A Phase 3 Study to Evaluate Cefepime-taniborbactam Compared to Meropenem in Adults With Ventilator Associated Bacterial Pneumonia (VABP) or Ventilated Hospital Acquired Bacterial Pneumonia (vHABP)

This is a Phase 3, randomized, multicenter, double-blind, non-inferiority study to evaluate the efficacy and safety of cefepime-taniborbactam compared to meropenem in patients ≥ 18 years of age with ventilated HABP or VABP.

Start Date01 Jun 2025

Sponsor / Collaborator

Venatorx Pharmaceuticals, Inc.

[+1]

NCT04951505

/ CompletedPhase 1

A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects

This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.

Start Date29 Jun 2021

Sponsor / Collaborator

Venatorx Pharmaceuticals, Inc.

CTR20191681

/ CompletedPhase 1

头孢吡肟/VNRX-5133在中国健康受试者中单剂和多剂静脉输注给药的药代动力学、安全性和耐受性的1期临床试验

[Translation] Phase 1 clinical trial of the pharmacokinetics, safety, and tolerability of single and multiple intravenous infusions of cefepime/VNRX-5133 in healthy Chinese subjects

1. 评价中国健康受试者中头孢吡肟/VNRX-5133单剂和多剂静脉（IV）输注给药的药代动力学。 2. 评价中国健康受试者中头孢吡肟/VNRX-5133单剂和多剂静脉输注给药的安全性和耐受性。

[Translation]

1. To evaluate the pharmacokinetics of single and multiple intravenous (IV) infusions of cefepime/VNRX-5133 in healthy Chinese subjects. 2. To evaluate the safety and tolerability of single and multiple intravenous infusions of cefepime/VNRX-5133 in healthy Chinese subjects.

Start Date06 Jun 2020

Sponsor / Collaborator

Lyophilization Services of New England, Inc.

[+2]

100 Clinical Results associated with Cefepime Hydrochloride/Taniborbactam

100 Translational Medicine associated with Cefepime Hydrochloride/Taniborbactam

100 Patents (Medical) associated with Cefepime Hydrochloride/Taniborbactam

829

Literatures (Medical) associated with Cefepime Hydrochloride/Taniborbactam

01 Oct 2025·INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS

Rapid detection of cefepime-taniborbactam susceptibility/resistance in Enterobacterales

Article

Author: Nordmann, Patrice ; Le Terrier, Christophe ; Poirel, Laurent ; Kerbol, Auriane ; Bouvier, Maxime

OBJECTIVE:

Metallo-β-lactamase-producing Enterobacterales is widely distributed and confers resistance to all β-lactams, including carbapenems. Recently, a cefepime-taniborbactam combination has been developed that aims to provide a treatment option for infections caused by metallo-β-lactamase-producing bacteria. The objective of this study was to develop a rapid diagnostic test, namely the Rapid Cefepime-Taniborbactam NP test, for the early identification of cefepime-taniborbactam susceptibility or resistance in Enterobacterales.

METHODS:

The Rapid Cefepime-Taniborbactam NP test is based on the detection of glucose metabolism resulting from bacterial growth, detectable by a change in colour of a red phenol (from red to yellow) in the presence of cefepime-taniborbactam. A total of 103 Enterobacterales isolates, including 94 carbapenemase producers, were selected for evaluation of the performance of the Rapid Cefepime-Taniborbactam NP test. In the absence of available breakpoints, two provisional breakpoints were taken for the interpretation-one corresponding to the current Clinical and Laboratory Standards Institute cefepime resistance breakpoint (R ≥ 16 mg/L) and one following current literature on this combination (R ≥ 32 mg/L).

RESULTS:

The test demonstrated a sensitivity and specificity of 95% and 98%, respectively, following a resistance breakpoint of ≥16 mg/L. When considering a resistance breakpoint of ≥32 mg/L, the sensitivity and specificity were found to be 100% and 91%, respectively. All results were obtained within a 3 h incubation period at 35°C ± 2°C, representing a significant reduction in time compared with current antimicrobial susceptibility testing methods.

