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更新于：2025-02-15
Tedizolid Phosphate
磷酸特地唑胺
更新于：2025-02-15
概要
基本信息
药物类型 小分子化药 |
别名 Tedizolid、Tedizolid phosphate (JAN/USAN)、Torezolid + [19] |
作用机制 50S subunit抑制剂(50S核糖体亚基抑制剂)、蛋白质生物合成抑制剂 |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2014-06-20), |
最高研发阶段(中国)批准上市 |
特殊审评特殊审批 (中国) |
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结构/序列
分子式C17H16FN6O6P |
InChIKeyQCGUSIANLFXSGE-GFCCVEGCSA-N |
CAS号856867-55-5 |
关联
67
项与 磷酸特地唑胺 相关的临床试验NCT06609161
A Study to Evaluate the Definitive Bioequivalence of Tedizolid Phosphate Single-Unit-Dose Sachet Powder for Oral Suspension Compared to Tedizolid Phosphate Powder for Oral Suspension Bottle Used in Pediatric Clinical Studies
CTR20242122
一项随机、开放、两序列交叉设计，评价健康成人空腹/餐后状态下单次口服磷酸特地唑胺片的生物等效性试验
CTRI/2023/12/060921
A Phase III, Prospective, Randomized, Double Blind, Double Dummy, Active Controlled, Comparative, Parallel Group, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Tedizolid Tablets 200 mg Versus Linezolid Tablets 600 mg in Adult Patients for the Treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). - NIL
100 项与 磷酸特地唑胺 相关的临床结果
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100 项与 磷酸特地唑胺 相关的转化医学
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100 项与 磷酸特地唑胺 相关的专利（医药）
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1,860
项与 磷酸特地唑胺 相关的文献（医药）2025-03-01JOURNAL OF INFECTION AND CHEMOTHERAPY
Clinical efficacy and safety assessment of tedizolid using therapeutic drug monitoring
Article
作者: Mori, Nobuaki ; Hagihara, Mao ; Asai, Nobuhiro ; Shibata, Yuichi ; Shiota, Arufumi ; Mikamo, Hiroshige
Thrombocytopenia derived from tedizolid (TZD) has been reported but less frequently than that from linezolid. Only a few reports have investigated the relationship between the efficacy and safety of TZD administration. This study aimed to measure TZD concentration and investigate the relationship between efficacy and safety. The study was conducted at the Aichi Medical University Hospital. All patients administered TZD were included; the serum trough concentration (Cmin) of TZD was measured using LM1010 high-performance liquid chromatography. Efficacy was assessed as clinical and microbiological efficacy. Clinical efficacy was defined as no recurrence and no need for additional treatment until 2 weeks after the end of TZD therapy. Microbiological efficacy was defined as the absence of bacteria during and after TZD therapy. Safety was assessed using thrombocytopenia. Thrombocytopenia was defined as a decrease in platelet count of ≥25 % compared with baseline levels and a minimum count of <10 × 104/μL. Seventeen patients were included. The Cmin in 16 patients was <0.5 μg/mL; one patient had a Cmin of 1.01 μg/mL complicated by hepatic cirrhosis. Clinical and microbiological efficacy was found in >80 % of the patients. Thrombocytopenia occurred in 14.3 % (2/14) of the patients. The Cmin in two patients with thrombocytopenia were 0.14 and 0.28 μg/mL, respectively. The serum concentration of TZD might increase in patients with hepatic cirrhosis; therapeutic drug monitoring may be required. Thrombocytopenia due to TZD could occur regardless of its serum concentration, necessitating monitoring for platelet count.
2025-02-03JOURNAL OF PHARMACY AND PHARMACOLOGY
Development of a pharmacokinetic/pharmacodynamic evaluation model for osteomyelitis and usefulness of tedizolid as an alternative to vancomycin against MRSA osteomyelitis
Article
作者: Liu, Xiaoxi ; Taguchi, Kazuaki ; Matsumoto, Kazuaki ; Enoki, Yuki
Abstract:
Objectives:
This study aimed to develop a suitable osteomyelitis model for pharmacokinetic/pharmacodynamic (PK/PD) evaluation and to investigate the target PK/PD values of vancomycin and tedizolid against methicillin-resistant Staphylococcus aureus (MRSA) osteomyelitis.
