A Phase 1, Multi-Center, Open-Label Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Sulopenem Etzadroxil + Probenecid in Adolescent Patients With Bacterial Infection

The goal of this clinical trial is to evaluate the use of sulopenem etzadroxil plus probenecid in adolescent patients being treated for bacterial infection. The main questions it aims to answer are:
Is sulopenem etzadroxil plus probenecid safe to use in adolescents? Is sulopenem etzadroxil plus probenecid tolerable when used in adolescents? When ingested, what does the adolescent body do to sulopenem etzadroxil plus probenecid, in terms of the movement of the drug into, through, and out of the body.
Participants will receive standard of care antibiotics for their bacterial infection as directed by their physician. In addition, participants will be asked to take a single oral dose of sulopenem etzadroxil plus probenecid. Blood samples will be collected before the dose of sulopenem etzadroxil plus probenecid, as well as at specified timepoints after the dose. Likewise, urine will be collected at specified time periods after the dose. During the course of the study, data will be collected from participants including vital sign measurements, physical examination findings, and the details of any adverse events that are reported.

开始日期2026-01-01

申办/合作机构

Iterum Therapeutics International Ltd.

RBR-4fc33kz

/ CompletedN/AIIT

Glycemic response of individuals to the consumption of enteral nutrition formula

开始日期2024-03-06

申办/合作机构-

NCT05584657

/ Completed临床3期

A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

Study 310 is a clinical study which compares the effectiveness of oral sulopenem versus oral amoxicillin/clavulanate for the treatment of adult women with uncomplicated urinary tract infection.

开始日期2022-10-18

申办/合作机构

Iterum Therapeutics International Ltd.

100 项与 Sulopenem etzadroxil/Probenecid 相关的临床结果

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100 项与 Sulopenem etzadroxil/Probenecid 相关的转化医学

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100 项与 Sulopenem etzadroxil/Probenecid 相关的专利（医药）

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项与 Sulopenem etzadroxil/Probenecid 相关的文献（医药）

2025-11-01·Annals of Medicine and Surgery

Redefining uUTI therapy: Orlynvah as a promising oral alternative (sulopenem etzadroxil and probenecid)

作者: Waafira, Aminath ; Khalid, Maliha ; Shahid, Kamran ; Shahid, Syeda Rabiah

On December 24, the U.S. Food and Drug Administration approved Orlynvah (sulopenem etzadroxil, Iterum Therapeutics) as the first oral carbapenem for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. uUTIs, commonly caused by Escherichia coli , are limited to women without underlying comorbidities or anatomical abnormalities. Orlynvah, a prodrug hydrolyzed to sulopenem, exhibits broad-spectrum activity, including against multidrug-resistant and extended-spectrum β-lactamase-producing Enterobacteriaceae. The efficacy of Orlynvah was established through two large multicenter trials, which demonstrated superior outcomes compared to amoxicillin–clavulanate and improved efficacy over ciprofloxacin in cases involving resistant pathogens. The drug was generally well-tolerated, with few serious adverse events reported. Orlynvah offers a promising oral alternative in the era of rising antimicrobial resistance and represents a significant advancement in the management of uUTIs.

2025-08-01·NURSE PRACTITIONER

The Drug Update

Article

作者: Plummer, Janna ; Sarpong, Rebecca ; Marino, Adriane B. ; Theroux, Jenna D. ; Drake, Evan S. ; Hughes, Ashlyn ; Osteen, Ryan

ABSTRACT:

In the final half of 2024, the US FDA approved several new drugs that have relevance for those practicing in primary care. This article highlights the following new medications: donanemab-azbt (Kisunla), nalmefene injection (Zurnai), epinephrine nasal spray (neffy), palopegteriparatide (Yorvipath), xanomeline and trospium chloride (Cobenfy), and sulopenem etzadroxil/probenecid (Orlynvah). Additionally, this article highlights the recent approval of obstructive sleep apnea as a new indication for tirzepatide (Zepbound) and chronic obstructive pulmonary disease as a new indication for dupilumab (Dupixent).

2022-04-01·Drugs1区 · 医学

Sulopenem: An Intravenous and Oral Penem for the Treatment of Urinary Tract Infections Due to Multidrug-Resistant Bacteria

1区 · 医学

Review

作者: Karlowsky, James A ; Zhanel, George G ; Schweizer, Frank ; Naber, Kurt ; Irfan, Neal ; Adam, Heather ; Lagacé-Wiens, Philippe ; Lynch, Joseph P ; Pozdirca, Marianna ; Zelenitsky, Sheryl ; Walkty, Andrew ; Zhanel, Michael A ; Golden, Alyssa R ; Berry, Liam ; Bay, Denice ; Lawrence, Courtney K

