This study aims to compare the efficacy and safety of two antibiotic combinations (Colistin + Meropenem) vs (Imipenem/cilastatin+ Tigecycline) in the treatment of adults with MDR gram-negative infections.

Start Date01 Apr 2026

Sponsor / Collaborator

Ain Shams University

ChiCTR2500114879

/ CompletedPhase 4IIT

Efficacy and safety of colistimethate sodium in treating carbapenem-resistant Gram-negative bacterial infections: an open-label, single-center, single-arm study in Chinese adults.

Start Date01 Nov 2023

Sponsor / Collaborator

Xijing Hospital

NCT05925309

/ RecruitingNot ApplicableIIT

Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy in Biliary Atresia: a Randomized Controlled Trial

This study is non-inferiority trial design. This study aimed to investigate the effect of prophylactic oral antibiotics on preventing cholangitis in biliary atresia (BA) patients after Kasai portoenterostomy (KP) by comparing the cholangitis rate in BA patients who received prophylactic oral antibiotics and those who did not. The patients were followed up for 2 years after KP.

Start Date01 Jul 2023

Sponsor / Collaborator

Paediatrics Hospital Affiliated To Fudan University

100 Clinical Results associated with Imipenem

100 Translational Medicine associated with Imipenem

100 Patents (Medical) associated with Imipenem

18,148

Literatures (Medical) associated with Imipenem

31 Dec 2026·ANNALS OF MEDICINE

Comparative evaluation of molecular technologies for the identification of prevalent non-tuberculous mycobacteria in pulmonary infections: a systematic review and meta-analysis

Review

Author: Molicotti, Paola ; Sechi, Leonardo Antonio ; You, Yanshan ; Chen, Xiang ; Sun, Jiawen ; Chen, Xibin

BACKGROUND:

The increasing prevalence of non-tuberculous mycobacteria pulmonary disease (NTM PD) is a burden to public health. Successful management of NTM PD critically depends on accurate species identification and reliable drug susceptibility testing to guide appropriate antibiotic therapy. Emerging molecular technologies offer rapid diagnostic solutions compared to conventional methods, but their performance varies. This study aims to provide a comprehensive evaluation of current molecular techniques for NTM identification and to present a global antibiotic resistance profile.

METHODS:

A systematic literature search was conducted in PubMed and Web of Science for studies published between 2005 and 2024. Studies applying molecular methods for NTM identification and resistance detection in humans were included. Data on study characteristics, diagnostic methods, sample types, sample sizes, identification sensitivity, and drug susceptibility results were extracted. Meta-analysis was performed using R with the meta4diag package. The quality of included studies was assessed using the QUADAS-2 tool.

RESULTS:

The analysis included 49 studies on NTM identification and 33 studies on antibiotic resistance. For species identification, all evaluated molecular technologies (MALDI-TOF MS, PCR-based methods, Sequencing, DNA chip, and DNA strip) demonstrated high pooled sensitivities (>0.92). Subgroup analysis revealed that sample type significantly affected performance for MALDI-TOF MS. Preliminary analysis of antibiotic resistance rates revealed varying patterns. For slowly growing mycobacteria, a significantly high Ethambutol resistance rate was observed in M. avium (69.20%). Among rapidly growing mycobacteria, resistance to Imipenem was notable (54.22%), and Clarithromycin resistance varied significantly within the Mycobacterium abscessus complex.

CONCLUSION:

Emerging molecular technologies have revolutionized the methodology for NTM identification with excellent performance. However, their performance can be influenced by sample type, particularly for MALDI-TOF MS. The alarming and heterogeneous antibiotic resistance patterns also highlight the critical need for rapid and accurate species identification and drug susceptibility testing to inform effective therapeutic strategies. Key messagesMolecular technologies demonstrate high accuracy for NTM identification.Antibiotic resistance is a serious concern with variations among NTM species and subspecies.Rapid and accurate species identification and drug susceptibility testing are crucial for guiding effective clinical management of NTM PD.