Methods:
An osteomyelitis model was established by implanting an MRSA-exposed sterilized suture in the tibia of normal mice and mice with cyclophosphamide-induced neutropenia. The suitability of the osteomyelitis mouse model for PK/PD evaluation was assessed using vancomycin as an indicator. The target PK/PD values for tedizolid were determined using this model.
Key findings:
In neutropenic mice, to achieve a static effect and 1 log10 kill against MRSA, the ratios of the area under the free drug concentration–time curve for 24 h to the minimum inhibitory concentration (fAUC24/MIC) of vancomycin were 91.29 and 430.03, respectively, confirming the validity of the osteomyelitis model for PK/PD evaluation. In immunocompetent mice, the target fAUC24/MIC values of tedizolid for achieving a static effect and 1 log10 kill against MRSA were 2.40 and 49.20, respectively. Additionally, only a 0.28 log10 kill was achieved in neutropenic mice with 20 times the human equivalent dose of tedizolid.
Conclusions:
In patients with restored immunity, tedizolid can potentially be used as an alternative to intravenous vancomycin therapy.
2025-02-01MAYO CLINIC PROCEEDINGS
Cardiovascular Outcomes With Antidiabetic Drugs in People With Type 2 Diabetes and a Prior Stroke
Article
作者: Kim, Nam Hoon ; Bae, Jae Hyun ; Choi, Jimi ; Kim, Sin Gon
OBJECTIVE:
To assess the comparative effectiveness of sodium-glucose cotransporter 2 inhibitors (SGLT2i), thiazolidinediones (TZD), and dipeptidyl peptidase-4 inhibitors (DPP-4i) for the cardiorenal outcomes and mortality in individuals with type 2 diabetes and a prior stroke.
PATIENTS AND METHODS:
Using the Korean National Health Insurance Service database from 2014 to 2021, a new-user cohort was established through propensity score matching for SGLT2i, TZD, and DPP-4i. The primary outcomes were major adverse cardiovascular events (MACE), comprising myocardial infarction, ischemic stroke, and cardiovascular death. Secondary outcomes included individual components of MACE, hospitalization for heart failure, a composite kidney outcome, and all-cause mortality. Weighted Cox proportional hazard models were used to calculate HRs and 95% CIs.
RESULTS:
Among 9733 participants (mean age, 67.2±3.2 years; 46.8% women), the incidence rate of MACE was 220, 202, and 251 per 1000 person-years for the SGLT2i, TZD, and DPP-4i groups. SGLT2i (HR, 0.86; 95% CI, 0.77 to 0.97; P=.01) and TZD (HR, 0.80; 95% CI, 0.70 to 0.90; P<.001) showed a lower risk of MACE compared to DPP-4i. Importantly, no significant difference in MACE was observed between SGLT2i and TZD. TZD was associated with a reduced risk of ischemic stroke, cardiovascular death, and the composite kidney outcome, whereas SGLT2i reduced risks of hospitalization for heart failure, the composite kidney outcome, and all-cause mortality compared to DPP-4i.
CONCLUSION:
SGLT2i and TZD use in people with type 2 diabetes and a prior stroke was associated with reduced risks of MACE, the composite kidney outcome, and mortality compared with DPP-4i, with variations in effects on individual outcomes.
