A Phase 1, Open-label Study to Characterize Single and Repeat Dose Pharmacokinetics (Including Food Effect) of Tebipenem-pivoxil-hydrobromide and Its Major Metabolite (SPR1349) in Healthy Participants

The main purpose of the study is to characterize the systemic pharmacokinetic (PK) parameters (plasma, whole blood) of tebipenem (TBP) pharmacologically active moiety of tebipenem-pivoxil-hydrobromide (TBP-PI-HBr) and its urinary excretion at different dose levels in healthy participants. The study also aims to assess the plasma and urine PK parameters of SPR1349, a major metabolite of TBP.

开始日期2024-11-20

申办/合作机构

Spero Therapeutics, Inc.

[+1]

CTR20241033

/ CompletedN/A

替比培南匹伏酯细粒剂在健康受试者中随机、开放、两制剂、两序列、单次给药、两周期交叉设计空腹和餐后状态下生物等效性试验

主要目的：以石药集团中诺药业（石家庄）有限公司生产的替比培南匹伏酯细粒剂为受试制剂，以Meiji Seikaファルマ的替比培南匹伏酯细粒剂（商品名：ORAPENEM）为参比制剂，按生物等效性试验的相关规定，比较替比培南匹伏酯细粒剂在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：评价健康受试者单次空腹/餐后口服替比培南匹伏酯细粒剂受试制剂和参比制剂后的安全性。研究替比培南匹伏酯细粒剂在健康受试者血浆和尿液中可能的代谢产物，研究替比培南在尿液中的PK特征。

开始日期2024-04-17

申办/合作机构

石药集团中诺药业（石家庄）有限公司

NCT06059846

/ Completed临床3期

A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)

The primary purpose of this study is to assess the efficacy of oral TBP-PI-HBr as compared with intravenous (IV) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the Test-of-Cure (TOC) visit in hospitalized adult participants (≥18 years of age) with cUTI or AP.

开始日期2023-12-21

申办/合作机构

Spero Therapeutics, Inc.

[+1]

100 项与替比培南酯相关的临床结果

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100 项与替比培南酯相关的转化医学

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100 项与替比培南酯相关的专利（医药）

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167

项与替比培南酯相关的文献（医药）

2025-08-13·mBio

Exploring β-lactam interactions with DacB1: unraveling optimal therapies for combating drug-resistant Mycobacterium tuberculosis

Article

作者: Nantongo, Mary ; Kurz, Sebastian G. ; Dousa, Khalid M. ; Nguyen, David C. ; Shin, Eunjeong ; Bethel, Christopher R. ; Li, Qing ; Rubin, Eric J. ; Fletcher, Shane ; Kreiswirth, Barry N. ; Boom, W. Henry ; Taracila, Magdalena A. ; Holland, Steve ; Bonomo, Robert A.

ABSTRACT:

Tuberculosis (TB) continues to pose a global public health threat, exacerbated by rising drug-resistant strains of Mycobacterium tuberculosis (Mtb). DacB1, a D,D-carboxypeptidase critical in Mtb peptidoglycan biosynthesis, is a promising target for β-lactam antibiotics (BLs), which remain underutilized in TB treatment. Dual BL therapy may enhance efficacy by inactivating multiple targets within the peptidoglyan synthesis pathway. Minimum inhibitory concentrations (MICs) for β-lactams and β-lactamase inhibitors against Mtb H37Ra, H37Rv, and clinical isolates showed that imipenem, meropenem, or tebipenem MICs were reduced when combined with amoxicillin or ceftriaxone or β-lactamase inhibitors such as clavulanate or durlobactam. Timed electrospray ionization mass spectrometry (ESI-MS) captured acyl-enzyme adducts between DacB1 and BLs, revealing binding interactions with carbapenems (imipenem, meropenem, and tebipenem) but not most penicillins or cephalosporins except cloxacillin and cefoxitin. Differential scanning fluorimetry (DSF) combined with circular dichroism (CD) confirmed physical and structural changes in DacB1 upon BL binding despite no alteration in melting temperature. Carbapenem-DacB1 interactions were notably faster with imipenem, likely due to reduced steric hindrance compared to meropenem and tebipenem. Molecular modeling revealed conserved penicillin-binding protein motifs within the active site of DacB1: S 121 XXK124, S176XN178, and K282TG284 (PDB ID # 4PPR). Building on this, molecular docking suggested favorable interactions between these motifs and the carbapenems: the carbapenem carbonyl group aids in positioning within DacB1’s oxyanion hole, ready for acylation, while hydrophobic interactions with the cyclic R2 side chains and C1 methyl groups in meropenem and tebipenem contribute to steric hindrance hence slow acyl-enzyme formation. These findings enhance our understanding of DacB1 inhibition and suggest that carbapenems, particularly in combination therapies, hold promise as effective TB treatments.