31 Dec 2026·Human Vaccines & Immunotherapeutics

Targeting a conserved flagellin D1 epitope with 16G10 confers cross-serotype protection in murine Pseudomonas aeruginosa infection models

Article

Author: Zhu, Zifan ; Zhang, Yueyue ; Wang, Ying ; Wang, Yating ; Gu, Jiang ; Jiang, Jianxin ; Zhao, Hui ; Zou, Quanming ; Cheng, Xin ; Liu, Xinglong ; Wang, Qian ; Cai, Qingli ; Li, Yuhang

Escalating resistance in Pseudomonas aeruginosa (PA) underscores the need for resistance-agnostic immunotherapies. In this study, we generated a panel of 20 monoclonal antibodies against the flagellin protein FliC and identified 16G10 as a high-affinity lead. Epitope mapping revealed a conserved linear site within the D1 domain (Gly71-Ile88), a region essential for filament assembly. In vitro, 16G10 induced bacterial aggregation, suppressed swimming motility, and significantly reduced adhesion to and invasion of A549 cells, while limiting biofilm biomass by SEM and confocal 3D imaging. In vivo, in murine pneumonia, where 16G10 administered either after pre-incubation with imipenem-resistant PA strain or as post-infection therapy, it improved survival, lowered lung bacterial loads, reduced IL-6 and TNF-α concentrations, and attenuated histologic inflammation. Protection extended across serotype A and B flagellated strains, indicating broad coverage. These data nominate 16G10 as a promising candidate for immunotherapy of drug-resistant PA lung infections and establish a druggable flagellin epitope for future vaccine and antibody designs.

01 Dec 2026·MOLECULAR BIOLOGY REPORTS

Molecular characterization of IMP and NDM resistance genes in carbapenemase-producing Enterobacteriaceae isolates in urine

Article

Author: Simpore, Jacques ; Ouedraogo, Rogomenoma Alice ; Sorgho, Pegdwendé Abel ; Bambara, Lionel Eliada Benoit ; Bado, Prosper ; Zohoncon, Théodora Mahoukèdè ; Yonli, Albert Théophane ; Kabore, Delwendé Leslie

INTRODUCTION:

Extended-spectrum beta-lactamase and carbapenemase-producing Enterobacteriaceae, implicated in urinary tract infections, represent a major challenge and limit therapeutic options. Our study sought to characterize the genes of resistance to IMP and NDM in urine samples from patients in the city of Ouagadougou by real-time PCR.

METHODOLOGY:

This cross-sectional study focused on 130 bacterial isolates collected from February to July 2023 at HOSCO and CERBA. The determination of the enterobacterium species was followed by the performance of an antibiogram. Gene detection consisted of the extraction of bacterial DNA and its amplification by real-time PCR.

RESULT:

60 isolates came from male patients (46.2%) and 70 from female patients (53.8%), for a sex ratio (M/F) of 0.85 and an age between 51 days and 83 years, including 87.7% over 20 years. The most frequent species were respectively Escherichia coli (64.6%), Klebsiella sp. (30.8%), Proteus sp. (3.1%) and Enterobacter cloacae (1.5%). Resistance to imipenem for all Enterobacteriaceae strains was 19.2% and the majority gene was NDM (70%). The IMP gene was rare with only one positive case (0.8%) which was a coexistence of the 2 genes IMP and NDM.

CONCLUSION:

The NDM gene could be a cause of resistance to antibiotics, particularly imipenem, and special attention should be paid to Escherichia coli in the fight against the emergence of extended-spectrum β-lactamases. Real-time PCR could serve as a routine analytical technique to facilitate obtaining more reliable results in a short timeframe.

News (Medical) associated with Imipenem

02 Sep 2026

·www.synactpharma.com

SynAct Pharma to present new resomelagon preclinical data on Phase 3-ready RA therapeutic candidate at the 17th World Congress of Inflammation 2026