Sulopenem (formerly known as CP-70,429, and CP-65,207 when a component of a racemic mixture with its R isomer) is an intravenous and oral penem that possesses in vitro activity against fluoroquinolone-resistant, extended spectrum β-lactamases (ESBL)-producing, multidrug-resistant (MDR) Enterobacterales. Sulopenem is being developed to treat patients with uncomplicated and complicated urinary tract infections (UTIs) as well as intra-abdominal infections. This review will focus mainly on its use in UTIs. The chemical structure of sulopenem shares properties of penicillins, cephalosporins, and carbapenems. Sulopenem is available as an oral prodrug formulation, sulopenem etzadroxil, which is hydrolyzed by intestinal esterases, resulting in active sulopenem. In early studies, the S isomer of CP-65,207, later developed as sulopenem, demonstrated greater absorption, higher drug concentrations in the urine, and increased stability against the renal enzyme dehydropeptidase-1 compared with the R isomer, which set the stage for its further development as a UTI antimicrobial. Sulopenem is active against both Gram-negative and Gram-positive microorganisms. Sulopenem's β-lactam ring alkylates the serine residues of penicillin-binding protein (PBP), which inhibits peptidoglycan cross-linking. Due to its ionization and low molecular weight, sulopenem passes through outer membrane proteins to reach PBPs of Gram-negative bacteria. While sulopenem activity is unaffected by many β-lactamases, resistance arises from alterations in PBPs (e.g., methicillin-resistant Staphylococcus aureus [MRSA]), expression of carbapenemases (e.g., carbapenemase-producing Enterobacterales and in Stenotrophomonas maltophilia), reduction in the expression of outer membrane proteins (e.g., some Klebsiella spp.), and the presence of efflux pumps (e.g., MexAB-OprM in Pseudomonas aeruginosa), or a combination of these mechanisms. In vitro studies have reported that sulopenem demonstrates greater activity than meropenem and ertapenem against Enterococcus faecalis, Listeria monocytogenes, methicillin-susceptible S. aureus (MSSA), and Staphylococcus epidermidis, as well as similar activity to carbapenems against Streptococcus agalactiae, Streptococcus pneumoniae, and Streptococcus pyogenes. With some exceptions, sulopenem activity against Gram-negative aerobes was less than ertapenem and meropenem but greater than imipenem. Sulopenem activity against Escherichia coli carrying ESBL, CTX-M, or Amp-C enzymes, or demonstrating MDR phenotypes, as well as against ESBL-producing Klebsiella pneumoniae, was nearly identical to ertapenem and meropenem and greater than imipenem. Sulopenem exhibited identical or slightly greater activity than imipenem against many Gram-positive and Gram-negative anaerobes, including Bacteroides fragilis. The pharmacokinetics of intravenous sulopenem appear similar to carbapenems such as imipenem-cilastatin, meropenem, and doripenem. In healthy subjects, reported volumes of distribution (V_d) ranged from 15.8 to 27.6 L, total drug clearances (CL_T) of 18.9-24.9 L/h, protein binding of approximately 10%, and elimination half-lives (t_½) of 0.88-1.03 h. The estimated renal clearance (CL_R) of sulopenem is 8.0-10.6 L/h, with 35.5% ± 6.7% of a 1000 mg dose recovered unchanged in the urine. An ester prodrug, sulopenem etzadroxil, has been developed for oral administration. Initial investigations reported a variable oral bioavailability of 20-34% under fasted conditions, however subsequent work showed that bioavailability is significantly improved by administering sulopenem with food to increase its oral absorption or with probenecid to reduce its renal tubular secretion. Food consumption increases the area under the curve (AUC) of oral sulopenem (500 mg twice daily) by 23.6% when administered alone and 62% when administered with 500 mg of probenecid. Like carbapenems, sulopenem demonstrates bactericidal activity that is associated with the percentage of time that free concentrations exceed the MIC (%f T > MIC). In animal models, bacteriostasis was associated with %f T > MICs ranging from 8.6 to 17%, whereas 2-log₁₀ kill was seen at values ranging from 12 to 28%. No pharmacodynamic targets have been documented for suppression of resistance. Sulopenem concentrations in urine are variable, ranging from 21.8 to 420.0 mg/L (median 84.4 mg/L) in fasted subjects and 28.8 to 609.0 mg/L (median 87.3 mg/L) in those who were fed. Sulopenem has been compared with carbapenems and cephalosporins in guinea pig and murine systemic and lung infection animal models. Studied pathogens included Acinetobacter calcoaceticus, B. fragilis, Citrobacter freundii, Enterobacter cloacae, E. coli, K. pneumoniae, Proteus vulgaris, and Serratia marcescens. These studies reported that overall, sulopenem was non-inferior to carbapenems but appeared to be superior to cephalosporins. A phase III clinical trial (SURE-1) reported that sulopenem was not non-inferior to ciprofloxacin in women infected with fluoroquinolone-susceptible pathogens, due to a higher rate of asymptomatic bacteriuria in sulopenem-treated patients at the test-of-cure visit. However, the researchers reported superiority of sulopenem etzadroxil/probenecid over ciprofloxacin for the treatment of uncomplicated UTIs in women infected with fluoroquinolone/non-susceptible pathogens, and non-inferiority in all patients with a positive urine culture. A phase III clinical trial (SURE-2) compared intravenous sulopenem followed by oral sulopenem etzadroxil/probenecid with ertapenem in the treatment of complicated UTIs. No difference in overall success was noted at the end of therapy. However, intravenous sulopenem followed by oral sulopenem etzadroxil was not non-inferior to ertapenem followed by oral stepdown therapy in overall success at test-of-cure due to a higher rate of asymptomatic bacteriuria in the sulopenem arm. After a meeting with the US FDA, Iterum stated that they are currently evaluating the optimal design for an additional phase III uncomplicated UTI study to be conducted prior to the potential resubmission of the New Drug Application (NDA). It is unclear at this time whether Iterum intends to apply for EMA or Japanese regulatory approval. The safety and tolerability of sulopenem has been reported in various phase I pharmacokinetic studies and phase III clinical trials. Sulopenem (intravenous and oral) appears to be well tolerated in healthy subjects, with and without the coadministration of probenecid, with few serious drug-related treatment-emergent adverse events (TEAEs) reported to date. Reported TEAEs affecting ≥1% of patients were (from most to least common) diarrhea, nausea, headache, vomiting and dizziness. Discontinuation rates were low and were not different than comparator agents. Sulopenem administered orally and/or intravenously represents a potentially well tolerated and effective option for treating uncomplicated and complicated UTIs, especially in patients with documented or highly suspected antimicrobial pathogens to commonly used agents (e.g. fluoroquinolone-resistant E. coli), and in patients with documented microbiological or clinical failure or patients who demonstrate intolerance/adverse effects to first-line agents. This agent will likely be used orally in the outpatient setting, and intravenously followed by oral stepdown in the hospital setting. Sulopenem also allows for oral stepdown therapy in the hospital setting from intravenous non-sulopenem therapy. More clinical data are required to fully assess the clinical efficacy and safety of sulopenem, especially in patients with complicated UTIs caused by resistant pathogens such as ESBL-producing, Amp-C, MDR E. coli. Antimicrobial stewardship programs will need to create guidelines for when this oral and intravenous penem should be used.

项与 Sulopenem etzadroxil/Probenecid 相关的新闻（医药）

2025-10-31

·凯美科

天然产物衍生药物的临床开发与审批现状综述(2014-2025)