IMPORTANCE:

TB remains a significant public health threat, particularly due to the rising prevalence of drug-resistant Mtb strains. Current treatment options for drug-resistant TB are costly, toxic, and often ineffective, necessitating the exploration of alternative therapeutic strategies. This study is of critical importance as it investigates the potential of β-lactam antibiotics (BLs), a class historically considered ineffective against Mtb, for repurposing in TB treatment. By targeting DacB1, a key enzyme in Mtb peptidoglycan biosynthesis, this research provides new insights into the mechanism of β-lactam interactions and their potential to disrupt cell wall synthesis. The findings demonstrate that dual β-lactam therapy and β-lactam/β-lactamase inhibitor combinations enhance antibiotic efficacy, suggesting a promising avenue for combating drug-resistant TB. Furthermore, structural and molecular analyses confirm that carbapenems, particularly imipenem, meropenem, and tebipenem, effectively bind to DacB1, paving the way for optimized treatment strategies. Given the challenges in developing new TB drugs, repurposing β-lactams offers a cost-effective and readily implementable solution to address antimicrobial resistance. This study contributes valuable knowledge that could accelerate the development of novel TB therapies, improve treatment success rates, and ultimately reduce TB-related mortality worldwide.

2025-08-08·Journal of Global Antimicrobial Resistance

SUSCEPTIBILITY OF MULTI-DRUG RESISTANT ESCHERICHIA COLI AND KLEBSIELLA PNEUMONIAE TO ORAL ANTIBIOTICS IN AUSTRALIA.

Article

作者: O'Neill, Bethany Rachel ; Jayawardena, Menuk ; Sandaradura, Indy ; Ginn, Andrew

OBJECTIVES:

In Australia, resistance to β-lactam-class antibiotics in Enterobacterales has increased. This study aimed to identify potential oral treatments for these multi-drug-resistant infections by investigating four β-lactam (mecillinam, tebipenem, sulopenem and faropenem) and three non-β-lactam (fosfomycin, omadacycline and delafloxacin) antibiotics, and to elucidate the genetic resistance mechanisms.

METHODS:

Seventy-four E. coli and twenty-four K. pneumoniae, with extended-spectrum β-lactamase or plasmid-mediated AmpC β-lactamases genes, were isolated from New South Wales hospital patients in 2021. Minimum inhibitory concentrations (MIC) were determined using Clinical and Laboratory Standards Institute guidelines with agar dilution for fosfomycin and mecillinam, and broth microdilution for the remaining antibiotics. Multiplex polymerase-chain-reaction and whole genome sequencing (Illumina) confirmed bacterial resistance mechanisms.

RESULTS:

The E. coli were mostly susceptible to mecillinam (97%), and had low MIC₉₀ to tebipenem, sulopenem and faropenem (0.125mg/L, 0.5mg/L and 4mg/L). K. pneumoniae were mostly susceptible to mecillinam (96%), and had low MIC₉₀ to tebipenem and sulopenem, but higher MIC₉₀ to faropenem (2mg/L, 2mg/L and 8mg/L). Moreover, the E. coli were mostly susceptible to fosfomycin and omadacycline, but not delafloxacin (100%, 95% and 16%); K. pneumoniae susceptibilities to these antibiotics were 92%, 50% and 17%, respectively. Resistance mechanisms included tet(A) and ramR mutations for omadacycline; gyrA, parC and qnr mutations for delafloxacin; and ompK36 gene deletions for fosfomycin, mecillinam, tebipenem, sulopenem and faropenem.

CONCLUSIONS:

The favourable results support the use of mecillinam, tebipenem, sulopenem, faropenem, fosfomycin and omadacycline against multi-drug resistant E. coli. Mecillinam, sulopenem and fosfomycin may be useful for multi-drug resistant K. pneumoniae in Australia.

