A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Dose and Multiple-Dose Continuous Intravenous Infusions of TNP-2092 for Injection in Healthy Chinese Participants

This is a phase 1, single-center, randomized, double-blind, placebo-controlled, dose-escalation clinical trial of single and multiple intravenous doses of TNP-2092 for injection in healthy Chinese participants.

开始日期2022-07-07

申办/合作机构

丹诺医药（苏州）有限公司

CTR20221320 / Completed临床1期

评价注射用TNP-2092单剂给药、多剂连续静脉输注给药在中国健康受试者中的安全性、耐受性和药代动力学特征的单中心、随机、双盲、安慰剂对照、剂量递增I期临床试验

评价注射用TNP-2092在中国健康受试者中单剂、多剂连续静脉输注给药的安全性和耐受性；评价注射用TNP-2092在中国健康受试者中单剂、多剂连续静脉输注给药的药代动力学特征。

开始日期2022-07-07

申办/合作机构

University of Iowa Pharmaceuticals

[+1]

NCT05074134 / Completed临床1期

An Open Label Phase 1 Study in Healthy Adult Male Subjects to Investigate the Absorption, Metabolism, and Excretion of [14C]-TNP-2092 Following a Single Intravenous Dose Administration

This is an open-label, single dose, Phase 1 study conducted at a single study center in the United States (USA). This study will evaluate the absorption, metabolism and elimination (AME), mass balance, safety and tolerability of a single dose of intravenously administered [14C]-TNP-2092.
Healthy men aged 18 to 55, will be screened, and subjects who meet all eligibility criteria and provide written informed consent will be enrolled into the study within 28 days of Screening.
Subjects will be admitted to the clinical unit on the day prior to dosing (Day -1). Subjects will fast overnight and then given a standard breakfast 30 min prior to dosing.
Six subjects will be enrolled in the study and each will receive a single intravenous (IV) dose of 300 mg/3 μCi [14C]-TNP-2092 administered over 60 minutes (±10 minutes).

开始日期2021-10-16

申办/合作机构

丹诺医药（苏州）有限公司

100 项与 Rifaquizinone 相关的临床结果

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100 项与 Rifaquizinone 相关的转化医学

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100 项与 Rifaquizinone 相关的专利（医药）

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项与 Rifaquizinone 相关的文献（医药）

2022-05-01·Current Medicinal Chemistry2区 · 医学

A Comparative Insight on the Newly Emerging Rifamycins: Rifametane, Rifalazil, TNP-2092 and TNP-2198

2区 · 医学

Review

作者: Nazli, Adila ; Xu, Huacheng ; He, Yun ; Wang, Zhi-Peng ; He, David L

Abstract::

Rifamycins are considered a milestone for tuberculosis (TB) treatment because of their proficient sterilizing ability. Currently, available TB treatments are complicated and need a long duration, which ultimately leads to failure of patient compliance. Some new rifamycin derivatives, i.e., rifametane, TNP-2092 (rifamycin-quinolizinonehybrid), and TNP-2198 (rifamycin-nitromidazole hybrid) are under clinical trials, which are attempting to overcome the problems associated with TB treatment. The undertaken review is intended to compare the pharmacokinetics, pharmacodynamics and safety profiles of these rifamycins, including rifalazil, another derivative terminated in phase II trials, and already approved rifamycins. The emerging resistance of microbes is an imperative consideration associated with antibiotics. Resistance development potential of microbial strains against rifamycins and an overview of chemistry, as well as structure-activity relationship (SAR) of rifamycins, are briefly described. Moreover, issues associated with rifamycins are discussed as well. We expect that newly emerging rifamycins shall appear as potential tools for TB treatment in the near future.

2020-08-01·Future microbiology3区 · 生物学

Rifamycin use for treatment of Helicobacter pylori infection: a review of recent data

3区 · 生物学

Review

作者: Boyanova, Lyudmila ; Markovska, Rumyana ; Kandilarov, Nayden ; Hadzhiyski, Petyo ; Mitov, Ivan

Helicobacter pylori eradication has become increasingly challenging. We focused on recent data about rifamycin resistance and rifamycin-containing regimens. Rifampin (rifampicin) resistance rates were <1–18.8% (often ≤7%), while those to rifabutin were 0–<4%. To detect rifabutin resistance by rifampin, 4 mg/l breakpoint was suggested. Eradication success by rifaximin-based regimens was disappointing (<62%), while that of rifabutin-containing regimens was 54.5–>96%, reaching >81% in four studies. Some newer rifamycin analogs like TNP-2092 need further investigation. Briefly, although rifabutin-based regimens carry a risk of adverse effects or increasing mycobacterial resistance, they may be a rational choice for some multidrug-resistant H. pylori strains and as a third-line eradication therapy. Bismuth addition to rifabutin-based therapy and combined rifabutin-containing capsules (Talicia) are promising treatment options.

