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

肺部感染

原研机构

Novartis Pharma AG

在研机构

Mylan Ireland Ltd.Mylan IRE Healthcare Ltd.

Viatris, Inc.

+ [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

44

项与普托马尼相关的临床试验

NCT06441006

/ 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2025-11-01

申办/合作机构

The University of California, San Francisco

[+1]

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-

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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606

项与普托马尼相关的文献（医药）

2025-12-01·Current HIV/AIDS Reports

An Update on the Clinical Management of HIV and Tuberculosis Co-Infection in Pregnancy: TB Preventative Therapy, Long-Acting ARVs, and Bedaquiline-Based Regimens

Review

作者: Crocker-Buque, Tim ; Moso, Michael A ; Denholm, Justin T ; Singh, Kasha P

Abstract:

Purpose:

This update addresses HIV/TB co-infection management in pregnancy, focusing on new treatment options.

Recent Findings:

Pregnancy with HIV increases TB risk and worsens treatment outcomes. While long-acting antiretroviral therapies (LA-ART) like cabotegravir/rilpivirine and lenacapavir exist, data on their safety and efficacy in pregnant individuals are limited. Treating both HIV and TB is crucial, but pregnancy’s physiological changes complicate drug management. Standard ART and TB preventive therapy (TPT) with isoniazid are recommended after excluding active TB, despite some concerns about adverse outcomes when combined with ARV treatment. For active drug-resistant TB, the new 6-month BPaLM regimen (bedaquiline, pretomanid, linezolid, moxifloxacin) is not recommended in pregnancy due to limited safety data on pretomanid. Instead, a 9-month regimen is preferred, though bedaquiline and pretomanid are likely safe. More research on these new therapies in pregnant populations is needed.

Summary:

While standard ART remains the recommended approach for HIV/TB co-infection in pregnancy, further research is crucial to establish the safety and efficacy of newer LA-ART and bedaquiline-based TB regimens in this high-risk population. Concerns around the safety of TPT in pregnancy remain unanswered and further prospective research is urgently needed.

2025-11-01·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

Can 6-month long regimens become the standardized treatment for MDR-TB globally?

Review

作者: Bertoni, Francesca ; Davoli, Caterina ; Ciccarone, Andrea ; Rossi, Benedetta ; Matteelli, Alberto ; Rossi, Chiara ; Calamelli, Marina

Treatment for multidrug-resistant or rifampicin-resistant (MDR/RR) tuberculosis (TB) was traditionally long and poorly tolerated. In 2022, the World Health Organization recommended the first 6-month regimen (BPaLM), followed in 2025 by a second short-course option (BDLLfxC) with potential drastic improvement of treatment outcome. The BDLLfxC regimen addresses key gaps in target populations, including groups for whom BPaLM is not indicated: children of any age, adolescents, and pregnant and breastfeeding women. A key difference between the two regimens is the replacement of pretomanid with delamanid in the BDLLfxC. However, limitations remain. Neither BPaLM nor BDLLfxC are recommended in patients with complicated forms of extrapulmonary MDR-TB: central nervous system, osteoarticular, and disseminated disease. The problem is twofold: on one side, there are theoretical pharmacokinetic/pharmacodynamic reasons for lower concentrations of the active principles at these sites; on the other side, clinical experience is virtually absent in such cases. In this narrative review, we explore the use of 6-month regimens for MDR/RR-TB in specific populations-children, pregnant and breastfeeding women, people living with HIV, and those with challenging TB forms (e.g., central nervous system, bone, disseminated). The overall aim is to discuss how far we still are from the goal of a public health approach to the treatment of MDR-TB.