Preclinical data support broad efficacy and potential for resomelagon’s distinct pro-resolution mechanism of action First study supports resomelagon development to treat osteoarthritis Second study in pseudomonas supports resomelagon development as additive effect to antibiotics for hard-to-treat bacterial infections SynAct Pharma AB (publ) (”SynAct”) (Nasdaq Stockholm: SYNACT), a clinical-stage biotechnological company focused on treating inflammation through a novel therapeutic approach called “pro-resolution”, today announces two poster presentations supporting the differentiated therapeutic potential of resomelagon (AP1189), the Company’s lead Phase 3-ready candidate at the 17th World Congress of Inflammation, to be held in Foz do Iguaçu, Brazil, from September 8–12, 2026. The data further reinforce growing evidence on the role of pro-resolution mechanisms in treating inflammatory and infectious diseases, including osteoarthritis (OA) and hard-to-treat bacterial infections. Inflammation in OA and in infection can be related through shared innate immune pathways, cytokines, and signaling hubs, even though innate immune activation in OA is predominantly sterile while infection is driven by microbes. As a selective MC1R/MC3R agonist, resomelagon represents a novel approach to modulating inflammation and restoring tissue homeostasis, with potential applications across multiple therapeutic areas. “SynAct’s focus on the pro-resolution mechanism sets us apart in the field of anti-inflammatory therapeutics,” said Thomas Jonassen, Chief Scientific Officer of SynAct Pharma. “These data further outline how resomelagon activates pro-resolution pathways to reduce inflammation and biomarkers, and its potential as a novel therapy for osteoarthritis and severe bacterial infections by resolving inflammation without broad immunosuppression.” Resolution is the active, receptor-mediated termination of inflammation — a distinct biological program comprising cessation of neutrophil influx, efferocytosis of apoptotic cells, macrophage reprogramming toward a reparative phenotype, and restoration of tissue architecture. SynAct's resomelagon, an orally available, once-daily biased agonist of the MC1 and MC3 melanocortin receptors, was designed to engage this program directly, offering the potential to control inflammation both in resolution-deficient autoimmunity such as rheumatoid arthritis and in host-damaging responses to infection, without the immunosuppression that limits current standards of care. Details of the presentations Effects of MC1R/MC3R Melanocortin Receptor Agonism on Osteoarthritis Inflammation, Joint Damage, and Pain Time: September 11, 2026, 18:30–19:30 Location: Poster Session The first poster outlines how activation of specific melanocortin receptors engages pro-resolution pathways, tamping down inflammation and associated biomarkers. In short, resomelagon, offers a promising novel therapeutic approach for halting osteoarthritis progression and alleviating associated pain, without compromising the immune system, the way marketed therapies do. This study, led by researchers from the Federal University of Minas Gerais (UFMG) and SynAct, investigates the effects of resomelagon in a murine model of OA induced by destabilization of the medial meniscus (DMM). Preliminary results demonstrate that resomelagon exerts a potential therapeutic effect by modulating the inflammatory profile and preventing the progression of experimental OA. Data showed it reduces cellular infiltration, modulates pro-inflammatory cytokines such as IL-1β and TGF-β, and prevents histopathological changes associated with OA progression. Notably, treated animals did not develop OA-like alterations, suggesting a potential disease-modifying effect. OA is a highly prevalent joint disorder affecting 595 million people globally[1] characterized by chronic pain and functional impairment. Increasing evidence indicates that sustained low‑grade inflammation contributes to disease progression and structural joint damage. Study of the Therapeutic Potential of a Biased Melanocortin Receptor Agonist (MRA) Against Pseudomonas aeruginosa-Induced Pneumonia in Mice Time: September 9, 2026, 18:00–19:30 Location: Poster Session The second poster demonstrates how resomelagon promotes a pro-resolving inflammatory milieu, without broad immunosuppression, and thus addresses a critical gap in the treatment of severe bacterial infections. Inflammation in response to bacterial infection plays an important role, orchestrating the recruitment of immune cells to contain and clear the pathogen — however, when excessive or dysregulated, it can drive collateral tissue damage, sepsis, and chronic disease. Resomelagon was evaluated as both a monotherapy and in combination with the antibiotic imipenem in a murine model of P. aeruginosa-induced pneumonia. Treatment with resomelagon reduced mortality, lung histopathology scores, and intra-alveolar neutrophil accumulation, while trending toward a reduction in pro-inflammatory cytokines (IL-1β, IL-6, TNF-α) and an increase in the anti-inflammatory cytokine IL-10. The results underscore the potential of melanocortin receptor agonism to modulate, rather than suppress, the inflammatory response, thereby improving survival and limiting tissue damage. [1] Lancet Rheumatol 2023; 5: e508–22 For further information, please contact: Jeppe Øvlesen CEO, SynAct Pharma AB Phone: + 45 2844 7567 E-mail: investor.relations@synactpharma.com Investors and Media Mary-Ann Chang, Cohesion Bureau E-mail: synactpharma@cohesionbureau.com About SynAct Pharma AB SynAct Pharma AB (Nasdaq Stockholm: SYNACT) is a clinical-stage biotechnology company pioneering pro-resolution therapies for inflammation through selective activation of the melanocortin system. Its lead asset, resomelagon (AP1189), is a once-daily oral, first-in-class biased agonist of the MC1 and MC3 melanocortin receptors, that has completed Phase 2b development in rheumatoid arthritis, and is in Phase 2 development as host-directed therapy to treat inflammation caused by infections, including respiratory viral infection and dengue. Behind resomelagon, SynAct is building a broad portfolio of oral small molecule and injectable peptide melanocortin agonists designed to induce anti-inflammatory pro-resolution activity, helping patients restore immune balance. For more information, please visit www.synactpharma.com. Attachments SynAct Pharma to present new resomelagon preclinical data on Phase 3-ready RA therapeutic candidate at the 17th World Congress of Inflammation 2026

