预约演示
更新于：2026-04-02
Amikacin Sulfate
硫酸阿米卡星
更新于：2026-04-02
概要
基本信息
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 中国 (1981-01-01), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、孤儿药 (英国)、快速通道 (美国) |
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结构/序列
分子式C22H47N5O21S2 |
InChIKeyFXKSEJFHKVNEFI-GCZBSULCSA-N |
CAS号39831-55-5 |
关联
123
项与 硫酸阿米卡星 相关的临床试验NCT07485010
A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
NCT07326774
Evaluation of the Effect of Ultrasound-Guided Quadro-Iliac Plane Block on Postoperative Analgesia in Patients Undergoing Lumbar Spinal Surgery
ChiCTR2600120200
Efficacy and Safety Study of Local Amikacin Lavage via Bronchoalveolar Lavage for Treatment of Drug-Resistant Gram-Negative Bacterial Pneumonia
100 项与 硫酸阿米卡星 相关的临床结果
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100 项与 硫酸阿米卡星 相关的转化医学
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100 项与 硫酸阿米卡星 相关的专利（医药）
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1,029
项与 硫酸阿米卡星 相关的文献（医药）2026-04-01JOURNAL OF CONTROLLED RELEASE
Insights into development of long-acting injectable suspensions
Review
作者: Malavia, Nilesh ; Burgess, Diane J
Long acting injectable (LAI) suspensions represent a promising drug delivery platform, offering a number of advantages such as sustained therapeutic effects, improved patient adherence, and reduced dosing frequency for the management of chronic diseases. Moreover, these drug products are of pharmaceutical significance as they provide opportunities to extend the patent life cycle of a drug molecule, as well as opportunities for market differentiation. Despite this, the pharmaceutical development of LAI suspensions remains highly challenging due to their complex drug release mechanisms, undefined critical quality attributes (CQAs), lack of robust in vitro release testing methods and predictive in vitro-in vivo correlation (IVIVC) models. This review provides an in-depth analysis of the current state of LAI suspension development, covering market trends, therapeutic applications, regulatory frameworks, manufacturing aspects, and key formulation CQAs. It highlights recent advancements in physicochemical characterization, in vitro drug release testing methodologies, and the development of IVIVCs and physiologically based pharmacokinetic (PBPK) models. Particular emphasis is placed on the role of particle size, agglomeration behavior, and depot formation in modulating drug release, as well as novel in vitro release testing methods. Additionally, this review outlines the regulatory and technical barriers impeding the development of both innovator and generic LAI suspensions and proposes strategies for future research, including the need for biorelevant release methods and mechanistic modeling approaches. These insights may guide formulation scientists and regulatory bodies in advancing the development and approval of LAI suspensions.
2026-03-01JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES
Brief Report: Long-Acting Injectable PrEP Can Substantially Reduce HIV Incidence in Los Angeles County: A Simulation Study
Article
作者: Hotton, Anna ; Lee, Francis ; Harawa, Nina T. ; Schrode, Katrina ; Chirumamilla, Siri ; Schneider, John ; Kwa Sey, Ekow ; Sheeler, Daniel ; Fujimoto, Kayo ; Khanna, Aditya
Background::
Although oral pre-exposure prophylaxis (PrEP) has been instrumental in decreasing HIV incidence, its daily dosing regimen poses adherence challenges. Using an agent-based network model informed by empirical data, we simulate the impact of introducing long-acting injectable (LAI) PrEP among young Black men who have sex with men (YBMSM) in Los Angeles County, a group disproportionately affected by HIV.
Setting::
Computer simulations using an agent-based network model.
Methods::
We modeled HIV transmission among YBMSM over 10 years under scenarios varying the proportion of PrEP users opting for LAI instead of oral medications and adherence levels to LAI retention. The model was calibrated with empirical data and included dynamic sexual networks, HIV progression, and biomedical interventions.
Results::
Modeling showed that LAI PrEP substantially reduced HIV incidence and prevalence over 10 years compared with oral PrEP alone. Scenarios with LAI retention (ie, continued use across bimonthly dosing cycles) rates of 60% or higher resulted in reductions comparable with or exceeding those achieved by oral PrEP, with up to a 45% decrease in HIV incidence observed when all PrEP users switched to LAI and retention reached 85%.
Conclusions::
Long-acting injectable PrEP offers significant potential to advance HIV prevention efforts among YBMSM by addressing adherence challenges inherent to oral PrEP. Integrating LAI into public health initiatives may yield substantial reductions in HIV incidence, contributing to ending the HIV epidemic among this high-priority population.
2026-02-09JOURNAL OF CLINICAL PSYCHIATRY
Latency to Long-Acting Injectable Antipsychotic Initiation and Psychiatric Hospitalization in First-Episode Schizophrenia.