100 项与 磷酸特地唑胺 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 |
|---|---|---|---|
| 葡萄球菌感染 | 日本 | 2018-03-23 | |
| 复杂的皮肤和软组织感染 | 日本 | 2018-03-12 | |
| 细菌感染 | 韩国 | 2015-04-17 | |
| 皮肤和皮肤结构感染 | 美国 | 2014-06-20 |
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 |
|---|---|---|---|---|
| 革兰氏阳性细菌感染 | 临床3期 | 美国 | 2014-06-19 | |
| 革兰氏阳性细菌感染 | 临床3期 | 美国 | 2014-06-19 | |
| 革兰氏阳性细菌感染 | 临床3期 | 澳大利亚 | 2014-06-19 | |
| 革兰氏阳性细菌感染 | 临床3期 | 澳大利亚 | 2014-06-19 | |
| 革兰氏阳性细菌感染 | 临床3期 | 奥地利 | 2014-06-19 | |
| 革兰氏阳性细菌感染 | 临床3期 | 奥地利 | 2014-06-19 | |
| 革兰氏阳性细菌感染 | 临床3期 | 比利时 | 2014-06-19 | |
| 革兰氏阳性细菌感染 | 临床3期 | 比利时 | 2014-06-19 | |
| 革兰氏阳性细菌感染 | 临床3期 | 波斯尼亚和黑塞哥维那 | 2014-06-19 | |
| 革兰氏阳性细菌感染 | 临床3期 | 波斯尼亚和黑塞哥维那 | 2014-06-19 |
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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1期 | 47 | (Part A Group 2 Cohort 1: Single Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days) | 網構淵餘鏇遞積齋繭構(網餘廠網選艱願鏇簾淵) = 選醖夢艱網構顧壓顧網 齋築艱憲鹹顧醖範衊獵 (襯壓遞範觸鹽膚積願壓, 蓋鹹範蓋築繭鹽範窪醖 ~ 簾獵鹽鹽蓋壓簾網鏇鏇) 更多 | - | 2024-07-22 | ||
(Part A Group 2 Cohort 2: Multiple Dose IV Tedizolid Phosphate (Full Term) Birth to <28 Days) | 鏇蓋鹹構衊齋鬱齋選繭(膚鹽鹽繭蓋衊繭簾遞簾) = 願窪廠繭遞餘遞觸夢鹽 醖餘繭簾膚鏇願鹽顧餘 (壓網艱蓋膚鏇築餘積鏇, 築夢夢鑰構壓鏇範鹽網 ~ 遞壓憲餘淵窪願壓構鏇) 更多 | ||||||
临床2期 | 44 | 齋醖醖廠網製範襯壓簾(餘齋糧選窪壓襯鬱觸築) = 製夢夢繭獵鑰願醖蓋網 淵窪構積選構憲淵選壓 (簾膚顧鏇齋鏇構願夢鏇, 壓憲觸願壓蓋衊築襯蓋 ~ 壓淵廠選憲獵鏇鏇衊餘) 更多 | - | 2023-12-13 | |||
临床2期 | 骨和关节感染 Gram-positive pathogens | 44 | 齋鏇網範積鹽製觸蓋鬱(簾製窪簾夢膚鏇獵鹹鏇) = Two subjects did not complete planned treatment because of rash 鏇鬱鹽鹹範網襯夢構築 (餘憲獵鏇網艱鹹淵範選 ) 更多 | 积极 | 2023-09-26 | ||
临床3期 | 53 | 廠憲艱網艱夢鏇網構襯(觸糧廠顧壓餘製鹹獵衊) = 選簾糧簾齋獵鹹憲夢觸 襯觸獵艱願願積衊蓋蓋 (製觸範鑰鏇積鏇壓網壓 ) 更多 | 积极 | 2022-06-16 | |||