Phase 2Phase 3Clinical Result

18 Jun 2026

·www.biospace.com

Utebzi (tebipenem pivoxil) approved in the US for adults with complicated urinary tract infections (cUTIs)

First and only oral carbapenem antibiotic approved in the US Approval based on PIVOT-PO trial demonstrating non-inferiority compared to intravenous treatment i More than 3 million cases of cUTIs are treated annually in the US with a third of patients impacted by resistant infections ii ,iii CAMBRIDGE, Mass., June 17, 2026 (GLOBE NEWSWIRE) -- Spero Therapeutics , Inc. (Nasdaq: SPRO) and GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Utebzi, an oral antibiotic for the treatment of complicated urinary tract infections (cUTIs) including pyelonephritis 1 , caused by certain susceptible pathogens 2 in adult patients who have limited or no alternative oral treatment options. This is the first and only oral carbapenem antibiotic approved for these patients. This approval is a result of GSK’s development and exclusive global licensing agreement (excluding select Asian territories) with Spero Therapeutics. iv There are more than 3 million cases of cUTI in the US annually and treatment failure impacts up to 34% of patients. 2,3 Often caused by multidrug-resistant pathogens, v these infections account for over $6 billion per year in healthcare costs. 3 Carbapenems are the standard treatment for severe or resistant infections, but until now have only been available through intravenous administration vi , increasing hospital resource use and reducing patients’ quality of life. vii Tebipenem pivoxil offers the potential for an effective oral alternative taken outside of a hospital setting. Tony Wood, Chief Scientific Officer, GSK, said: “With antibiotic resistance continuing to rise, patients and healthcare professionals need new treatment options. The approval of Utebzi provides the first and only oral carbapenem antibiotic for appropriate adults with complicated UTIs, a solution that could help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections.” Dr. Bilal Chughtai, Chief of Urology at Plainview Hospital, Northwell Health and Associate Professor of Urology at the Zucker School of Medicine at Hofstra/Northwell , said: “For patients with complicated urinary tract infections (cUTIs) and their caregivers, this approval is a major milestone as today’s standard of care places a serious burden on them and hospitals. A new effective oral treatment offering an alternative option to intravenous care has the potential to enable more treatment in the outpatient settings with the ambition to improve their experience.” Esther Rajavelu, President and Chief Executive Officer, Spero Therapeutics added: “The FDA approval of tebipenem pivoxil marks the culmination of more than a decade of dedication from our team, partners, and, most importantly, the patients who placed their trust in this program. We are proud to reach this important milestone. Through our partnership with GSK, we look forward to this much-needed oral treatment option reaching cUTI patients to help reduce the burden of the disease.” This approval is supported by positive results from the PIVOT-PO phase III trial, which demonstrated non-inferiority of tebipenem pivoxil compared to intravenous imipenem-cilastatin in hospitalized patients with cUTI, including pyelonephritis, based on the overall response (composite of clinical cure plus microbiological eradication) at the test of cure visit. Tebipenem pivoxil (oral, 600 mg) achieved a 58.5% overall success rate (261/446 participants) compared to 60.2% overall success rate (291/483 participants) for imipenem-cilastatin (intravenous, 500 mg) (adjusted treatment difference: −1.3%; 95% CI: −7.5%, 4.8%). The safety pro tebipenem pivoxil was generally similar to that of imipenem-cilastatin and other carbapenem antibiotics. The most frequently reported adverse events (in ≥3% of patients) were diarrhoea and headache; these events were all mild or moderate and non-serious. viii Tebipenem pivoxil is anticipated to be made available to US patients by the end of 2026. This approval confirms the successful and productive collaboration between GSK and Spero Therapeutics. The development of tebipenem pivoxil has been supported in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract numbers HHSO100201800015C and HHSO100201300011C. About tebipenem pivoxil Tebipenem pivoxil was developed in collaboration with Spero Therapeutics ix for the treatment of cUTIs, including pyelonephritis. In September 2022, GSK entered into an exclusive license agreement with Spero Therapeutics for the development and commercialization in all markets, except certain Asian territories. Under this agreement, GSK sub-licensed back to Spero Therapeutics the rights and responsibility to conduct certain development work, including the PIVOT-PO phase III study. The sponsorship of the New Drug Application has been transferred to GSK. As part of the license agreement, tebipenem pivoxil has received Qualified Infectious Disease Product and Fast Track designations from the US FDA. The US Prescribing Information will be available here [ ] About the PIVOT-PO trial The PIVOT-PO trial was a global, randomized, double-blind, pivotal, non-inferiority (NI margin: -10%) phase III trial evaluating the potential of oral tebipenem pivoxil compared to IV imipenem-cilastatin, in hospitalized adult patients with complicated urinary tract infections, including acute pyelonephritis. Patients were randomized 1:1 to receive tebipenem pivoxil (600 mg) orally every six hours, or imipenem-cilastatin (500 mg) IV every six hours, for a total of seven to ten days. Dose adjustments were made for patients with reduced renal function. Matching placebos were used to maintain blinding. The primary efficacy endpoint was composite response (combined per-patient clinical cure and microbiological response) at the test-of-cure visit (about 17 days from first dose administration of study drug) in patients with qualifying pathogens susceptible to imipenem. The trial enrolled a total of 1,690 patients, with randomization stratified by age, baseline diagnosis (cUTI or acute pyelonephritis), and the presence or absence of urinary tract instrumentation. For further details on the trial, refer to clinicaltrials.gov identifier NCT06059846. x About complicated urinary tract infections (cUTIs) cUTIs are broadly described as any UTI that carries an increased risk of morbidity and mortality. 5 Definitions of cUTIs are not currently uniform among international societies and regulatory agencies. cUTIs encompass a heterogeneous patient population due to the wide range of host factors, comorbidities and urological abnormalities associated with cUTIs. Risk factors for cUTIs include indwelling catheters, ureteric stents, neurogenic bladder, obstructive uropathy, urinary retention, urinary diversion, kidney stones, diabetes mellitus, immune deficiency, urinary tract modification and UTIs in renal transplant patients. xi ,xii,xiii,xiv About GSK GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. Find out more at gsk.com. About Spero Therapeutics Spero Therapeutics, headquartered in Cambridge, Massachusetts, is a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and diseases with high unmet need. For more information, visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the potential Utebzi to meaningfully improve treatment options for cUTI patients; the potential of Utebzi to help reduce reliance on hospital-based intravenous care and support efforts to address resistant infections; the potential of Utebzi to enable more treatment options in outpatient settings with the ambition to improve patients’ experience; the potential of tebipenem HBr to set a new standard of care and decrease the disease burden. In some cases, forward-looking statements may be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intent,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of these terms or other similar expressions. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of important risks, uncertainties and other factors that may cause actual results to differ materially from those indicated by such forward looking statements, including, but not limited to, whether Spero and GSK will successfully perform their respective obligations under the collaboration between Spero and GSK; risks and uncertainties related to the successful commercial launch of Utebzi and market acceptance; the competitive landscape for Utebzi, risks related to Spero’s expectations regarding the potential clinical benefit of Utebzi to patients; the risk that any regulatory approval may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the uncertainties inherent in research and development, including clinical results; regulatory actions or delays or government regulation generally; Spero’s ability to protect its intellectual property portfolio; Spero’s reliance on third parties to manufacture, develop, and commercialize its product candidates; Spero’s reliance on GSK, pursuant to the exclusive GSK License Agreement, to advance development of tebipenem pivoxil and GSK’s right thereunder to determine, in its sole discretion, whether to further develop and commercialize tebipenem pivoxil; Spero’s need for additional funding; Spero’s ability to retain key personnel; whether Spero’s cash resources will be sufficient to fund its continuing operations for the periods anticipated; and other factors discussed in the “Risk Factors” set forth in filings that Spero periodically makes with the SEC. The forward-looking statements included in this press release represent Spero’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, Spero explicitly disclaims any obligation to update any forward-looking statements. Investor Relations Contact: Shai Biran, PhD Spero Therapeutics IR@Sperotherapeutics.com Media Inquiries: media@sperotherapeutics.com 1 Pyelonephritis is a specific type of UTI that has travelled up the urinary tract to infect one or both kidneys. 2 Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae species complex, Klebsiella oxytoc a, and Enterococcus faecalis . i GSK press release, “Positive PIVOT-PO phase III data show tebipenem HBr’s potential as the first oral carbapenem antibiotic for patients with complicated urinary tract infections (cUTIs)”, October 2025. Available at: press-release-tebi-pivot-po-phase-iii-read-out.pdf (last accessed: May 2026) ii Carreno JJ, et al. “Longitudinal, nationwide, cohort study to assess incidence, outcomes, and costs associated with complicated urinary tract infection” in Open Forum Infect Dis . 2019;7:ofil446. doi: 10.1093/ofid/ofz446 iii Lodise TP, et al. Hospital admission patterns of adult patients with complicated urinary tract infections who present to the hospital by disease acuity and comorbid conditions: How many admissions are potentially avoidable? Am J Infect Control . 2021;49(12):1528-1534. iv GSK press release, GSK and Spero Therapeutics announce exclusive licence agreement for tebipenem HBr, a late-stage antibiotic that may treat complicated urinary tract infections , 22 September 2022 v Sabih A, Leslie SW. “Complicated urinary tract infections” in StatPearls . 2023. StatPearls Publishing: Treasure Island, FL, USA. vi Eckburg PB, et al. “Oral tebipenem pivoxil hydrobromide in complicated urinary tract infection”. In New England Journal of Medicine, . 2022;386:1327-1338. doi: 10.1056/NEJMoa2105462 vii NHS. Reducing complications with a prolonged hospital stay. 2024. Available from: (last accessed: May 2026) viii GSK press release, Positive PIVOT-PO phase III data show tebipenem HBr’s potential as the first oral carbapenem antibiotic for patients with complicated urinary tract infections ( cUTIs) , October 2025 ix GSK press release, GSK and Spero Therapeutics announce exclusive licence agreement for tebipenem HBr, a late-stage antibiotic that may treat complicated urinary tract infections , 22 September 2022 x CT.gov, A Study of Oral Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenous Imipenem-cilastatin in Participants With Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP) (PIVOT-PO), last updated on 01 July 2025 xi Bonkat G, et al. “Keep it Simple: A Proposal for a New Definition of Uncomplicated and Complicated Urinary Tract Infections from the EAU Urological Infections Guidelines Panel”. Eur Urol. 2024;86(3):195-197. xii Wagenlehner FME, et al. Epidemiology, definition and treatment of complicated urinary tract infections. Nat Rev Urol. 2020;17(10):586-600. xiii Gomila A, et al. Predictive factors for multidrug-resistant gram-negative bacteria among hospitalized patients with complicated urinary tract infections. Antimicrob Resist Infect Control. 2018;7:111. xiv Altunal N, et al. Ureteral stent infections: a prospective study. Braz J Infect Dis. 2017;21(3):361-364.

