普托马尼(Pretomanid) - 药物靶点：CYP2C19 x CYP2C8_在研适应症：耐药结核病，多重耐药性肺结核，耐多药结核病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Pretomanid (USAN/INN)、普瑞玛尼、PA 824

+ [5]

靶点

CYP2C19 x CYP2C8

作用方式

抑制剂、供体

作用机制

CYP2C19 inhibitors(cytochrome P450 family 2 subfamily C member 19 inhibitors)、CYP2C8抑制剂(cytochrome P450 family 2 subfamily C member 8 inhibitors)、细胞壁抑制剂

治疗领域

感染呼吸系统疾病

在研适应症

耐药结核病多重耐药性肺结核耐多药结核病+ [3]

非在研适应症

原研机构

在研机构

Global Alliance for TB Drug Development

+ [5]

非在研机构-

权益机构

MacLeods Pharmaceuticals Ltd.Beatrice Korea Co., Ltd.

Global Alliance for TB Drug Development

+ [5]

最高研发阶段批准上市

首次获批日期

美国 (2019-08-14),

广泛耐药结核病结核

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、孤儿药 (韩国)、孤儿药 (澳大利亚)

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结构/序列

分子式C14H12F3N3O5

InChIKeyZLHZLMOSPGACSZ-NSHDSACASA-N

CAS号187235-37-6

关联

43

项与普托马尼相关的临床试验

NCT07126639

/ Not yet recruitingN/AIIT

A Study on the Short-course Treatment Regimen Containing Pretomanid for Drug-resistant Tuberculosis

Rifampicin-resistant tuberculosis (RR-TB) is characterized by a long treatment course, high incidence of adverse reactions, low cure rate and high recurrence rate. This is related to the large number of drugs in the RR-TB treatment regimen, high incidence of adverse reactions and long treatment course, which leads to poor patient compliance. There is an urgent need for new, effective and safe short-course regimens for drug-resistant tuberculosis. A 6-month short-course oral regimen containing pretomanid was introduced in 2020. However, as pretomanid is not yet available in China, it has not been verified and promoted in China. Pretomanid is expected to be launched in China in 2025, and it is urgent to evaluate the application of the new short-course regimen containing pretomanid in the Chinese population. This study is a prospective, randomized, controlled clinical trial. It plans to include RR-TB patients aged ≥12 years in multiple domestic centers. Under the guidance of rapid molecular drug susceptibility test results, the experimental group will be treated with bedaquiline, pretomanid, linezolid and moxifloxacin for 6 months, while the control group will be treated with bedaquiline, delamanid, linezolid and levofloxacin or bedaquiline, delamanid, linezolid and clofazimine for 6 months, depending on the susceptibility to fluoroquinolones. For patients with unknown susceptibility to fluoroquinolones, bedaquiline, delamanid, linezolid, levofloxacin and clofazimine will be used for 6 months. The efficacy and safety will be evaluated to provide a basis for the introduction and implementation of new short-course regimens for RR-TB in China.

开始日期2025-09-01

申办/合作机构-

NCT06441006

/ Not yet recruiting临床2/3期IIT

Program for Rifampicin-Resistant Disease With Stratified Medicine for Tuberculosis (PRISM-TB)

PRISM-TB is an international, seamless, multicenter, open-label, randomized, controlled, pragmatic, stratified medicine, treatment shortening, multi-arm multi-stage (MAMS), noninferiority Phase 2/3 clinical trial for fluoroquinolone-susceptible multidrug-resistant/rifampin-resistant pulmonary tuberculosis (FQ-S MDR/RR-TB). In Stage 1, participants will be randomized among one of three treatment arms (one control and two experimental). Following the interim analysis (at the end of Stage 1) based on DOOR outcome comparisons and the entirety of the data, one of the four possible experimental strategies will be identified and continue into Stage 2. In Stage 2, participants will be randomized among one of two treatment arms (one control and one experimental).
The trial objective is to identify, among participants with fluoroquinolone-susceptible multidrug-resistant/rifampicin-resistant tuberculosis (FQ-S MDR/RR-TB), the preferred BPaLM strategy of 13 or 17 weeks for participants stratified to receive shorter treatment and 17 or 24 weeks for participants stratified to receive longer treatment, as defined by a prespecified stratification algorithm, and to evaluate whether this BPaLM strategy has noninferior efficacy to the control strategy at Week 73.