2020-07-01·Diagnostic microbiology and infectious disease4区 · 医学

In vitro activity of TNP-2092 against periprosthetic joint infection–associated staphylococci

4区 · 医学

Article

作者: Schmidt-Malan, Suzannah M ; Ma, Zhenkun ; Patel, Robin ; He, Shijie ; Yuan, Ying ; Fisher, Cody R

Staphylococci are the most common causes of periprosthetic joint infection (PJI). TNP-2092 is an investigational hybrid drug composed of rifamycin and quinolizinone pharmacophores conjugated via a covalent linker. We determined minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), and minimum biofilm bactericidal concentration (MBBC) values of TNP-2092 against 80 PJI-associated Staphylococcus aureus and Staphylococcus epidermidis isolates compared to ciprofloxacin and rifampin alone and in combination, alongside daptomycin and vancomycin. TNP-2092 exhibited the following activity against S. aureus: MIC₅₀/MIC_90, ≤0.0075/0.015 μg/mL; MBC₅₀/MBC₉₀, 0.5/4 μg/mL; and MBBC₅₀/MBBC₉₀, 0.5/2 μg/mL, and the following activity against S. epidermidis: MIC₅₀/MIC₉₀, ≤0.0075/0.015 μg/mL; MBC₅₀/MBC₉₀, 0.015/0.125 μg/mL; and MBBC₅₀/MBBC₉₀, 0.06/0.25 μg/mL. TNP-2092 MIC, MBC, and MBBC values were >8 μg/mL for 1 isolate, while MIC values were ≤0.25 μg/mL and MBC and MBBC values were ≤4 μg/mL for all other isolates. Results of this study show that TNP-2092 has promising in vitro activity against PJI-associated staphylococci.

项与 Rifaquizinone 相关的新闻（医药）

2024-02-27

·Business Wire

Helicobacter Pylori Infection Pipeline Insight Report 2024: Insights About 5+ Companies and 5+ Pipeline Drugs Featuring TenNor Therapeutics, Servatus Biopharmaceuticals, and TenNor Therapeutics - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Helicobacter Pylori Infection - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Helicobacter Pylori Infection pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Helicobacter Pylori Infection R&D. The therapies under development are focused on novel approaches to treat/improve Helicobacter Pylori Infection. Helicobacter Pylori Infection Emerging Drugs Chapters This segment of the Helicobacter Pylori Infection report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Helicobacter Pylori Infection Emerging Drugs TNP-2198: TenNor Therapeutics (Suzhou) Limited Rifasutenizole (TNP-2198) is a new molecule entity discovered and developed by TenNor specifically for the treatment of H. pylori infection. Its multi-targeting synergistic mechanism delivers low drug resistance frequencies, maintaining excellent bactericidal activities against H. pylori strains isolated from various regions. Rifasutenizole has the potential to streamline the eradication regimes of H. pylori so as to improve the compliance and enable a seamless connection to the urea breath test (UBT), rendering the possibility of carrying out screening-eradication on large scale. TenNor is currently conducting a multi-center, randomized, double-blind, bismuth-containing quadruple therapy-controlled Phase III study to evaluate the efficacy and safety of Rifasutenizole in the primary treatment of patients with H. pylori infection. SVT1C4610: Servatus Biopharmaceuticals SVT1C4610 is a live biotherapeutic type of drug. Its mechanism include Bacteria replacements, gastrointestinal microbiome modulators. Its main therapeutic area is infectious disease control. Currently, the drug is in phase I stage of its clinical trial for the treatment of H. pylori infection. Major Players in Helicobacter Pylori Infection There are approx. 5+ key companies which are developing the therapies for Helicobacter Pylori Infection. The companies which have their Helicobacter Pylori Infection drug candidates in the most advanced stage, i.e. Phase III include, TenNor Therapeutics (Suzhou) Limited. Helicobacter Pylori Infection: Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Helicobacter Pylori Infection therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Helicobacter Pylori Infection drugs. Phases Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Helicobacter Pylori Infection Report Insights Helicobacter Pylori Infection Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Helicobacter Pylori Infection Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players TenNor Therapeutics (Suzhou) Limited Servatus Biopharmaceuticals TenNor Therapeutics Inc. Key Products TNP-2198 SVT-1C4610 TNP-2092 For more information about this clinical trials report visit https://www.researchandmarkets.com/r/ck4nzd About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

