A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to the standard treatments. It will also learn about the safety of this new combination antibiotic treatment when compared to the standard treatments. The main questions it aims to answer are:
* How well does Arm D treat mycobacterium abscessus pulmonary disease?
* What side effects does Arm D cause when used to treat mycobacterium abscessus pulmonary disease? Researchers will compare Arm D to the current standard of care treatments to see if Arm D treats mycobacterium abscessus pulmonary disease better and if it will cause less side effects.
Participants will:
* Be screened and recruited to the FORMaT adaptive platform trial (NCT04310930)
* Be given Arm D for 4 weeks or standard of care treatments for 6 weeks.
* Be reviewed by the study doctors weekly for checkups and tests.
* Provide respiratory samples (sample coughed up from the chest), respond to quality-of-life questionnaires, have CT lung scans and blood tests.

开始日期2027-04-01

申办/合作机构

The University of Queensland

[+1]

NCT07675954

/ Not yet recruiting临床3期IIT

A Phase 3, Open-Label, Randomised Controlled Trial to Evaluate a 6-Month "MDR-END Plus" Regimen (Bedaquiline, Delamanid, Delpazolid, Levofloxacin and Pyrazinamide) Versus the South African Standard of Care Treatment for Rifampicin-Resistant Tuberculosis

This is a phase 3, open-label, randomized clinical trial in adults and adolescents aged 15 years or older who need treatment for rifampicin-resistant tuberculosis in South Africa.
The goal of this clinical trial is to learn whether a 6-month MDR-END Plus regimen works as well as current standard of care (SoC) treatment for rifampicin-resistant tuberculosis. The trial will also learn whether the MDR-END Plus regimen is safer and easier to tolerate than SoC regimens.
The main questions this trial aims to answer are:
* Does the MDR-END Plus regimen lead to a favorable treatment outcome 12 months after treatment is stopped, compared with SoC regimens?
* Do participants receiving the MDR-END Plus regimen have fewer important safety or tolerability problems during treatment and up to 90 days after treatment is stopped, compared with SoC regimens?
Researchers will compare the MDR-END Plus regimen with South African standard of care (SoC) treatment for rifampicin-resistant tuberculosis.
Participants will:
* Be randomly assigned to receive either the MDR-END Plus regimen or SoC treatment.
* Take tuberculosis medicines for about 6 months, although treatment may be extended in some cases.
* Attend study visits during treatment and after treatment is stopped.
* Have clinical assessments, blood tests, heart tracing tests, vision and nerve assessments, and tuberculosis tests.
* Be followed for 12 months after treatment is stopped.

开始日期2026-10-01

申办/合作机构

Seoul National University Hospital

[+5]

NCT06568484

/ Recruiting临床2/3期IIT

Bedaquiline Roll-out Evidence in Contacts and People Living With HIV to Prevent TB (BREACH-TB)

A seamless, staged Phase II/III, open-label, multicenter, non-inferiority trial, to compare the efficacy and safety of 4 weeks of bedaquiline (BDQ) versus a a standard regimen for preventing regimen for preventing confirmed or probable tuberculosis disease (TBD) during 72 weeks of follow-up among people living with HIV (PLHIV) and high-risk Close Contacts (CC) of adults with Drug Susceptible (DS) or Rifampin Resistant (RR) TB.

开始日期2026-05-08

申办/合作机构

The Johns Hopkins University

[+1]

100 项与富马酸贝达喹啉相关的临床结果

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100 项与富马酸贝达喹啉相关的转化医学

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100 项与富马酸贝达喹啉相关的专利（医药）

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2,650

项与富马酸贝达喹啉相关的文献（医药）

2026-07-01·Life Science Alliance

Machine learning method for the prediction of Bedaquiline-resistant Mycobacterium tuberculosis.

Article

作者: Ghosh, Stuti ; Saha, Sudipto ; Bhattacharjee, Sudipto

The study addresses the increasing resistance to the FDA-approved drug Bedaquiline (BDQ) in Mycobacterium tuberculosis (MTB). The absence of any defined resistance locus and the wide variation in the drug targets across clinical isolates have raised a big question about our understanding of the molecular basis of BDQ resistance acquisition. Using machine learning (ML) methods, BDQ resistance was predicted from whole-genome sequencing data for MTB clinical isolates. Variant calling format data generation involved several steps, including adapter trimming and alignment to the H37Rv reference genome. The ML models, namely, Multilayer Perceptron and Random Forest (RF), achieved high accuracies of 83.60% and 79.64%, respectively. The top 50 features were mapped to the H37Rv reference genome, and several new drug targets were identified. In addition to the coding regions, some non-coding intergenic regions were also obtained. Mapping of these features to the H37Rv genome revealed 15 new antibiotic-resistant genes. In addition, the use of explainable AI (XAI) methods, such as SHapley Additive exPlanations, facilitated the identification of mutations associated with BDQ resistance. In conclusion, the ML models demonstrated effective predictive capabilities for BDQ resistance, whereas XAI contributed to understanding key resistance features.

2026-07-01·JOURNAL OF THE AMERICAN PHARMACISTS ASSOCIATION

Sulfamethoxazole-trimethoprim-induced Stevens-Johnson syndrome in a NAT2 slow acetylator: A case for pre-emptive pharmacogenomic screening?

Article

作者: Kok Choon, Raymond Fong ; Lee, Siok Ying

OBJECTIVE:

Severe Cutaneous Adverse Reactions (SCAR), such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are serious complications associated with several high-risk medications and can result in significant morbidity and mortality. While HLA-mediated SCARs have been well-characterized-particularly involving drugs like carbamazepine, abacavir, and allopurinol-there is limited data on the role of N-acetyltransferase 2 (NAT2) polymorphisms in SCAR pathogenesis.

CASE SUMMARY:

We present a case of sulfamethoxazole-trimethoprim-(SMX-TMP)- induced SJS (Naranjo probability score: seven), hypothesized to be linked to NAT2 slow acetylator (SA) status.

PRACTICE IMPLICATIONS:

This case underscores the potential utility of pre-emptive pharmacogenomic screening to reduce the incidence of SCARs. NAT2 SA status has also been strongly associated with isoniazid-induced liver injury; Clinical Pharmacogenetics Implementation Consortium (CPIC) recently published a guideline that NAT2 SA predicted for hydralazine-induced systemic lupus erythematosus (SLE) and were at higher risk of side effects, suggesting broader clinical implications for routine NAT2 genotyping.¹ Aside from G6PD testing, there is an emergent role to test for NAT2 genotype in preparation for SMX-TMP therapy. Clinically relevant NAT2 alleles include *4, *5, *6, and *7. Given that multiple single nucleotide variant (SNV) must be tested, multiplex pharmacogenomic panels may offer a more cost-effective and comprehensive approach than reactive testing. Some multiplex panels that may be employed include: GeneXpert NAT2-PGx Assay--a rapid assay targeting 5 key polymorphisms to predict isoniazid-acetylation, nanopore sequencing-based panels --a scalable targeted sequencing panel useful for NAT2 and other antitubercular genes (rifampicin, linezolid and bedaquiline), Fulgent genetics pharmacogenomics comprehensive panel, CleanPlex® pharmacogenomics kit and GenoPharm®.

