This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), or BDLLfxC regimen, to treat rifampin-resistant pulmonary tuberculosis (RR-TB) in Chinese teenagers and adults (aged 12 years or above). The main questions it aims to answer are:
* Is BDLLfxC regimen effective to treat RR-TB in Chinese participants?
* Is BDLLfxC regimen safe in Chinese RR-TB participants? Participants will take BDLLfxC regimen to treat their RR-TB. There will be no additional hospital visits, laboratory tests or radiological examinations other than routine clinical practice.

开始日期2024-11-15

申办/合作机构

复旦大学附属华山医院

[+1]

NCT06418711

/ Recruiting临床3期

ICoN-1: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Clofazimine Inhalation Suspension When Added to Guideline-Based Therapy in Participants With Nontuberculous Mycobacterial Infection

This clinical trial is designed to compare the efficacy and safety of Clofazimine Inhalation Suspension versus placebo when added to guideline-based therapy (GBT)

开始日期2024-09-11

申办/合作机构

MannKind Corp.

NCT06081361

/ Recruiting临床3期IIT

A Multicenter, Randomized, Open-Label Study To Evaluate The Efficacy And Safety Of A Contezolid, Delamanid and Bedaquiline-Containing Short Regimen For The Treatment Of Rifampicin-Resistant Pulmonary Tuberculosis

The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are:
Is the efficacy of short regimen non-inferior to standard regimen?
Is the short regimen safe enough to replace the standard regimen?
Participants will:
Be given with either short or standard regimen for RR-TB treatment
Be asked to complete the scheduled visit as planned.

开始日期2023-12-22

申办/合作机构

首都医科大学附属北京胸科医院

[+1]

100 项与氯法齐明相关的临床结果

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100 项与氯法齐明相关的转化医学

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100 项与氯法齐明相关的专利（医药）

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2,747

项与氯法齐明相关的文献（医药）

2025-12-31·European Clinical Respiratory Journal

The complexities of elexacaftor/tezacaftor/ivacaftor therapeutic drug monitoring in a person with cystic fibrosis and Mycobacterium abscessus pulmonary disease

Article

作者: Riddles, Timothy ; Evans, Ieuan E S ; Matson, Angela G ; Johnson, Ellie ; Mou, Claire Y ; Reid, David W ; Henderson, Daniel J ; Swenson, Rebecca ; Herd, Karen M ; McWhinney, Brett ; Burke, Andrew

Therapeutic drug monitoring (TDM) of elexacaftor/tezacaftor/ivacaftor (ETI) remains challenging due to a lack of clarity around the parameters that govern ETI plasma concentrations, whilst the use of concomitant CYP3A inducers rifabutin and rifampicin is not recommended. We present the complexities of TDM for ETI performed in a person with cystic fibrosis and refractory Mycobacterium abscessus pulmonary disease. Utilising National Association of Testing Authorities (NATA) accredited assays and target considerations published by the Therapeutic Goods Administration (TGA), Australia, ETI plasma concentration variability was monitored over the course of an acute admission with added complexity from an antibiotic regimen including rifabutin, a moderate cytochrome P450 3A (CYP3A) inducer, and clofazimine, a mild CYP3A inhibitor. This case highlights the challenges surrounding ETI TDM in the context of acute severe illness, malnutrition, chronic infection, and drug-to-drug interactions. The marked clinical improvement seen, alongside sustained ETI plasma concentrations and suppressed sweat chloride levels on serial testing, provided reassurance of the use of ETI and rifabutin concomitantly in this case, and highlights the potential utility of TDM in helping guide clinical practice. Though a current barrier to the application of TDM includes ETI only being available as a fixed dose combination.

