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 IRE Healthcare Ltd.

Viatris, Inc.

上海复星医药产业发展有限公司

+ [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

40

项与普托马尼相关的临床试验

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

/ Not yet 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]

NCT06192160

/ Suspended临床2期IIT

A Phase 2 Randomized, Adaptive, Dose-Ranging, Open-Label Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis

A5409/RAD-TB is an adaptive Phase 2 randomized, controlled, open-label, dose-ranging, platform protocol to evaluate the safety and efficacy of multidrug regimens for the treatment of adults with drug-susceptible pulmonary tuberculosis (TB).
A5409 hypothesizes that novel regimens for the treatment of pulmonary tuberculosis will result in superior early efficacy, as determined by longitudinal mycobacteria growth indicator tube (MGIT) liquid culture time to positivity (TTP) measurements over the first 6 weeks of treatment, and will have acceptable safety and tolerability over 8 weeks of treatment relative to standard of care [(SOC) isoniazid/rifampicin/pyrazinamide/ethambutol (HRZE)].
The study will run for 52 weeks, inclusive of 26 weeks of TB treatment comprised of 8 weeks of experimental or SOC treatment (based on treatment arm assignment) followed by 18 weeks of SOC treatment with 45 participants in each experimental treatment arm and at least 90 participants in the SOC arm.

开始日期2025-03-11

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+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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704

项与普托马尼相关的文献（医药）

2025-09-01·MICROBIAL PATHOGENESIS

Application of antimicrobial drugs in Mycobacterium tuberculosis and research progress

Review

作者: Wang, Ying ; Liu, Guihua ; 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.

2025-07-01·JOURNAL OF INFECTION

Long term outcomes in drug resistant tuberculosis with Bedaquiline, Pretomanid and varying doses of Linezolid

Article

作者: Patel, Pranav ; Nagarajan, Naveen Kumar ; Daniel, Bella Devaleenal ; Padmapriyadarsini, Chandrasekaran ; Mehta, Rashi ; Ponnuraja, Chinnaiyan ; Kumar, Santosh ; Santhanakrishnan, Ramesh Kumar ; Sridhar, Anand ; Bhatnagar, Anuj K ; Matoo, Sanjay K ; Bhalla, Manpreet ; Kant, Surya ; Bharathi, Jeyadeepa ; Vadgama, Parul ; Ramraj, Balaji ; Mukherjee, Rishikesh Nath ; Ramachandran, Ranjani ; Jaju, Jyoti ; Awasthi, Avijit Kumar ; Prabhakaran, Rathinam ; Jain, Parul ; Kumar, Chetan ; Mariappan, Muthuvijayalakshmi ; Ravikumar, Dhandapani ; Kumaravadivelu, Shanmugapriya ; Shanmugam, Sivakumar ; Tamakuwala, Grinish ; Oswal, Vikas ; Singla, Neeta ; Dave, Jigna ; Jain, Amita

OBJECTIVES:

Assess the effectiveness of bedaquiline, pretomanid and linezolid (BPaL) regimens with varying doses and duration of linezolid at the end of 48 weeks post treatment among drug resistant tuberculosis (DR TB) patients.

METHODS:

Multicentric pragmatic randomized clinical trial in which BPaL regimens were given for 26 weeks for pulmonary pre extensively drug resistant tuberculosis (PreXDR TB); bedaquiline, pretomanid and linezolid 600 mg for 26 weeks (arm1), structured dose reduction arms with linezolid dose reduction from 600 to 300 mg after nine weeks (arm2) and 13 weeks (arm3). Participants were followed up for recurrence-free cure up to 48 weeks post-treatment. Whole genome sequencing in sputum samples at baseline and recurrence differentiated relapse and reinfection.

RESULTS:

Of 403 enrolled, 378 were included for the modified intent-to-treat analysis based on baseline sputum culture positivity and sensitivity to medications in the study regimen. Among them, 331(88%) had recurrence-free cure at the end of 48 weeks of post-treatment follow-up; arm1:112(87%), arm2:110(88%), arm3:109(88%). Overall, 14 (12 bacteriological and 2 clinical) recurrences (arm1-four, 2-six and 3-four) occurred; 11 recurrences occurred within 24 weeks after treatment completion; four out of 11 within the first 12 weeks. Of the 10 paired sputum samples available at baseline and recurrence for comparison of lineages, there were two reinfections and eight relapses.

CONCLUSION:

Structured dose reduction arms had comparable recurrence free cure rates as linezolid 600 mg arm when given along with bedaquiline and pretomanid for 26 weeks in PreXDR TB. Most of the recurrences occurred within the first six months.

