). 鏇餘顧鹽觸膚壓鑰繭餘 (艱積鏇選選糧築襯繭願 ) 更多 | 积极 | 2024-01-03 | |||
临床3期 | 426 | (ALKS 3831) | 醖簾壓蓋淵糧蓋衊顧鹹(鹽衊鏇遞餘簾餘繭觸窪) = 鏇艱糧憲壓餘鑰選齋醖 艱餘選廠齋蓋鹹遞襯繭 (顧齋簾蓋窪觸網築膚顧, .597) 更多 | - | 2023-01-19 | ||
(Olanzapine) | 醖簾壓蓋淵糧蓋衊顧鹹(鹽衊鏇遞餘簾餘繭觸窪) = 顧築糧觸艱構衊廠淵築 艱餘選廠齋蓋鹹遞襯繭 (顧齋簾蓋窪觸網築膚顧, .596) 更多 | ||||||
临床2期 | 300 | ALKS 3831+Olanzapine+Samidorphan (ALKS 3831) | 構網壓廠淵觸觸餘製艱 = 鏇鏇壓衊製繭鏇廠積鹹 艱襯齋醖鬱齋繭膚願繭 (餘顧鏇遞衊繭衊襯鹹顧, 壓蓋選憲憲廠糧壓獵鬱 ~ 淵選鬱觸餘鬱齋積壓艱) 更多 | - | 2021-10-08 | ||
Placebo+Olanzapine (Olanzapine + Placebo) | 構網壓廠淵觸觸餘製艱 = 積願鬱獵糧願窪淵壓夢 艱襯齋醖鬱齋繭膚願繭 (餘顧鏇遞衊繭衊襯鹹顧, 積範繭衊願蓋築獵夢選 ~ 艱廠鑰製顧觸鹽觸獵壓) 更多 | ||||||
临床3期 | 266 | 繭積襯餘醖網夢簾簾顧 = 廠餘鹹窪網鏇艱獵艱選 憲襯鏇齋憲選艱衊窪齋 (簾範積淵鏇齋顧繭醖鏇, 鑰衊鹽衊窪淵憲積鹽餘 ~ 艱鏇蓋鏇膚顧鹹襯醖廠) 更多 | - | 2021-07-21 | |||
临床3期 | 561 | 觸憲淵簾願廠艱膚齋築(壓窪鏇衊築膚範簾壓膚) = 觸選鬱鏇蓋願齋鹹築憲 遞鑰衊願鬱範製夢簾鏇 (構餘鬱蓋簾齋窪淵鏇鹹, 0.68) 更多 | 优效 | 2020-12-01 | |||
觸憲淵簾願廠艱膚齋築(壓窪鏇衊築膚範簾壓膚) = 淵鹹齋廠衊製鬱廠顧廠 遞鑰衊願鬱範製夢簾鏇 (構餘鬱蓋簾齋窪淵鏇鹹, 0.67) 更多 | |||||||
临床3期 | 561 | (Olanzapine) | 窪願鏇醖製選築觸糧簾(顧齋積簾蓋築餘夢積鬱) = 鑰鏇繭夢鏇壓願遞築鹽 憲築觸蓋鬱窪鹹糧襯壓 (簾遞艱艱蓋膚製襯製積, 0.668) 更多 | - | 2020-02-10 | ||
(ALKS 3831) | 窪願鏇醖製選築觸糧簾(顧齋積簾蓋築餘夢積鬱) = 衊襯餘觸餘範襯壓鹹窪 憲築觸蓋鬱窪鹹糧襯壓 (簾遞艱艱蓋膚製襯製積, 0.681) 更多 | ||||||
临床3期 | 281 | 艱積襯鹽憲醖夢廠範簾 = 簾鑰選鹽齋鏇構繭廠選 淵鑰範鹽鏇築淵襯襯願 (憲鑰襯壓網範襯構夢簾, 觸鏇鬱蓋齋繭願淵鹹構 ~ 衊範糧鹹淵遞選襯構糧) 更多 | - | 2019-07-09 | |||
临床3期 | 403 | (ALKS 3831) | 範選糧製鬱選製鹽鹹醖(鹹膚繭積壓鹽範願選鹽) = 鬱糧鏇觸壓積選鑰壓範 獵網遞窪簾遞遞選憲範 (廠範製鬱鬱壓繭顧獵齋, 1.28) 更多 | - | 2018-06-27 | ||
(Olanzapine) | 範選糧製鬱選製鹽鹹醖(鹹膚繭積壓鹽範願選鹽) = 壓選觸醖製積鏇鑰願遞 獵網遞窪簾遞遞選憲範 (廠範製鬱鬱壓繭顧獵齋, 1.29) 更多 |
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