2025-03-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development and validation of a liquid chromatography-tandem mass spectrometry assay for the simultaneous analysis of isoniazid and pyrazinamide in cerebrospinal fluid

Article

作者: Dooley, Kelly E ; Wiesner, Lubbe ; Joubert, Anton ; Wasserman, Sean ; van der Merwe, Marthinus ; Maputla, Sydwell Poulo ; Zangenberg, Edda ; Castel, Sandra

For the effective treatment of tuberculosis with first-line anti-tubercular drugs, drug concentrations need to be measured at the site of infection to determine drug exposure. To enable the measurement of the anti-tuberculosis drugs isoniazid and pyrazinamide in the nervous system of patients with tuberculous meningitis, an analytical method was developed and validated for the quantification of these drugs in human cerebrospinal fluid. Samples were prepared by solid phase extraction using Strata-X polymeric extraction plates. The analytes were separated by high-performance liquid chromatography on an Atlantis T3, 100 A, 3 µm, 2.1 mm × 100 mm analytical column with gradient elution, employing a mobile phase that consisted of acetonitrile-methanol-formic acid (50:50:0.1, v/v/v), at a flowrate of 0.25 mL/min. The total run time was 4.5 minutes, and the average retention times of isoniazid and pyrazinamide were 1.1 and 1.3 min, respectively. The analytes and their respective deuterated internal standards were detected on a Sciex API4000 triple quadrupole mass spectrometer applying positive electrospray ionization with multiple reaction monitoring as the detection mode. The method was validated according to the FDA and EMA guidelines. The method was demonstrated to be accurate, reproducible, and robust, showing the necessary sensitivity and specificity for the quantification of isoniazid and pyrazinamide in cerebrospinal fluid. The method was successfully applied to analyze clinical samples from the LASER-TBM and TBM-KIDS clinical studies.

2025-02-13·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

Performance of a broth microdilution assay for routine minimum inhibitory concentration determination of 14 anti-tuberculous drugs against the Mycobacterium tuberculosis complex based on the EUCAST reference protocol

Article

作者: Mansjö, Mikael ; Samanci, Ishak ; Espinosa-Gongora, Carmen ; Groenheit, Ramona ; Werngren, Jim

ABSTRACT:

This comparative study aimed at qualifying a broth microdilution (BMD) assay for phenotypic drug susceptibility testing (pDST) of Mycobacterium tuberculosis complex (MTBC) strains for implementation in a routine DST workflow. The assay was developed based on the EUCAST (European Committee on Antimicrobial Susceptibility Testing) reference protocol for determination of the minimum inhibitory concentration (MIC) of 14 anti-tuberculous drugs (isoniazid [INH], rifampicin [RIF], ethambutol [EMB], amikacin [AMI], moxifloxacin [MFX], levofloxacin [LFX], bedaquiline [BDQ], clofazimine [CFZ], delamanid [DLM], pretomanid [PA], para-aminosalicylic acid [PAS], linezolid [LZD], ethionamide [ETH], and cycloserine [CS]). Forty MTBC strains with various drug resistance profiles were tested to determine the agreement between MIC results and genotypic drug susceptibility testing (gDST) results derived from whole-genome sequencing (WGS). The agreement between the BMD and gDST results was solid for the majority of the drugs (average agreement 98%, range 90%–100%), including key drugs such as INH, RIF, MFX, LFX, BDQ, DLM, and PA. Ten discrepancies were identified (corresponding to 1.8% of the total number of MIC determinations) and most (8/10) were characterized by MICs equal or close to the potential critical concentration (pCC) applied in the BMD assay. Importantly, the assay can be adjusted to new drug recommendations and concentrations, tailored to local needs. We conclude that the BMD assay provides reliable results, and its implementation in our MTBC routine workflow will produce valuable data that improve our understanding and management of MTBC drug resistance.