2025-06-01·JOURNAL OF INFECTION AND CHEMOTHERAPY

Antimicrobial activity of tebipenem to Escherichia coli isolates from outpatients with complicated urinary tract infections

Article

作者: Tanaka, Kaori ; Hayashi, Masahiro ; Yasuda, Mitsuru ; Ito, Masaya

Extended-spectrum β-lactamases (ESBL)-producing Escherichia coli have emerged as a global concern in urinary tract infections (UTIs). This study investigated the susceptibility of clinical isolates of E. coli from complicated UTIs (cUTIs) to tebipenem pivoxil (TBPM), an oral carbapenem developed in Japan. In 2019, 229 non-ESBL-producing and 61 ESBL-producing E. coli strains were collected from five major hospitals in the Gifu Prefecture. Susceptibility was assessed following the Clinical and Laboratory Standards Institute guidelines (M07 and M100), and TBPM was compared with other commonly used antibiotics. The MIC₅₀ and MIC₉₀ values of TBPM for non-ESBL and ESBL-producing E. coli were ≤0.03 μg/mL, with MIC ranges of ≤0.03-0.25 μg/mL and ≤0.03-0.06 μg/mL, respectively, indicating its strong antimicrobial activity. Notably, no strains demonstrated reduced susceptibility to TBPM. These results were comparable to those of intravenous carbapenems such as imipenem and meropenem. Additionally, these findings align with the national Japanese surveillance data, suggesting that the trends observed in this study may reflect broader patterns across Japan. In the United States, an ongoing study is evaluating TBPM hydrobromide for cUTIs, highlighting its potential as an effective oral carbapenem. TBPM may be a promising treatment option for cUTIs caused by ESBL-producing E. coli, offering an alternative to intravenous therapies and potentially reducing the need for hospitalization. However, careful use of TBPM in antimicrobial stewardship programs is crucial to prevent resistance and ensure its continued efficacy in outpatient settings.