天然产物（NPs）历来是药物研发的重要基石，从古代草药疗法到吗啡、奎宁等具有里程碑意义的药物，均源于天然产物的发现。20世纪中期，天然来源抗生素的发现进入"黄金时代"，随后其应用逐步扩展至其他治疗领域。然而，到20世纪末，随着合成化学、分子生物学等技术的迅速发展，天然产物在药物研发中的核心地位逐渐被多元化的技术路径所替代。本文系统梳理了2014年以来获批的天然产物衍生（NP-D）药物，并分析了截至2024年底处于临床研发阶段的候选药物，旨在客观评估天然产物在当代药物研发体系中的实际地位与价值。研究显示，2014年1月至2025年6月期间，全球共有58款天然产物相关药物获批上市，其中包括45个天然产物及其衍生物新化学实体（NCEs），以及13个天然产物-抗体偶联药物（NP-ADCs）。进一步对2014–2024年全球批准的579种药物进行分析（其中NCEs为388种，占67%；新生物实体NBEs为191种，占33%），根据本研究的界定标准，共有56种药物（占总数的9.7%）被归类为天然产物或其衍生物，具体包括44个NCEs（占总批准数的7.6%，占NCEs的11.3%）和12个NP-ADCs（占总批准数的2.1%，占NBEs的6.3%）。从年度趋势来看，自2014年起，新型NP-D NCEs与NP-ADCs的年批准数量在0至8款之间波动，年均批准约5款。此外，研究还识别出截至2024年12月底处于临床试验或注册审评阶段的125种天然产物及其衍生化合物。值得关注的是，其中33种化合物具有全新的药效骨架，但过去十五年间仅有1种全新骨架被发现。本综述指出，尽管天然产物在整体药物研发中的比重有所下降，其持续贡献仍不容忽视，并呼吁重新重视以生物活性为导向的天然产物分离、鉴定及机制研究，以拓展先导化合物的发现空间。 1. 引言天然产物（NPs）在医学史上具有重要地位，其粗提物作为传统药物已沿用数百年。这些药物至今仍在全球范围内发挥重要作用，尤其在发展中国家，它们仍是医疗保健体系的重要组成部分。19世纪是药物发现的关键转折点，纯化技术的出现使得吗啡、奎宁、毛果芸香碱、地高辛、水杨苷和麻黄碱等化合物得以从植物中分离。20世纪早中期，合成药物的兴起促使天然产物、合成化学和疫苗在现代医学中形成动态互动。这一趋势在抗生素研究中尤为显著：1930年代合成磺胺类药物的发现推动了青霉素的研发（1942年首次临床应用），进而引发了对微生物源抗生素的广泛探索。1940年代，短杆菌素、Gramicidin S、Gramicidin D、杆菌肽、链霉素和金霉素相继被发现。这一时期常被称为"抗生素的黄金时代"，开启了长达约30年以天然产物为核心的抗生素及其他治疗领域研究。然而，20世纪末的技术进步彻底改变了药物研发模式。天然产物曾是先导化合物的主要来源，如今已成为药物发现工具箱中的选项之一。进入21世纪的首个25年，生物药（表1）显著崛起，其影响力已与小分子药物相当。例如，2014年全球批准的47种药物中生物药占10种（21.3%），而2024年批准的75种药物中生物药增至32种（42.7%）（图1）1,2。值得注意的是，天然产物在抗体-药物偶联物（ADCs）中作为"弹头"发挥了新作用。在此背景下，一个关键问题浮出水面：天然产物先导化合物的发现与药物开发，应如何适应这一不断演变的制药版图？图1 2014–2024年全球获批新化学实体（NCEs）与新生物实体（NBEs）的分类统计在本综述中，"天然产物（NP）"特指从天然来源（包括海洋与陆生植物、微生物及海洋动物）中分离获得的、结构明确的小分子纯品，例如萜类、聚酮化合物、多肽、脂质及混合生物合成来源的化合物。通常与初级代谢相关或主要发挥营养功能的分子（如甾体、胆汁酸、氨基酸、唾液酸、前列腺素、类视黄醇、激素、核苷以及人体蛋白质和蛋白质片段）不在讨论范围内。在图示中，天然产物结构以蓝色标注，天然产物衍生化合物则以黑色表示。已获批天然产物衍生药物的适应症拓展研究在第2.2节中讨论，但不纳入整体统计分析。本文涉及的化合物按分子属性分为三类（天然产物NP、天然产物衍生化合物NP-D、天然产物-抗体偶联药物NP-ADC），并按生产工艺分为三大类别（表1），同时明确定义了新化学实体（NCEs）与新生物实体（NBEs）。将化合物属性与生产工艺分类独立分析，不同于本系列既往综述的框架3–6，这一调整旨在简化分析流程，同时便于深入探讨生产工艺细节。表1 法规、化合物和制造类别符合以下任一标准的化合物未被纳入本次分析：（1）临床试验注册信息显示试验已于2021年12月31日或之前完成，且无活跃研发计划证据；（2）临床开发已终止；（3）化合物已被开发方从研发管线中移除且未进行授权。此外，COVID-19疫情对临床试验及企业资金投入的冲击也已纳入考量。尽管已对公开数据进行全面分析，部分天然产物及天然产物衍生化合物（尤其是临床研发早期阶段的项目）可能未被涵盖。需要说明的是，临床试验格局与企业参与情况动态变化，建议读者通过企业官网、临床试验注册平台及最新文献获取最新信息。本综述系统梳理了2014年1月至2025年6月期间全球获批的天然产物（NP）、天然产物衍生药物（NP-D）及天然产物-抗体偶联药物（NP-ADC）（第2节，表2和表3）；进而对截至2024年12月31日处于临床评估或注册阶段的NP、NP-D与NP-ADC，按疾病领域进行分类阐述：感染性疾病（第3节）、神经系统疾病（第4节）、心血管与代谢疾病（第5节）、免疫性及炎症相关疾病（第6节）和肿瘤学（第7节）。针对进入II期及以上临床试验的含天然产物衍生弹头的ADC药物，在第7.3节专门讨论。此外，本文还详细分析了这些化合物的给药途径及其先导天然产物结构来源（第8节），并在第9节总结了处于研发后期阶段的NP-D化合物及具有新颖药效团的临床候选药物。 2. 2014年1月至2025年6月全球获批的NP、NP-D及NP-ADC药物 2.1 NP衍生药物概述 2014年1月至2025年6月期间，全球共批准58款天然产物（NP）相关药物，其中45款为NP及NP-D类新化学实体（NCEs）（表2），13款为NP-抗体偶联药物（NP-ADCs）（表3）。在45款NCEs中，6款为直接天然产物（NPs），39款为NP衍生药物（NP-Ds），其生产工艺包括3款基于生物质合成、18款半合成及24款全合成。45款NCEs中有9款属于全新作用机制的人用药物类别（表2），而13款NP-ADCs中有2款采用首创型"弹头"结构（表3）。表2 2014年1月1日至2025年6月30日期间获批的NP衍生小分子药物本节按治疗领域（第2.1.1–2.1.5节）简要介绍2014–2024年间批准的55款NP衍生药物及其结构特征，并分别在第3.1、第6及第7.3节中说明截至2025年6月获批的3款NP-D药物（那氟霉素3.01、阿科尔 Tremon 6.06和替利索妥珠单抗维多汀7.55）。