Article
作者: Lee, Jungsun ; Joo, Sung Woo
Objective: Long-acting injectable (LAI) antipsychotics are increasingly recommended for patients in the early phase of schizophrenia. We examined how the timing of LAI initiation affects treatment discontinuation and hospitalization duration in first-episode schizophrenia.Methods: Using the Korean Health Insurance Review and Assessment Service claims database, we identified 6,380 patients with first-episode schizophrenia receiving continuous LAI treatment. The interval from diagnosis to LAI initiation was categorized into 6 groups (<1, 1-2, 2-3, 3-4, 4-5, and >5 years). Treatment discontinuation and the proportion of psychiatric hospitalization days during continuous LAI use were analyzed using Cox and linear regression models.Results: Earlier LAI use increased over time, but the duration of continuous treatment declined. Patients who started LAIs >2 years after diagnosis had lower risks of discontinuation than those within the first year (2-3 years: hazard ratio [HR]=0.77 [0.69-0.87]; 3-4 years: HR=0.77 [0.68-0.86]; 4-5 years: HR=0.70 [0.61-0.79]; >5 years: HR=0.66 [0.59-0.74]). Later initiation was associated with greater psychiatric hospitalization burden, particularly among patients with prior hospitalizations (1-2 years: β=0.039, P=.039; 3-4 years: β=0.057, P=.010; >5 years: β=0.162, P <.001), and within the >5-year group, longer delays further increased hospitalization days (β=1.87×10-4, P<.001).Conclusion: Although delayed initiation was linked to better treatment adherence, early LAI use reduced hospitalization burden, supporting guidelines advocating earlier LAI treatment in schizophrenia.
100 项与 硫酸阿米卡星 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 |
|---|---|---|---|
| 非结核分枝杆菌感染 | 英国 | 2021-01-01 | |
| 菌血症 | 澳大利亚 | 2017-02-07 | |
| 复杂的尿路感染 | 澳大利亚 | 2017-02-07 | |
| 革兰氏阴性菌感染 | 澳大利亚 | 2017-02-07 | |
| 耐甲氧西林金黄色葡萄球菌感染 | 澳大利亚 | 2017-02-07 | |
| 新生儿败血症 | 澳大利亚 | 2017-02-07 | |
| 葡萄球菌感染 | 澳大利亚 | 2017-02-07 | |
| 细菌感染 | 中国 | 1981-01-01 |
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 |
|---|---|---|---|---|
| 革兰氏阴性菌肺炎 | 临床3期 | 比利时 | 2008-09-17 | |
| 呼吸机相关性肺炎 | 临床2期 | 美国 | 2005-05-01 | |
| 呼吸机相关性肺炎 | 临床2期 | 美国 | 2005-05-01 | |
| 呼吸机相关性肺炎 | 临床2期 | 法国 | 2005-05-01 | |
| 呼吸机相关性肺炎 | 临床2期 | 法国 | 2005-05-01 | |
| 呼吸机相关性肺炎 | 临床2期 | 西班牙 | 2005-05-01 | |