项与氯法齐明相关的新闻（医药）

2025-02-06

·drugs

Three All-Oral Shortened Regimens Noninferior for Rifampin-Resistant TB

THURSDAY, Feb. 6, 2025 -- Three all-oral shortened regimens have noninferior efficacy compared with standard therapy for fluoroquinolone-susceptible, rifampin -resistant tuberculosis , according to a study published in the Jan. 30 issue of the New England Journal of Medicine . Lorenzo Guglielmetti, M.D., Ph.D., from Médecins Sans Frontières in Paris, and colleagues conducted a phase 3, multinational, noninferiority trial to compare standard therapy for treatment of fluoroquinolone-susceptible, rifampin-resistant tuberculosis to five nine-month oral regimens, including combinations of bedaquiline (B), delamanid (D), linezolid (L), levofloxacin (Lfx) or moxifloxacin (M), clofazimine (C), and pyrazinamide (Z). A total of 754 participants were randomly assigned to one of five combinations or standard therapy; 699 were included in the modified intention-to-treat analysis and 562 were included in the per-protocol analysis. The primary end point was a favorable outcome at week 73, defined by two negative sputum culture results or favorable bacteriologic, clinical, and radiologic evolution. The noninferiority margin was −12 percentage points. The researchers found that 80.7 percent of the patients in the standard-therapy group had favorable outcomes in the modified intention-to-treat analysis. In the modified intention-to-treat population, the risk difference between standard therapy and each of the four new regimens was noninferior: 9.8, 8.3, 4.6, and 2.5 percentage points for BCLLfxZ, BLMZ, BDLLfxZ, and DCMZ, respectively. In the per-protocol population, the differences were similar, apart from DCMZ, which was not noninferior. Across the regimens, the proportion of participants with grade 3 or higher adverse events was similar. "The results of this trial support the noninferior efficacy of three all-oral shortened regimens for the treatment of rifampin-resistant tuberculosis," the authors write. Two authors disclosed ties to the biopharmaceutical industry. Abstract/Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

临床3期临床结果

2024-12-23

·药筛

先为达伊诺格鲁肽上市申请（12.16-12.22）

统计每周新药申报、上市申请（12.16-12.22） 1、新药上市申请获批药品名称企业名称类型受理号注射用牛肺表面活性剂Lyomark Pharma GmbH5.1JXHS2400029磷酸盛格列汀片盛世泰科生物医药技术（苏州）股份有限公司;南京海纳制药有限公司1CXHS2300023 注：灰色字体部分受理号结论为不批准。 2、新药上市申请受理药品名称企业名称类型受理号布西珠单抗注射液Novartis Pharma Schweiz AG2.2JXSS2400111布西珠单抗注射液Novartis Pharma Schweiz AG2.2JXSS2400112氟替美维吸入粉雾剂GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND5.1JXHS2400115氟替美维吸入粉雾剂GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND5.1JXHS2400116氯法齐明软胶囊Dong-A ST Co., Ltd.5.2JYHS2400065仁术健胃颗粒南京中山制药有限公司1.1CXZS2400037盐酸卡马替尼片Novartis Pharma Schweiz AG5.1JXHS2400114盐酸卡马替尼片Novartis Pharma Schweiz AG5.1JXHS2400113伊诺格鲁肽注射液杭州先为达生物科技股份有限公司;美药星（南京）制药有限公司1CXSS2400140伊诺格鲁肽注射液杭州先为达生物科技股份有限公司;美药星（南京）制药有限公司1CXSS2400141伊曲莫德片EVEREST MEDICINES (SINGAPORE) PTE. LTD.5.1JXHS2400112 数据来源：摩熵医药用摩熵药筛小程序，随时随地查周报