全球药物批准趋势分析根据2014–2024年全球批准的NCE与NBE药物数据1,2,8–27，其可分为NP/NP-D NCEs、NP-ADCs及其他NCEs/NBEs（图1）。此期间共批准579款新药，包含388款（67%）NCEs和191款（33%）NBEs。其中： 44款NCEs为NP或NP-D药物（占总批准数7.6%，占NCEs的11.3%）； 12款NBEs为NP-ADCs（占总批准数2.1%，占NBEs的6.3%）；按本综述的NP定义，共有56款（9.7%）药物属于NP、NP-D或NP-ADC类别。若将甾体、胆汁酸、氨基酸等排除在外的类天然分子纳入统计，此比例将进一步升高。关键趋势解读（图1） NCEs数量小幅增长：过去十年NCEs批准量较此前14年总体略有上升，但2022–2023年因新冠疫情出现回落； NBEs显著增加：近10年NBE类药物批准数量大幅上升； NP衍生药物稳定输出：2014–2024年间，NP衍生NCEs与NP-ADCs年批准量在0–8款之间波动，年均约5款； NP-ADCs前景可期：自2014年以来已有13款NP-ADCs获批（表3），且后期临床及注册阶段候选药物众多（第7.3节），预计未来数量将持续增加。表3 2014年1月1日至2025年6月30日期间获批的NP-ADCs药物 2.1.1 用于治疗感染性疾病的新型天然产物（NP）及天然产物衍生药物（NP-D）在此期间共有15款新型抗感染药物获批上市，其中包括： 11款抗菌药物（含1种β-内酰胺酶抑制剂） 2款抗真菌药物 1款抗病毒药物 1款抗寄生虫药物（一）抗菌药物按药物类别划分，具体包括：四环素类（3种）：艾拉环素（eravacycline, 2.18）34 沙瑞环素（sarecycline, 2.20）35 奥马环素（omadacycline, 2.29）36 糖肽类（2种）：达巴万星（dalbavancin, 2.02）37 奥利万星（oritavancin, 2.07）38 β-内酰胺类（2种）：头孢地尔（cefiderocol, 2.23）39 舒罗培南酯羟丙基（sulopenem etzadroxil, 2.43）40 β-内酰胺/β-内酰胺酶抑制剂复方（1种）：恩美他唑巴坦（enmetazobactam, 2.40）41 氨基糖苷类（1种）：普拉佐米星（plazomicin, 2.17）42 截短侧耳素类（1种）：来法莫林（lefamulin, 2.22）43 大环内酯混合物（1种）：卡里霉素（carrimycin, 2.24a–2.24c）44,45 （二）抗真菌药物伊布雷沙芬净（ibrexafungerp, 2.30）46,47：属新型Fungerp类化合物49 雷扎芬净（rezafungin, 2.35）48：属已确立的棘白菌素类50 （三）抗病毒药物斑蝥素（cantharidin, 2.39）作为局部外用抗病毒药物，获批用于治疗传染性软疣（一种DNA痘病毒感染）51。该药物早有应用历史，既见于中医传统疗法52，亦于1950年代在欧美用于抗疣治疗53。（四）抗寄生虫药物莫西菌素（moxidectin, 2.15）为一种由兽用驱虫药转换用途而来的抗寄生虫药物54。 2.1.2 用于治疗神经系统疾病的新型NP与NP-D药物地那布啡癸二酸酯（dinalbuphine sebacate, 2.13）为阿片类镇痛药纳布啡的前体药物，用于术后疼痛治疗55。萨米多芬（samidorphan, 2.29）与奥氮平的复方制剂获批用于治疗精神分裂症及双相情感障碍56，其中萨米多芬的加入旨在减轻奥氮平常见的体重增加副作用。沙诺美林（xanomeline, 2.42）57为槟榔碱衍生物58，可作用于M1与M4毒蕈碱型乙酰胆碱受体，曾用于阿尔茨海默病及精神分裂症的研究，但因严重副作用于1998年终止开发。后续研究发现将其与非选择性毒蕈碱拮抗剂曲司氯铵（trospium chloride）59联用可降低不良反应60，该复方于2024年9月获批用于治疗精神分裂症。 2.1.3 用于治疗心血管与代谢疾病的新型NP-D药物共14款新型NP-D药物获批用于心血管与代谢疾病治疗，主要包括： 11种根皮苷衍生物61：用于2型糖尿病治疗，包括：恩格列净（empagliflozin, 2.03）伊格列净（ipragliflozin, 2.04）鲁格列净（luseogliflozin, 2.05）托格列净（tofogliflozin, 2.06）厄格列净（ertugliflozin, 2.11）雷格列净碳酸乙酯（remogliflozin etabonate, 2.25）亨格列净（henagliflozin, 2.27）贝格列净（bexagliflozin, 2.33）索格列净（sotagliflozin, 2.36）依那格列净（enavogliflozin, 2.38）贾那格列净（janagliflozin, 2.41）米加拉司他（migalastat, 2.09）：为1-脱氧野尻霉素衍生物，获批用于法布里病治疗62。沃拉帕沙（vorapaxar, 2.01）：作为首创类药物用于血栓性心血管事件预防，其结构源于植物生物碱himbacine的对映体63,64。麦芽酚铁（ferric maltol, 2.10）：用于缺铁性贫血治疗，系麦芽酚衍生物的首个临床应用实例65；麦芽酚本身以往仅作为药用辅料或食品风味增强剂使用。 2.1.4 用于治疗免疫性、炎症性及相关疾病的新型NP-D药物纳洛昔醇（naloxegol, 2.08）66与那地麦定（naldemedine, 2.14）67为吗啡衍生物，用于治疗阿片类药物引起的便秘。西波尼莫德（siponimod, 2.21）与依曲莫德（etrasimod, 2.37）为多球壳菌素（myriocin）衍生物，分别获批用于多发性硬化症68及重度溃疡性结肠炎69治疗。伏环孢素（voclosporin, 2.28）为环孢菌素衍生物，获批用于狼疮性肾炎治疗70。两款首创类药物：他匹那罗（tapinarof, 2.32）为二苯乙烯类化合物，用于斑块型银屑病治疗71。奥马维酮（omaveloxolone, 2.34）为齐墩果酸衍生物，获批用于弗里德赖希共济失调治疗72。 2.1.5 新型NP、NP-D及NP-ADC抗癌药物 2014年以来获批的两款首创类抗癌药物：米哚妥林（midostaurin, 2.12）73：星孢菌素衍生物。普利西普辛（plitidepsin, 2.16）74,75：从海鞘Aplidium albicans中分离得到的环状缩肽。其他NP-D抗癌药物：卢比奈克丁（lurbinectedin, 2.26）为曲贝替定（trabectedin, 7.45）类似物，其合成以氰化萨夫拉辛B（源自荧光假单胞菌）为关键中间体76,77。