开始日期2025-09-01

申办/合作机构

The University of California, San Francisco

[+1]

CTRI/2025/03/082318

/ RecruitingN/A

A Phase I, Non-Randomized, Open-Label, Single-Dose Study Comparing the Pharmacokinetics, Safety, and Tolerability of Pretomanid Tablets 200 mg in Subjects with Moderate and Severe Hepatic Impairment Relative to Matched Control Subjects with Normal Hepatic Function. - Nil

开始日期2025-04-18

申办/合作机构

Mylan Laboratories Ltd.

[+1]

100 项与普托马尼相关的临床结果

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100 项与普托马尼相关的转化医学

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100 项与普托马尼相关的专利（医药）

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655

项与普托马尼相关的文献（医药）

2025-12-01·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Validation and clinical application of an LC-MS/MS method designed to simultaneously measure seven second-line TB drugs and two metabolites in human lung tissue

Article

作者: Wiesner, Lubbe ; Pooran, Anil ; van der Merwe, Marthinus ; Foster, Katie Kriegler ; Zangenberg, Edda ; Dheda, Keertan ; Joubert, Anton ; Castel, Sandra

We developed and validated a novel bioanalytical method for the simultaneous quantification of levofloxacin, linezolid, moxifloxacin, delamanid, bedaquiline, clofazimine, and pretomanid, along with the metabolites of delamanid (DM-6705) and bedaquiline (N-desmethyl-bedaquiline, M2), in human lung tissue samples. Following homogenization by bead beating and extraction by protein precipitation, the analytes were separated on an Agilent 1260 Infinity II HPLC system using a Poroshell 120 C18 EC (2.1 mm×50 mm, 2.7 µm) column with gradient elution, applying a mobile phase consisting of 0.1 % formic acid in water and 0.1 % formic acid in a mixture of acetonitrile and methanol. Detection and quantification of the analytes and their stable isotope labelled internal standards were performed on a Sciex API 5500 QTrap mass spectrometer using positive electrospray ionization and multiple reaction monitoring. Validation according to the guidelines of the FDA and EMA proved the method to be precise, accurate, and robust with no significant influence of matrix components. The application of the method to the analysis of clinical samples demonstrated the feasibility of quantifying the second-line anti-tuberculosis drugs in human lung tissue and the potential to provide insights into the drug distribution across the infection sites in the lung.

2025-09-01·MICROBIAL PATHOGENESIS

Application of antimicrobial drugs in Mycobacterium tuberculosis and research progress

Review

作者: Liu, Guihua ; Wang, Ying ; Cao, Daxing

Treatment regimens for Tuberculosis (TB) primarily rely on first-line drugs such as isoniazid, rifampicin, ethambutol, and pyrazinamide. Although these drugs have been pivotal in the treatment of drug-resistant tuberculosis, their high costs limit widespread use in low- and middle-income countries. However, the emergence of multidrug-resistant TB and extensively drug-resistant TB necessitates the development of new anti-TB drugs and therapeutic strategies. In terms of treatment, new drugs such as bedaquiline, delamanid, and pretomanid have shown significant efficacy against MDR-TB and XDR-TB. Combination therapies have substantially improved cure rates and reduced treatment duration. Despite these advancements, drug resistance and adverse effects remain substantial challenges. Understanding the resistant genes and biochemical mechanisms of M. tuberculosis, developing drugs that disrupt its biofilms, optimizing drug combinations, and personalizing treatments are crucial for reducing tuberculosis mortality and controlling its spread, thus achieving WHO's goal of global tuberculosis eradication. Future research should focus on improving drug accessibility and affordability, and making significantly contributions to global public health goals.