2026-07-01·ANNALS OF EPIDEMIOLOGY

Early adherence predicts treatment outcomes and mortality in people living with HIV and multidrug-resistant tuberculosis

Article

作者: Rivet Amico, K ; O'Donnell, Max R ; Cummings, Matthew J ; Friedland, Gerald ; Perumal, Rubeshan ; Seepamore, Boitumelo ; Cheung, Ying Kuen ; Zelnick, Jennifer ; Wolf, Allison ; Daftary, Amrita ; Naidoo, Kogieleum ; Padayatchi, Nesri ; Guzman, Kevin J ; Boodhram, Resha ; Reis, Karl ; Lu, Xuan

PURPOSE:

Treatment success for RR/MDR-TB remains suboptimal, particularly among people living with HIV. Electronic dose monitors support adherence, but strategies to act on these data are limited. We hypothesized that early adherence to bedaquiline predicts treatment outcomes and could guide individualized interventions.

METHODS:

We prospectively enrolled adults with RR/MDR-TB and HIV initiating bedaquiline-containing regimens in KwaZulu-Natal, South Africa. Adherence was measured using real-time electronic dose monitors. Weekly adherence data through week 24 trained time-aware XGBoost models to predict end-of-treatment outcomes, and latent class growth analysis (LCGA) at the earliest predictive time point identified distinct adherence trajectories.

RESULTS:

Among 282 participants, model performance improved over time, achieving good discrimination by week 4 (AUC > 0.80), predictive of subsequent adherence. LCGA using 4-week data identified three adherence trajectories: high, moderate-stable, and early-declining. Favorable outcomes were lowest in the early-declining group (55% vs. 77% and 76%), which also had the highest mortality (36% vs. 12% and 12%). Cox models confirmed a higher risk of unfavorable outcomes among early decliners.

CONCLUSION:

Adherence in the first four weeks of bedaquiline therapy provides a powerful, early signal of treatment outcomes. Real-time adherence monitoring could enable risk stratification and tailored interventions to improve RR/MDR-TB and HIV care.

229

项与富马酸贝达喹啉相关的新闻（医药）

2026-06-30

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长效药物市场到2033年将达到133亿美元，在持续给药技术和慢性病管理进步的推动下不断扩张 - Persistence Market ResearchLong-Acting Drugs Market to Reach US$ 13.3 Billion by 2033 Expands Amid Advances in Sustained Drug Delivery and Chronic Disease Management - Persistence Market Research