乌替隆（utidelone, 2.31）（depoxythilone，埃博霉素D）属埃博霉素类78，该类此前仅有伊沙匹隆获批。淫羊藿苷元（icaritin, 2.44）为从淫羊藿属植物中分离的异戊烯化黄酮醇，亦是淫羊藿苷类衍生物的肠道代谢产物79–81，2022年在中国获批用于肝细胞癌的预防与治疗。抗体偶联药物（ADC）进展 2014至2024年间共批准12款ADC药物（表2），其发展基于此前已获批的三款ADC药物基础：吉妥珠单抗奥佐米星（2000年，美国，弹头：卡奇霉素，靶点：CD33）维布妥昔单抗（2011年，美国，弹头：海兔毒素MMAE，靶点：CD30）曲妥珠单抗美坦新（2013年，美国，弹头：美登素DM1，靶点：HER2） 12款ADC中，7款采用上述NP-D弹头（卡奇霉素×1、海兔毒素×5、美登素×1），其余5款使用新型NP来源弹头（喜树碱类×4、安曲霉素×1）。本节提供了奥加珠单抗奥佐米星（inotuzumab ozogamicin, 2.37）和朗妥昔单抗泰西兰（loncastuximab tesirine, 2.38）的结构示例，其他NP来源弹头的代表性案例详见第7.3节。 2.2 已获批天然产物（NP）及天然产物衍生药物（NP-D）的后期研发进展替比培南匹酯（Tebipenem pivoxil）已上市药物新适应症 III期临床试验 2009年首次在日本上市（商品名：Orapenem®） Spero Therapeutics与GSK正在开展一项III期临床试验（NCT06059846），评估其用于治疗复杂性尿路感染（cUTI），旨在推动该药在亚洲以外市场获批。试验于2025年5月因中期分析确认其疗效不劣于静脉注射用亚胺培南-西司他丁而提前终止82,83。氨曲南-阿维巴坦复方（Emblaveo®）新复方制剂已获批由单环β-内酰胺类抗生素氨曲南（1984年首次上市）与β-内酰胺酶抑制剂阿维巴坦（2015年上市）组成。2024年3月获欧洲药品管理局（EMA）批准，用于治疗：复杂性腹腔内感染复杂性尿路感染医院获得性肺炎治疗选择有限的需氧革兰氏阴性菌感染参考：84,85 利福布汀静脉制剂（BV100）新剂型开发 II期临床试验完成口服制剂于1992年首次获批用于分枝杆菌感染 BioVersys AG开发的静脉制剂已完成一项II期临床试验（NCT06059846），评估其治疗碳青霉烯类耐药鲍曼不动杆菌引起的严重感染的潜力86。大麻二酚（Cannabidiol）与屈大麻酚（Dronabinol）已上市药物新适应症多项II/III期临床试验进行中大麻二酚（2018年FDA批准用于癫痫）和屈大麻酚（1985年FDA批准用于化疗相关恶心呕吐）目前正在进行多项II期和III期临床试验，评估其在其他神经系统疾病中的应用。金雀花碱（Cytisine / Cytisinicline）老药新用全球多项II/III期临床试验该药物自1960年代起已在苏联和东欧国家使用87，并在其他少数国家获批上市88,89。目前正在全球范围内开展多项II期和III期临床试验，评估其辅助戒烟疗效。待续 ACD/Labs作为一款专业的化学分析软件平台将大数据与人工智能技术结合在天然产物化学研究领域提供了多方位的支持！ 1、基于碳谱数据库的天然产物结构排重基于核磁碳谱数据库检索来快速确认已知化合物的结构或者得到骨架参考信息，是目前天然产物结构解析工作中一个重要的手段，能有效提高结构定性的效率！ACD碳谱数据库已经收录了130多万的天然产物及类天然产物的核磁碳谱信息，是目前最大的天然产物核磁碳谱数据库，为天然产物的结构排重、辅助结构鉴定提供了强有力的支持！了解更多 2、基于MS数据的天然产物识别 MS Structure ID Suite基于样品组分的高分辨质谱数据，通过Molecules Formula Generator工具快速计算化合物的精确分子组成，结合目前最大的天然产物数据库COCONUT2.0进行检索，并可结合色谱保留时间参数及质谱碎片特征对候选结构进行筛选分析，以获得最优结果。了解更多 3、人工智能助力天然产物结构解析 ACD/Structure Elucidator软件作为CASE技术应用的佼佼者，经过20多年的技术打磨及功能完善，已经为全球不同领域的用户解决了超过1000多个复杂化合物结构解析的难题，并且接近有100篇文献报道了该软件技术的应用。另外，基于多谱图同步处理技术(NMR Sync)，ACD软件可帮助我们更快地对整套谱图进行标峰处理；基于Combined Concurrent Verification (CCV)和Unbiased Verification(UBV)技术可实现同分异构体的快速确认。软件可实现一键自动标峰、结构-谱图自动归属验证打分、一键导出详细、专业的报告等功能，为核磁解析的研究者大大提升工作效率！了解更多 4、专业的化合物谱图数据库管理平台对天然产物化学研究领域而言，有效地把已有的化学实验数据(尤其是化学结构、原始谱图文件等)进行电子化储存、管理，无疑对后续的实验有很大的帮助，如实现结构排重、避免重复实验、快速查询数据等。从实验室管理的角度而言，对不同实验人员产生的实验数据电子化储存的规范化、统一化也尤为重要，有利于科研数据的有效积累，形成实验室内部的知识库。ACD/Spectrus平台为此提供了强有力的帮助！了解更多 5、基于成药性质的天然产物结构改造 ACD/Percepta从分子结构出发，可快速、准确地预测化合物的物理化学性质、 ADME/Tox 性质。用户也可以基于化合物的 ADME-Tox 性质对先导化合物进行结构优化和设计，从而得到满足成药性要求的目标物，加快新药项目研发。了解更多广州凯美科信息技术有限公司是一家以化学信息学软件为核心业务的企业。公司成立于2019年10月，竭诚为国内医药、化工、食品等领域用户提供高质量的化学信息学软件解决方案和技术服务。作为加拿大ACD/Labs公司在国内的合作伙伴，我们在化合物结构鉴定、化学信息管理、色谱方法开发、化合物成药性评价、药物分子设计、分子模拟等方面累积了丰富的服务经验，并且得到广泛好评。产品包括(点击查看详情)： ✅ 化合物波谱解析系列 ✅ 化合物成药性预测 ✅ 化合物性质预测系列 ✅ 色谱方法开发系列 ✅ 实验室化学信息管理 —————————————————— ✅ 智能解析｜👉 [申请核磁/质谱解析软件演示]✅ 疑难攻坚｜📩 [提交疑难数据，获取专家支援]✅ 购买升级｜💼 [单位采购/版本更新/技术培训] 📢 联系我们：▔▔▔▔▔▔▔▔▔▔▔🧑 产品经理｜胡炽文📲 电话/微信｜18680221948📮 服务邮箱｜hcw@chemico.com.cn🌍 官网直达｜www.chemico.com.cn 扫码咨询