2025-09-01·EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY

Pretomanid can significantly increase plasma rivaroxaban concentrations—a case report

Article

作者: Chikura, Teurai ; Chin, Paul Ken Leong ; McCrostie, Sarah ; Fan, Dali

BACKGROUND:

Rivaroxaban, a direct factor Xa inhibitor, is an oral anticoagulant used in the prevention and treatment of thromboembolic disease. The clearance of rivaroxaban involves excretion unchanged via the kidneys where it is subject to active secretion into the renal tubules, involving P-glycoprotein (P-gp) and organic anion transporter 3 (OAT3). Pretomanid, a nitroimidazole antibiotic used for multidrug-resistant tuberculosis (MDR-TB), is an OAT3 inhibitor based on in vitro data. This case report describes a "natural experiment" involving rivaroxaban concentration monitoring. It entails a novel pharmacokinetic interaction between rivaroxaban and pretomanid in a 61-year-old male undergoing MDR-TB treatment.

RESULT:

Following pretomanid initiation, rivaroxaban trough plasma concentration increased more than two-fold, prompting a halving of rivaroxaban dose, and subsequent restoration of trough concentration to pre-pretomanid value.

DISCUSSION:

This interaction appears to be mediated by pretomanid inhibition of OAT3, which reduces renal clearance of rivaroxaban. Other components of MDR-TB regimen and pre-existing medications are unlikely to be contributory based on their pharmacokinetic profiles.

CONCLUSION:

This case highlights the potential impact of drug interactions involving pretomanid and known OAT3 perpetrators on the pharmacokinetics of rivaroxaban and other OAT3 substrates, particularly those of low therapeutic index, such as methotrexate. Given the global rise in MDR-TB, further research into pretomanid as a perpetrator of drug interactions is warranted.

58

项与普托马尼相关的新闻（医药）

2025-06-27

·ETPharma

Plans to restrict open market access to tuberculosis medicines

With cases of drug-resistant tuberculosis on the rise in India, authorities are set to tighten open market access to newer anti-TB drugs Bedaquiline and Delamanid , which went off patent last year. The Central TB division-which is under the health ministry-had written to the Central Drugs Standard Control Organisation (CDSCO) citing "access risks" that are leading to indiscriminate use, potentially increasing cases of treatment failure and resistance to these drugs. The patents for Bedaquiline and Delamanid expired last year, paving the way for pharmaceutical companies to manufacture the molecule. The drugs eventually became available in the market. The newer anti-TB drugs, including Bedaquiline, Delamanid, Pretomanid and Rifapentine, are available in the market. This week, the matter was taken up by the Drugs Consultative Committee (DCC), an expert committee under the CDSCO, which suggested that licences be issued on the condition that the use of Bedaquiline, Delamanid, Pretomanid and Rifapentine will be as per Standards of TB Care in India (STCI), and that there should be conditional access through the National TB Elimination programme (NTEP). The experts also said that if such a condition is not mentioned in the existing licences, it should be modified accordingly. It also said the label on the container of the drug, as well as the packaging, should bear the warning-"For use in NTEP", which shall be in a box with a red background. "The DCC, after detailed deliberation, agreed with the proposal to issue suitable guidance to all state licensing authorities to address the issue uniformly. The DCC also recommended that in case some SLAs had already issued the manufacturing licence for such a product, they can issue separate letters for communicating the above conditions," the minutes of the meeting suggested. By Teena Thacker ,

2025-04-24

·PRNewswire

Price of Key DR-TB Medicine Drops 25% as TB Alliance's Multi-Manufacturer Strategy Expands Access