131

项与替比培南酯相关的新闻（医药）

2025-05-29

·药明康德

超90%患者肿瘤缩小！潜在“best-in-class”小分子达3期主要终点；潜在首款！GSK小分子有望今年递交上市申请……

潜在首款！GSK小分子疗法关键3期试验达主要终点，今年递交上市申请GSK与Spero Therapeutics今日宣布，其所开发的抗生素tebipenem HBr在关键3期PIVOT-PO临床试验中取得积极结果。基于该疗法用于治疗复杂性尿路感染（cUTI，包括肾盂肾炎）患者的中期分析疗效数据，独立数据监查委员会（IDMC）建议提前终止试验。GSK预计将在2025年下半年将试验结果递交给美国FDA，作为上市申请的一部分。根据新闻稿，如果获得批准，tebipenem HBr将成为治疗cUTI的首个美国FDA批准的口服碳青霉烯类抗菌药物。此次试验结果包含入组的1690例患者的数据。分析显示，试验达到主要终点：在住院cUTI（包括肾盂肾炎）成人患者中，tebipenem HBr在治愈评估访视（test-of-cure visit）时的总缓解率（包括临床治愈和微生物清除的复合指标）不劣于静脉注射的亚胺培南-西司他丁。IDMC在审查过程中未发现该药物新的安全问题，最常见的不良事件为腹泻和头痛。Tebipenem HBr（原名SPR994）是Spero所开发的一种碳青霉烯类口服抗生素。该抗生素自2009年起以商品名Orapenem在日本用于治疗肺炎、中耳炎和鼻窦炎的儿科感染。碳青霉烯类是抗生素的一个重要子类，已观察到它们在治疗耐药革兰氏阴性细菌感染方面是安全有效的。GSK在2022年9月取得该疗法的独家许可，使其可在除日本和某些其他亚洲国家和地区以外的所有地区对tebipenem HBr进行商业化。首款！百时美施贵宝单抗皮下制剂获欧盟委员会批准百时美施贵宝（Bristol Myers Squibb）今日宣布，欧盟委员会（EC）已批准Opdivo（nivolumab，纳武利尤单抗）皮下注射剂（600 mg/瓶），用于多种成人实体瘤的治疗，包括单药治疗、静脉注射Opdivo联合Yervoy（伊匹单抗）治疗后的单药维持治疗，或与化疗或卡博替尼联合使用。根据新闻稿，Opdivo是在欧盟首个获批可皮下注射使用的PD-1抑制剂。这次欧盟委员会的批准主要基于CheckMate-67T的临床试验结果，显示Opdivo皮下注射剂（n=248）与静脉注射剂（n=247）在药代动力学（PK）和安全性方面的结果一致。分析显示，在既往接受不超过两种系统性治疗、但未接受过免疫治疗的晚期或转移性透明细胞肾细胞癌（ccRCC）成人患者中，Opdivo皮下注射剂与静脉注射剂相比，在PK主要终点上达非劣性。28天平均血药浓度的几何均数比（GMR）为2.10（90% CI：2.00–2.20），稳态谷浓度的GMR为1.77（90% CI：1.63–1.93）。此外，在关键次要终点客观缓解率（ORR）上，Opdivo皮下注射剂组为24%（95% CI：19–30），而静脉注射剂组为18%（95% CI：14–24），显示Opdivo两种剂型在疗效方面具有相似性。超90%患者肿瘤缩小！潜在“best-in-class”小分子3期试验达主要终点德国默克（Merck KGaA）今日公布了MANEUVER临床3期试验第一部分的详细积极结果。该试验评估了由与和誉医药（Abbisko Therapeutics）联合开发的集落刺激因子-1受体（CSF-1R）抑制剂pimicotinib用于治疗腱鞘巨细胞瘤（TGCT）患者的疗效。分析显示，每日一次口服的pimicotinib在试验第25周达到主要终点——由盲法独立评审委员会（BIRC）评估的客观缓解率显著优于安慰剂，分别为54.0%与3.2%（p<0.0001）。研究还在所有与TGCT相关的关键患者报告结局的次要终点上显示出具有统计学意义且临床显著的改善。Pimicotinib起效迅速，在13周时已有41.3%的患者（63人中的26人）达成客观缓解。在主要分析数据截止时，BIRC根据RECIST v1.1标准评估发现，几乎所有pimicotinib组患者（63人中的58人，92.1%）的肿瘤体积出现缩小，其中1人获得完全缓解，33人获得部分缓解。而针对TGCT专门设定的终点指标——肿瘤体积评分（TVS）显示，近三分之二接受pimicotinib治疗患者的肿瘤体积减少至少50%（pimicotinib组61.9% vs安慰剂组3.2%，p<0.0001）。Pimicotinib（ABSK021）是和誉医药研发的一款口服、高选择性与活性、潜在“best-in-class”的CSF-1R小分子抑制剂，用于治疗不可手术的腱鞘巨细胞瘤。参考资料：[1] PIVOT-PO phase III study for tebipenem HBr stopped early for efficacy following review by Independent Data Monitoring Committee. Retrieved May 28, 2025 from https://www.gsk.com/en-gb/media/press-releases/pivot-po-phase-iii-study-for-tebipenem-hbr-stopped-early-for-efficacy-following-review-by-independent-data-monitoring-committee/[2] Bristol Myers Squibb Receives European Commission Approval for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications. Retrieved May 28, 2025 from https://investors.bms.com/iframes/press-releases/press-release-details/2025/Bristol-Myers-Squibb-Receives-European-Commission-Approval-for-the-Subcutaneous-Formulation-of-Opdivo-nivolumab-Across-Multiple-Solid-Tumor-Indications/default.aspx[3] Pimicotinib Demonstrates Best-in-Class Potential with Significant Efficacy and Clinically Meaningful Improvements in Patients with Tenosynovial Giant Cell Tumor. Retrieved May 28, 2025 from https://www.businesswire.com/news/home/20250527338086/en/Pimicotinib-Demonstrates-Best-in-Class-Potential-with-Significant-Efficacy-and-Clinically-Meaningful-Improvements-in-Patients-with-Tenosynovial-Giant-Cell-Tumor免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床结果上市批准免疫疗法