抗体药物偶联物上市批准疫苗免疫疗法

2025-08-20

·FiercePharma

Behind Iterum's 'dual-track' strategy to launch nation's first new uncomplicated UTI drug in 25 years

“Our goal has always been to get this product to market,” Iterum Therapeutics CEO Corey Fishman said. “And whether that was us, whether that was a partnership or someone else, that’s still our goal.” With three new antibiotics set to shake up the stagnant treatment landscape for uncomplicated urinary tract infections (uUTIs) in the U.S., Dublin-based Iterum Therapeutics has made it to market first, edging out generics juggernaut Alembic Pharmaceuticals and British Big Pharma GSK.Wednesday, Iterum officially launched Orlynvah, which secured FDA approval last October to treat uUTIs caused by E. coli, Klebsiella pneumoniae or Proteus mirabilis in adult women for whom other oral treatment options are limited or unavailable.Aside from being the first new branded uUTI treatment to launch in the U.S. in nearly three decades, Orlynvah is the only oral penem antibiotic to have received a green light from the FDA.The introduction of Orlynvah into the market—plus the looming debut of new treatments from Alembic and GSK—comes at a crucial time as the rising tide of antimicrobial resistance erodes the potency of antibiotics long-used to fight infections in the U.S.“We’re talking about a space that hasn’t seen any new products on the branded side in over 25 years,” Iterum CEO Corey Fishman said in a recent interview with Fierce Pharma.Without innovation on that front, resistance to the current slate of antibiotic treatments has risen, the chief executive explained: “Resistance keeps going up, efficacies are going down, and you’ve got an enormous market that is really struggling to find new and effective treatments.” Iterum figures Orlynvah has a major role to play in uUTI treatment given its distinction as the U.S.’ only oral penem antibiotic. Penem antibiotics have long been considered the “go-to class of drugs for serious infections,” but, up until now, have traditionally been infused in a hospital, Fishman noted.Iterum has singled out a total uUTI treatment market of roughly 40 million prescriptions per year in the U.S., but the company will focus its attention on “at-risk patients” specifically—a category that includes those with comorbidities like diabetes or heart failure, are older or have compromised immune systems and those who live with recurrent infections, according to the company’s CEO.That works out to about 26 million annual prescriptions that could be addressed with Orlynvah, Fishman said.“We know with those folks, if you don’t treat them well the first time, you can have some really negative outcomes,” he said. Anatomy of a launch Upon winning approval last October, Iterum said it would “renew” efforts to pin down a “strategic transaction” involving Orlynvah.But none of the options presented to Iterum or its board were to their satisfaction, prompting the company to take commercialization into its own hands, Fishman explained. At the same time, the CEO caveated that transactions and business development deals are “never off the table.”“Our goal has always been to get this product to market,” he said, “And whether that was us, whether that was a partnership or someone else, that’s still our goal.”Nevertheless, Iterum is a small company boasting just nine employees, Fishman pointed out. In turn, the biotech simply didn’t have the resources to prepare for Orlynvah’s launch years in advance.So, after winning FDA approval in late October, Iterum kicked off a “dual-track approach” to bring Orlynvah to market, scrutinizing potential deals while simultaneously prepping for a launch of its own, Fishman said.Given Iterum’s size, the company has now partnered with Eversana Life Sciences Services to help carry the launch through. The company has also teamed up with a specialty pharmacy to help with distribution, Fishman explained.As for where Iterum will aim its marketing muscle, the company has targeted regions along three lines: rate of antibiotic resistance in the area, the number of high-prescribing doctors for uUTIs there and the region’s projected market access rates.“We’re going to start with 20 geographies in phase one of our launch, and that’s going to represent roughly 2,300 physician targets,” Fishman explained. Those geographies are “really clustered around seven states,” he added, pointing to New York, New Jersey, Connecticut, Pennsylvania, Texas, Florida and Georgia.During that initial phase, Iterum’s primary goal is to “generate an amount of demand that shows that this is a product that has a real place in the market,” Fishman said.“With additional financing over time, we’ll be able to potentially expand and get into further territories and grow the organization that way,” he added.The company is setting the list price for Orlynvah at a range between $1,400 and $4,700 per prescription, which doesn’t factor in discounts or rebates through insurance. However, eligible patients will be able to pay just $25 for an Orlynvah prescription through an Iterum copay savings program, Fishman noted.The company aimed to price its drug along the same lines as other branded oral antibiotics that have debuted in the past half-decade or so, Fishman said. Orlynvah’s price also reflects the antibiotic’s role as a treatment for an acute infection rather than something that is prescribed regularly, he added. Competition looms With its launch Wednesday, Orlynvah now has some lead to feel out the market before the nearing U.S. launches of two other novel uUTI agents from GSK and Alembic Pharmaceuticals. GSK plans to launch its first-in-class uUTI treatment Blujepa—approved in late March—in the second half of 2025, while Alembic has said it expects its oral treatment Pivya to be available in the U.S. by the fourth quarter.Alembic picked up Pivya, also known as pivmecillinam, when it acquired the small company Utility Therapeutics in July. The FDA greenlighted pivmecillinam for the first time in April 2024, though the antibiotic has been available in Europe for more than 40 years.In the meantime, Iterum isn’t sweating the competition, with Fishman speculating that “there is plenty of space to be able to coexist completely.”It’s also worth pointing out that the vast majority of the uUTI treatment market is and will likely continue to be dominated by generics. In turn, Iterum would be “quite happy if we captured 5% of the market, well north of a million prescriptions at peak,” Fishman said. The entrance of multiple new players might also shine a spotlight on the issue of antibiotic resistance more broadly, he pointed out.“By having these new drugs that don’t have any resistances to start, if you treat the right bug and the right patient with the right dose at the right time, [you’re] unlikely to get much resistance for a very, very long time,” Fishman explained.