TB Alliance's third licensed manufacturer makes pretomanid available through the Global Drug Facility, further improving affordability and access NEW YORK, April 24, 2025 /PRNewswire/ -- TB Alliance applauds a new milestone in the fight against drug-resistant tuberculosis (DR-TB): a 25% price reduction for pretomanid, a key component of the BPaL/M regimens. Pretomanid is now available through the Global Drug Facility (GDF) at just $169 per treatment course—less than $1 per day, a key pricing benchmark identified by the global TB advocacy community. This latest price drop—down from $364 upon pretomanid's initial approval in 2019, and down further from $224 in October 2024—reflects ongoing efforts by TB Alliance and its partners to broaden access and improve affordability through a multi-manufacturer approach to access. TB Alliance, a nonprofit organization that developed pretomanid, has pioneered an innovative access model by partnering with multiple quality-assured manufacturers. This strategy helped launch pretomanid at an initial low price and ensured rapid, sustainable, and affordable access across high-TB burden countries. Simultaneously, by enabling healthy competition and fostering multiple high-quality supply sources, TB Alliance's strategy expanded availability while driving down costs. "This progress demonstrates how thoughtful collaboration and planning can translate into real-world impact," said Dr. Mel Spigelman, President and CEO of TB Alliance. "By enabling multiple high-quality producers to supply this medicine, we're fostering a healthy and sustainable market to deliver on our mandate that the life-saving medicines we develop will be adopted, available, and affordable to all those in need. We're grateful to partners such as Lupin and GDF for their shared commitment to supplying the market with life-saving TB medicines and stand committed to working with all our manufacturing partners to ensure equitable and affordable access." The current GDF price reduction, led by Lupin Limited, represents a crucial step in delivering on this vision. Procurement through GDF will save an estimated $37 million annually according to The Stop TB Partnership, the organization responsible for managing GDF, allowing for the treatment of an additional 120,000 people with DR-TB. Together with recent price reductions for the other regimen components, the cost of a full BPaL/M treatment course has dropped to a new low of $310—less than $2 per day, and a 47% reduction from its December 2022 price. BPaL/M is a six-month treatment recommended by the World Health Organization to treat most forms of DR-TB. It consists of bedaquiline (B), pretomanid (Pa), and linezolid (L), with or without moxifloxacin (M). In 2024 alone, approximately 110,000 courses of pretomanid were ordered across the world—enough to treat more than 60% of the global market for DR-TB treatment, perhaps the fastest ever scale up for a new TB medicine in modern times. "Lupin is proud to collaborate with TB Alliance and the Global Drug Facility to make pretomanid, an essential medicine in the fight against multidrug-resistant TB, more accessible and affordable for TB patients across the globe," said Ramesh Swaminathan, Global CFO, Executive Director, Head of API Plus SBU at Lupin. "The recent price reduction reflects our strong and deep-rooted commitment to delivering high-quality and affordable medicines to TB patients worldwide. Through this partnership, we reaffirm our dedication to patient-centric innovation and equitable access, ensuring that countries burdened by TB have the necessary treatment options they need to save lives and strengthen public health systems." "For years, advocates from the TB community have called for TB treatments that are not just effective, but also affordable for every person who needs them," said Olya Klymenko, Development Director of TBPeopleUkraine. "The full BPaL/M regimen now costing less than $2 per day is deeply meaningful. We express our gratitude to everyone who made this result possible. There really is no reason for governments and health systems around the world to not provide these treatments to every person who can benefit from them." TB Alliance remains committed to expanding its innovative access model to ensure new innovations in TB treatment reach all who need them as rapidly as possible. With additional planned future tenders, TB Alliance expects additional price reductions for pretomanid in the future. Beyond pricing strategies, TB Alliance continues to develop and execute innovative market access initiatives like LIFT-TB, SLASH-TB, and the PeerLINC Knowledge Hub to speed the global uptake, procurement, and implementation of shortened DR-TB treatments for all who need them around the world. About TB TB is a difficult infection to cure, requiring patients to take a combination of medicines for at least four to six months. Even after symptoms disappear, medicines still need to be taken so that all traces of the disease can be fully eradicated. The scope and intensity of TB globally is in large part fueled by antiquated and inadequate TB drugs. Novel drug regimens are urgently needed to bring the TB pandemic under control. About BPaL The BPaL regimen—which combines the antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L)—was first clinically studied by TB Alliance. Pretomanid, as part of the BPaL regimen, received its first regulatory approval in August 2019 for use against highly drug-resistant strains of TB. Previously, less than two-thirds of drug-resistant TB patients around the world had been successfully treated. Treatment options were limited, expensive, toxic, and lengthy – requiring patients to take more than 20 pills per day for 9-20 months. About TB Alliance TB Alliance is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight TB. Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. TB Alliance operates with support from Australia's Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, Foreign, Commonwealth and Development Office (United Kingdom), Cystic Fibrosis Foundation, Germany's Federal Ministry of Education and Research through KfW, Global Disease Eradication Fund (South Korea), Global Health Innovative Technology Fund, Irish Aid, Korea International Cooperation Agency, National Institute of Allergy and Infectious Diseases, South Korea's Ministry of Foreign Affairs, Unitaid, and the United States Agency for International Development. For more information, please visit: . Media Contact: Jess Wiggs at [email protected] SOURCE TB Alliance WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准