申请上市上市批准

2024-12-23

·药筛

布比卡因脂质体仿制不批准，久安肾上腺素注射液（预充式）上市申请 | 仿制药周报（12.16-12.22）

统计每周仿制药一致性评价申报、上市申请（12.16-12.22） 1、仿制药上市申请获批药品名称企业名称类型受理号氨溴特罗口服溶液海门普适医药有限公司3CYHS2302491布比卡因脂质体注射液浙江圣兆药物科技股份有限公司;杭州澳亚生物技术股份有限公司3CYHS2403649布比卡因脂质体注射液浙江圣兆药物科技股份有限公司;杭州澳亚生物技术股份有限公司3CYHS2403648复合磷酸氢钾注射液仁合益康汇泽药业河北有限公司;河北仁合益康药业有限公司3CYHS2400682黄体酮注射液北京布霖生物科技有限公司;华夏生生药业（北京）有限公司3CYHS2301078黄体酮注射液华夏生生药业（北京）有限公司3CYHS2301003甲硝唑凝胶江苏晨牌邦德药业有限公司4CYHS2301950硝普钠注射液南京泽恒医药技术开发有限公司;天津金耀药业有限公司3CYHS2301878盐酸环喷托酯滴眼液沈阳兴齐眼药股份有限公司4CYHS2303317盐酸肾上腺素注射液马鞍山丰原制药有限公司3CYHS2400756乙酰半胱氨酸注射液合肥国药诺和药业有限公司;国药集团国瑞药业有限公司3CYHS2400493乙酰半胱氨酸注射液福安药业集团庆余堂制药有限公司3CYHS2301671 注：灰色字体部分受理号结论为不批准。 2、一致性评补充申请获批药品名称企业名称类型醋酸泼尼松片安徽金太阳生化药业有限公司CYHB2450402甲硝唑片湖北省宏源药业科技股份有限公司;湖北同德堂药业有限公司CYHB2350652聚普瑞锌颗粒吉林省博大伟业制药有限公司CYHB2350908硫酸阿米卡星注射液浙江诚意药业股份有限公司CYHB2350563尼可地尔片天方药业有限公司CYHB2450242维生素B6片山西亨瑞达制药有限公司CYHB2150625盐酸丁螺环酮片北大医药股份有限公司CYHB2350812盐酸丁螺环酮片北大医药股份有限公司CYHB2350813盐酸二甲双胍肠溶胶囊北京圣永制药有限公司CYHB2350790盐酸二甲双胍肠溶胶囊北京圣永制药有限公司CYHB2350789盐酸伐昔洛韦片湖北广济药业股份有限公司CYHB2450037注射用哌拉西林钠他唑巴坦钠海口奇力制药股份有限公司CYHB2350895注射用哌拉西林钠他唑巴坦钠海口奇力制药股份有限公司CYHB2350897注射用哌拉西林钠他唑巴坦钠海口奇力制药股份有限公司CYHB2350896注射用头孢哌酮钠舒巴坦钠(2:1)广东金城金素制药有限公司CYHB2350849注射用头孢哌酮钠舒巴坦钠(2:1)广东金城金素制药有限公司CYHB2350848注射用头孢他啶苏州二叶制药有限公司CYHB2350861注射用头孢他啶苏州二叶制药有限公司CYHB2350860注射用头孢他啶苏州二叶制药有限公司CYHB2350859注射用头孢西丁钠浙江惠迪森药业有限公司CYHB2350845注射用头孢西丁钠浙江惠迪森药业有限公司CYHB2350846 注：灰色字体部分受理号结论为不批准。 3、新增仿制药上市申请药品名称企业名称类型受理号阿法骨化醇软胶囊南京海鲸药业股份有限公司4CYHS2404441阿法骨化醇软胶囊南京海鲸药业股份有限公司4CYHS2404443他达拉非片珠海联邦制药股份有限公司中山分公司4CYHS2404459甲磺酸沙非胺片南京正大天晴制药有限公司4CYHS2404454枸橼酸西地那非片广东培杰药物研究有限公司;江苏永安制药有限公司4CYHS2404446枸橼酸氢钾钠颗粒成都恒瑞制药有限公司4CYHS2404449盐酸伐昔洛韦片浙江车头制药股份有限公司;杭州领业医药科技有限公司4CYHS2404440他达拉非片珠海联邦制药股份有限公司中山分公司4CYHS2404458碘[131I]化钠口服溶液广东君奇医药科技有限公司3CYHS2404438玻璃酸钠滴眼液江苏福邦药业有限公司4CYHS2404460阿法骨化醇软胶囊南京海鲸药业股份有限公司4CYHS2404444维生素B6注射液江西远超医药科技有限公司;朗