Phase 3Clinical ResultLicense out/inFast TrackDrug Approval

15 Apr 2026

·www.biospace.com

Meiji Seika Pharma’s Nacubactam to Be Featured in 10 Presentations at ESCMID Global 2026 — Including Phase III Integral-2 Results

TOKYO--(BUSINESS WIRE)--Meiji Seika Pharma Co., Ltd. (headquartered in Tokyo; President and Representative Director: Toshiaki Nagasato) today announced that at ESCMID Global 2026, to be held from 17 to 21 April 2026, it will present a total of ten studies on its novel β-lactamase inhibitor nacubactam (development code: OP0595), for which a manufacturing and marketing authorisation application is under review in Japan. The presentations include results from Integral-2, an international, multicentre Phase III clinical trial in patients with infections due to carbapenem-resistant Enterobacterales (CRE). Currently, carbapenem-resistant bacteria pose a global threat because carbapenems are considered last-resort agents for severe infections. The development and approval of effective agents against multidrug-resistant Gram-negative bacteria, including CRE, are urgently needed ( WHO Bacterial Priority Pathogens List, 2024 ). In December 2025, Meiji Seika Pharma submitted an application for manufacturing and marketing approval of nacubactam in Japan and remains committed to contributing to global efforts against AMR—the “silent pandemic.” The planned presentations are as follows: Efficacy and safety of cefepime/nacubactam and aztreonam/nacubactam vs best available therapy in adults with cUTI/AP, HABP/VABP, cIAI due to carbapenem resistant Enterobacterales: Integral-2, single-blind, randomised phase III trial — Oral presentation (O0107); Clinical Outcomes of cefepime/nacubactam and aztreonam/nacubactam for treatment of cUTI/AP patients with CRE: subgroup analysis of Integral-1 study — Poster (P2876); Poster Walkthrough (R0058); Clinical Outcomes of cefepime/nacubactam and aztreonam/nacubactam in cUTI/AP patients with ESBL-producing bacteria enrolled into prospective phase III randomised clinical study (Integral-1) — Poster (P2864); Clinical Efficacy and safety of cefepime/nacubactam and aztreonam/nacubactam compared with imipenem/cilastatin for complicated urinary tract infection or acute uncomplicated pyelonephritis: Integral-1, a double-blind, randomised phase III trial — Poster (P2857); Clinical The in vitro activity of aztreonam/nacubactam and cefepime/nacubactam against molecularly characterised Enterobacterales isolates including those with ceftazidime-avibactam and aztreonam/avibactam resistance mechanisms collected globally from 2021–2023 — Top Rated Poster (P1622); Non-clinical Activity of the novel combination therapy cefepime/nacubactam against 17,220 clinical isolates of Enterobacterales collected worldwide during 2021–2024 — Poster (P1197); Non-clinical In vitro activity of nacubactam against broad-spectrum β-lactamases — Poster (P2659); Non-clinical Probability of target attainment of cefepime/nacubactam and aztreonam/nacubactam for carbapenem-resistant Enterobacterales infections — Poster (P2742); PK/PD Population pharmacokinetic analysis of nacubactam, cefepime, and aztreonam and exposure–response analysis of efficacy results from phase III clinical trials — Poster (P2743); PK/PD Determination of the nonclinical PK/PD target value for nacubactam in a mouse thigh infection model using carbapenem-resistant Enterobacterales under co-administration of cefepime or aztreonam — Poster (P2744); PK/PD Following congress selection, O0107 was chosen for an Oral Presentation, P2876 for the Poster Walkthrough session, and P1622 as a Top Rated Poster (top 2%). About nacubactam (development code: OP0595) Nacubactam (development code: OP0595) is a novel β-lactamase inhibitor discovered by Meiji Seika Pharma. In combination with existing β-lactam antibiotics such as cefepime or aztreonam, nacubactam is expected to be effective against carbapenem-resistant Enterobacterales (CRE), including carbapenemase-producing strains. In addition, nacubactam inhibits penicillin-binding protein 2 (PBP2), an enzyme involved in the biosynthesis of peptidoglycan in the bacterial cell wall, thereby conferring a property that distinguishes it from other β-lactamase inhibitors. In the Integral-1 trial, for the primary endpoint of composite clinical and microbiological response at seven days after the end of treatment, superiority of cefepime/nacubactam over imipenem/cilastatin and non-inferiority of aztreonam/nacubactam to the same comparator were demonstrated. With respect to safety, no significant safety concerns were observed (press release dated 14 March 2025). In the Integral-2 trial, for the primary endpoint of overall composite response at seven days after the end of treatment across all enrolled indications, high efficacy of both cefepime/nacubactam and aztreonam/nacubactam was confirmed compared with best available therapy. With respect to safety, no significant safety concerns were observed. Contacts For further information: Meiji Seika Pharma Co., Ltd. Hayato Okade Project Manager, Nacubactam pr-pharma@meiji.com

100 Deals associated with Imipenem

External Link

KEGG	Wiki	ATC	Drug Bank
D00206	Imipenem	J01DH51	DB01598

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Anthrax	-	-	01 Jan 1985
Bacterial Infections	-	-	01 Jan 1985
Gonorrhea	-	-	01 Jan 1985