2025-04-20

·微信

头部药企研发投入公布！百济、恒瑞、复星、百利天恒…

编者按：本文来自药智网，作者白夜行；赛柏蓝授权转载，编辑yuki同花顺财经数据显示，2024年A股上市药企研发投入TOP10总计投入达387.73亿元，相比2023年的356.64亿元，同比增长9%。从榜单来看，TOP3企业的研发投入均超过50亿元，第一名高达143亿元。值得一提的是，2024年A股上市药企研发投入TOP10中，有5家企业实现研发投入同比正增长（4家增长超10%），其中百利天恒增长率最高（93%），从2023年约7亿元增长至2024年14亿元。表1 2024年A股上市药企研发投入TOP1001百济神州遥遥领先百济神州以19.53亿美元（约合人民币143亿元）的研发投入，成为2024年A股上市药企研发投入第一名，再次彰显了其在创新药研发领域的雄心与实力。2024年，百济神州共完成了将13个新分子实体推进临床开发阶段。预计在2025年，将于2025年上半年对BGB-43395（CDK4抑制剂）、BG-68501（CDK2抑制剂）和BG-C9074（B7H4 ADC）进行数据读出；预计将于2025年下半年取得多个项目的内部概念验证数据，包括：BG-60366（EGFR CDAC）、BGB-53038（泛KRAS抑制剂）等。图1 百济神州全球自主研发和合作管线在重点瘤种的深度布局上，百济神州展现了其在血液瘤和实体瘤领域的强大竞争力。泽布替尼2024年销售额达到26亿美元，同比大增105%，并获得多个新适应症批准；替雷利珠单抗2024全年销售额为6.21亿美元，同比增长16%。百济神州的国际化优势是其研发管线得以快速推进的重要保障，2024年，其海外收入占比超过60%。通过与诺华等国际药企的合作，百济神州不仅共享了资源和技术，还进一步拓展了市场渠道。这种全球化布局不仅提升了其研发效率，也为其产品进入欧美等高价值市场提供了保障。值得一提的是，2024年百济神州实现营收38亿美元，同比增长55%，净亏损持续收窄。尽管短期内仍面临盈利压力，但随着研发管线的逐步推进和明星产品的持续放量，百济神州有望在2025年实现经营利润为正。02恒瑞医药再创新高2024年，恒瑞医药以82.28亿元的研发投入，创下其历史新高。图2 恒瑞医药2015年—2024年研发投入（点击查看大图）这一年，恒瑞医药的研发管线布局呈现出多点开花、全面发力的态势，从肿瘤到代谢疾病，从免疫到呼吸系统疾病，恒瑞医药在多个领域都取得了显著的进展。2024年至今，恒瑞医药共获得了9项创新药的上市批准，其中包括4款1类创新药，如富马酸泰吉利定、夫那奇珠单抗等。在持续加大自主创新力度的同时，恒瑞医药也积极开展国际合作，通过BD授权交易等方式，将自主研发的创新药推向国际市场。2024年，恒瑞医药实现了多笔创新药海外授权合作，其中包括将GLP-1类创新药许可给美国Kailera公司，首付款加里程碑付款累计可高达60亿美元。在研管线方面，恒瑞医药涵盖了肿瘤、代谢及心血管疾病、免疫和呼吸系统疾病等多个治疗领域。截至2024年底，恒瑞医药共有18项上市申请获NMPA受理，90多个自主创新产品正在临床开发，约400项临床试验在国内外开展。未来三年，恒瑞医药预计有47项创新成果获批上市，其中包括HER2 ADC、GLP-1药物等重磅产品。临床试验方面也取得了显著的进展。2024年，恒瑞共取得创新药临床批件112个，24项临床推进至Ⅲ期，27项进入Ⅱ期，26项启动Ⅰ期临床试验。此外，恒瑞医药的多项临床试验获得了国家药监局的突破性治疗品种认定，以及美国FDA快速通道资格和EMA孤儿药认证。