LONDON 伦敦, ，June 30, 2026 2026年6月30日/PRNewswire/ -- The global /美通社/ -- 全球long-acting drugs market 长效药物市场is growing steadily, expected to be valued at around US$ 7.2 billion in 2026 and projected to reach US$ 13.3 billion by 2033, with a CAGR of 8.9% in the coming years. This expansion comes from the increasing prevalence of chronic diseases, rising demand for patient-friendly therapies, and rapid innovation in sustained-release drug delivery systems. 稳步增长，预计2026年市场规模将达到约72亿美元，并有望在2033年达到133亿美元，未来几年的复合年增长率（CAGR）为8.9%。这一扩张源于慢性疾病患病率的不断上升、对患者友好型疗法需求的增加，以及缓释药物递送系统的快速创新。Long-acting formulations are increasingly used in oncology, diabetes, HIV, psychiatric disorders, and cardiovascular diseases, where consistent therapeutic levels are critical for long-term management.. 长效制剂在肿瘤学、糖尿病、HIV、精神障碍和心血管疾病中的应用日益广泛，在这些疾病中，维持稳定的治疗水平对于长期管理至关重要。Rising Burden of Chronic Diseases Fuels Demand for Long-Acting Therapies 慢性病负担加重推动对长效疗法的需求The worldwide increase in chronic diseases is significantly boosting demand for long-acting drugs. Conditions such as cancer, diabetes, schizophrenia, HIV, and cardiovascular disorders require prolonged treatment regimens, where patient adherence often becomes a major challenge. Long-acting formulations address this issue by reducing dosing frequency and maintaining stable drug concentrations over weeks or months.. 全球慢性病的增加显著推动了对长效药物的需求。癌症、糖尿病、精神分裂症、HIV和心血管疾病等状况需要长期的治疗方案，而患者的依从性往往成为一大挑战。长效制剂通过减少给药频率并在数周或数月内维持稳定的药物浓度来解决这一问题。For instance, the World Health Organization reported nearly 20 million new cancer cases globally in 2022, while diabetes continues to affect more than 500 million people worldwide. This growing patient population is encouraging healthcare providers to adopt therapies that improve convenience and reduce relapse risks.. 例如，世界卫生组织报告称，2022年全球新增癌症病例近2000万例，而糖尿病继续影响着全球超过5亿人口。不断扩大的患者群体正促使医疗保健提供者采用能够提高便利性并降低复发风险的治疗方案。Long-acting injectables and polymer-based depots are increasingly used in psychiatric care, where treatment interruptions can lead to hospitalization. Similarly, HIV prevention therapies such as injectable cabotegravir have transformed adherence patterns by replacing daily oral regimens with bi-monthly dosing schedules.. 长效注射剂和聚合物基缓释 depot 在精神科护理中日益得到应用，因为治疗中断可能导致住院。同样，诸如注射用卡博特韦等 HIV 预防疗法通过将每日口服方案替换为每两月一次的给药计划，改变了患者的依从性模式。Pharmaceutical companies are responding with advanced formulations that enhance bioavailability, extend therapeutic action, and minimize side effects. In 2025, investments in long-acting oncology and CNS therapies accelerated as healthcare systems prioritized improved patient outcomes and lower treatment costs.. 制药公司正通过先进制剂作出回应，这些制剂可提高生物利用度、延长治疗作用并最大限度地减少副作用。2025年，随着医疗系统优先改善患者预后并降低治疗成本，对长效肿瘤学和中枢神经系统疗法的投资加速增长。Get a Free Sample: 获取免费样品：https://www.persistencemarketresearch.com/samples/34040 https://www.persistencemarketresearch.com/samples/34040Key Highlights 重点摘要The global long-acting drugs market is projected to grow from US$ 7.2 billion in 2026 to US$ 13.3 billion by 2033, registering a CAGR of 8.9%. 全球长效药物市场预计将从2026年的72亿美元增长至2033年的133亿美元，年复合增长率（CAGR）为8.9%。Rising prevalence of chronic diseases such as cancer, diabetes, HIV, and CNS disorders is accelerating demand for sustained-release therapies worldwide. 癌症、糖尿病、HIV 和中枢神经系统疾病等慢性病的患病率不断上升，正在加速全球对缓释疗法的需求。North America leads the market with 41.2% share, supported by advanced healthcare infrastructure and strong pharmaceutical R&D investments. 北美以41.2%的市场份额领先全球，这得益于其先进的医疗基础设施和强劲的制药研发投入。Asia Pacific is emerging as the fastest-growing region due to expanding healthcare access, increasing patient population, and government support for innovative therapies. 亚太地区正成为增长最快的地区，这得益于医疗保健可及性的扩大、患者群体的增加以及政府对创新疗法的支持。Microsphere-Based Systems dominate delivery technology adoption because of their controlled drug release capabilities and improved patient adherence. 基于微球的系统因其可控的药物释放能力和提高的患者依从性，在递送技术采用中占据主导地位。Technological Advancements in Drug Delivery Systems Accelerate Innovation 药物递送系统的技术进步加速创新Innovation in drug delivery technology is another major driver of the long-acting drugs market. Pharmaceutical companies are developing advanced systems such as microspheres, liposomes, 药物递送技术的创新是长效药物市场的另一大驱动因素。制药公司正在开发微球、脂质体等先进系统，biodegradable implants 可生物降解植入物, and polymer depots to deliver controlled and sustained drug release. ，以及用于实现药物控释和缓释的聚合物储库。Microsphere-based systems remain the dominant technology because they provide precise release profiles and improve drug stability. These formulations are widely used in oncology, hormonal therapies, and central nervous system disorders due to their ability to maintain therapeutic effectiveness for extended periods.. 微球系统因其能够提供精确的释放曲线并提高药物稳定性，仍然是主导技术。这些制剂由于能够在较长时间内维持治疗效果，被广泛应用于肿瘤学、激素疗法和中枢神经系统疾病的治疗中。The rise of oral long-acting biologics also represents a transformative opportunity. Technologies using permeation enhancers and protective coatings are enabling peptide-based therapies to survive gastric degradation and maintain bioavailability. Products such as oral semaglutide and next-generation . 口服长效生物制剂的兴起也代表着一个变革性的机遇。利用渗透增强剂和保护涂层的技术，使得基于肽的疗法能够抵御胃部降解并保持生物利用度。诸如口服司美格鲁肽和下一代产品等。GLP-1 胰高血糖素样肽-1therapies demonstrate how sustained-release technologies are expanding beyond injectables. 这些疗法表明，缓释技术正逐渐超越注射剂的范畴。Manufacturers are also investing in sensor-enabled delivery systems and 制造商也在投资配备传感器的递送系统，并smart packaging solutions 智能包装解决方案that improve dose tracking and patient monitoring. These innovations support adherence while helping healthcare providers optimize treatment plans through real-time data collection. 这些创新有助于改善剂量追踪和患者监测，在通过实时数据收集帮助医疗保健提供者优化治疗方案的同时，提高患者的依从性。Key Highlight: Eli Lilly Advances Oral 重点亮点：礼来公司推进口服药物研发GLP-1 GLP-1Innovation in 2025 2025年的创新A standout event in 2025 was the advancement of Eli Lilly and Company's oral 2025年的一大亮点事件是礼来公司口服药物的进展GLP-1 GLP-1receptor agonist, orforglipron, following successful Phase III clinical trial results in diabetes and obesity management. According to the company, the therapy demonstrated statistically significant improvements in blood sugar control and body weight reduction across multiple late-stage studies involving adults with type 2 diabetes and obesity.. 受体激动剂orforglipron在糖尿病和肥胖管理的III期临床试验中取得成功后。据该公司称，该疗法在涉及患有2型糖尿病和肥胖的成年人的多项后期研究中，显示出在血糖控制和体重减轻方面的统计学显著改善。The development highlighted growing industry interest in oral alternatives to injectable 这一进展凸显了业界对注射剂口服替代方案日益增长的兴趣GLP-1 GLP-1therapies. Eli Lilly stated that orforglipron is a once-daily oral small-molecule 疗法。礼来公司表示，orforglipron 是一种每日一次口服的小分子GLP-1 胰高血糖素样肽-1receptor agonist designed without food and water intake restrictions, differentiating it from existing oral 一种无需限制饮食和饮水的受体激动剂，使其区别于现有的口服GLP-1 GLP-1treatments. In one Phase III study, the drug showed superior efficacy compared with oral semaglutide in reducing A1C and body weight. 治疗。在一项III期研究中，该药物在降低糖化血红蛋白（A1C）和体重方面显示出优于口服司美格鲁肽的疗效。The innovation also reflects increasing commercial focus on expanding obesity and diabetes treatment access through convenient oral therapies. Reuters reported that Eli Lilly expected obesity trial results for orforglipron during 2025 as demand for 这一创新也反映出，业界正日益注重通过便捷的口服疗法来扩大肥胖症和糖尿病治疗的可及性。据路透社报道，随着对GLP-1 GLP-1therapies continued to surge globally. Additional media reports noted that the company aimed to pursue regulatory approvals following positive trial outcomes. 疗法在全球范围内持续激增。更多媒体报道指出，该公司旨在在试验结果积极后寻求监管批准。This development signals a broader transition toward patient-focused chronic disease therapies that prioritize ease of administration and long-term treatment adherence. The progress of oral 这一进展标志着向以患者为中心的慢性病疗法更广泛的转变，这些疗法优先考虑给药的便捷性和长期治疗依从性。口服药物的进展GLP-1 胰高血糖素样肽-1medicines is expected to intensify competition within diabetes and obesity management markets, encouraging further investments in next-generation oral metabolic therapies. 预计药物将加剧糖尿病和肥胖症管理市场的竞争，从而推动对下一代口服代谢疗法的进一步投资。Request a Customization: 申请定制：https://www.persistencemarketresearch.com/request-customization/34040 https://www.persistencemarketresearch.com/request-customization/34040Segmentation Insights: Microsphere-Based Systems Lead Delivery Technology Segment with Superior Sustained-Release Performance 细分洞察：微球系统凭借卓越的缓释性能，领跑递送技术领域Microsphere-Based Systems dominate the delivery technology segment of the long-acting drugs market due to their ability to provide controlled and sustained drug release, improving therapeutic effectiveness and patient compliance. These biodegradable polymer particles gradually release active ingredients over weeks or months, significantly reducing dosing frequency in chronic disease treatments. 微球系统在长效药物市场的递送技术领域占据主导地位，这得益于其能够提供可控且持续的药物释放，从而提高治疗效果和患者依从性。这些可生物降解的聚合物颗粒在数周或数月内逐渐释放活性成分，显著降低了慢性疾病治疗中的给药频率。The technology is widely used across oncology, hormonal therapies, CNS disorders, and . 该技术广泛应用于肿瘤学、激素疗法、中枢神经系统疾病等领域。infectious disease management 传染病管理because of its versatility and compatibility with injectable formulations. Microspheres also improve drug stability, bioavailability, and targeted delivery while minimizing side effects. Strong regulatory familiarity, expanding clinical adoption, and continuous advancements in biodegradable polymer technologies further strengthen their leadership position in the global long-acting drugs market.. 凭借其多功能性以及与注射制剂的兼容性。微球还能提高药物稳定性、生物利用度和靶向递送能力，同时最大限度地减少副作用。监管机构对其高度熟悉、临床应用不断扩大，以及可生物降解聚合物技术的持续进步，进一步巩固了其在全球长效药物市场中的领先地位。