2025-05-28

·医药笔记

Spero股价大涨200%：首个口服碳青霉烯类抗生素三期临床成功

▎Armstrong2025年5月28日，葛兰素史克与Spero Therapeutics宣布Tebipenem HBr治疗复杂尿路感染（cUTIs）的三期临床PIVOT-PO由于疗效提前终止。这一决定是基于IDMC根据1690例患者中期分析数据给出的建议。Tebipenem HBr将成为首款口服碳青霉烯类抗生素。该三期临床达到了相比于静脉注射亚胺培南－西拉司丁钠的非劣效性主要终点。受此消息影响，Spero Therapeutics盘前股价大涨227%，市值达到1.3亿美元。该三期临床原本计划入组2628例患者。2022年9月22日，葛兰素史克引进Tebipenem HBr在除日本和其他亚洲国家以外的全球权益，Spero Therapeutics获得6600万美元的首付款，900万美元股权投资，以及额外的5.5亿美元里程碑付款。总结Tebipenem HBr为Spero Therapeutics的核心管线，为一款口服可利用的碳青霉烯类抗生素前药，在肠细胞快速转化为活性药物分子。Armstrong技术全梳理系列GPRC5D靶点全梳理；CD40靶点全梳理；CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向；Claudin 6靶点全梳理；Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇；CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理；Ambrx技术全梳理；Vir Biotech技术全梳理；Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理；Momenta技术全梳理；NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床3期引进/卖出抗体药物偶联物

2025-05-28

·FierceBiotech

GSK\'s $66M bet on Spero\'s rejected UTI antibiotic pays off with a phase 3 win

GSK recently scored a regulatory success against complicated UTIs when the FDA approved Blujepa.\n GSK’s decision to swoop in and save Spero Therapeutics’ antibiotic three years ago appears to have paid off based on a fresh phase 3 readout.The trial of 1,690 hospitalized patients with complicated urinary tract infections (cUTIs) has been halted early after it looked certain that the candidate, called tebipenem HBr, would hit the study’s primary endpoint of showing its non-inferiority to intravenous treatment with the antibiotic imipenem/cilastatin.Armed with the new phase 3 data, GSK is planning its own push for a potential FDA review this year. If it gets the nod from the regulator, tebipenem HBr would become the first oral carbapenem antibiotic available for U.S. patients with cUTIs, GSK pointed out in a May 28 release.“Complicated UTIs can have a profound impact on patients and carry a high risk of clinical complications, including sepsis and septic shock,” GSK Chief Scientific Officer Tony Wood, Ph.D., said in the release.“Currently, many need hospital-based intravenous treatment due to limited oral options for drug-resistant infections, contributing to over $6 billion per year in U.S. healthcare costs,” Wood added. “These positive results add to our growing anti-infectives portfolio and reinforce the potential of tebipenem HBr as an effective oral alternative taken at home.”GSK recently scored a regulatory success against uncomplicated UTIs when the FDA approved its antibiotic Blujepa, also known as gepotidacin, in March. The Big Pharma saw similar promise in tebipenem HBr back in 2022, despite the FDA having at the time recently rejected Spero’s approval application. The biotech used the $66 million upfront payment it received from GSK as part of the licensing deal to fund the phase 3 trial that read out today.“Achieving the primary endpoint in the PIVOT-PO trial marks a significant milestone for tebipenem HBr,” Spero’s CEO Esther Rajavelu said in this morning’s release. “If approved, we believe tebipenem HBr is well-positioned to change the treatment landscape for patients diagnosed with cUTI, including pyelonephritis.”The late-stage win for tebipenem HBr is a welcome boost for Spero, which has spent the past year navigating layoffs and stripping back its pipeline. This included halting work on the oral antibiotic SPR720 after it failed to beat placebo and showed signs of liver toxicity in a phase 2 trial for non-tuberculous mycobacterial pulmonary disease.The low return on investment means many of the biggest biopharmas have given up working on new antifungals or antibiotics in recent years—although GSK in particular has continued to sign deals and post encouraging clinical results against infections like gonorrhea.

$GSK\'s $66M bet on Spero\'s rejected UTI antibiotic pays off with a phase 3 win$

临床3期临床2期引进/卖出

100 项与替比培南酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09598	替比培南酯	J01DH06	-

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
中耳炎	日本	Meiji Seika Pharma Co., Ltd.	2009-04-22
肺炎	日本	Meiji Seika Pharma Co., Ltd.	2009-04-22
鼻窦炎	日本	Meiji Seika Pharma Co., Ltd.	2009-04-22

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
复杂的尿路感染	申请上市	美国	Spero Therapeutics, Inc.	2021-10-28
脓尿	临床3期	美国	GSK Plc	2023-12-21
脓尿	临床3期	美国	Spero Therapeutics, Inc.	2023-12-21
脓尿	临床3期	阿根廷	Spero Therapeutics, Inc.	2023-12-21
脓尿	临床3期	阿根廷	GSK Plc	2023-12-21
脓尿	临床3期	波斯尼亚和黑塞哥维那	GSK Plc	2023-12-21
脓尿	临床3期	波斯尼亚和黑塞哥维那	Spero Therapeutics, Inc.	2023-12-21
脓尿	临床3期	巴西	Spero Therapeutics, Inc.	2023-12-21
脓尿	临床3期	巴西	GSK Plc	2023-12-21
脓尿	临床3期	保加利亚	Spero Therapeutics, Inc.	2023-12-21