03复星医药重金押注2024年，复星医药以55.54亿元的研发投入，成为2024年A股上市药企研发投入第三名。其中，制药业务研发投入49.1亿元，占制药业务收入的16.98%。2024年，复星医药自主研发及许可引进的7个创新药/生物类似药共16项适应症获批上市，8个创新药/生物类似药进入上市前审批/关键临床阶段，共有18项创新药/生物类似药项目（按适应症计算）获批开展临床试验。图3 2024年复星医药研发投入情况在乳腺癌、胃癌等高发癌症领域，复星医药自主研发的单抗生物类似药汉曲优（注射用曲妥珠单抗）已成功在中国、欧盟、美国等50个国家和地区获批上市，并进入中国、英国等多个国家的医保目录。在非肿瘤领域，复星医药自主研发的冻干人用狂犬病疫苗（Vero细胞）、汉达远（阿达木单抗注射液）4项新增适应症以及许可引进普瑞尼（普托马尼片）、苏可欣（马来酸阿伐曲泊帕片）第二项适应症于中国境内获批。持续加大自主创新力度的同时，复星医药积极开展国际合作，通过BD授权交易等方式，将自主研发的创新药推向国际市场。2024年，复星医药实现了多笔创新药海外授权合作，其中包括将DAXXIFY（达希斐）引入中国市场，填补管线空白等。END内容沟通：郑瑶（13810174402）

抗体药物偶联物医药出海财报上市批准引进/卖出

100 项与普托马尼相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10722	普托马尼	J04	DB05154

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
耐药结核病	中国香港	上海复星高科技（集团）有限公司	2022-12-15
多重耐药性肺结核	韩国	Viatris, Inc.	2021-10-15
耐多药结核病	欧盟	Mylan IRE Healthcare Ltd.	2020-07-31
耐多药结核病	冰岛	Mylan IRE Healthcare Ltd.	2020-07-31
耐多药结核病	列支敦士登	Mylan IRE Healthcare Ltd.	2020-07-31
耐多药结核病	挪威	Mylan IRE Healthcare Ltd.	2020-07-31
广泛耐药结核病	美国	Mylan Ireland Ltd.	2019-08-14
结核	美国	Mylan Ireland Ltd.	2019-08-14

未上市

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适应症	最高研发状态	国家/地区	公司	日期
肺部感染	临床3期	南非	Global Alliance for TB Drug Development	2015-03-01
肺结核	临床3期	南非	Global Alliance for TB Drug Development	2015-03-01
利福平耐药结核病	临床1期	巴西	Global Alliance for TB Drug Development	2023-10-03
利福平耐药结核病	临床1期	印度	Global Alliance for TB Drug Development	2023-10-03
利福平耐药结核病	临床1期	南非	Global Alliance for TB Drug Development	2023-10-03
利福平耐药结核病	临床1期	泰国	Global Alliance for TB Drug Development	2023-10-03