天药业（湖北）有限公司3CYHS2404453他达拉非片珠海联邦制药股份有限公司中山分公司4CYHS2404457注射用硫酸艾沙康唑湖南科伦制药有限公司4CYHS2404461甲磺酸沙非胺片南京正大天晴制药有限公司4CYHS2404455比索洛尔氨氯地平片江苏德源药业股份有限公司4CYHS2404456枸橼酸西地那非片广东培杰药物研究有限公司;江苏永安制药有限公司4CYHS2404448甲磺酸沙非胺片石家庄四药有限公司4CYHS2404435恩他卡朋双多巴片（Ⅱ）浙江京新药业股份有限公司4CYHS2404442重酒石酸去甲肾上腺素注射液山西普恒制药有限公司3CYHS2404450枸橼酸西地那非片广东培杰药物研究有限公司;江苏永安制药有限公司4CYHS2404447双氯芬酸钠肠溶片四川天德制药有限公司4CYHS2404451复合磷酸氢钾注射液内蒙古白医制药股份有限公司3CYHS2404445依折麦布阿托伐他汀钙片（II）重庆圣华曦药业股份有限公司4CYHS2404452丁溴东莨菪碱注射液广东博卓医药科技有限公司;烟台鲁银药业有限公司4CYHS2404439盐酸溴己新口服溶液河北汇德旭盛医药科技有限公司;石家庄科仁医药科技有限公司3CYHS2404428注射用乳糖酸红霉素广东态森德制药有限公司;广东星昊药业有限公司3CYHS2404422盐酸溴己新口服溶液河北汇德旭盛医药科技有限公司;石家庄科仁医药科技有限公司3CYHS2404429双氯芬酸依泊胺贴杭州端本医药科技有限公司;南京海纳制药有限公司3CYHS2404427尼莫地平口服溶液江苏联环药业股份有限公司3CYHS2404430注射用磷酸特地唑胺吉林津升制药有限公司4CYHS2404420美阿沙坦钾片合肥立方制药股份有限公司4CYHS2404425甲磺酸沙非胺片石家庄四药有限公司4CYHS2404436美阿沙坦钾片合肥立方制药股份有限公司4CYHS2404426盐酸氮卓斯汀滴眼液江西马应龙美康药业有限公司;浙江尖峰药业有限公司4CYHS2404424注射用氟氧头孢钠四川制药制剂有限公司;浙江惠迪森药业有限公司4CYHS2404423盐酸尼卡地平注射液江西东抚制药有限公司4CYHS2404434甲磺酸沙非胺片四川科伦药业股份有限公司4CYHS2404431甲磺酸沙非胺片四川科伦药业股份有限公司4CYHS2404432尼莫地平口服溶液江苏联环药业股份有限公司3CYHS2404433盐酸赛庚啶口服溶液苏州华健瑞达医药技术有限公司;浙江京新药业股份有限公司3CYHS2404421苯磺贝他斯汀口崩片漯河市汇创医药有限公司;裕松源药业有限公司3CYHS2404404非奈利酮片天地恒一制药股份有限公司4CYHS2404406重酒石酸去甲肾上腺素注射液浙江尚科生物医药有限公司3CYHS2404416富马酸伏诺拉生片重庆世森医药科技有限公司;烟台鲁银药业有限公司4CYHS2404409比索洛尔氨氯地平片浙江百代医药科技有限公司;浙江赛默制药有限公司4CYHS2404419硫酸镁注射液江苏润恒制药有限公司3CYHS2404413卡泊三醇搽剂福元药业有限公司4CYHS2404415钆特醇注射液河北仁合益康药业有限公司4CYHS2404414环索奈德吸入气雾剂上海上药信谊药厂有限公司3CYHS2404405头孢克肟颗粒广东华南药业集团有限公司;金鸿药业股份有限公司3CYHS2404410倍他米松磷酸钠注射液河南利华制药有限公司;河南润弘制药股份有限公司3CYHS2404411吸入用盐酸丙卡特罗溶液合肥国药诺和药业有限公司;江苏大红鹰恒顺药业有限公司3CYHS2404418硫酸镁注射液江苏润恒制药有限公司3CYHS2404412富马酸伏诺拉生片重庆世森医药科技有限公司;烟台鲁银药业有限公司4CYHS2404408布美他尼注射液云南华派医药科技有限公司;楚雄和创药业有限责任公司3CYHS2404407吸入用盐酸丙卡特罗溶液合肥国药诺和药业有限公司;江苏大红鹰恒顺药业有限公司3CYHS2404417盐酸布比卡因注射液湖北津药药业股份有限公司3CYHS2404387阿昔莫司胶囊河北锐健医药科技有限公司;淄博万杰制药有限公司4CYHS2404391聚乙