CONCLUSIONS:

The results of this study demonstrate that the Rapid Cefepime-Taniborbactam NP test is a highly accurate and time-efficient technique for the detection of bacterial resistance.

07 Aug 2025·AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE

A Retrospective Analysis of Bacterial Infections (2021–2024) in a Reference Laboratory in Kathmandu, Nepal

Article

Author: Adhikari, Jeevan ; Shrestha, Ranjan Bhele ; Basnet, Ajaya ; Bajracharya, Sohani

Of all the recognized public health threats, antimicrobial resistance (AMR) is among the most serious. Antimicrobial resistance may have a higher prevalence in low- and middle-income countries, where antimicrobial misuse is compounded by inadequate infection control measures. In this study, we examined AMR trends in bacterial infections in a reference laboratory in Kathmandu, Nepal, from 2021 to 2024. We collected the clinical records of infected patients, including demographic details, pathogen profiles, and antibiograms, from the electronic laboratory information system and analyzed them using SPSS version 17.0 (IBM Corp., Armonk, NY). Among 3,720 patients, 703 (19.7%; median age: 40 years; 395 [54.0%] female) had infections primarily caused by bacteria (91.7%; 723/731), followed by yeast (3.8%; 28/731). Urinary tract infections (55.9%; 290/703) were the most common. The predominant pathogen was Escherichia coli (41.3%; 290/703). Resistance rates in Enterobacterales, nonfermenters, and Gram-positive cocci were 31.0%, 43.4%, and 13.5%, respectively, for aminoglycosides; 49.7%, 42.8%, and 40.2%, respectively, for fluoroquinolones; 64.9%, 59.0%, and 65.6%, respectively, for cephalosporins; 47.3%, 77.4%, and 27.2%, respectively, for trimethoprim–sulfamethoxazole; and 83.0%, 100.0%, and 85.0%, respectively, for penicillins. Extensively drug-resistant (XDR; 19.1%; 134/703) and multidrug-resistant (29.2%; 205/703) bacteria exhibited >90% resistance to ciprofloxacin, erythromycin, and beta-lactams. Over time (2022–2024), resistance increased for aminoglycosides (27.7–32.3%), fluoroquinolones (43.5–54.1%), and penicillin with beta-lactamase inhibitors (PwBLIs; 35.9–58.7%) but decreased for cephalosporins (67.5–62.8%), carbapenems (23.3–18.7%), penicillins (85.2–82.1%), trimethoprim–sulfamethoxazole (59.6–42.2%), and nitrofurantoin (39.0–3.7%). A low rate of bacterial infections was detected among hospital visitors. Urinary tract infections were the most prevalent type of infection. Multidrug-resistant bacteria predominated over XDR bacteria. Resistance to beta-lactams declined over time; however, resistance to aminoglycosides, fluoroquinolones, and PwBLIs increased.

05 Aug 2025·Microbiology Spectrum

Shifts in bla genes and Class 1 integron prevalence in beta-lactamase-producing bacteria before and after the COVID-19 pandemic in Mendoza, Argentina

Article

Author: Rathour, V. S. ; Contreras, L. ; Zuloaga, L. ; Dominguez, S. ; Secotaro, A. ; Márquez-Friedrichs, F. ; Nolly, M. B. ; Sánchez, D. G. ; Ferreyra, A. ; Damiani, M. T.

ABSTRACT:

This study analyzes the molecular epidemiology of bla genes and Class 1 integron in broad-spectrum beta-lactamase (BSBL) and extended-spectrum beta-lactamase (ESBL) producing strains of bacteria isolated from clinical samples of hospitalized and ambulatory patients before and after the COVID-19 pandemic. Isolates obtained in two periods were compared: the first corresponding to the years November 2019–March 2020, and the second to the years November 2021–April 2022. We evaluate changes in resistance patterns of antibiotics associated with pressures on the healthcare system and social lockdowns. A total of 156 isolates were analyzed: 78 from the first period (61 hospitalized, 17 ambulatory) and 78 from the second period (47 hospitalized, 31 ambulatory). Escherichia coli and Klebsiella pneumoniae were the predominant bacterial species, representing 85% of the isolates in both periods. The frequency of ambulatory ESBL-producing isolates increased significantly, from 22% (17/78) to 40% (31/78; P < 0.01) in the second period. The prevalence of blaSHV increased from 24% (19/78) to 72% (56/78; P < 0.01) in the second period, while the blaCTX-M-2 group, absent in the first period, was detected in 43% (34/78) of isolates from the second period. Strains from the second period exhibited greater genetic complexity, with an increased prevalence of combinations involving three or more bla genes, including isolates carrying up to five of such genes. Class 1 integron showed a strong correlation with resistance to ciprofloxacin and trimethoprim-sulfamethoxazole. The gene blaOXA-1 , previously associated with resistance to beta-lactamase inhibitors, did not show a clear pattern in the second period.

IMPORTANCE:

Antimicrobial resistance associated with the production of extended-spectrum beta-lactamase (ESBL) represents a critical global health challenge, particularly due to the limited development of new antibiotics. This is the first report from Argentina’s central-west region examining the prevalence of beta-lactamase-encoding genes, providing a framework for future research. Our findings reveal a significant increase in bacteria with the ESBL phenotype, particularly among ambulatory populations post-pandemic, suggesting a concerning spread of multidrug-resistant bacteria outside hospital environments. This could compromise empirical antibiotic treatments for ambulatory patients, increasing the risk of severe complications. Our results highlight the urgent need for ongoing surveillance to detect virulent strains before clonal spread or horizontal gene transfer occurs in the community. They also emphasize the importance of strategies to ensure the prudent use of antimicrobials and mitigate the increasing prevalence of resistance genes, which threatens the effectiveness of current therapeutic options.