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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


NCT02422524 (CTgov)	临床1期	肝功能不全 \| 结核	14	PA-824	鏇醖鑰鹹願憲壓壓壓製(構膚積醖積餘選網製選) = 獵繭衊膚遞顧糧蓋製顧壓範構鹹鏇繭壓齋廠鹽 (膚鑰鏇繭壓繭蓋鹽繭醖, 6410) 更多	-	2025-03-05
NCT04179500 (PaSEM, CTgov)	临床2期	多重耐药性肺结核 \| 耐多药结核病	26	BPaMZ (BPaMZ)	選窪獵製糧廠積築網蓋(鏇鏇繭遞選願網製齋鬱) = 網醖積憲簾淵壓淵壓憲蓋窪鹽餘繭積鑰鏇鹹憲 (獵鹹餘齋憲選製糧築醖, 97.3) 更多	-	2024-09-19
				moxifloxacin+bedaquiline+pyrazinamide (BPaMZ Baseline)	遞構願網蓋醖壓鬱醖衊(繭積膚鹹遞糧襯願築選) = 網夢顧願顧鹹鹽壓膚觸鬱膚蓋餘齋範鹽壓鏇範 (膚選鹽齋廠觸醖夢糧鹽, 窪膚鹹餘艱築願蓋鏇齋 ~ 艱選醖齋艱鹹鏇築簾廠) 更多
NCT03338621 (SimpliciTB, Pubmed \| Lancet Infect Dis)	临床2期	肺结核	455	Bedaquiline-pretomanid-moxifloxacin-pyrazinamide (BPaMZ) 4 months	衊獵遞膚衊糧鑰齋顧淵(憲窪壓遞齋艱繭積觸選) = three participants [1%] 夢膚齋願築製繭齋製積 (觸鏇衊繭壓鏇鏇積鹽製 ) 更多	积极	2024-09-01
NCT02589782 (TB-PRACTECAL, Pubmed) 人工标引	临床2/3期	广泛耐药结核病	552	rifampicin (Standard care)	糧鏇製淵範鹹製範夢築(觸願淵糧膚憲繭製鏇積) = 艱選膚憲遞顧壓醖獵夢衊觸鬱餘齋廠糧夢範蓋 (鹹夢窪鑰蓋夢醖齋衊醖 ) 更多	积极	2024-02-01
				rifampbedaquilinepretomanidlinezolidmoxifloxacin (BPaLM)	糧鏇製淵範鹹製範夢築(觸願淵糧膚憲繭製鏇積) = 淵網觸鬱醖顧繭膚鏇鏇衊觸鬱餘齋廠糧夢範蓋 (鹹夢窪鑰蓋夢醖齋衊醖 ) 更多
NCT03338621 (SimpliciTB, CTgov)	临床2/3期	多重耐药性肺结核 \| 耐多药结核病	455	ethambutol+rifampicin+isoniazid+pyrazinamide (Drug Sensitive-TB 2HRZE/4HR)	顧簾醖遞遞齋襯願築窪 = 鏇鹽衊鏇餘鬱壓顧獵顧壓獵鬱顧醖糧鏇憲網獵 (鏇鏇願鏇膚醖鑰觸淵製, 齋鑰選製醖蓋鑰壓鏇鹽 ~ 襯鹹網構網範夢遞範積) 更多	-	2023-11-08
				4BPaMZ (Drug Sensitive-TB 4BPaMZ)	顧簾醖遞遞齋襯願築窪 = 廠廠鹹鏇餘艱築遞築艱壓獵鬱顧醖糧鏇憲網獵 (鏇鏇願鏇膚醖鑰觸淵製, 範淵艱廠築廠鬱窪網窪 ~ 齋憲窪廠鑰膚憲繭醖廠) 更多
NCT02256696 (CTgov)	临床2期	肺结核	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	齋窪獵醖製觸夢夢網遞(窪鏇範鑰簾淵繭醖遞繭) = 齋夢廠觸獵構選糧製壓憲鬱繭簾餘憲簾顧遞襯 (範選窪醖範膚築餘鹽築, 範窪範襯築艱鑰襯選醖 ~ 窪夢遞簾憲蓋鹹淵觸廠) 更多	-	2023-07-18