二醇4000散（儿童型）郑州泰丰制药有限公司3CYHS2404390熊去氧胆酸片中山百灵生物技术股份有限公司;安士制药（中山）有限公司3CYHS2404398小儿法罗培南钠颗粒广东九明制药有限公司4CYHS2404389阿贝西利片齐鲁制药有限公司4CYHS2404403盐酸奥洛他定滴眼液武汉新瑞医药科技有限公司;武汉五景药业有限公司4CYHS2404399盐酸尼卡地平注射液浙江花园药业有限公司4CYHS2404394培哚普利氨氯地平片（III）浙江华海药业股份有限公司4CYHS2404395夫西地酸乳膏西藏奥斯必秀医药有限公司;浙江康恩贝制药股份有限公司4CYHS2404386阿贝西利片齐鲁制药有限公司4CYHS2404402苯磺酸氨氯地平口服溶液四川奥邦古得药业有限公司;南京海纳制药有限公司3CYHS2404396盐酸伐地那非口崩片哈尔滨三联药业股份有限公司3CYHS2404392异氟烷福建海西联合药业有限公司4CYHS2404388盐酸丙卡特罗颗粒四川大冢制药有限公司3CYHS2404400格拉司琼透皮贴片杭州朱养心药业有限公司4CYHS2404393阿贝西利片齐鲁制药有限公司4CYHS2404401硫酸羟氯喹片珠海润都制药股份有限公司4CYHS2404397氢溴酸替格列汀片常州千红生化制药股份有限公司4CYHS2404378达格列净二甲双胍缓释片（Ⅰ）南通联亚药业股份有限公司4CYHS2404362替米沙坦氨氯地平片江苏百佑药业有限公司;山东丰金生物医药有限公司4CYHS2404374托吡酯片山东新时代药业有限公司4CYHS2404365阿托伐他汀钙片浙江江北药业有限公司4CYHS2404379吸入用盐酸丙卡特罗溶液石家庄四药有限公司3CYHS2404384夫西地酸乳膏广东科泓药业有限公司4CYHS2404370醋酸特利加压素注射液武汉华龙生物制药有限公司3CYHS2404363恩格列净二甲双胍缓释片山东力诺制药有限公司;重庆博腾药业有限公司3CYHS2404372肾上腺素注射液（预充式）武汉久安药物研究院有限公司;武汉久安药业有限公司3CYHS2404369硫代硫酸钠注射液赤峰源生药业有限公司3CYHS2404371氧氟沙星滴耳液江苏宝东医药科技有限公司;知和（山东）大药厂有限公司4CYHS2404382马来酸曲美布汀片浙江诺得药业有限公司3CYHS2404381氯法齐明软胶囊Dong-A ST Co., Ltd.5.2JYHS2400065复方电解质醋酸钠注射液浙江高跖医药科技股份有限公司;浙江赛默制药有限公司3CYHS2404375氨酚羟考酮片北京华素制药股份有限公司3CYHS2404364托吡酯片山东新时代药业有限公司4CYHS2404366妥布霉素滴眼液江苏宝东医药科技有限公司;知和（山东）大药厂有限公4CYHS2404383盐酸头孢卡品酯颗粒苏州盛达药业有限公司;苏州第三制药厂有限责任公司4CYHS2404377阿托伐他汀钙片浙江江北药业有限公司4CYHS2404380阿仑膦酸钠口服溶液湖北欣泽霏药业有限公司3CYHS2404385恩格列净二甲双胍缓释片山东力诺制药有限公司;重庆博腾药业有限公司3CYHS2404373盐酸溴己新口服溶液湖北民康药业集团有限公司;南京海纳制药有限公司3CYHS2404367依折麦布阿托伐他汀钙片（Ⅱ）浙江昂利康制药股份有限公司4CYHS2404376盐酸溴己新口服溶液湖北民康药业集团有限公司;南京海纳制药有限公司3CYHS2404368 4、新增一致性评价补充申报药品名称企业名称受理号盐酸吡格列酮分散片双鹤天安药业（贵州）股份有限公司CYHB2450619地高辛片上海上药信谊药厂有限公司CYHB2450620甲硝唑片贵州百灵企业集团制药股份有限公司CYHB2450618头孢克肟胶囊海南日中天制药有限公司CYHB2450613地塞米松磷酸钠注射液广州白云山天心制药股份有限公司CYHB2450616法莫替丁注射液国药集团容生制药有限公司CYHB2450615阿司匹林肠溶片广东彼迪药业有限公司CYHB2450617头孢克肟胶囊海南日中天制药有限公司CYHB2450614 数据来源：摩熵医药用摩熵药筛小程序，随时随地查周报