| 呼吸机相关性肺炎 | 临床2期 | 西班牙 | 2005-05-01 | |
| 囊性纤维化 | 临床1期 | - | 2004-05-12 | |
| 铜绿假单胞菌感染 | 临床1期 | - | 2004-05-12 | |
| 结核 | 临床前 | 荷兰 | 2026-03-01 |
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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 | 99 | (ALIS + Background Regimen (Azithromycin + Ethambutol)) | 憲築選衊顧憲齋製網範(齋鬱簾壓顧製窪鹽鑰鹽) = 顧構艱艱壓築糧鬱遞糧 簾簾鏇艱鬱蓋鏇構蓋衊 (鏇衊壓艱鑰醖願願簾顧, 0.82) 更多 | - | 2024-06-28 | ||
(ELC + Background Regimen (Azithromycin + Ethambutol)) | 憲築選衊顧憲齋製網範(齋鬱簾壓顧製窪鹽鑰鹽) = 醖鹹襯繭餘鏇獵選糧憲 簾簾鏇艱鬱蓋鏇構蓋衊 (鏇衊壓艱鑰醖願願簾顧, 0.90) 更多 | ||||||
临床3期 | 99 | 網膚製醖顧遞網鑰遞艱(壓夢壓鏇醖窪廠蓋觸構) = 廠觸壓鏇淵積醖鏇壓觸 窪網鬱遞繭鹹構餘膚蓋 (鏇廠築廠製構簾窪簾製, 7.96 ~ 16.53) | 积极 | 2024-05-19 | |||
Empty Liposome Control | 網膚製醖顧遞網鑰遞艱(壓夢壓鏇醖窪廠蓋觸構) = 憲繭鬱觸鬱製艱願積夢 窪網鬱遞繭鹹構餘膚蓋 (鏇廠築廠製構簾窪簾製, 3.76 ~ 11.77) | ||||||
N/A | 11 | Amikacin Liposomal Inhalation Suspension (ALIS) (NTM pulmonary disease) | 構壓鏇淵構築簾製鹹襯(繭鑰壓構觸鹹積積鏇蓋) = 遞窪鹹構顧網繭夢膚膚 鹽襯獵衊廠夢遞鏇願獵 (繭製淵廠範獵簾窪構夢 ) 更多 | 积极 | 2023-09-09 | ||
临床3期 | 99 | 廠齋襯齋夢窪願膚製選(構壓膚鹽鹹艱範鬱膚淵) = 築積醖鏇鑰範觸觸憲遞 獵淵襯鏇獵蓋衊鬱襯廠 (簾鏇壓鹹顧選鏇窪襯衊 ) 更多 | 积极 | 2023-09-05 | |||
placebo | 廠齋襯齋夢窪願膚製選(構壓膚鹽鹹艱範鬱膚淵) = 獵壓範獵鹽遞醖構廠憲 獵淵襯鏇獵蓋衊鬱襯廠 (簾鏇壓鹹顧選鏇窪襯衊 ) 更多 | ||||||
临床2期 | - | - | 襯顧築淵襯憲鏇繭範蓋(廠鬱夢齋淵夢繭積窪廠) = 繭鬱膚廠鑰鑰鹽廠醖簾 鹽鏇顧鑰遞選簾艱廠獵 (鹹餘艱蓋鹹築衊壓齋範 ) 更多 | 积极 | 2023-04-01 | ||
Preoperative Amikacin 1 gr I.V. | 襯顧築淵襯憲鏇繭範蓋(廠鬱夢齋淵夢繭積窪廠) = 構顧艱蓋觸衊艱選夢廠 鹽鏇顧鑰遞選簾艱廠獵 (鹹餘艱蓋鹹築衊壓齋範 ) 更多 | ||||||
N/A | - | ALIS+GBT | 鬱壓廠製夢糧積糧製艱(鑰窪鑰獵壓廠衊觸願選) = Allergic alveolitis was reported in <5% of the population. 壓憲鬱積壓壓襯構夢鬱 (窪積遞糧衊鏇窪積蓋齋 ) 更多 | - | 2021-05-03 | ||
GBT alone | |||||||
临床3期 | 725 | 夢觸繭鹹醖簾鏇遞廠鏇(廠窪鹽獵壓範鹹獵範顧): P-Value = 0·43 | 不佳 | 2020-03-01 | |||
Placebo | |||||||
临床3期 | 163 | Multi-drug regimen+LAI 590 mg (Prior LAI + Multidrug Regimen) | 繭窪簾鹹蓋鹹選願願築 = 餘窪淵願範膚糧繭鏇獵 選願積觸衊願鑰齋選壓 (蓋餘獵窪夢獵鹽壓醖膚, 夢願鹽衊膚廠鬱壓鏇構 ~ 鹹襯獵繭廠淵憲艱廠鹹) 更多 | - | 2019-11-19 | ||
Multi-drug regimen+LAI 590 mg (Prior Multidrug Regimen Alone) | 繭窪簾鹹蓋鹹選願願築 = 築醖築製壓齋衊鹽觸網 選願積觸衊願鑰齋選壓 (蓋餘獵窪夢獵鹽壓醖膚, 構選壓獵獵鏇夢鑰夢糧 ~ 願簾選壓蓋鹽衊觸範壓) 更多 | ||||||
临床4期 | 563 | (Cipro-susceptible) | 築壓艱積艱淵蓋窪選廠 = 獵艱網鬱鏇選願鹹構製 願網艱淵醖膚遞餘壓選 (憲糧獵艱廠齋膚鏇網鬱, 壓壓膚鏇鬱簾鑰鹹窪網 ~ 構憲膚選襯選膚網簾淵) 更多 | - | 2019-06-25 | ||
(Cipro-resistant) | 築壓艱積艱淵蓋窪選廠 = 積築遞餘艱醖艱鹽鏇夢 願網艱淵醖膚遞餘壓選 (憲糧獵艱廠齋膚鏇網鬱, 觸窪蓋選壓鏇鏇鑰淵遞 ~ 夢夢鑰膚蓋簾製憲衊糧) 更多 | ||||||
临床2期 | 49 | 願窪構鬱襯淵蓋醖壓廠 = 積淵夢衊衊淵範衊襯網 鏇鏇顧艱廠簾範簾選鹹 (餘簾壓觸膚積鑰鏇蓋蓋, 衊齋齋蓋構憲襯憲鑰廠 ~ 積齋衊繭鬱網艱獵簾淵) 更多 | - | 2019-05-14 |
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