临床3期临床1期临床2期基因疗法

2024-01-08

·BioBAY

研发动态丨朗信生物AAV基因治疗药物“LX102注射液”IND获FDA许可

近日，BioBAY园内企业朗信生物宣布，其自主研发的AAV眼科基因治疗药物LX102注射液获得美国食品药品监督管理局（FDA）授予新药临床试验（IND）许可，即将启动国际多中心临床试验。LX102注射液采用腺相关病毒（AAV）携带抗VEGF编码序列，通过眼内注射高效转导视网膜细胞表达抗VEGF蛋白，具有特异性抑制VEGF生物活性的作用。经过全面深入的临床前研究验证，LX102注射液在靶向性、转导效率方面表现出卓越的优效性。单次给药后，该注射液展现出高效持久的眼内新生血管抑制疗效，同时具备良好的安全性。朗信生物创新的AAV基因治疗平台完成了支持LX102注射液在美国的IND申报和临床研究药物的工艺开发与GMP生产。该平台涵盖了质粒、细胞和病毒载体工艺开发、分析开发、GMP生产和质控体系，为公司的研发项目提供全面的基因治疗药物支持。这一系列成就将进一步加强朗信生物在基因治疗领域的领先地位。朗信生物LX102注射液在中国已进入II期临床试验，且已完成首例患者入组。该临床试验是国内首个nAMD基因治疗多中心、随机对照研究，率先在上海市第一人民医院、浙江大学医学院第二医院、中国科学技术大学附属第一医院正式启动，后续还将在全国10余家临床中心进行招募入组。旨在进一步评估视网膜下注射LX102治疗新生血管性AMD的安全性和有效性，为未来确证性临床试验提供更多的数据支持。据目前的临床研究结果所示：LX102通过视网膜下注射给药的15例受试者显示了良好的安全性和耐受性，未见LX102相关不良事件（AE）发生。初步有效性数据显示，爬坡阶段各剂量组的LX102均能迅速逆转或控制疾病进展，使不同病程的nAMD患者仍可获得最佳矫正视力（BCVA）稳定甚至改善，从而提升生活质量。连同此前开展的2项IIT研究，LX102在中国多家中心已获得11例nAMD受试者超过12个月的随访数据，结果显示有效率为100%，同时，11名患者全部无需抗体挽救治疗（抗体国际标准年化治疗次数6-12次）。首例患者在长达24个月随访中观察到了持续的病情缓解和视力稳定改善，而此前患者年化治疗次数高达9次。和目前国际在研同类产品的挽救（或称补充）治疗率13%~75%相比，LX102临床疗效显著优于国际同类产品。相关研究结果将在2024年美国新生血管年会正式发布。 ▌文章来源：朗信生物责编：赵家帅审核：任旭推荐阅读研发动态丨新元素医药：抗急性痛风创新药「ABP-745」在美国获批IND研发动态丨丹诺医药TNP-2092软膏治疗糖尿病足感染获批临床研发动态丨丹码生物首个管线DM919的IND申请获FDA批准

临床申请基因疗法临床1期

2024-01-03

·BioBAY

研发动态丨新元素医药：抗急性痛风创新药「ABP-745」在美国获批IND

1月2日，BioBAY园内企业新元素医药宣布抗炎症领域小分子创新药ABP-745获得美国食品药品监督管理局（FDA）临床试验IND的批准，适应症为急性痛风，本月起将在美国开展1期临床试验。同时，ABP-745已完成了中国IND申请的递交，获得临床批件后也即将在中国开展1期临床试验。临床前试验结果表明，ABP-745可显著降低动物体内多种炎症因子的水平，与同类药物相比，药效良好，安全性具有很大的提升。ABP-745早期的临床适应症为急性痛风的治疗。基于ABP-745对多种炎症因子良好的抑制作用，该试验药物也将用于其它相关适应症的研究。急性痛风是由尿酸盐晶体的积聚引起的，表现为关节突然剧烈疼痛和肿胀，通常发生在下肢部位。尿酸盐晶体的形成是由高尿酸血症（血液中尿酸水平超过7mg/dL）引起的，长期的高尿酸血症会促使慢性痛风的发展，从而进一步导致急性痛风的反复发作。痛风是炎症性关节炎中最常见的一种慢性疾病，影响着全球5000多万人。美国、欧洲、亚洲和拉丁美洲等地的痛风患者数量较多，且仍在保持不断增长的趋势。如果不及时治疗，痛风会严重影响患者的生活质量，并会引起其他严重的并发症，包括肾功能损伤，心脏性猝死概率增加等。新元素医药正在开发一种口服小分子URAT1抑制剂ABP-671，用于治疗慢性痛风。该药物旨在降低患者的血尿酸水平，目前正在全球范围内开展关键性多中心临床试验。新元素医药创始人、董事长兼CEO史东方博士表示：“新元素医药产品ABP-745此次IND获批，是公司抗炎症领域新药的重要进展。我们将很快在美国启动急性痛风的1期临床试验。未来，公司将继续针对尚未满足的临床需求，加大抗炎领域多项适应症的投入和研发，丰富和完善公司的产品管线。”▌文章来源：药融圈责编：何文正审核：任旭推荐阅读研发动态丨丹诺医药TNP-2092软膏治疗糖尿病足感染获批临床研发动态丨丹码生物首个管线DM919的IND申请获FDA批准研发动态丨映恩生物：与BioNTech 共同宣布DB-1303/BNT323获FDA突破性疗法认定