一致性评价上市批准

100 项与氯法齐明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00278	氯法齐明	J04BA01	DB00845

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
麻风	美国	Novartis Pharmaceuticals Corp.	1986-12-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
非结核分枝杆菌感染	临床3期	美国	MannKind Corp.	2024-09-11
肺部疾病	临床申请批准	日本	MannKind Corp.	-

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02589782 (TB-PRACTECAL, Pubmed) 人工标引	临床2/3期	广泛耐药结核病	552	rifampicin (Standard care)	鹽醖觸範糧選積淵顧廠(築鹹觸壓蓋選網齋齋餘) = 廠鬱蓋構築醖夢顧鹹範獵鏇醖積窪製膚醖築蓋 (餘醖廠網衊壓糧廠簾餘 ) 更多	积极	2024-02-01
				rifampbedaquilinepretomanidlinezolidmoxifloxacin (BPaLM)	鹽醖觸範糧選積淵顧廠(築鹹觸壓蓋選網齋齋餘) = 糧積選選衊襯鹹願夢蓋獵鏇醖積窪製膚醖築蓋 (餘醖廠網衊壓糧廠簾餘 ) 更多
NCT03561753 (Pubmed)	临床4期	肺结核	93	Short-course regimen	範衊膚膚鏇淵遞獵顧艱(憲觸鹽願鹽窪鏇鑰獵鏇) = 16/17 衊膚齋顧淵齋壓顧鹹獵 (夢鹽鑰壓簾願獵繭積積 )	-	2023-03-06
				Standard regimen
ATS2022	N/A	非结核分枝杆菌感染	-	Clofazimine	廠積範窪窪襯齋遞鹽簾(簾鑰膚繭齋夢襯鬱顧顧) = 餘構觸鏇鑰積構選衊鑰齋餘遞鏇窪夢蓋壓膚蓋 (淵淵襯衊襯製窪積餘鏇 ) 更多	-	2022-05-15
NCT03341767 (Pubmed) 人工标引	临床2期	隐孢子虫病 \| HIV感染	-	Clofazimine	鏇簾遞衊廠鏇鏇鹹廠顧(醖鹹鹹顧積襯築淵顧遞) = The most frequent solicited adverse effects were diarrhea, abdominal pain, and malaise. 淵窪構糧餘繭襯醖顧願 (鹹鬱獵願齋遞夢艱襯衊 ) 更多	不佳	2021-07-15
				Placebo
ERS2015	N/A	耐多药结核病	105	Cfz therapy group	願廠繭構廠範鬱鬱鏇鏇(積觸製獵齋鹽艱膚選繭) = 47.2% 餘襯網壓鏇鹹鹽餘鑰憲 (衊壓膚願簾願獵獵窪範 ) 更多	积极	2015-09-01
				Clofazimine
ERS2013	N/A	耐多药结核病	32	Clofazimine	壓蓋製糧鹽構鹹衊鬱顧(窪積衊構鹹鏇構齋網獵) = Skin discoloration occurred in all patients and nine patients stopped clofazimine treatment due to adverse effects: skin discolorization(n=3), liver toxicity(n=3), and gastrointestinal disturbance(n=3) 願鹹鏇範糧繭構艱憲憲 (壓齋糧鹽壓網獵衊顧憲 )	不佳	2013-09-01
ERS2013	N/A	耐多药结核病	92	Clofazimine therapy	夢醖選鑰鹽齋願鑰鹽齋(簾願艱廠夢築觸鏇醖鬱) = ichthyosis occurred in 40 patients of clofazimine therapy group 壓製繭襯夢觸憲夢製糧 (網範窪艱繭壓蓋網齋範 ) 更多	积极	2013-09-01
				Clofazimine