上市批准并购

2025-04-16

·ChenFJMU

新药速递｜2025年3月FDA批准上市2款新药【解读：从剂型，到临床药理，到合理用药】

ChenFJMU团队编辑（原创）思语湖畔QuoteThe only way to do great work is to love what you do. If you haven’t found it yet, keep looking. Don’t settle. — Steve JobsFDA新药速递【25年3月】看点FDA于2025年3月批准2款新药，分别为用于治疗体重至少为40 kg的12岁及以上女性由微生物引起的无并发症尿路感染（uUTI）患者的三氮杂苊类抗生素Blujepa；用于常规预防或减少12 岁及以上患有血友病 A/B 儿童和成人患者出血发作频率的抗凝血酶（AT）降低疗法Fitusiran。01 近三十年首款——GSK的“First-in-class”药物Blujepa开创uUTI抗菌新疗法。02 重磅预防——全球第七款siRNA药物Fitusiran获批，用于血友病A/B出血发作，每两月皮下注射一次！细说FDA新药【25年3月】（ChenFJMU）Blujepa，01Blujepa（Gepotidacin，吉泊达星），由英国制药公司葛兰素史克研发，于2025年3月25日获得FDA的批准。Gepotidacin用于治疗由特定敏感微生物引起的儿科患者和成年女性的单纯性尿路感染（uUTIs），这些微生物包括大肠杆菌、肺炎克雷伯菌、弗氏柠檬酸杆菌复合菌、腐生葡萄球菌和粪肠球菌。uUTIs是女性最常见的感染之一，患者对新型口服抗生素（尤其是对产生耐药的尿路感染病原体）的治疗需求仍未得到满足。作为近三十年来首个具有新型作用机制的口服抗生素， Blujepa的获批为反复感染和对现有治疗耐药上升的患者提供了新选择。此外，全球获FDA批准用于治疗uUTI的药物还有多款，包括两款传统抗菌药物（Nitrofurantoin，呋喃妥因和Ciprofloxacin，环丙沙星）以及2024年获批的Pivya（Pivmecillinam，吡美西林）和Orlynvah（Sulopenem etzadroxil/Probenecid，舒洛培南和丙磺舒）。FDA批准用于治疗uUTI的药物（ChenFJMU原创）注：ChenFJMU原创，转载需要标注出处！【结构与剂型处方】Blujepa片剂含有活性成分Gepotidacin，这是一种抑制细菌DNA回旋酶和拓扑异构酶IV的三氮杂苊抗菌剂，化学名称为（R）-2-((4-(((3，4-二氢-2H-吡喃并[2，3-c]吡啶-6-基)甲基)氨基)哌啶-1-基)甲基)-1，2-二氢-3H，8H-2a，5，8a-三氮杂苊-3，8-二酮甲磺酸盐二水合物，分子式为C24H28N6O3●CH4O3S●2H2O，分子量为580.66。化学结构如下：每片Blujepa口服片剂含有750 mg Gepotidacin（相当于910.7 mg无水Gepotidacin甲磺酸盐）。非活性成分包括：二氧化硅胶体、交联羧甲基纤维素钠、硬脂酸镁、微晶纤维素、聚乙二醇、聚乙烯醇、滑石、二氧化钛和黄铁氧化物。【作用机制】Gepotidacin是一种新型三氮杂苊烯类口服抗生素，通过抑制细菌的II型拓扑异构酶（包括细菌DNA拓扑异构酶II（促旋酶）和拓扑异构酶IV），来抑制细菌DNA复制而发挥良好的杀菌作用。这种独特的结合位点和作用机制使其对大多数目标病原体（如大肠杆菌和腐生葡萄球菌）具有活性，包括对现有抗生素耐药的菌株。经时间杀伤研究证实，Gepotidacin对病原体具有杀菌活性。体外研究表明，在最低抑菌浓度（MIC）为5倍的情况下，Gepotidacin对大肠杆菌的抗生素后作用为1.8~2.2 h，对肺炎克雷伯菌的作用为1~6.6 h，对奇异杆菌的作用为1.4~3 h，对弗氏梭菌的作用为1.5~2.6 h，对腐生链球菌的作用为2.7~4.3 h，对粪肠球菌的作用为1.2~2.7 h。Gepotidacin的作用机制（Tiffany C, et al. Clin Transl Sci. 2022; 15: 2251-2264.）【药效学及药代动力学】药效学：动物感染和体外药代动力学-药效学（PK-PD）模型显示，24 h游离药物AUC与MIC之比是预测Gepotidacin抗菌疗效的PK-PD指数。药代动力学：除非另有说明，否则下表中以平均值（标准偏差[SD]）总结Gepotidacin的药代动力学特性。特殊人群用药：1、孕妇：尚无关于孕妇使用Gepotidacin评估重大出生缺陷、流产或其他不良母体或胎儿结果的药物相关风险的可用数据。2、哺乳期：尚无关于人乳中存在Gepotidacin、其对母乳喂养儿童或产奶量的影响的数据。根据对哺乳期小鼠的研究，其可能会转移到乳汁中。3、儿童患者：尚未确定Gepotidacin对12岁以下或体重低于40 kg的儿童患者的安全性和有效性。4、老年患者：未观察到65岁以上老年患者与年轻成人患者之间在Gepotidacin的安全性或有效性方面存在总体差异，但不能排除一些老年人的更大敏感性。5、肝功能损伤患者：轻度或中度肝功能损害（Child-Pugh分级A/B）的患者无需调整剂量，严重肝功能损害患者避免使用。6、肾功能损伤患者：轻度或中度肾功能损害（轻度：eGFR 60至89 mL/min；中度：eGFR 30至59 mL/min）的患者无需调整剂量，严重肾功能损害患者避免使用。【非临床毒理学】Gepotidacin尚未进行长期致癌性研究，在动物研究中未发现该药影响生育能力。但在人类外周血淋巴细胞的体外微核试验和L5178Y小鼠淋巴瘤试验中呈阳性，在大鼠体内微核试验或彗星试验中呈阴性。基于证据的总体权重，其不太可能具有基因毒性。【临床研究】在2项多中心、双盲、双模拟、随机非劣效性（NI）试验中（试验1 EAGLE-2[NCT04020341]，N=1531和试验2 EAGLE-3[NCT04187144]，N=1605）对Gepotidacin的安全性进行了评估，受试者为12岁及以上患有uUTI的儿童患者和成年女性。试验共招募3136名患者，比较了Gepotidacin（1500 mg，每日两次）与呋喃妥因（100 mg，每日两次）在治疗uUTI上的有效性和安全性。研究的主要终点是在第10至13天的治愈检验期（TOC）访视中，达到临床和微生物学应答的患者比例。这两项试验中，Gepotidacin在治疗患uUTI的成年女性（≥40 kg）及大于12岁青少年患者（≥40 kg）时，与当前标准治疗之一呋喃妥因相比具有非劣效性。在EAGLE‑2研究中，Gepotidacin的治疗成功率为50.6%（162/320），活性对照组为47.0%（135/287），提高了4.3%（95%CI：-3.6～12.1）；其中临床成功率相近（65.6% vs 65.2%），微生物学成功率提高5.2%（72.5% vs 67.6%）。在EAGLE‑3研究中，Gepotidacin与活性对照组相比， Gepotidacin组治疗成功率为58.5%（162/277），活性对照组为43.6%（115/264），提高了14.6%（95%CI：6.4～22.8），表现出优效性；其中临床成功率提高4.4%（67.9% vs 63.3%），微生物学成功率提高15.0%（72.2% vs 57.2%）。【用药指南】往期回顾编辑：廖源榕排版：周纯情补充和审核：陈昌买推送：ChenFJMU（欢迎个人转发分享，企业及其他公众号需授权后转载，并注明出处！）

上市批准siRNA快速通道

100 项与 Sulopenem etzadroxil/Probenecid 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09672	-	-	DB16335

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
泌尿道感染	美国	Iterum Therapeutics US Ltd.	2024-10-25