News (Medical) associated with Cefepime Hydrochloride/Taniborbactam

14 Aug 2025

·pipelinereview.com

Basilea announces in-licensing of a novel clinical phase 3-ready oral antibiotic

ALLSCHWIL, Switzerland I August 14, 2025 I Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an exclusive license agreement with Venatorx Pharmaceuticals, Inc., to acquire the global rights to ceftibuten-ledaborbactam etzadroxil, a clinical phase 3-ready oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination for the potential treatment of complicated urinary tract infections (cUTI), including pyelonephritis. Ceftibuten-ledaborbactam etzadroxil is the combination of ceftibuten, an orally bioavailable cephalosporin antibiotic, and ledaborbactam etzadroxil, the orally bioavailable prodrug of the novel beta-lactamase inhibitor ledaborbactam. The combination demonstrates bactericidal activity against Enterobacterales, including multidrug-resistant pathogens, the major cause of cUTI. [1] In the USA, cUTI account for more than 600,000 hospital admissions each year. [2] This underscores the significant clinical burden and need for effective oral treatment options, which may shorten or entirely avoid hospitalization. In preclinical and clinical phase 1 studies, ceftibuten and ledaborbactam etzadroxil were shown to be safe and well tolerated. [3] David Veitch, Chief Executive Officer of Basilea, said: “This agreement allows us to strengthen our late-stage clinical pipeline and supports our strategy of ensuring that we have a continuous stream of potential new product launches in the near-term future, positioning us for sustainable substantial revenue growth. Ceftibuten-ledaborbactam etzadroxil holds strong promise in addressing the critical unmet need for the oral treatment of cUTI caused by multidrug-resistant Gram-negative bacteria and represents a compelling global commercial opportunity. We expect starting a registrational phase 3 program in cUTI in about 18 months.” Under the terms of the agreement, Basilea will make an upfront payment and potential milestone payments in 2025. Following the successful completion of the phase 3 clinical development program and after the grant of regulatory approval and start of commercialization, Venatorx is eligible to receive tiered mid-single-digit royalties and additional potential milestone payments of up to USD 325 million in total, if all agreed commercial milestone events are triggered over the term of the contract. The transaction is expected to result in approximately CHF 15 million of additional research and development expenses in 2025, including the full upfront payment, all potential pre-commercial milestone payments and expected R&D expenses in 2025. Basilea will provide updated financial guidance for the full-year 2025, reflecting this transaction, with the half-year earnings report on August 19, 2025. About beta-lactam/beta-lactamase inhibitor (BL/BLI) combinations Many Gram-negative bacteria express enzymes such as extended spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Beta-lactamase inhibitors block these enzymes and restore the activity of beta-lactam antibiotics against initially resistant Gram-negative bacteria, therefore BL/BLI combinations are an important addition to the armamentarium for the treatment of infections by multidrug-resistant bacterial pathogens. About ceftibuten-ledaborbactam etzadroxil Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor, which is being developed in combination with ceftibuten, an oral cephalosporin antibiotic, which is approved in the US for the treatment of upper and lower respiratory tract infections and for urinary tract infections outside the US. In vitro and in vivo studies demonstrated that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases (KPC and OXA-48, respectively) as well as multidrug-resistant (MDR) Enterobacterales. [4] Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US Food and Drug Administration (FDA) for cUTI and uncomplicated urinary tract infections. Ceftibuten-ledaborbactam etzadroxil is an investigational drug and is not yet approved in any country for commercial use. About complicated urinary tract infections (cUTI) Complicated UTIs, which include pyelonephritis (kidney infections), are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms and are one of the most common bacterial infections in hospital and community settings. Increasing resistance of bacteria causing complicated urinary tract infections has led to limited availability of effective oral antibiotic treatment options. [1] Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that are effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A & D serine carbapenemases (KPC and OXA-48). About Venatorx Pharmaceuticals, Inc. Venatorx is a private, late-stage clinical pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx also developed cefepime-taniborbactam, an intravenous-only antibiotic that successfully completed a Phase 3 study in adults with complicated urinary tract infections (cUTI), including pyelonephritis. The ceftibuten-ledaborbactam etzadroxil project has been funded in whole or in part with Federal funds from National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201600029C and the Department of Health and Human Services; Office of the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00050. For more information about Venatorx and its anti-infectives portfolio, please visit www.venatorx.com . About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com . References SOURCE: Basilea

Phase 3License out/inDrug ApprovalPhase 1Fast Track

23 May 2024

·www.outsourcing-pharma.com

What can pharma companies do to get promising antimicrobials to the frontlines of drug resistance?