Regional Insights: North America Leads Long-Acting Drugs Market While Asia Pacific Emerges as Fastest-Growing Regional Hub 区域洞察：北美主导长效药物市场，而亚太地区成为增长最快的区域中心North America holds the largest share of the long-acting drugs market, accounting for about 41.2% of global value, supported by strong pharmaceutical R&D activity, advanced healthcare infrastructure, and favorable regulatory approvals. The U.S. dominates regional demand due to increasing adoption of long-acting injectables in oncology, diabetes, schizophrenia, and HIV therapies. 北美占据长效药物市场的最大份额，约占全球价值的41.2%，这得益于强劲的医药研发活动、先进的医疗基础设施以及有利的监管审批。美国在区域需求中占据主导地位，原因是长效注射剂在肿瘤学、糖尿病、精神分裂症和HIV治疗中的应用日益广泛。FDA approvals for sustained-release formulations and strong reimbursement policies continue to strengthen market expansion.. FDA对缓释制剂的批准以及强有力的报销政策持续推动市场扩张。Asia Pacific is the fastest-growing region. China and India are leading regional growth due to rising chronic disease prevalence, improving healthcare access, and expanding 亚太地区是增长最快的地区。由于慢性病患病率上升、医疗可及性改善以及不断扩张，中国和印度引领着该地区的增长。pharmaceutical manufacturing 药品制造capabilities. Government healthcare initiatives and growing investments in drug delivery innovation are encouraging adoption of long-acting therapies across large patient populations. 能力。政府的医疗保健倡议以及对药物递送创新日益增长的投资，正在推动长效疗法在广大患者群体中的普及应用。Europe follows with strong growth supported by aging populations, increasing clinical trial activity, and investments in advanced drug delivery technologies. Regulatory support from the European Medicines Agency and funding initiatives focused on innovative therapeutics continue to strengthen the region's position.. 欧洲紧随其后，在人口老龄化、临床试验活动增加以及对先进药物递送技术投资的推动下，实现了强劲增长。欧洲药品管理局的监管支持以及专注于创新疗法的资助计划，持续巩固了该地区在这一领域的地位。Key Players and Business Strategies 关键参与者与商业策略Leading players include Eli Lilly and Company, ViiV Healthcare, Johnson & Johnson, Novartis AG, and AstraZeneca plc. 主要参与者包括礼来公司、ViiV Healthcare、强生公司、诺华公司和阿斯利康公司。Eli Lilly is expanding its metabolic disease portfolio through advanced oral 礼来公司正通过先进的口服药物扩大其代谢疾病产品组合GLP-1 胰高血糖素样肽-1therapies and sustained-release drug delivery innovation targeting diabetes and obesity treatment. 针对糖尿病和肥胖症治疗的疗法及缓释药物递送创新。ViiV Healthcare focuses on long-acting HIV prevention and treatment solutions, strengthening its position through injectable therapies that improve patient adherence and reduce dosing frequency. ViiV Healthcare 专注于长效 HIV 预防和治疗解决方案，通过提高患者依从性并减少给药频率的注射疗法，巩固其市场地位。Johnson & Johnson continues investing in long-acting psychiatric therapies, particularly injectable antipsychotics designed to improve treatment persistence in schizophrenia management. 强生公司持续投资长效精神疾病疗法，特别是旨在提高精神分裂症治疗依从性的注射用抗精神病药物。Novartis is strengthening oncology-focused sustained-release formulations and precision medicine initiatives to improve therapeutic effectiveness across chronic conditions. 诺华正在加强以肿瘤学为重点的缓释制剂和精准医疗举措，以提高慢性疾病的治疗效果。AstraZeneca is investing in biologic delivery technologies and strategic partnerships aimed at enhancing long-term treatment outcomes in cardiovascular and metabolic diseases. 阿斯利康正在投资生物制剂递送技术并建立战略合作伙伴关系，旨在改善心血管和代谢性疾病的长期治疗结果。Strategies across the industry emphasize advanced delivery technologies, expansion of chronic disease portfolios, patient-centric formulations, and partnerships supporting innovation in sustained-release therapeutics. 全行业战略均强调先进递送技术、慢性病产品组合扩张、以患者为中心的制剂开发，以及支持缓释疗法创新的合作伙伴关系。Buy Now 立即购买: ：https://www.persistencemarketresearch.com/checkout/34040 https://www.persistencemarketresearch.com/checkout/34040Market Segmentation 市场细分By Delivery Technology 按配送技术Liposome-Based Systems 基于脂质体的系统Microsphere-Based Systems 基于微球的系统Polymer-Based Depots 聚合物基储库In-Situ Forming Gels 原位形成凝胶Nanoparticle-based systems 基于纳米颗粒的系统By Route of Administration 按给药途径Injectable 可注射的Implant 植入物Oral 口头By Therapeutic Area 按治疗领域Cancer 癌症Central Nervous System (CNS) Disorders 中枢神经系统（CNS）疾病Hormone Disorders 激素紊乱Infectious Diseases 传染病Pain Management 疼痛管理Contraception 避孕By Material Used 按所用材料Polymer 聚合物Non-Polymer 非聚合物By Distribution Channel 按分销渠道Hospital Pharmacies 医院药房Retail Pharmacies 零售药店Online Pharmacies 网上药店Specialty Clinics 专科诊所By Region 按地区North America 北美洲Europe 欧洲East Asia 东亚South Asia & Oceania 南亚与大洋洲Latin America 拉丁美洲Middle East and Africa 中东和非洲Get More Insights — Related 获取更多见解 — 相关Healthcare Market Reports 医疗保健市场报告: ：Sterile Injectable Drugs Market 无菌注射药物市场by Product Type (Large, Small Molecule), Drug Class (Monoclonal Antibodies, Cytokines, Insulin), Administration Route (Intradermal, Intramuscular), Dosage Form, and Regional Analysis for 2025 – 2032 按产品类型（大分子、小分子）、药物类别（单克隆抗体、细胞因子、胰岛素）、给药途径（皮内、肌肉注射）、剂型以及2025–2032年区域分析U.S. Antipsychotic Drugs Market 美国抗精神病药物市场by Disease (Schizophrenia, Bipolar Disorder, Others), Therapeutic Class (First Generation, Second Generation, Third Generation), Distribution Channel (Hospital Pharmacies, Others), and Zone Analysis 2026 – 2033 按疾病（精神分裂症、双相情感障碍、其他）、治疗类别（第一代、第二代、第三代）、分销渠道（医院药房、其他）及区域分析，2026–2033年Medical Marijuana Market 医用大麻市场by Product Type (Flowers, Edibles, Concentrates, Others), Application (Chronic Pain, Cancer, Mental Disorders, Others), End-user (Research & Development, Pharmaceutical), and Regional Analysis for 2026 – 2033 按产品类型（花卉、食用产品、浓缩物、其他）、应用领域（慢性疼痛、癌症、精神障碍、其他）、终端用户（研发、制药）以及2026年至2033年的区域分析Injectable Drug Delivery Market 注射药物递送市场by Device Type (Conventional Injection Devices, Prefilled Syringes, Auto-Injectors, Others), Route of Administration (Intravenous, Intramuscular, Subcutaneous), End-user (Hospitals & Clinics, Home Care Settings, Others), and Regional Analysis for 2026 – 2033 按设备类型（传统注射装置、预充式注射器、自动注射器、其他）、给药途径（静脉注射、肌肉注射、皮下注射）、最终用户（医院与诊所、家庭护理环境、其他）以及2026年至2033年的区域分析Metered Dose Inhalers Market 定量吸入器市场by Inhaler Type (Standard Metered Dose Inhalers, Others), Disease Type (Asthma, COPD, Others), Medication Type (Reliever Inhalers, Preventive Inhalers, Combination Therapy Inhalers), and Regional Analysis for 2026 – 2033 按吸入器类型（标准定量吸入器、其他）、疾病类型（哮喘、慢性阻塞性肺病、其他）、药物类型（缓解型吸入器、预防型吸入器、联合治疗吸入器）以及2026年至2033年的区域分析Diabetic Nephropathy Market 糖尿病肾病市场by Drug Class (ACE Inhibitors, Angiotensin Receptor Blockers, SGLT2 Inhibitors, Others), Distribution Channel (Hospital Pharmacies, Drug Stores & Retail Pharmacies, Others), and Regional Analysis for 2026 – 2033 按药物类别（ACE抑制剂、血管紧张素受体阻滞剂、SGLT2抑制剂、其他）、分销渠道（医院药房、药店和零售药房、其他）以及2026-2033年的区域分析Low and Middle Income Countries Opioid Substitution Therapy Market 中低收入国家阿片类药物替代治疗市场by Drug Class (Opioid Antagonists, Opioid Agonists and Partial Agonists), Indication (Pain Management, Opioid Withdrawal/Opioid Use Disorder (OUD), Others), and Regional Analysis for 2026 – 2033 按药物类别（阿片受体拮抗剂、阿片受体激动剂及部分激动剂）、适应症（疼痛管理、阿片戒断/阿片使用障碍（OUD）、其他）以及2026–2033年区域分析Giant Cell Arteritis Treatment Market 巨细胞动脉炎治疗市场by Treatment Type (Corticosteroid Therapy, Immunosuppressive Agents, Anticoagulants, and Monoclonal Antibodies), Route of Administration (Oral, Intravenous, and Subcutaneous), and Regional Analysis for 2026 – 2033 按治疗类型（皮质类固醇疗法、免疫抑制剂、抗凝剂和单克隆抗体）、给药途径（口服、静脉注射和皮下注射）以及2026-2033年的区域分析Ciprofloxacin Market 环丙沙星市场by Dosage Form (Powder, Suspension, Tablet, Eye drops, Intravenous preparation) Application (Urinary tract infections, Lower respiratory infections, Nosocomial pneumonia, Others), and Regional Analysis for 2026 – 2033 按剂型（粉剂、混悬剂、片剂、滴眼液、静脉注射制剂）、适应症（尿路感染、下呼吸道感染、医院获得性肺炎、其他）以及2026–2033年区域分析Drug-Resistant Tuberculosis Market 耐药结核病市场by Drug Class (Amoxicillin/Clavulanate, Bedaquiline, Carbapenems with Clavulanic Acid, Clofazimine, Others), Disease Type (Active TB, Latent TB), Treatment Type, Distribution Channel, and Regional Analysis for 2026 - 2033 按药物类别（阿莫西林/克拉维酸、贝达喹啉、含克拉维酸的碳青霉烯类、氯法齐明、其他）、疾病类型（活动性结核病、潜伏性结核病）、治疗类型、分销渠道以及2026-2033年区域分析About 关于Persistence Market Research Persistence Market Research: ：At Persistence Market Research, we are pioneers in Market Research and Consulting, bringing you the most dynamic insights into market trends, consumer behaviours, and competitive intelligence! For over a decade, we've been at the forefront of delivering game-changing analytics and research that drive businesses toward growth.. 在Persistence Market Research，我们是市场研究和咨询领域的先驱，为您提供关于市场趋势、消费者行为和竞争情报的最具活力的洞察！十多年来，我们始终处于提供变革性分析和研究的前沿，推动企业实现增长。Our extensive market report database is a go-to resource for Fortune 500 companies, savvy business investors, media and entertainment channels, and academic institutions, empowering them to navigate the global and regional business landscape with confidence. With thousands of statistics and in-depth analyses covering over 20 diverse industries across 25 major countries, we provide the insights you need to succeed in today's competitive environment.. 我们庞大的市场报告数据库是财富500强企业、精明的商业投资者、媒体与娱乐频道以及学术机构的首选资源，助力他们自信地驾驭全球及区域商业格局。凭借涵盖25个主要国家、20多个多元化行业的数千项统计数据和深度分析，我们为您提供在当今竞争环境中取得成功所需的洞察。Contact 联系Ankush Nikam 安库什·尼卡姆Persistence Market Research Persistence Market ResearchSecond Floor, 150 Fleet Street, London, EC4A 2DQ 伦敦舰队街150号二楼，邮编EC4A 2DQ+44 203-837-5656 +44 203-837-5656United Kingdom 英国USA Phone - +1 646-878-6329 美国电话 - +1 646-878-6329Email: 电子邮件：[emailprotected] [email protected]Logo: 徽标：https://mma.prnewswire.com/media/2876873/Persistence_Market_Research_Logo.jpg https://mma.prnewswire.com/media/2876873/Persistence_Market_Research_Logo.jpgSOURCE Persistence Market Research Pvt. Ltd. 来源：Persistence Market Research Pvt. Ltd.21 二十一% %more press release views with 更多新闻稿浏览量，通过Request a Demo 申请演示

