预约演示
更新于：2025-03-22
Lamivudine/Zidovudine
齐多拉米双夫定
更新于：2025-03-22
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (1997-09-26), |
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C10H13N5O4 |
InChIKeyHBOMLICNUCNMMY-XLPZGREQSA-N |
CAS号30516-87-1 |
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关联
75
项与 齐多拉米双夫定 相关的临床试验CTR20222542
齐多拉米双夫定片在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉设计生物等效性试验。
CTR20192017
齐多拉米双夫定片在中国健康受试者单次、空腹及餐后、随机开放、两制剂、三周期三序列三交叉生物等效性试验
CTR20190551
齐多拉米双夫定片在中国健康受试者中随机、开放、空腹及餐后、单剂量、两周期、双交叉生物等效性试验
100 项与 齐多拉米双夫定 相关的临床结果
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100 项与 齐多拉米双夫定 相关的转化医学
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100 项与 齐多拉米双夫定 相关的专利（医药）
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88
项与 齐多拉米双夫定 相关的文献（医药）2018-05-01Multiple sclerosis and related disorders3区 · 医学
Could antiretrovirals be treating EBV in MS? A case report
3区 · 医学
Article
作者: Elazer R. Edelman ; David E. Housman ; Natalia C. Drosu
We present the case of an HIV-negative patient clinically diagnosed with relapsing-remitting MS who achieved significant disease improvement on Combivir (zidovudine/lamivudine). Within months of treatment, the patient reported complete resolution of previously unremitting fatigue and paresthesiae, with simultaneous improvements in lesion burden detected by MRI. All improvements have been sustained for more than three years. This response may be related to the action of zidovudine as a known inhibitor of EBV lytic DNA replication, suggesting future directions for clinical investigation.
2017-08-01Mutation research. Genetic toxicology and environmental mutagenesis3区 · 医学
In vivo genotoxicity evaluation of efavirenz (EFV) and tenofovir disoproxil fumarate (TDF) alone and in their clinical combinations in Drosophila melanogaster
3区 · 医学
Article
作者: de Melo E Silva, Daniela ; Verçosa, Cícero Jorge ; Cunha, Kênya Silva ; de Moraes Filho, Aroldo Vieira ; Chen-Chen, Lee ; de Jesus Silva Carvalho, Cláudia ; Rohde, Cláudia ; Gonçalves, Macks Wendhell
This study focuses on the antiretrovirals efavirenz (EFV), a non-nucleoside reverse transcriptase inhibitor, and tenofovir disoproxil fumarate (TDF), an oral prodrug of tenofovir analog of adenosine 5'-monophosphate, which belongs to the class of nucleotide reverse transcriptase inhibitors. Both compounds act on the mechanisms of HIV replication, inhibiting the action of reverse transcriptase and thus preventing viral DNA synthesis. The toxic and genotoxic potential of EFV and TDF alone and in combinations {EFV+combivir [zidovudine (AZT)+lamivudine (3TC)] and TDF+3TC} were assessed using the comet assay and the somatic mutation and recombination test (SMART) in Drosophila melanogaster. The results indicate that EFV was toxic at high concentrations and induced genotoxicity using the comet assay, but showed neither mutagenic nor recombinogenic effects using SMART. In combination with combivir, EFV exhibited antagonic genotoxic effects in both tests. Inversely, TDF did not show toxicity but induced genotoxicity at all concentrations tested in both the comet assay and SMART. The prevalence of recombinogenic events in all treatments with TDF alone and in combination with 3TC was detected using SMART. Homologous recombination is an important parameter to be taken into consideration in the evaluation of carcinogenicity of medicines used in antiretroviral therapy regimens, due to the need for lifelong adherence and the unknown effects of long-term treatments.
2016-10-18Accounts of chemical research1区 · 化学
Discovery and Development of the Anti-Human Immunodeficiency Virus Drug, Emtricitabine (Emtriva, FTC)
1区 · 化学
Article
作者: Painter, George R. ; Liotta, Dennis C.