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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


NCT06059846 (PIVOT-PO, NEWS) 人工标引	临床3期	复杂的尿路感染	1,690	tebipenem HBr	範繭襯窪鑰鹹簾遞艱製(鹹製廠淵壓製餘觸願願) = tebipenem HBr achieved non-inferiority compared to IV imipenem cilastatin 製遞襯鹽繭淵遞簾簾遞 (糧窪餘鏇醖廠壓壓襯膚 )	非劣	2025-05-28
				imipenem cilastatin
NCT03788967 (ADAPT-PO, CTgov)	临床3期	急性肾盂肾炎 \| 复杂的尿路感染	1,372	Dummy Infusion+TBPM-PI-HBr (TBPM-PI-HBr 600 mg)	衊糧鬱艱觸餘艱壓鬱網 = 醖衊構鏇衊壓鏇繭築糧餘鹹襯築製鏇糧壓醖觸 (選網繭憲鬱壓簾選選衊, 遞鏇鏇糧製遞蓋糧鑰製 ~ 網醖願鏇範鏇齋鑰繭鏇) 更多	-	2022-07-25
				Dummy tablets+Ertapenem (Ertapenem 1 g)	衊糧鬱艱觸餘艱壓鬱網 = 築遞鏇製壓餘廠積夢鬱餘鹹襯築製鏇糧壓醖觸 (選網繭憲鬱壓簾選選衊, 願願膚構壓範襯淵顧鹽 ~ 選憲鹽鏇範範襯構憲獵) 更多
NCT04178577 (Pubmed \| Antimicrob Agents Chemother)	临床1期	肾功能不全	39	Tebipenem Pivoxil Hydrobromide (Cohort 1 (normal renal function))	鹹鑰壓鬱築簾鬱衊選蓋(遞鹹觸遞網膚繭選鬱選) = 鬱醖構壓憲網積膚夢醖夢襯範鹹顧鹽淵鏇膚淵 (膚獵齋齋繭選膚獵夢願 ) 更多	-	2022-04-14
				Tebipenem Pivoxil Hydrobromide (Cohort 3 (moderate renal impairment))	簾繭選網廠糧觸淵蓋遞(鑰觸廠鏇築淵獵鬱鹹襯) = 鹽餘鬱鹽鹹鏇廠簾鬱餘鏇衊膚鹽獵願夢繭範襯 (糧膚糧積願鏇鹹獵築鑰 )
NCT03788967 (ADAPT-PO, Pubmed \| N Engl J Med)	临床3期	复杂的尿路感染	1,372	Tebipenem pivoxil hydrobromide	膚醖鹽觸壓餘衊餘選顧(廠鑰襯遞遞製繭鑰醖蓋) = 齋蓋繭選糧醖窪艱壓鏇鹹餘壓繭齋鹽築顧願夢 (夢醖願餘醖願積醖鹹鹹 ) 更多	积极	2022-04-07
				Intravenous ertapenem	膚醖鹽觸壓餘衊餘選顧(廠鑰襯遞遞製繭鑰醖蓋) = 衊膚範鏇襯膚獵製糧鏇鹹餘壓繭齋鹽築顧願夢 (夢醖願餘醖願積醖鹹鹹 ) 更多
NCT03788967 (ADAPT-PO, GlobeNewswire) 人工标引	临床3期	泌尿道感染 \| 急性肾盂肾炎	1,372	tebipenem HBr	鹽獵窪廠鑰壓網糧鑰鏇(繭範醖築窪築衊艱築艱) = 糧鏇觸願餘積遞膚廠憲觸繭鹹艱醖鬱製襯衊願 (醖遞網獵積壓蓋顧襯築 ) 更多	非劣	2020-09-08
				Ertapenem Sodium	鹽獵窪廠鑰壓網糧鑰鏇(繭範醖築窪築衊艱築艱) = 醖齋範範觸襯淵遞淵壓觸繭鹹艱醖鬱製襯衊願 (醖遞網獵積壓蓋顧襯築 ) 更多