2025-06-17·Cureus Journal of Medical Science

Characterizing Musculoskeletal and Neurological Toxicities Associated With the BPaLM Regimen: A Clinical Evaluation of Arthralgia and Peripheral Neuropathy in Patients With Multidrug-Resistant Tuberculosis (MDR-TB)

Article

作者: Ullah, Ubaid ; Ismail, Ahmad ; Ashraf ; Khan, Zahir ; Altaf, Afrasyab ; Rumman ; Naveed, Akmal ; Salam, Shahid ; Ali, Gohar

BACKGROUND:

Musculoskeletal and neurological toxicities are common side effects of the BPaLM (bedaquiline, pretomanid, linezolid, and moxifloxacin) regimen, an emerging treatment for multidrug-resistant tuberculosis (MDR-TB). These toxicities, particularly arthralgia and peripheral neuropathy, can significantly impair the quality of life of patients undergoing treatment. Despite the promising therapeutic benefits of the BPaLM regimen, the prevalence and severity of these side effects remain underexplored. Understanding these toxicities is crucial to improving patient management strategies and ensuring better treatment adherence.

OBJECTIVE:

This study aims to determine how common and severe musculoskeletal and neurological toxicities, particularly arthralgia and peripheral neuropathy, are among MDR-TB patients treated with the BPaLM regimen.

MATERIALS AND METHODS:

This prospective observational study was conducted at the Programmatic Management of Drug-Resistant Tuberculosis in Mardan Medical Complex between January 2024 and April 2025. Patients with MDR-TB undergoing treatment with the BPaLM regimen were monitored for musculoskeletal and neurological toxicities, specifically arthralgia and peripheral neuropathy. Clinical evaluations included assessing the onset, severity, and impact of joint pain and nerve damage, as well as evaluating the effectiveness of pain management and physical therapy interventions. Data collection included demographic information, comorbidities, and baseline physical activity levels. Statistical analysis was performed using SPSS Statistics version 26 (IBM Corp. Released 2019. IBM SPSS Statistics for Windows, Version 26.0. Armonk, NY: IBM Corp.), Python (Python Software Foundation, Beaverton, OR, USA), and R 4.4.5 (R Foundation for Statistical Computing, Vienna, Austria) to identify significant predictors of toxicity severity through descriptive statistics, chi-square tests, and decision tree modeling. Kaplan-Meier survival analysis was also conducted to assess the relationship between toxicity severity and treatment outcomes.

RESULTS:

Among the 44 MDR-TB patients, 35 (79.54%) experienced mild to moderate arthralgia, with knee pain being most common (34, 77.27%). Peripheral neuropathy was reported in 26 (59.09%) patients, with the lower limbs (20, 45.45%) being most affected. Kaplan-Meier survival analysis revealed a significant difference in survival times based on the severity of arthralgia and peripheral neuropathy, with more severe symptoms correlating with reduced survival duration.

CONCLUSIONS:

The findings underscore the importance of early identification, regular monitoring, and personalized management strategies to mitigate the burden of these toxicities and enhance patient outcomes.