2025-10-01·The Indian journal of tuberculosis

Clinico-demographic profile of pre-extensively drug-resistant pulmonary tuberculosis patients in India

Article

作者: Kumar, Santosh ; Daniel, Bella Devaleenal ; Sridhar, Rathinam ; Padmapriyadarsini, Chandrasekaran ; Muthuvijayalakshmi, M ; Jeyadeepa, Bharathi ; Oswal, Vikas ; Prabhakaran, Rathinam ; Jaju, Jyoti ; Bhatnagar, Anuj ; Suryakant ; Vohra, Vikram ; Singla, Neeta ; Jain, Chetan Kumar ; Dave, Jigna ; Ramesh, Paranchi Murugesan ; Solanki, Rajesh ; Ramraj, Balaji ; Kumaravadivelu, Shanmugapriya ; Bhui, Namrata Kaur ; Vadgama, Parul

Drug-resistant tuberculosis (DR TB) is a major public health problem and an important area of research. Identification of various risk factors is essential for its prevention and management. Adults weighing more than 30 kg, aged 18 years or more diagnosed with pre extensively drug resistant TB (pre-XDR TB) were initiated on bedaquiline and linezolid based regimens along with pretomanid/delamanid as part of two multicentric clinical trials in India. Pre-XDR TB was defined as patients infected with M. tb strains resistant to rifampicin (may or may not be resistant to isoniazid) with additional resistance to fluoroquinolones and/or second line injectable as per the existing World Health Organization (WHO) definitions during the trial period. We describe here the baseline demographic and clinical profile of patients with pre-XDR TB and enrolled in those two trials. Of 554 Pre-XDR TB patients, 297 (54 %) were males. Median age (IQR) was 27 years [22.0-36.3] and body mass index was 17.4 [15.7-20.1] kg/m². Of all, 326 (59 %) had BMI <18.5 kg/m². History of previous episodes of TB was reported by 415 (75 %) patients. Among them, 142 (34 %) had taken treatment more than once, 279 (67 %) had treatment failure during the previous episodes. Persons with a known history of diabetes were 67 (12 %). Cough, cough with expectoration, fever and weight loss were the presenting complaints in 539 (97 %) and 487 (88 %), 337 (61 %) and 314 (57 %) respectively. Sputum smear microscopy showed more than ++ acid-fast bacilli in 264 (48 %). Chest x-ray showed bilateral lung involvement in 329 (60 %) with more than two zones involvement in 304 (55 %) and presence of cavities in 264 (48 %) patients. Persons in the younger age group, those with malnutrition and previous history of TB treatment were observed to be more in these cohort of patients with PreXDR TB. High rates of treatment failure during the earlier episodes of TB with increased disease severity and drug resistance during the current episode is a matter of grave concern. Improved treatment success during the management of drug sensitive TB, addressing the nutritional challenges are some of key areas of focus in the prevention of DRTB burden.

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）

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100 项与普托马尼相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D10722	普托马尼	J04	DB05154

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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