2026-06-30

·结核病东方论坛

CTBS2026｜大咖云集聚焦临床证据，协同推动结核病诊疗创新

2026年6月26日，中华医学会2026年结核病学术大会临床试验专场在武汉光谷希尔顿酒店北京厅B成功举办。本次专场紧扣大会“创新引领，智慧防治，多方协作”主题，聚焦结核病临床试验体系建设、全球关键研究进展、治疗方案优化、新药与新疗法转化、创新诊断技术验证及多中心协作研究等重点内容，集中展示了我国结核病临床研究领域的最新成果与发展方向。本次专场学术阵容强大，充分体现了我国结核病临床试验领域深厚的学术积淀与传承发展。唐神结教授、刘宇红教授、高孟秋教授、裴异教授、吴桂辉教授、沙巍教授等多位专家莅临指导。来自全国结核病、呼吸病学、感染性疾病、临床药理、新药研发、诊断技术及转化医学等领域的专家学者齐聚江城，共同围绕“以临床证据驱动结核病诊疗革新”展开深入交流。会议由上海市肺科医院刘一典教授主持开场。来自成都市公共卫生临床医疗中心吴桂辉教授致开幕词。吴教授表示，临床试验是连接科学发现、药物研发、诊疗规范和患者获益的重要桥梁，面对结核病诊治中的多种复杂情况，需要以规范严谨的临床研究体系和真实可靠的临床证据，推动结核病诊疗模式持续革新。会议开篇聚焦我国结核病临床试验发展格局与国际研究前沿。唐神结教授作《我国结核病临床试验的现状和思考》专题报告，系统梳理我国结核病临床试验的发展基础、现实挑战与未来方向，回顾了我国已参与的多项重要国际临床试验，指出目前国产创新药物WX-081、TBI-166等也展现出良好发展潜力。未来应进一步加强临床试验机构建设、专业人才培养、多中心协作和质量控制，推动我国结核病临床研究由“积极参与”迈向“自主设计、协同实施、国际引领”。刘宇红教授作《全球在研结核病关键临床试验盘点及其临床启示》报告，围绕药物敏感结核病短程治疗、耐药结核病新方案、无症状结核、结核性脑膜炎等方向，系统介绍TBTC Study 38、OptiRiMoxTB等国际关键研究，为我国临床研究者把握全球试验设计思路、研究终点选择和成果转化路径提供了重要参考。围绕临床诊疗中的关键问题，沙巍教授从人群选择、药物组合、疗效评价和安全性管理等方面，分享药物敏感结核病短程治疗的研究思考；丁卫民教授介绍气管支气管结核瘢痕狭窄型相关研究进展，强调结核病管理应从病原学治愈进一步延伸至结构保护、功能恢复和长期结局改善；裴异教授结合综合医院诊疗场景，分享肺结核高效诊断路径探索，为提升早期识别、规范诊断和及时转诊效率提供了实践参考。指南转化与方案优化是本次专场的重要内容。吴桂辉教授系统解读2026年《耐多药/利福平耐药结核病化学治疗指南》，围绕方案选择、核心药物、疗程设置、疗效监测和安全性管理等关键环节，深入解析指南更新依据及临床意义。付亮教授围绕德拉马尼治疗敏感与耐药结核病的研究进展，介绍BDL/M研究、EAST-TB研究等探索，展示了我国在优化新药组合、缩短治疗疗程和构建适合中国患者治疗方案方面的积极进展。在创新药物与新型治疗策略方面，杜鹃教授发布新型抗结核药物JDB0131的Ⅱa期临床试验结果，介绍其早期疗效、安全性及后续开发前景，体现了我国自主创新抗结核药物从基础研发走向临床验证的重要进展。刘一典教授系统介绍宿主导向治疗在结核病中的全球临床试验进展与中国研究实践，探讨通过调节宿主免疫反应、控制炎症损伤和改善病灶微环境，为传统抗菌治疗提供新的补充策略。魏双教授分享低氧诱导型CEA靶向CAR-T细胞疗法用于复发Ⅳ期非小细胞肺癌的探索性临床研究，为跨学科临床试验设计和创新治疗评价提供了新的思考。诊断技术创新与多中心临床验证同样亮点突出。李强教授介绍基于ROP的全新IGRA方法用于结核病诊断的全国多中心临床研究；贺建清教授分享ANKRD22作为结核病新型诊断生物标志物及免疫调节因子的多队列与临床验证研究；朱艳钦老师报告含德拉马尼方案治疗耐多药/利福平耐药结核病的疗效与安全性评价，为耐药结核病精准诊疗提供了宝贵的多中心研究证据。多中心研究成果交流进一步体现了本次会议的问题导向和实践价值。费镇涛博士介绍康替唑胺对比吡嗪酰胺治疗老年药物敏感性肺结核的研究结果：康替唑胺组与吡嗪酰胺组早期疗效相近，痰结核菌阴转率分别为90.5%和93.8%；康替唑胺组不良反应发生率为27.6%，低于吡嗪酰胺组的57.1%。邹莉萍教授汇报含贝达喹啉及利奈唑胺全口服长疗程方案治疗耐药结核病的有效性及安全性研究，为不适合短程方案的耐药结核病患者提供了新的临床证据和实践参考。会议最后，杜鹃教授作总结发言。她指出，本次临床试验专场内容丰富、主题鲜明，覆盖国内外临床试验前沿、短程治疗、耐药结核指南转化、国产新药、宿主导向治疗、创新诊断技术及全国多中心研究等多个方向。各位专家以临床问题为导向，以高质量证据为支撑，展示了我国结核病临床研究从方案设计、试验实施到成果转化的整体能力。临床试验承载着从科学发现走向临床获益、从中国数据形成中国方案的重要使命。本次专场的成功举办，不仅集中展示了我国结核病临床研究的最新进展，也进一步凝聚了临床试验领域老中青专家协同奋进的学术共识。未来，我们将继续以临床需求为牵引，以规范研究为基础，以多中心协作为支撑，以患者获益为目标，持续推动我国结核病临床研究体系建设和高质量证据产出，为我国结核病防治贡献更多中国智慧、中国经验和中国方案。报道：胡晓萌武汉市肺科医院审校：杜鹃武汉市肺科医院刘一典上海市肺科医院 = END =