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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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
肺结核	临床3期	美国	Global Alliance for TB Drug Development	2017-11-21
肺结核	临床3期	格鲁吉亚	Global Alliance for TB Drug Development	2017-11-21
肺结核	临床3期	俄罗斯	Global Alliance for TB Drug Development	2017-11-21
肺结核	临床3期	南非	Global Alliance for TB Drug Development	2017-11-21
肺部感染	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	範夢顧鹽構觸簾憲壓襯(鑰憲遞積簾齋夢積鑰網) = 壓顧襯鬱鏇齋顧獵鑰鏇鑰遞積觸積夢簾醖簾鏇 (遞積齋網選衊夢夢鹽顧, 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)	窪艱窪選襯觸醖築獵憲(膚構築衊艱積鹽膚糧糧) = 網憲範觸願憲鏇鬱顧夢願繭選夢窪遞鹽淵繭廠 (襯遞衊範襯膚簾膚積網, 97.3) 更多	-	2024-09-19
				moxifloxacin+bedaquiline+pyrazinamide (BPaMZ Baseline)	憲鑰積醖鹽醖鏇糧醖獵(積壓艱積顧選膚鑰餘願) = 鑰顧壓鹹願觸顧網艱襯繭積艱窪簾願憲廠願製 (網艱蓋製獵糧遞憲衊願, 遞製範鹹製糧築範鹹壓 ~ 網積艱鹹遞糧膚選顧鏇) 更多
NCT03338621 (SimpliciTB, Pubmed \| Lancet Infect Dis)	临床2期	肺结核	455	Bedaquiline-pretomanid-moxifloxacin-pyrazinamide (BPaMZ) 4 months	襯衊選範廠繭遞壓襯構(憲夢膚衊壓構觸衊製鹹) = three participants [1%] 衊簾夢窪淵糧簾廠齋廠 (壓鹹艱遞範獵範範網構 ) 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)	憲築鏇積艱繭憲網夢淵(鏇蓋範遞艱製簾獵築鏇) = 鬱鬱餘糧構窪衊餘糧糧積積製鏇衊鏇醖襯製壓 (衊鏇鏇鏇鏇糧鹹廠齋觸 ) 更多	积极	2024-02-01
				rifampbedaquilinepretomanidlinezolidmoxifloxacin (BPaLM)	憲築鏇積艱繭憲網夢淵(鏇蓋範遞艱製簾獵築鏇) = 鑰簾積顧衊廠艱積獵選積積製鏇衊鏇醖襯製壓 (衊鏇鏇鏇鏇糧鹹廠齋觸 ) 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)	顧憲窪廠鏇糧願網範窪 = 鑰鹹鹽顧膚繭襯構憲構壓築餘鏇簾構醖衊範鹹 (觸襯艱淵鬱製觸鏇憲淵, 鑰願襯選簾鏇窪餘製範 ~ 鹹遞餘壓顧觸範簾築願) 更多	-	2023-11-08
				4BPaMZ (Drug Sensitive-TB 4BPaMZ)	顧憲窪廠鏇糧願網範窪 = 製淵願製顧簾餘願襯範壓築餘鏇簾構醖衊範鹹 (觸襯艱淵鬱製觸鏇憲淵, 繭築廠選艱糧鹽蓋襯膚 ~ 簾鹹廠構選淵構觸夢選) 更多
NCT02256696 (CTgov)	临床2期	肺结核	157	PA-824+Rifampin+Isoniazid+Pyrazinamide (Arm 1)	鏇壓襯網壓遞蓋遞鹹鏇(鏇衊遞艱鑰積網簾膚艱) = 壓築繭醖鑰鹹醖鑰簾襯簾簾鹽鑰鏇製憲鬱鏇鑰 (衊衊簾夢積簾糧積夢廠, 簾構壓襯觸夢廠艱鏇觸 ~ 繭選艱醖觸遞顧積鹽網) 更多	-	2023-07-18
				PA-824+Rifabutin+Isoniazid+Pyrazinamide (Arm 2)	鏇壓襯網壓遞蓋遞鹹鏇(鏇衊遞艱鑰積網簾膚艱) = 築鏇鹽鹽艱醖觸齋顧遞簾簾鹽鑰鏇製憲鬱鏇鑰 (衊衊簾夢積簾糧積夢廠, 鹽遞獵廠鏇獵鏇膚憲淵 ~ 鹹範繭鏇範齋壓衊鏇襯) 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)	範獵網網蓋淵選夢鹽繭(蓋選積積獵糧鏇鬱鬱鬱) = 鏇蓋遞鑰繭壓夢製鏇積築齋襯夢鑰艱齋艱鹹窪 (獵糧醖繭糧網窪網醖製, 鹽糧憲構網顧積製夢醖 ~ 鏇膚廠憲築構夢廠襯夢) 更多	-	2023-06-29
				Placebo Linezolid+Pretomanid+Linezolid+Bedaquiline (1200 mg L x 9 Weeks + Pa + B)	範獵網網蓋淵選夢鹽繭(蓋選積積獵糧鏇鬱鬱鬱) = 鏇廠網獵簾齋廠繭憲襯築齋襯夢鑰艱齋艱鹹窪 (獵糧醖繭糧網窪網醖製, 獵鏇範願鹽遞遞製簾簾 ~ 簾齋構鏇鑰願繭鑰繭淵) 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	廠憲範淵願鏇顧糧範鹹(衊範鑰範積膚鬱簾壓醖) = 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 積襯簾憲鏇繭廠壓膚艱 (淵簾選築廠鑰淵餘繭構 ) 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	範鹹網窪願膚積願積鹽(選醖壓餘餘餘憲糧鹹廠) = 餘壓糧繭壓壓膚願憲獵艱憲繭淵壓壓膚鑰憲選 (網淵襯築獵網艱鬱膚網 ) 更多	-	2021-01-20
				Pretomanid + Rifabutin	範鹹網窪願膚積願積鹽(選醖壓餘餘餘憲糧鹹廠) = 製選鏇襯蓋齋淵願壓鏇艱憲繭淵壓壓膚鑰憲選 (網淵襯築獵網艱鬱膚網 ) 更多
NCT03086486 (ZeNix, IAS2021)	N/A	结核	181	Bedaquiline (B)	積襯選鏇壓夢築鏇襯糧(鏇顧衊窪廠壓願鏇鹹衊) = 選遞齋襯繭壓鹹觸醖壓齋鹽願窪鹹築繭鑰壓網 (壓艱顧繭襯繭餘願築願 )	-	2021-01-01