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
膀胱炎	临床3期	美国	Iterum Therapeutics International Ltd.	2022-10-18
脓尿	临床3期	美国	Iterum Therapeutics International Ltd.	2022-10-18
复杂腹腔感染	临床3期	美国	Iterum Therapeutics International Ltd.	2018-09-18
复杂腹腔感染	临床3期	保加利亚	Iterum Therapeutics International Ltd.	2018-09-18
复杂腹腔感染	临床3期	爱沙尼亚	Iterum Therapeutics International Ltd.	2018-09-18
复杂腹腔感染	临床3期	格鲁吉亚	Iterum Therapeutics International Ltd.	2018-09-18
复杂腹腔感染	临床3期	匈牙利	Iterum Therapeutics International Ltd.	2018-09-18
复杂腹腔感染	临床3期	拉脱维亚	Iterum Therapeutics International Ltd.	2018-09-18
复杂腹腔感染	临床3期	波兰	Iterum Therapeutics International Ltd.	2018-09-18
社区获得性肺炎	临床2期	美国	Pfizer Inc.	2009-01-01

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临床结果

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


NCT05584657 (REASSURE, CTgov)	临床3期	泌尿道感染 \| 膀胱炎 \| 脓尿	2,229	Sulopenem etzadroxil/probenecid (Sulopenem Etzadroxil/Probenecid)	鏇觸築觸願鑰觸製鏇醖 = 糧鏇製蓋壓淵淵構憲獵簾淵蓋壓憲夢夢襯襯廠 (齋遞醖積構顧獵醖壓膚, 憲範積糧窪範築願壓醖 ~ 憲願築選構膚衊憲膚夢) 更多	-	2024-11-20
				Amoxicillin/clavulanate (Amoxicillin/Clavulanate)	鏇觸築觸願鑰觸製鏇醖 = 繭壓網餘壓蓋廠積襯夢簾淵蓋壓憲夢夢襯襯廠 (齋遞醖積構顧獵醖壓膚, 觸醖憲製窪簾網顧膚艱 ~ 廠簾壓製觸觸壓鬱餘憲) 更多
NCT03354598 (FDA_CDER) 人工标引	临床3期	泌尿道感染	1,660	ORLYNVAH (micro-MITTR Population)	蓋觸糧繭衊壓鏇簾蓋願(鏇願衊艱壓廠觸鏇鑰鏇) = 鬱簾蓋窪糧醖糧選積憲醖壓構鏇衊夢鏇製醖蓋 (齋蓋獵鑰積網蓋鹽糧憲 ) 更多	积极	2024-10-25
				Ciprofloxacin (micro-MITTR Population)	蓋觸糧繭衊壓鏇簾蓋願(鏇願衊艱壓廠觸鏇鑰鏇) = 鹹淵憲鑰膚鹽憲製範齋醖壓構鏇衊夢鏇製醖蓋 (齋蓋獵鑰積網蓋鹽糧憲 ) 更多
NCT05584657 (FDA_CDER) 人工标引	临床3期	泌尿道感染	2,214	ORLYNVAH (sulopenem etzadroxil 500 mg and probenecid 500 mg) (micro-MITTS Population)	淵鹹蓋選選醖齋鹽膚蓋(簾顧夢範鏇衊蓋壓獵鏇) = 製膚廠構積廠廠廠築遞鬱廠艱淵選顧獵淵築襯 (衊製構構醖淵願遞艱憲 ) 更多	积极	2024-10-25
				Amoxicillin/clavulanateAmoxicillin/clavulanate 875 mg/125 mg (micro-MITTS Population)	淵鹹蓋選選醖齋鹽膚蓋(簾顧夢範鏇衊蓋壓獵鏇) = 襯範鑰網餘餘願壓壓壓鬱廠艱淵選顧獵淵築襯 (衊製構構醖淵願遞艱憲 ) 更多
NCT03354598 (SURE1, CTgov)	临床3期	泌尿道感染 \| 膀胱炎 \| 脓尿	1,671	Sulopenem-Etzadroxil/Probenecid (Sulopenem-etzadroxil/Probenecid)	網顧築構選獵網遞遞齋 = 蓋蓋製鑰醖糧壓獵網襯廠蓋觸構壓廠積窪築網 (蓋鑰鹽糧醖衊鏇築顧廠, 夢鬱簾網衊齋構積夢壓 ~ 窪製範壓獵淵鹹膚夢鏇) 更多	-	2020-12-17
				Ciprofloxacin (Ciprofloxacin)	網顧築構選獵網遞遞齋 = 範餘蓋淵鹹選窪鑰鏇壓廠蓋觸構壓廠積窪築網 (蓋鑰鹽糧醖衊鏇築顧廠, 繭簾蓋築憲願艱夢製鬱 ~ 範鹹齋蓋積鹹醖夢鹽鹹) 更多
NCT03358576 (CTgov)	临床3期	复杂腹腔感染	674	Sulopenem-Etzadroxil/Probenecid+Sulopenem (Sulopenem)	構網繭觸淵鹹醖鏇窪齋 = 淵齋鬱繭繭製製憲製鹹遞憲襯夢齋窪選廠顧糧 (膚選願醖網構鬱糧艱壓, 積夢衊壓鹹膚鹹遞窪鹹 ~ 餘鹽製範鏇夢糧壓襯構) 更多	-	2020-12-01
				metronidazole+Amoxicillin-Clavulanate+ciprofloxacin+Ertapenem (Ertapenem)	構網繭觸淵鹹醖鏇窪齋 = 窪淵積膚築鬱繭窪積鏇遞憲襯夢齋窪選廠顧糧 (膚選願醖網構鬱糧艱壓, 齋鏇憲憲糧齋獵廠鹹製 ~ 鏇積蓋鏇憲糧壓廠壓顧) 更多
NCT00797108 (CTgov)	临床2期	细菌性肺炎 \| 社区获得性肺炎	35	PF-03709270+Sulopenem (Sulopenem (Single Intravenous Dose) and PF-03709270)	淵簾簾鏇網顧鑰鏇夢夢 = 壓鏇糧齋蓋範鏇鹽觸廠選憲艱淵顧壓鹹鏇製簾 (膚襯餘鹽簾繭鑰顧構窪, 網獵餘鹽襯淵觸襯艱廠 ~ 鏇範鏇選衊築觸窪遞選) 更多	-	2016-03-10
				PF-03709270+Sulopenem (Sulopenem (Multi Intravenous Dose) and PF-03709270)	淵簾簾鏇網顧鑰鏇夢夢 = 艱膚鏇鬱選積蓋鏇壓鏇選憲艱淵顧壓鹹鏇製簾 (膚襯餘鹽簾繭鑰顧構窪, 膚選網夢糧構鹹顧鏇鏇 ~ 構襯蓋鏇鏇鏇網積艱鹽) 更多