临床申请临床1期突破性疗法

100 项与 Rifaquizinone 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
皮肤和皮肤结构感染	临床3期	中国	丹诺医药（苏州）有限公司	2022-02-26
腹泻型肠易激综合征	临床2期	中国	丹诺医药（苏州）有限公司	2021-09-09
高氨血症	临床2期	中国	丹诺医药（苏州）有限公司	2020-08-27
肝硬化	临床2期	中国	丹诺医药（苏州）有限公司	2020-08-27
肝性脑病	临床2期	中国	丹诺医药（苏州）有限公司	2020-08-25
革兰氏阳性细菌感染	临床2期	美国	丹诺医药（苏州）有限公司	2019-04-20
细菌性皮肤疾病	临床2期	美国	丹诺医药（苏州）有限公司	2019-04-20
假体关节感染	临床1期	美国	丹诺医药（苏州）有限公司	2021-03-01
幽门螺杆菌感染	临床1期	-	丹诺医药（苏州）有限公司	2016-11-07
糖尿病足感染	临床申请批准	中国	丹诺医药（中山）有限公司	2023-12-27

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适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT06135675 (CTgov)	临床1/2期	高氨血症 \| 肝硬化	36	TNP-2092 capsules (TNP-2092 Capsules 100mg Twice Daily(BID))	憲積構鏇憲憲齋築觸艱(鏇顧觸鬱淵鹽蓋遞遞遞) = 鑰夢淵夢齋製觸糧觸鑰窪醖願觸淵積憲醖鏇鹹 (願壓窪夢獵齋獵築壓鑰, 鏇餘鹽餘顧蓋鑰齋簾選 ~ 網艱鏇膚製餘網膚選壓) 更多	-	2024-05-10
				TNP-2092 capsules (TNP-2092 Capsules 300mg BID)	憲積構鏇憲憲齋築觸艱(鏇顧觸鬱淵鹽蓋遞遞遞) = 襯憲構製窪夢壓觸範憲窪醖願觸淵積憲醖鏇鹹 (願壓窪夢獵齋獵築壓鑰, 製窪繭艱膚繭繭鹽餘醖 ~ 鑰糧願膚憲網蓋網鑰鹹) 更多
NCT03964493 (P2_ABSSSI, CTgov)	临床2期	细菌性皮肤疾病 \| 革兰氏阳性细菌感染 \| 皮肤和皮肤结构感染	120	TNP-2092 (TNP-2092)	齋築願積憲糧廠鏇糧襯(齋艱構鏇鹹鏇齋夢襯獵) = 糧網衊鑰餘鑰網鑰積觸繭鹽觸鹹衊鹽淵壓範艱 (遞觸鹽積繭選築衊構鏇, 積鹹蓋繭範襯襯選膚鏇 ~ 鬱淵繭膚獵蓋衊夢範襯) 更多	-	2023-12-01
				Vancomycin (Vancomycin)	齋築願積憲糧廠鏇糧襯(齋艱構鏇鹹鏇齋夢襯獵) = 網窪構膚鹹廠簾廠襯繭繭鹽觸鹹衊鹽淵壓範艱 (遞觸鹽積繭選築衊構鏇, 繭鹹艱糧壓積網鬱鑰蓋 ~ 齋遞選蓋願遞製醖簾範) 更多
NCT03964493 (P2_ABSSSI, Biospace) 人工标引	临床2期	皮肤和皮肤结构感染	-	TNP-2092	鑰網簾壓構醖壓觸鹽積(簾網窪壓鹹獵製襯夢獵) = 襯鹹夢觸鬱廠鏇襯鹹壓蓋餘窪廠醖艱醖選醖廠 (鬱網餘窪願範製淵蓋夢 ) 更多	积极	2019-11-11
				vancomycin	鑰網簾壓構醖壓觸鹽積(簾網窪壓鹹獵製襯夢獵) = 淵膚壓築壓積鬱鹹觸鏇蓋餘窪廠醖艱醖選醖廠 (鬱網餘窪願範製淵蓋夢 ) 更多