2026-06-30

·IQVIA艾昆纬

亚太地区结核病临床试验：挑战与应对之策

亚太地区结核病概况结核病（TB）是全球因传染病导致死亡的主要疾病之一,由结核分枝杆菌（Mycobacterium tuberculosis）感染引发，通过空气传播。当活动性结核患者咳嗽、说话、唱歌或打喷嚏时均可导致该病扩散。肺是结核分枝杆菌最常感染的器官，此病菌也可能侵袭身体其他任何器官，导致单器官或多器官患上结核病。WHO发布的《全球结核病报告》显示，在2023年，结核病发病率最高的地区是东南亚地区，占45%，其次是非洲地区（24%）和西太平洋地区（17%）。全球87% 的结核病例集中于30个高负担国家，其中印度（26%）、印度尼西亚（10%）、菲律宾（6.8%）、巴基斯坦（6.3%）和中国（6.8%）五国的病例数合计占全球总数的56%。结核病高负担状态下，患者及其家庭将面临灾难性的医疗总费用，即超过家庭年支出或收入的20%。结核病是一种可预防且可治疗的疾病，对于药物敏感的结核病（DS-TB）患者，6个月疗程治疗的成功率仍高达88%。然而，药物耐药结核（DR-TB）仍是一个重大公共卫生挑战。对利福平（最有效的一线抗结核药）的耐药性（RR-TB）是一个高度令人关注的问题。近一半新诊断的多重耐药/利福平耐药结核（MDR/RR-TB）病例来自亚太四国：印度（占全球病例的27%）、印度尼西亚（7.4%）、中国（7.3%）和菲律宾（7.2%）。采用二线药物治疗MDR/RR-TB的成功率为68%。尽管已有多种抗结核药物，但仍有抗结核新药研发的迫切需要。目前，各种临床试验正在筹划或进行中。结核病管理的全球标准 WHO的结核病综合治疗指南被视为全球通用标准（表1）。自2010年起，WHO建议对药物敏感性结核病（DS-TB）采用为期6个月的治疗方案（2HRZE/4HR）。药物组合为异烟肼（H）、利福平（R）、吡嗪酰胺（Z）和乙胺丁醇（E）；其中利福平应每日给药。治疗强化期和巩固期均不建议每周三次给药。针对MDR/RR-TB患者，WHO推荐为期6个月的治疗方案，包括贝达喹啉、普托马尼、利奈唑胺（600毫克）和莫西沙星（BPaLM方案）。或贝达喹啉、德拉马尼、利奈唑胺（600毫克）、左氧氟沙星和氯法齐明（BDLLfxC方案）（详见表 1）。对于已排除对氟喹诺酮类药物耐药的MDR/RR-TB患者，WHO建议采用为期9个月的全口服方案（BLMZ、BLLfxCZ及BDLLfxZ方案），而非更长时间（>18个月）的方案。接受 MDR/RR-TB治疗的患者应每月进行一次痰培养以监测治疗反应。 2025年，WHO、美国胸科学会（ATS）、美国疾控中心（CDC）、欧洲呼吸学会（ERS）及美国传染病学会（IDSA）共同建议，针对RR-TB患者，若存在氟喹诺酮类药物耐药，可采用为期6个月的贝达喹啉、普托马尼联合利奈唑胺方案（BPaL方案）；若对氟喹诺酮类药物敏感，则采用为期6个月的贝达喹啉、普托马尼、利奈唑胺联合莫西沙星方案（BPaLM方案）。与15个月或更长疗程相比，更推荐采用6个月的治疗方案。亚太区各国及地区结核病治疗概况亚太区大多数国家（包括印度、中国、菲律宾）已采用6个月治疗方案治疗RR-TB；而印度尼西亚、新加坡和澳大利亚的指南中，也纳入了4个月的治疗方案。在巴基斯坦，鉴于异烟肼耐药率较高，该国专家建议在整个维持期（治疗方案为2HRZE/4HRE）继续使用乙胺丁醇。亚太各国对MDR-/RR-TB的治疗方案在药物组合上可能略有差异，但大多数国家和地区已采用更短的6至9个月的方案，包括印度、菲律宾、印度尼西亚、泰国、巴基斯坦、马来西亚、中国台湾和澳大利亚。结核病临床试验面临的挑战及潜在解决方案由于全球结核病负担沉重、发病率和死亡率影响显著，且耐药病例不断增加，因此仍然亟需结核病诊断工具、新型结核病治疗方案和疫苗。临床试验的顺利开展面临诸多挑战，需要在研究初期就制定能够落实可行的解决方案。结核病临床试验现状 WHO的《终结结核病战略》旨在终结全球结核病流行，实现无结核病死亡、零疾病负担的无结核世界。到2035年，该战略致力于将结核病死亡率减少95%，发病率降低90%，并确保没有结核病患者家庭因病致贫的情况。实现这一目标的核心举措包括：优先关注结核病负担较重的国家，了解结核病漏诊情况、治疗启动延迟和应答不足以及识别DR-TB的出现；同时，要持续关注结核病试验。全球范围内的临床试验协作，如结核病联盟（TB Alliance）与结核病试验联盟（TBTC），仍在持续创造机会以优化结核病的诊断、治疗与结局。21世纪初，多种新型抗结核药物的问世，推动了多项临床试验的开展，其核心目标是缩短DS-TB 的治疗周期，并提升DR-TB的治愈率。近年来，结核病研究资金缺口明显（例如，2021年为10亿美元，2022年为10.35亿美元）。2023年联合国结核病问题高级别会议提出，到2027年每年为结核病研究提供50亿美元的资金。WHO还发布了《结核病研究》这一动态更新的数据库，可提供有关结核病和MDR-TB临床试验、操作研究及其他研究的最新信息。这些研究按名称、适应症、主题、研究类型、研究主题、地点、队列规模和结束日期进行索引。 WHO还公布了结核病在诊断、治疗、预防和疫苗领域的研究数据。截至2024年8月，多项诊断技术正处于WHO评审阶段，包括用于筛查、结核感染、结核病以及耐药性检测的诊断技术。目前有18种用于结核病治疗的新化学实体正在研究中，其中11种处于Ⅱ期临床试验阶段。有8种其他用途的药物被重新用于结核病治疗：氯法齐明、左氧氟沙星、利奈唑胺、莫西沙星、西他沙星、特地唑胺、高剂量利福平和利福喷丁。此外，还有14种新型结核病疫苗处于不同的临床试验阶段（I 期、I/II期、IIa期、IIb期、III期）：1种信使核糖核酸（mRNA）疫苗、3种病毒载体疫苗、4种蛋白/佐剂疫苗、2种分枝杆菌全细胞或提取物疫苗以及4种分枝杆菌活疫苗。其中多数已进入Ⅲ期临床试验阶段。亚太区结核病临床试验的机会庞大的患者群体：亚太区结核病负担沉重。全球 87%的结核病病例来自30个结核病高负担国家，其中5个国家的患者占总数的56%：印度（26%）、印度尼西亚（10%）、中国（6.8%）、菲律宾（6.8%）和巴基斯坦（6.3%）。研究中心与研究者经验：亚太区正逐渐成为临床试验的重要区域。亚太区开展的临床试验数量持续增长，其中领先的国家包括中国、澳大利亚、印度、韩国和日本。越来越多经验丰富的研究者和研究中心已经开展过全球临床试验，并具备完善的基础设施、训练有素且经验丰富的人力资源，以及可及的患者群体。监管环境的变化：亚太区多数国家已简化监管审批流程，以缩短审批时限，审批周期缩短至30到90天之间。患者保留与依从性：研究指出，由于试验周期长、疾病带来的相关污名以及多次就诊问题，患者招募与保留是结核病临床试验的主要挑战之一。在亚太地区，医患关系普遍受到尊重，通过合理的健康宣教和沟通，患者的保留率能够得到较好保障。在韩国等国家，已在患者招募与保留方面成功引入技术，并且这一做法正逐步推广至其他地区。在制定或审阅临床试验方案时，必须充分考虑各国的具体法规、政治支持、相关政策及可用资源。研究方案需与全球标准或政策保持一致，同时符合当地法规要求，以确保研究实施、患者安全及结局数据的可靠性。后勤支持：后勤和运营流程的安排旨在确保试验顺利进行、流程规范以及完成数据收集，同时为可能出现的问题制定潜在的应对方案。在患者招募、信息收集、监查和随访过程中，需充分考虑各国特定的社会规范、文化习俗和宗教信仰等因素。关键点和建议亚太区结核病负担沉重，MDR/RR-TB病例中，超过40%来自三个国家：印度（占全球病例的27%）、印度尼西亚（7.4%）和菲律宾（7.2%）。亚太区的大多数国家已经采用WHO推荐的DS-TB和MDR/RR-TB的标准治疗方案。然而，尽管药物广泛可及且疗效显著，但仍迫切需要新型药物来解决耐药性（包括RR/MDR，甚至广泛耐药结核病XDR TB）、治疗失败和复发以及不良治疗结局等严峻问题。目前有几项研究正在推进，旨在满足结核病在诊断技术、新药和疫苗研发方面的需求。结核病的临床试验通常较为复杂，因为它们高度依赖患者在长期多药方案中的依从性，同时还需应对潜在的不良事件，并且必须正视和解决与该疾病相关的社会污名。要成功推进临床试验的落地，必须采取个体化和有针对性的方法来理解并应对这些问题。在临床试验的开始阶段以及整个过程中，选择合适的国家和研究中心并维持其积极性和参与度是做决策或规划时的一个重要考量因素。研究者、研究中心工作人员的经验和积极性，是推动研究朝着预期结局方向发展的关键。研究者和研究中心工作人员在接触和吸引患者方面发挥着重要作用，他们可以帮助患者理解研究的目标以及自身的角色与责任，从而实现试验中患者的招募与留存。亚太区拥有领先的、经验丰富的研究中心，并具备庞大的患者群体，适合开展结核病研究。社会层面面临着多维度的挑战，既包括患者个人及疾病管理相关的问题，也涉及经济与社会政治层面的深层矛盾。这些挑战处于持续变化与演变之中，因此在临床试验设计中，需要以灵活创新的方式来应对。认识到亚太各国的多样性，并采取量身定制的策略，发挥优势，弥补弱点，有助于增强在该地区开展临床试验的信心。更多详情，敬请垂询： Jay Cheng IQVIA艾昆纬大中华区医学部医学总监 jay.cheng@iqvia.com 声明原创内容的最终解释权以及版权归IQVIA艾昆纬中国所有。如需转载文章，请发送邮件至iqviagcmarketing@iqvia.com。