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hospital acquired bacterial pneumonia	Phase 3	-	Merck Sharp & Dohme Corp.	24 Nov 2015
Ventilator associated bacterial pneumonia	Phase 3	-	Merck Sharp & Dohme Corp.	24 Nov 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ARVO2025	Not Applicable	Endophthalmitis	421	Intravitreal vancomycin + ceftazidime	cbczsziznh(uocyhmjpgy) = abqezskcnz gcsmkkaatr (auagoidbqo ) View more	Positive	04 May 2025
NCT03858387 (Pubmed \| Pharmacotherapy)	Not Applicable	Severe infection	50	imipenem (Critically ill patients with life-threatening severe infections with ECMO support)	bcodtkskup(rkedeoqkmd) = qwjeyefhfl xcjkbkesbh (aavbfamyde ) View more	-	26 May 2021
				imipenem (Critically ill patients with life-threatening severe infections without ECMO support)	bcodtkskup(rkedeoqkmd) = btfjffajzy xcjkbkesbh (aavbfamyde ) View more
NCT03776305 (Pubmed \| Eur J Drug Metab Pharmacokinet)	Phase 4	Extracorporeal membrane oxygenation complication	10	Imipenem 0.5g	faecgiodvy(myliihrzsj) = teiktkmsca onfhretdpy (oyfdjwdaqh ) View more	-	01 Dec 2020
NCT02616354 (Two-step Dosing Of Imipenem, Pubmed \| Adv Ther)	Phase 4	Sepsis \| Shock, Septic	35	Imipenem (Two-step infusion)	sjhzjpybwr(fmwwsqvnzz) = ihrvuddfpk lsifkxvlfg (ybawwfujja )	-	01 May 2020
				Imipenem (Extended infusion)	sjhzjpybwr(fmwwsqvnzz) = xzxnpxmccf lsifkxvlfg (ybawwfujja )
NCT02493764 (RESTORE-IMI 2 \| MK-7655A-014 \| 7655A-014, CTgov)	Phase 3	Hospital acquired bacterial pneumonia \| Ventilator associated bacterial pneumonia	537	Imipenem+Relebactam+Cilastatin+Linezolid (IMI/REL)	baxfnuzwip = qdtvzgcihc oymyswsehg (dsmptbajiv, vfnyjxmhck - tiwrbdlzzr) View more	-	16 Apr 2020
				Linezolid+Piperacillin+Tazobactam (PIP/TAZ)	baxfnuzwip = dvunwvbhez oymyswsehg (dsmptbajiv, gadttoyudp - bdaqycavtv) View more
NCT03308214 (Pubmed \| J Infect Dis)	Not Applicable	Sepsis \| Shock, Septic	25	Imipenem (Sepsis)	sghekipnma(ejdamtrdmp) = wkujrduepy szifgbjjvj (srkydefjvr ) View more	-	16 Mar 2020
				Imipenem (Septic shock)	sghekipnma(ejdamtrdmp) = aymsniwnnr szifgbjjvj (srkydefjvr ) View more
NCT01659866 (CTgov)	Phase 4	Infectious Diseases	563	Ciprofloxacin (Cipro-susceptible)	ebfwqexvec = jqbfdupgmk udolygpgme (vwneoiymdf, azjqcknssm - irivfpklgc) View more	-	25 Jun 2019
				imipenem+aztreonam+trimethoprim-sulfamethoxazole+cefuroxime+gentamicin+ceftriaxone+amikacin (Cipro-resistant)	ebfwqexvec = yqbauvszdi udolygpgme (vwneoiymdf, gtbmhfcgbb - wqmudxxwsd) View more
UEGW2015	Phase 3	Pancreatitis	-	Imipenem 500 mg i.v.	aghrhahobc(uwecdjzdjw) = aykpyxssvr phttcdevnw (vfzdprcyiv ) View more	Negative	01 Oct 2015
				Placebo	aghrhahobc(uwecdjzdjw) = frjbwmijvh phttcdevnw (vfzdprcyiv ) View more
NCT00950222 (Pubmed \| Br J Clin Pharmacol)	Not Applicable	Pneumonia, Ventilator-Associated	-	Imipenem 500 mg every 6 hours	rkmticaxps(ezkfcgcozq) = zhclmrvgau tjkmzdnchh (lwmbyiruhw )	-	01 Nov 2014
				Imipenem 750 mg every 6 hours	rkmticaxps(ezkfcgcozq) = nlsqwighgg tjkmzdnchh (lwmbyiruhw )
Pubmed \| Clin Infect Dis	Not Applicable	Febrile Neutropenia	541	Clinafloxacin	vnxpnperex(mmlxzmwfxl) = kkuhorqlac lmqxbnoumi (fdxbtyqsge ) View more	-	01 Feb 2001
				Imipenem	vnxpnperex(mmlxzmwfxl) = tubiqustoc lmqxbnoumi (fdxbtyqsge ) View more

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