According to the report, the race to create antibiotics and antifungals to conquer superbugs is falling perilously short, which the authors say is putting people across the world at risk. However, a shift in research and development (R&D), including investment in access and stewardship planning, can make a significant impact against antimicrobial resistance (AMR). As most large research-based pharmaceutical companies are no longer active in antimicrobial research and development (R&D), there are very few new treatments making it to market, leaving patients vulnerable to the rapid spread of AMR. Despite this reality, a handful of projects in late-stage clinical development could have a significant impact. Difficult-to-treat invasive, rare fungal mold infections The foundation is tracking five drugs which include gepotidacin, a small molecule commercialized by GSK with a leading phase 3 program in urinary tract infections and F2G’s olorofim, a first of the new orotomide class of antifungals in development for the treatment of difficult-to-treat invasive, rare fungal mold infections. Innoviva’s zoliflodacin is another treatment being tracked and is said to be one of the most promising new treatments for gonorrhoeae currently in phase 3 clinical trials. According to a report in Nature Scientific Reports, studies have found very little resistance to the drug currently circulating in strains, and in-vitro experiments demonstrated that it is difficult to induce resistance. Venatorx’s cefepime-taniborbactam is also under the foundation’s radar. The beta-lactam/beta-lactamase inhibitor (BL/BLI) combination antibiotic is being developed for the treatment of complicated urinary tract infections and hospital acquired bacterial pneumonia. googletag.cmd.push(function () { googletag.display('text-ad1'); }); Pfizer's recently approved aztreonam-avibactam (Emblaveo) is the first β-lactam/β-lactamase inhibitor antibiotic combination approved in the European Union for treating serious infections in adult patients caused by multidrug-resistant gram-negative bacteria, including metallo-β-lactamase-producing bacteria. Emblaveo was reviewed under European Medicines Agency accelerated assessment procedure, used when a pharmaceutical product is of major interest for public health and therapeutic innovation. People living on the frontlines of drug resistance Collectively, these projects could save at least 160,000 lives annually by providing much-needed medicines to treat drug-resistant gonorrhoea, urinary tract infections, intra-abdominal infections, respiratory infections, and invasive fungal infections. While these diseases affect a wide range of patients globally, women and children- especially those living in low-and middle-income countries (LMICs)- are disproportionately affected. Jayasree Iyer, CEO, at the Access to Medicine Foundation, said: “We have a small, but effective, arsenal in the race to combat drug-resistant infections. The difference between us winning or losing this race depends on how companies enable access to people living on the frontlines of drug resistance.” The foundation said that findings reveal that companies are employing diverse range of strategies within their access and stewardship plans but structured advance planning has not yet become standard. Encouragingly, it said, four of the five companies in scope, GSK, Pfizer, Innoviva, and Venatorx, are conducting or initiating clinical trials that directly target children, signalling progress in closing the gap between adult and paediatric access. Tackling the sheer scale and pace of drug resistance Commitments for registration were identified in five LMICs: China, India, Mexico, South Africa, and Thailand. However, for 108 of 113 LMICs in scope, where people also face high burdens of the diseases targeted by these projects, it is currently unclear whether any of them will be made available upon initial approval. The report identifies opportunities and recommendations for companies in focus and outlines actionable steps for global stakeholders in antimicrobial R&D to promote widespread adoption of advance access and stewardship planning. Marijn Verhoef, director of operations and research, at the Access to Medicine Foundation, said: “Tackling the sheer scale and pace of drug resistance is a complex global health issue that will require action from pharmaceutical companies across several areas. This includes providing appropriate access and implementing stewardship measures to safeguard the effectiveness of innovative antimicrobials. Failure to do this will limit efforts to tackle drug resistance.” The foundation added that as global health stakeholders prepare for 2024 UN General Assembly's High-level Meeting on AMR, this report comes at a crucial moment, emphasising the urgent gaps that need attention.