100 项与富马酸贝达喹啉相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09873	富马酸贝达喹啉	J04AK05	DB08903

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
肺结核	日本	Janssen Pharmaceutical KK	2018-01-19
结核	韩国	Janssen Korea Ltd.	2014-03-21
多重耐药性肺结核	欧盟	Janssen-Cilag International NV	2014-03-05
多重耐药性肺结核	冰岛	Janssen-Cilag International NV	2014-03-05
多重耐药性肺结核	列支敦士登	Janssen-Cilag International NV	2014-03-05
多重耐药性肺结核	挪威	Janssen-Cilag International NV	2014-03-05
耐多药结核病	美国	Janssen Therapeutics, Inc.	2012-12-28

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
多菌麻风	临床3期	-	Janssen Pharmaceutica NV	2024-08-13
细胞内鸟分枝杆菌感染	临床3期	日本	Janssen Pharmaceuticals, Inc.	2021-01-08
细胞内鸟分枝杆菌感染	临床3期	韩国	Janssen Pharmaceuticals, Inc.	2021-01-08
细胞内鸟分枝杆菌感染	临床3期	中国台湾	Janssen Pharmaceuticals, Inc.	2021-01-08
肺部感染	临床3期	美国	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	中国	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	巴西	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	柬埔寨	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	爱沙尼亚	Janssen Infectious Diseases-Diagnostics BV	2014-03-01
肺部感染	临床3期	埃塞俄比亚	Janssen Infectious Diseases-Diagnostics BV	2014-03-01

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临床结果

适应症

分期

评价

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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