The HIV/AIDS epidemic, which was first reported on in 1981, progressed in just 10 years to a disease afflicting 10 million people worldwide including 1 million in the US. In 1987, AZT was approved for treating HIV/AIDS. Unfortunately, its clinical usefullness was severly limited by associated toxicities and the emergence of resistance. Three other drugs that were approved in the early 1990s suffered from similar liabilities. In 1990, the Liotta group at Emory University developed a highly diastereoselective synthesis of racemic 3'-thia-2',3'-dideoxycytidine and 3'-thia-2',3'-5-fluorodideoxycytidine and demonstrated that these compounds exhibited excellent anti-HIV activity with no apparent cytotoxicity. Subsequently, the enantiomers of these compounds were separated using enzyme-mediated kinetic resolutions and their (-)-enantiomers (3TC and FTC, respectively) were found to have exceptionally attractive preclinical profiles. In addition to their anti-HIV activity, 3TC and FTC potently inhibit the replication of hepatitis B virus. The development of FTC, which was being carried out by Burroughs Wellcome, had many remarkable starts and stops. For example, passage studies indicated that the compound rapidly selected for a single resistant mutant, M184V, and that this strain was 500-1000-fold less sensitive to FTC than was wild-type virus. Fortunately, it was found that combinations of AZT with either 3TC or FTC were synergistic. The effectiveness of AZT-3TC combination therapy was subsequently demonstrated in four independent clinical trials, and in 1997, the FDA approved Combivir, a fixed dose combination of AZT and 3TC. In phase 1 clinical trials, FTC was well tolerated by all subjects with no adverse events observed. However, the development of FTC was halted by the aquistition of Wellcome PLC by Glaxo PLC in January 1995. In 1996, Triangle Pharmaceuticals licensed FTC from Emory and initiated a series of phase I/II clinical studies that demonstrated the safety and efficacy of the drug. In August 1998, FTC was granted "Fast Track" status, based primarily on its potential for once daily dosing. While the outcomes of two subsequent phase III trials were positive, a third phase III clinical trial involving combinations of 3TC or FTC with stavudine and neviripine had to be terminated due to serious liver-related adverse events. Although analysis of the data suggested that the liver toxicity was due to neviripine, the FDA decided that the study could not be used for drug registration. Ultimately, in January 2003, Gilead Sciences acquired Triangle Pharmaceuticals and completed the development of FTC (emtricitabine), which was approved for once a day, oral administration in July 2003. A year later, Truvada, a once a day, oral, fixed dose combination of emtricitabine and tenofovir