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	齋窪獵醖製觸夢夢網遞(窪鏇範鑰簾淵繭醖遞繭) = 鏇齋構醖網壓鹹憲鬱鬱憲鬱繭簾餘憲簾顧遞襯 (範選窪醖範膚築餘鹽築, 艱顧鬱淵鑰構衊觸糧繭 ~ 窪憲積蓋壓築壓糧窪憲) 更多
NCT03086486 (ZeNix, CTgov)	临床3期	广泛耐药结核病 \| 肺结核 \| 肺部感染	181	Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200mg L x 26 Weeks + Pa + B)	遞餘襯網糧顧鑰遞膚衊(艱觸鏇鹽鬱膚憲繭壓鑰) = 窪築鑰簾餘蓋獵襯醖觸構繭夢鏇積鬱顧遞憲顧 (艱構鹽顧淵鏇艱鬱網顧, 襯醖憲糧醖願糧遞鬱醖 ~ 遞獵繭鹹鑰獵築製襯衊) 更多	-	2023-06-29
				Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200 mg L x 9 Weeks + Pa + B)	遞餘襯網糧顧鑰遞膚衊(艱觸鏇鹽鬱膚憲繭壓鑰) = 餘鬱壓製願齋觸製積襯構繭夢鏇積鬱顧遞憲顧 (艱構鹽顧淵鏇艱鬱網顧, 選衊夢蓋衊顧壓廠糧選 ~ 鬱觸蓋壓壓膚淵壓齋襯) 更多
NCT03086486 (ZeNix, Pubmed \| N Engl J Med)	临床3期	耐药结核病	181	Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 26 weeks	選遞齋鬱築膚築鑰廠夢(鏇網網窪製製觸獵衊齋) = the linezolid dose was modified (i.e., interrupted, reduced, or discontinued) in 51%, 30%, 13%, and 13% of participants who received bedaquiline-pretomanid-linezolid with linezolid at a dose of 1200 mg for 26 weeks or 9 weeks or 600 mg for 26 weeks or 9 weeks, respectively 餘齋醖觸築觸構襯顧繭 (憲糧醖選鬱簾顧選獵醖 ) 更多	积极	2022-09-01
				Bedaquiline-pretomanid-linezolid with linezolid 1200mg for 9 weeks
NCT02256696 (Pubmed \| Antimicrob Agents Chemother)	临床1期	结核	157	Pretomanid + Rifampin	艱襯醖鑰蓋積製鏇鏇鑰(夢襯襯顧積窪願觸夢獵) = 築餘顧壓選網築襯願窪鹽鏇窪鬱餘糧淵選窪範 (齋鏇窪壓憲鏇製鹹願餘 ) 更多	-	2021-01-20
				Pretomanid + Rifabutin	艱襯醖鑰蓋積製鏇鏇鑰(夢襯襯顧積窪願觸夢獵) = 艱壓襯鹽糧顧願製艱鏇鹽鏇窪鬱餘糧淵選窪範 (齋鏇窪壓憲鏇製鹹願餘 ) 更多
NCT03086486 (ZeNix, IAS2021)	N/A	结核	181	Bedaquiline (B)	選醖醖選獵艱簾製願繭(鏇網積鏇製廠製製鏇衊) = 壓餘鬱齋獵願網廠鬱築糧簾醖糧廠鬱製鹽齋淵 (壓遞網憲築艱網繭醖鏇 )	-	2021-01-01