Phase 3Drug Approval

16 May 2024

·www.biospace.com

Venatorx Pharmaceuticals Announces Changes to Executive Leadership

MALVERN, Pa.--(BUSINESS WIRE)-- Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, announced today several changes to its executive leadership team. Manos Perros, PhD, has been appointed to the Board of Directors as Executive Chairman. Dr. Perros is a distinguished pharmaceutical and biotech executive with an impressive track record that includes more than 25 years in life sciences research and development. He was previously Chief Executive Officer and co-founder of Entasis Therapeutics, where he successfully positioned the company as a leader in the antimicrobial space, resulting in its acquisition by Innoviva in 2022. While at Entasis, Dr. Perros oversaw the development of Xacduro, which recently earned U.S. Food and Drug Administration approval as the first targeted treatment for Acinetobacter baumannii pneumonia. Prior to founding Entasis, Dr. Perros held the positions of Vice President and Head of AstraZeneca’s Infection Research and Early Development organization and Site Head for AstraZeneca’s Boston R&D research center. Dr. Perros also served as Director of the Novartis Institute for Tropical Diseases in Singapore, and Vice-President and Chief Scientific Officer, Antivirals, at Pfizer, where he led an R&D program that culminated in the approval of Selzentry, a first-in-class treatment for HIV. Dr. Perros’ appointment follows the resignation of Christopher J. Burns, Ph.D., who has stepped down as Chief Executive Officer and Director of Venatorx Pharmaceuticals. Additionally, Tomas J. Heyman has stepped down as Non-Executive Chairman of the Board. “On behalf of the entire Company, I would like to personally thank Chris for his dedication and tireless perseverance to lead Venatorx for over 14 years as an innovative pioneer in the fight against anti-microbial resistance. The Board of Directors sincerely appreciates his contributions along with the endless support and leadership that have guided the Company toward achieving its mission. I am delighted to join Venatorx Pharmaceuticals and to have an opportunity to help advance cefepime-taniborbactam through regulatory review and toward FDA approval to address the growing unmet need for novel treatments for patients suffering from multi-drug resistant gram-negative bacterial infections,” Dr. Perros said. “As recent Phase III data in The New England Journal of Medicine established, cefepime-taniborbactam met the primary noninferiority efficacy endpoint and demonstrated statistical superiority to meropenem for the treatment of complicated urinary tract infections (cUTIs), including acute pyelonephritis, while having a similar safety pro meropenem. This therapy has enormous potential and may represent a significant improvement over the standard of care that could support global health efforts to combat antibiotic-resistant infections for patients around the world.” About Venatorx Pharmaceuticals, Inc. Venatorx is a private, late-stage clinical pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections. Venatorx’s lead program, cefepime-taniborbactam, is a clinical-stage antibiotic that successfully completed a Phase 3 study in adults with complicated urinary tract infections (cUTI), including pyelonephritis. In October 2022, BARDA awarded a contract of up to $318M for development and procurement of cefepime-taniborbactam for the treatment of melioidosis and multi-drug resistant infections. Venatorx is also developing an oral antibacterial, ceftibuten-ledaborbactam (formerly known as VNRX-7145), for the treatment of cUTI, including pyelonephritis, caused by certain bacteria in adult patients with limited treatment options; this product is completing Phase 1 and will advance directly to a global Phase 3 cUTI clinical trial. For more information about Venatorx and its anti-infectives portfolio, please visit . Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the potential, safety, efficacy, and regulatory and clinical development of Venatorx Pharmaceuticals’ product candidates.

Phase 3Executive ChangeDrug ApprovalAcquisitionClinical Result

100 Deals associated with Cefepime Hydrochloride/Taniborbactam

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Complicated urinary tract infection	NDA/BLA	United States	Venatorx Pharmaceuticals, Inc.	15 Aug 2023
Pyelonephritis	NDA/BLA	United States	Venatorx Pharmaceuticals, Inc.	15 Aug 2023
Hospital-acquired pneumonia	Phase 3	-	Venatorx Pharmaceuticals, Inc.	01 Jun 2025
Ventilator associated bacterial pneumonia	Phase 3	-	Venatorx Pharmaceuticals, Inc.	01 Jun 2025
Acute pyelonephritis	Phase 3	United States	Everid Medicines (Beijing) Limited	07 Aug 2019
Acute pyelonephritis	Phase 3	United States	Venatorx Pharmaceuticals, Inc.	07 Aug 2019
Acute pyelonephritis	Phase 3	China	Venatorx Pharmaceuticals, Inc.	07 Aug 2019
Acute pyelonephritis	Phase 3	Argentina	Venatorx Pharmaceuticals, Inc.	07 Aug 2019
Acute pyelonephritis	Phase 3	Argentina	Everid Medicines (Beijing) Limited	07 Aug 2019
Acute pyelonephritis	Phase 3	Brazil	Everid Medicines (Beijing) Limited	07 Aug 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03840148 (CERTAIN-1, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Urinary Tract Infections	436	Cefepime/taniborbactam	njmfxvirfy(jcyjdruyeb) = lwkcmtxbrb dtgmajlkic (klvzgztlae ) View more	Positive	15 Feb 2024
NCT03840148 (CERTAIN-1, Corporate Publications) Manual	Phase 3	Complicated urinary tract infection	661	Cefepime/Taniborbactam	mxavdoumbd(othyidxwlv) = oduhmoowng ionlfzodzd (vmndxmvofu ) View more	Superior	10 Mar 2022
NCT03840148 (CERTAIN-1, Corporate Publications) Manual	Phase 3	Complicated urinary tract infection	661	meropenem	mxavdoumbd(othyidxwlv) = bmajbelmad ionlfzodzd (vmndxmvofu ) View more	Superior	10 Mar 2022

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