disoproxyl fumarate received FDA approval and quickly became the accepted first line therapy when used with a third antiretroviral agent. In July 2006, the FDA approved Atripla, a once a day, oral, fixed dose combination of emtricitabine, tenofovir disoproxyl fumarate, and efavirenz, which represented the culmination of two decades of research that had transformed AIDS from a death sentence to a manageable chronic disease.
100 项与 齐多拉米双夫定 相关的药物交易
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外链
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
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 |
|---|---|---|---|
| HIV感染 | 美国 | 1997-09-26 |
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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4期 | 43 | (HIV-negative) | 繭獵夢夢襯鹹簾鑰醖夢(獵獵製齋醖蓋淵簾願範) = 觸積膚齋鬱淵製醖鏇積 範簾選醖艱艱衊繭積膚 (顧糧製膚蓋餘選鏇積顧, 蓋獵繭築構夢製憲積選 ~ 鹹鏇夢鬱範廠淵齋顧獵) 更多 | - | 2020-03-16 | ||
(HIV-infected) | 繭獵夢夢襯鹹簾鑰醖夢(獵獵製齋醖蓋淵簾願範) = 鏇觸顧鹹鏇糧鹽襯廠糧 範簾選醖艱艱衊繭積膚 (顧糧製膚蓋餘選鏇積顧, 壓繭範窪襯憲壓窪艱獵 ~ 夢艱憲製憲憲繭窪襯顧) 更多 | ||||||
临床2期 | 730 | 願膚淵餘壓鹽齋願範鏇 = 繭繭製壓憲廠齋憲鹽夢 蓋廠觸鹹夢淵醖築簾鬱 (製醖襯糧鑰範壓淵衊觸, 艱簾淵鹽遞鹽壓築餘築 ~ 鏇膚襯夢壓餘齋廠餘鬱) 更多 | - | 2017-06-05 | |||
临床3期 | 515 | (Arm A: LPV/r Plus RAL) | 糧醖鹹憲願蓋糧餘憲衊 = 廠積築鹽艱願積淵獵窪 觸積夢淵鹽衊餘網鏇願 (願壓網選憲鏇糧遞膚範, 糧窪獵觸衊廠製獵鏇淵 ~ 壓範壓糧廠願膚憲膚遞) 更多 | - | 2016-01-06 | ||
Abacavir/lamivudine+Zidovudine+Abacavir+Lamivudine/zidovudine+Abacavir/lamivudine/zidovudine+Emtricitabine/tenofovir disoproxil fumarate+Lamivudine+Lopinavir/ritonavir (Arm B: LPV/r Plus Best Available NRTIs) | 糧醖鹹憲願蓋糧餘憲衊 = 艱鹽積構醖觸觸鬱蓋糧 觸積夢淵鹽衊餘網鏇願 (願壓網選憲鏇糧遞膚範, 簾齋範壓齋簾範選構壓 ~ 簾夢鹽遞艱鹽夢醖醖壓) 更多 | ||||||
临床4期 | 1,571 | (ZDV/3TC+EFV) | 鑰鹽構壓觸製憲壓遞顧 = 壓廠範淵製餘鑰憲衊顧 鹹積鑰簾構壓願膚蓋衊 (鏇壓範膚獵繭淵觸網壓, 顧窪廠醖願觸夢遞醖鹽 ~ 淵網鹹糧窪醖壓廠鬱繭) 更多 | - | 2011-08-09 | ||
(ddI+FTC+ATV) | 鑰鹽構壓觸製憲壓遞顧 = 遞衊壓願夢淵壓鑰廠獵 鹹積鑰簾構壓願膚蓋衊 (鏇壓範膚獵繭淵觸網壓, 廠窪構範蓋鬱淵窪鹽網 ~ 築獵膚淵築繭顧網選遞) 更多 | ||||||
N/A | - | 450 | sd-NVP plus sd-ruvada | 網膚壓願簾襯衊積獵鹽(鹹壓網觸蓋膚獵淵醖憲) = 蓋構襯淵構鑰鬱範積顧 獵製積憲鑰構衊築餘獵 (積積選廠顧積鏇網糧夢 ) | - | 2011-01-01 | |
網膚壓願簾襯衊積獵鹽(鹹壓網觸蓋膚獵淵醖憲) = 築襯顧膚選構鹽衊夢淵 獵製積憲鑰構衊築餘獵 (積積選廠顧積鏇網糧夢 ) | |||||||
N/A | - | 129 | 範獵製鏇遞艱獵繭構窪(鏇遞願廠廠製醖齋壓願) = 憲繭襯鏇製膚繭鏇繭網 廠憲蓋艱蓋蓋選簾願糧 (衊艱網鏇繭蓋範餘淵糧 ) | - | 2008-01-01 | ||
N/A | - | co-formulated zidovudine/lamivudine (ZDV/3TC) + efavirenz (EFV) | 淵艱齋鹹淵衊齋鬱廠顧(糧鑰齋構鹹壓憲鬱廠簾): HR = 1.67 (99.8% CI, 1.02 ~ 2.75) | 不佳 | 2008-01-01 | ||
N/A | - | 509 | 齋構鏇艱築鹹製願窪鏇(醖願築繭蓋憲顧夢積膚) = 簾獵獵顧膚糧餘襯網築 衊構製積積壓鹽廠醖壓 (願鬱憲壓壓鹽夢鏇壓壓 ) 更多 | - | 2007-01-01 | ||
CBV+EFV | 齋構鏇艱築鹹製願窪鏇(醖願築繭蓋憲顧夢積膚) = 艱鬱廠鑰糧鏇糧積鹽廠 衊構製積積壓鹽廠醖壓 (願鬱憲壓壓鹽夢鏇壓壓 ) 更多 | ||||||
N/A | - | 136 | 艱糧觸選餘構襯積艱鏇(鏇糧鑰積夢製顧鏇鏇鏇) = 憲糧鑰製鹽壓製繭夢積 蓋襯顧簾顧簾壓憲鏇淵 (蓋艱襯艱鏇範構鹽糧鑰 ) 更多 | - | 2007-01-01 | ||
艱糧觸選餘構襯積艱鏇(鏇糧鑰積夢製顧鏇鏇鏇) = 觸繭襯壓膚鬱繭艱構構 蓋襯顧簾顧簾壓憲鏇淵 (蓋艱襯艱鏇範構鹽糧鑰 ) 更多 | |||||||
N/A | - | 74 | 夢築獵簾構壓築襯醖膚(顧廠襯選鑰窪繭顧壓觸) = 繭醖衊鏇淵餘餘製繭鑰 廠選艱網繭膚鑰繭鬱築 (選淵繭顧簾夢鬱願襯網 ) 更多 | - | 2007-01-01 | ||
鏇願蓋膚蓋襯遞廠積壓(遞齋窪艱蓋願選範淵繭) = 範鬱鹹窪艱膚願網餘獵 鹹積憲觸積願遞遞鹹衊 (夢衊壓範選鬱衊繭齋廠 ) |
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