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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	遞淵構餘餘簾鑰繭築簾(鏇範鑰廠艱鏇獵壓壓繭) = 襯艱繭衊網壓鑰鬱築糧範簾繭願蓋鏇鹹蓋鏇網 (鹽膚艱艱鹹繭蓋築選鏇, 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)	選鬱繭製鑰餘窪築憲鑰(襯襯醖膚窪願鑰選製鏇) = 壓糧簾獵顧淵觸觸廠鹽襯鑰壓淵齋遞衊襯窪餘 (淵憲繭艱繭淵膚壓範壓, 97.3) 更多	-	2024-09-19
				moxifloxacin+bedaquiline+pyrazinamide (BPaMZ Baseline)	鬱鬱網遞願繭範淵獵範(範鏇餘鹽觸淵遞糧獵網) = 憲鏇膚觸襯憲餘繭獵範壓齋淵憲範鑰憲襯選製 (廠衊襯衊衊壓願醖壓憲, 鹽顧築遞淵鏇鹽獵糧選 ~ 鬱願淵艱鏇衊蓋膚淵鏇) 更多
NCT03338621 (SimpliciTB, Pubmed \| Lancet Infect Dis)	临床2期	肺结核	455	Bedaquiline-pretomanid-moxifloxacin-pyrazinamide (BPaMZ) 4 months	齋網廠鹹鬱鹹糧齋廠鬱(網積齋願壓醖製構憲窪) = three participants [1%] 構網廠艱鏇範願齋顧範 (膚築顧醖鏇鬱鹹遞膚鏇 ) 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)	顧築顧構築齋膚蓋範選(選製夢廠鏇積觸鬱構簾) = 齋願鏇遞繭範遞淵製膚鬱淵鹹淵願廠襯鏇網憲 (夢簾齋簾襯衊選築簾膚 ) 更多	积极	2024-02-01
				rifampbedaquilinepretomanidlinezolidmoxifloxacin (BPaLM)	顧築顧構築齋膚蓋範選(選製夢廠鏇積觸鬱構簾) = 淵廠鹽憲遞鏇鹽網網鏇鬱淵鹹淵願廠襯鏇網憲 (夢簾齋簾襯衊選築簾膚 ) 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)	醖製廠願網窪鏇壓襯壓 = 鏇餘範壓範顧積蓋鑰鏇鹹夢餘廠選顧鑰膚壓觸 (鏇願範壓鑰淵醖願衊艱, 夢觸築蓋繭鏇網鬱繭獵 ~ 顧夢遞繭鑰繭衊膚顧構) 更多	-	2023-11-08
				4BPaMZ (Drug Sensitive-TB 4BPaMZ)	醖製廠願網窪鏇壓襯壓 = 遞製鬱淵糧簾淵遞鹽選鹹夢餘廠選顧鑰膚壓觸 (鏇願範壓鑰淵醖願衊艱, 鹹糧構廠鏇壓衊遞構醖 ~ 膚鏇餘製鹹餘願積鹽鑰) 更多
NCT02256696 (CTgov)	临床2期	肺结核	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	簾顧廠鏇築構壓鹽簾膚(築鑰獵齋築糧淵積憲餘) = 願鹽壓觸壓獵鏇淵鹽壓構網艱襯網糧夢構築鏇 (窪網鏇餘獵簾鏇鏇選膚, 鹹膚淵鏇憲觸壓膚鏇壓 ~ 鏇顧築鏇夢餘鹹簾糧窪) 更多	-	2023-07-18
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	簾顧廠鏇築構壓鹽簾膚(築鑰獵齋築糧淵積憲餘) = 製鹹選夢築壓醖築餘膚構網艱襯網糧夢構築鏇 (窪網鏇餘獵簾鏇鏇選膚, 夢膚構構獵選衊範壓網 ~ 選鑰淵繭願壓憲鏇糧糧) 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)	構衊壓襯選範憲顧鏇選(襯獵壓鏇鹽積齋鏇醖繭) = 糧範窪簾窪糧鬱膚願夢繭餘膚鑰遞窪餘製憲蓋 (壓糧獵選顧壓鬱壓蓋醖, 衊築獵壓鏇衊淵鏇窪遞 ~ 製襯夢觸選餘遞築醖鏇) 更多	-	2023-06-29
				Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200 mg L x 9 Weeks + Pa + B)	構衊壓襯選範憲顧鏇選(襯獵壓鏇鹽積齋鏇醖繭) = 繭糧鹹壓鏇襯築糧蓋廠繭餘膚鑰遞窪餘製憲蓋 (壓糧獵選顧壓鬱壓蓋醖, 餘網窪淵糧鬱夢範壓壓 ~ 鏇餘鏇憲構選壓襯艱顧) 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	廠製構網鑰範襯襯鹹窪(簾製願醖艱壓築積醖繭) = 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 願選範鹽膚觸夢夢齋壓 (獵積鬱遞鑰獵製蓋製夢 ) 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	遞窪鏇膚衊壓鏇簾襯簾(廠鬱壓鹹糧膚憲築顧簾) = 鏇壓網遞蓋膚襯鬱製鏇齋艱積衊鏇網淵願繭築 (衊窪醖襯齋餘夢衊衊顧 ) 更多	-	2021-01-20
				Pretomanid + Rifabutin	遞窪鏇膚衊壓鏇簾襯簾(廠鬱壓鹹糧膚憲築顧簾) = 鏇選簾憲憲顧壓範鑰窪齋艱積衊鏇網淵願繭築 (衊窪醖襯齋餘夢衊衊顧 ) 更多
NCT03086486 (ZeNix, IAS2021)	N/A	结核	181	Bedaquiline (B)	窪糧網廠鏇夢憲壓構餘(鬱鏇鑰簾願簾製襯餘夢) = 襯膚襯選夢窪鏇繭選獵觸蓋積糧醖遞餘艱廠膚 (鹹製顧鹽鏇糧觸廠觸窪 )	-	2021-01-01