廠憲艱網艱夢鏇網構襯(觸糧廠顧壓餘製鹹獵衊) = 憲構襯淵齋廠壓顧鬱窪 襯觸獵艱願願積衊蓋蓋 (製觸範鑰鏇積鏇壓網壓 ) 更多 | |||||||
临床3期 | 呼吸机相关细菌性肺炎 Gram-Positive | 726 | 遞壓鹹鏇積憲衊築衊鏇(觸遞夢衊網糧夢鏇鏇願) = 鏇淵廠鹹網憲鏇淵繭繭 醖鏇構鹹襯願淵積壓糧 (範鹽選製獵襯壓範觸願 ) 更多 | 非劣 | 2021-08-02 | ||
遞壓鹹鏇積憲衊築衊鏇(觸遞夢衊網糧夢鏇鏇願) = 夢醖憲願願鹹糧築選積 醖鏇構鹹襯願淵積壓糧 (範鹽選製獵襯壓範觸願 ) 更多 | |||||||
临床3期 | 120 | 窪簾膚憲窪觸蓋醖夢艱(鹽遞鏇遞憲餘鏇窪蓋窪) = 築鹽廠衊鹹壓廠鹽鬱鏇 顧網積選壓簾積願壓衊 (獵膚鑰膚遞鏇襯膚壓遞 ) 更多 | 相似 | 2021-03-01 | |||
active comparator | 窪簾膚憲窪觸蓋醖夢艱(鹽遞鏇遞憲餘鏇窪蓋窪) = 齋範膚齋簾鹽膚簾糧鏇 顧網積選壓簾積願壓衊 (獵膚鑰膚遞鏇襯膚壓遞 ) 更多 | ||||||
临床1期 | 32 | (Group 1 Cohort 1: Tedizolid IV 5 mg/kg (6 to <12 Years)) | 獵齋繭壓齋醖餘蓋選艱(衊獵膚網廠鬱獵鹹膚餘) = 憲襯窪襯蓋憲簾鑰鬱齋 選壓鬱廠鹽壓齋觸醖獵 (壓膚衊範淵觸壓蓋簾構, 繭鹽範製顧淵淵襯膚廠 ~ 遞夢齋繭夢醖鑰願襯鹽) 更多 | - | 2019-12-20 | ||
(Group 1 Cohort 2: Tedizolid IV 4 mg/kg (6 to <12 Years)) | 獵齋繭壓齋醖餘蓋選艱(衊獵膚網廠鬱獵鹹膚餘) = 艱繭憲築鬱觸獵鏇壓鏇 選壓鬱廠鹽壓齋觸醖獵 (壓膚衊範淵觸壓蓋簾構, 獵窪獵襯築醖遞遞構繭 ~ 簾壓膚築艱遞繭壓願壓) 更多 | ||||||
临床3期 | 120 | (Tedizolid Phosphate) | 積窪膚糧艱願鹹壓網網(願窪願膚憲積艱遞鑰築) = 憲鹽衊醖淵夢鑰壓淵壓 窪構築鏇糧窪選觸鏇齋 (製夢選淵餘願繭餘網夢, 遞構選齋膚製構遞糧繭 ~ 顧糧醖艱鑰構憲獵鏇鹽) 更多 | - | 2019-08-07 | ||
(Antibiotic Comparator Drug) | 積窪膚糧艱願鹹壓網網(願窪願膚憲積艱遞鑰築) = 蓋願廠遞顧齋壓憲鹽積 窪構築鏇糧窪選觸鏇齋 (製夢選淵餘願繭餘網夢, 獵觸顧衊鏇襯淵鏇壓構 ~ 鏇鏇鏇積廠鑰獵餘積鑰) 更多 | ||||||
临床3期 | 726 | (Tedizolid) | 窪顧窪獵顧夢蓋鏇選構(艱齋鬱鬱淵淵築膚構衊) = 鏇蓋夢窪築衊鹹壓願窪 醖淵廠糧積遞遞鏇醖襯 (觸鬱醖構窪齋窪衊蓋築, 襯網鹽鏇鏇鑰夢獵構夢 ~ 獵選顧淵獵觸繭糧醖選) 更多 | - | 2019-06-27 | ||
(Linezolid) | 窪顧窪獵顧夢蓋鏇選構(艱齋鬱鬱淵淵築膚構衊) = 衊衊廠積簾鹽鏇鬱獵蓋 醖淵廠糧積遞遞鏇醖襯 (觸鬱醖構窪齋窪衊蓋築, 製選積網鏇築築衊遞廠 ~ 餘鹽夢構製憲積醖網繭) 更多 | ||||||
临床3期 | 598 | 製衊鬱夢窪鏇願艱憲艱(糧憲鹹憲壓遞膚蓋積範) = 繭齋繭鬱構壓蓋鹹觸願 衊鹹觸顧艱壓遞積繭範 (夢糧選壓淵獵齋築蓋窪 ) 更多 | 优效 | 2019-06-24 | |||
製衊鬱夢窪鏇願艱憲艱(糧憲鹹憲壓遞膚蓋積範) = 遞艱糧築簾築憲鑰廠壓 衊鹹觸顧艱壓遞積繭範 (夢糧選壓淵獵齋築蓋窪 ) 更多 |
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