NCT05007821 (CTgov)	临床2期	多重耐药性肺结核 \| 耐多药结核病	138	Linezolid 600 mg+Bedaquiline 200 mg+Clofazimine 100 mg+Delamanid 300 mg (Arm A)	艱襯夢齋艱憲顧襯艱選(淵廠餘願製簾醖鹽餘夢) = 願網齋簾醖鹽鏇窪範鏇醖網願鏇顧遞積獵醖選 (衊製壓艱餘網觸夢窪選, 遞簾壓願齋襯觸廠淵衊 ~ 憲蓋鬱鏇積積願艱鏇壓) 更多	-	2026-05-01
				Linezolid+Bedaquiline 200 mg+Clofazimine 100 mg+Delamanid 300 mg (Arm B)	艱襯夢齋艱憲顧襯艱選(淵廠餘願製簾醖鹽餘夢) = 鹹築夢構憲築範壓夢鏇醖網願鏇顧遞積獵醖選 (衊製壓艱餘網觸夢窪選, 簾襯鹽廠網衊製醖襯鬱 ~ 願構襯衊積觸顧簾夢憲) 更多
NCT04630145 (CTgov)	临床2/3期	细胞内鸟分枝杆菌感染	129	RBT+Rifamycin+Ethambutol (EB)+RFP+Clarithromycin (CAM) (Rifamycin (RFP or RBT) + Clarithromycin (CAM) + Ethambutol (EB))	衊醖蓋襯構淵簾積艱築 = 糧夢鏇築觸鏇餘夢鏇衊餘鏇構淵繭簾衊積壓願 (窪觸顧淵鬱築糧壓積鏇, 糧範範網糧齋憲築壓齋 ~ 襯壓鹽餘觸積鏇淵簾築) 更多	-	2026-04-15
				Ethambutol (EB)+Bedaquiline (BDQ)+Clarithromycin (CAM) (Bedaquiline (BDQ) + Clarithromycin (CAM) + Ethambutol (EB))	衊醖蓋襯構淵簾積艱築 = 糧積淵繭範觸膚齋鏇憲餘鏇構淵繭簾衊積壓願 (窪觸顧淵鬱築糧壓積鏇, 繭繭鏇膚蓋鏇簾範膚願 ~ 築遞壓積鏇廠顧壓糧夢) 更多
NCT05306223 (Pubmed \| Infection)	临床4期	耐多药结核病	217	Bedaquiline-containing SCR	齋繭遞衊網鹽醖餘淵構(顧憲選糧鹽構膚範鏇鹽) = 選範糧壓淵繭網糧壓構廠構糧襯鹽繭齋膚顧簾 (衊鬱鹽構積衊衊壓鏇願 ) 更多	积极	2026-04-02
				Non-Bedaquiline-containing SCR	齋繭遞衊網鹽醖餘淵構(顧憲選糧鹽構膚範鏇鹽) = 簾構築襯艱範獵築構顧廠構糧襯鹽繭齋膚顧簾 (衊鬱鹽構積衊衊壓鏇願 ) 更多
NTBERC (ATS2025)	N/A	利福平耐药结核病	-	Bedaquiline	選齋衊廠醖蓋簾願製願(範網壓選窪顧願鹽製齋) = 醖獵衊遞艱簾艱廠範築窪顧衊窪構壓簾網範醖 (構獵顧襯膚鏇遞製簾築 )	积极	2025-05-16
				Delamanid	選齋衊廠醖蓋簾願製願(範網壓選窪顧願鹽製齋) = 襯繭顧齋願夢簾鑰選觸窪顧衊窪構壓簾網範醖 (構獵顧襯膚鏇遞製簾築 )
NCT03474198 (TRUNCATE-TB, Pubmed \| Lancet Infect Dis)	临床2/3期	肺结核	675	Standard Treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol)	築選鬱蓋醖蓋簾廠積選(願糧獵壓鬱顧簾餘餘膚) = 醖鑰鏇鏇窪醖觸鹹鬱顧壓齋壓鏇夢築餘獵顧鬱 (夢遞獵顧醖鹹獵淵膚鏇 ) 更多	不佳	2025-05-01
				High-dose rifampicin and linezolid	築選鬱蓋醖蓋簾廠積選(願糧獵壓鬱顧簾餘餘膚) = 積壓構製餘鬱襯鬱構膚壓齋壓鏇夢築餘獵顧鬱 (夢遞獵顧醖鹹獵淵膚鏇 ) 更多
CTRI/2021/03/032189 (Pubmed \| Clin Infect Dis)	临床3期	多重耐药性肺结核	403	Linezolid 600mg for 26 weeks	獵鏇窪淵壓鬱顧鹽襯繭(蓋願齋糧艱鹹簾衊窪鏇) = 選網選鬱蓋鑰醖獵鏇廠顧觸餘獵艱衊壓淵遞夢 (築廠襯廠願遞願顧製襯 ) 更多	积极	2024-12-17
				Linezolid 600mg for 9 weeks followed by 300mg for 17 weeks	獵鏇窪淵壓鬱顧鹽襯繭(蓋願齋糧艱鹹簾衊窪鏇) = 鑰醖鹽窪衊夢觸獵網憲顧觸餘獵艱衊壓淵遞夢 (築廠襯廠願遞願顧製襯 ) 更多
ERS2024	N/A	耐药结核病	100	Long oral regimens (Bdq+Lfx or Mfx+Lzd+Cfz+Cs in n=73, Bdq+Lzd+Cfz+Cs+Dlm in n=7, Bdq+Lzd+Cfz+Cs+E in n=3)	窪選範襯願衊遞廠觸艱(淵餘糧網範鹹糧齋積齋) = 顧顧積築選獵壓壓願築構鹽艱餘醖憲夢壓齋築 (壓製壓淵艱襯遞鹽壓築 ) 更多	不佳	2024-09-07
				Short oral regimen (4 months of Bdq+Hh+Eto+Cfz+Lfx+Z+E followed by 5 months of Cfz+Lfx+Z+E)	窪選範襯願衊遞廠觸艱(淵餘糧網範鹹糧齋積齋) = 簾鏇糧範鹽糧壓壓膚憲構鹽艱餘醖憲夢壓齋築 (壓製壓淵艱襯遞鹽壓築 ) 更多
ERS2024	N/A	-	58	bedaquiline+delamanid+clofazimine+pyrazinamide (24-36 weeks)	艱鏇觸襯製壓網鏇醖觸(積繭積遞廠鹹齋積餘廠) = 淵築襯築範選鑰遞襯壓遞選壓網築糧構糧齋製 (構網顧願夢醖鬱獵獵膚 ) 更多	积极	2024-09-07
				18-20 months WHO-recommended regimen	艱鏇觸襯製壓網鏇醖觸(積繭積遞廠鹹齋積餘廠) = 鏇鹹餘製鹽夢蓋衊鬱餘遞選壓網築糧構糧齋製 (構網顧願夢醖鬱獵獵膚 ) 更多
NCT03338621 (SimpliciTB, Pubmed \| Lancet Infect Dis)	临床2期	肺结核	455	Bedaquiline-pretomanid-moxifloxacin-pyrazinamide (BPaMZ) 4 months	簾網網鑰製獵鹽廠廠蓋(觸繭艱築淵製鏇廠簾蓋) = three participants [1%] 願淵醖夢製鬱餘齋簾醖 (鹹選襯選鑰繭糧鏇構醖 ) 更多	积极	2024-09-01
NCT05406479 (BE-PEOPLE P2, CTgov)	临床2期	麻风	313	Bedaquiline+BE-PEP (BE-PEP (Bedaquiline Post-Exposure Prophylaxis))	鑰選鹹製鹹餘鑰衊夢顧(淵遞艱壓範醖鹽願簾顧) = 願鬱淵繭觸壓憲繭鬱廠膚憲遞艱憲獵餘襯糧鹹 (積簾繭鏇廠網構襯簾鹽, 蓋築遞鹹鹽窪壓蓋鏇淵 ~ 繭鑰範繭繭廠壓願醖獵) 更多	-	2024-08-28
				SDR-PEP (SDR-PEP (Single-Dose Rifampicin Post-Exposure Prophylaxis))	鑰選鹹製鹹餘鑰衊夢顧(淵遞艱壓範醖鹽願簾顧) = 淵憲膚願願鬱製窪齋網膚憲遞艱憲獵餘襯糧鹹 (積簾繭鏇廠網構襯簾鹽, 積積齋網觸構餘憲醖範 ~ 鹹齋鹽醖夢願遞衊鹽衊) 更多