Cedax (ceftibuten dihydrate) / Currax - LARVOL DELTA

Dose Selection for Ceftibuten Combined with Avibactam Tomilopil, a Potential Oral Alternative to Carbapenems for Patients with Complicated Urinary Tract Infections. (PubMed, J Clin Pharmacol) - P1 | "Based on joint probability of target attainment simulations using a simultaneous oral ceftibuten‑avibactam tomilopil population pharmacokinetic model, a tablet formulation ceftibuten 400 mg + avibactam tomilopil 1200 mg dosed every 8 h without regard to food is proposed for Phase 3 evaluation in adult patients with cUTIs. Trial registration: NCT03931876; NCT05554237; NCT06593054."

Clinical • Journal • Infectious Disease • Nephrology

Clinical Evidence in Respiratory and Urinary Tract Infections: focus on Ceftibuten. (PubMed, Pharmacology) - "Ceftibuten represents an oral treatment option for respiratory and urinary tract infections, particularly where resistance to other agents limits therapeutic choices. Its favourable pharmacokinetic profile, safety both in paediatric and adult populations, and efficacy against key resistant pathogens support use within approved indications. Finally, this antibiotic offers a favourable safety profile for both patients allergic to penicillin and cephalosporins, particularly third- and fourth-generation cephalosporins. Ensuring continued access to this antibiotic may contribute to appropriate management of infections in both community and hospital settings."

Journal • Review • Infectious Disease • Nephrology • Pediatrics

Chlorosulfate ester coupling to prepare Avibactam Tomilopil (ACS-Fall 2026) - "Avibactam tomilopil (AVP or AVT) is a beta-lactamase inhibitor being studied in combination with ceftibuten as a first in class oral therapy against severe infections. AVP features an alkyl sulfate functional group as a unique pro-drug moiety, the attachment of which to the main core was a significant focus. Management of substantial safety concerns, invention of a new alkylsulfate coupling methodology and development of process solutions that secured industrial production of AVP will be discussed."

Infectious Disease

Development of two scalable processes for the synthesis of avibactam Tomilopil (ACS-Fall 2026) - "Avibactam pro-drug in combination with ceftibuten offers a first in class oral antibiotic for extended spectrum beta-lactamase infections...A broad scope of alternative intermediates were synthesized to provide a crystallize solid reagent with a higher DSC onset (more stable). Activated (benz)imidazole compounds were found to be reactive in the final API step and machine learning was used to predict a more stable derivative."

Infectious Disease

VNRX-7145-106: Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Basilea Pharmaceutica | N=46 ➔ 96 | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Jun 2026 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date

Ceftibuten-polymyxin B combination alters resistance and cell wall gene expression in multidrug-resistant Klebsiella pneumoniae. (PubMed, PLoS One) - "Thus, combined CTB/PMB exposure was associated with modulation of gene expression involved in cell wall synthesis and antimicrobial resistance, suggesting transcriptional adaptive responses under antimicrobial pressure. These findings provide preliminary molecular insights into the response of multidrug-resistant K. pneumoniae to CTB/PMB exposure."

Journal • Infectious Disease • Pneumonia

Comparative activity of ceftibuten combinations with avibactam, ledaborbactam, and xeruborbactam against recombinant β-lactamase-producing Escherichia coli and contemporary WGS-characterized strains of carbapenemase-producing Enterobacterales. (PubMed, Antimicrob Agents Chemother) - "Ceftibuten/xeruborbactam also retained activity against VIM-producing clinical strains. Susceptibility rates for MBL producers varied, depending on the CLSI or EUCAST breakpoints applied."

Journal

Plasma and intrapulmonary pharmacokinetics of ceftibuten and ledaborbactam in healthy male and female adults. (PubMed, Antimicrob Agents Chemother) - P1 | "Both CTB/LED-E and CTB alone were safe and well tolerated; all adverse events were mild or moderate and unrelated to study drug. These results demonstrate pulmonary penetration of CTB and LED and support further evaluation of CTB/LED-E for the treatment of lower respiratory tract bacterial infections caused by susceptible pathogens.This study is registered with ClinicalTrials.gov as NCT06665555."

Journal • PK/PD data • Infectious Disease

Impact of acquired broad-spectrum _xFFFF_-lactamases on susceptibility to oral cephalosporin (ceftibuten) and oral carbapenem (tebipenem) in combination with new _xFFFF_-lactamase inhibitors ledaborbactam and xeruborbactam in Escherichia coli (ESCMID Global 2026) - No abstract available

Combination therapy

Ceftibuten/avibactam as an oral alternative to ceftazidime/avibactam for serine carbapenemase-producing Enterobacterales (ESCMID Global 2026) - No abstract available

The zone distribution for ceftibuten in 3GC resistant Escherichia coli indicates a high risk of reporting errors with current EUCAST breakpoint (ESCMID Global 2026) - No abstract available

Fosmanogepix and ceftibuten-ledaborbactam - lead assets in an innovative anti-infective portfolio (ESCMID Global 2026) - "Organised by Basilea"

IPT16 - Fosmanogepix and ceftibuten-ledaborbactam - lead assets in an innovative anti-infective portfolio (ESCMID Global 2026) - "Fosmanogepix, a first-in-class gepix antifungal available in intravenous and oral formulations, has shown promising efficacy and safety in ongoing Expanded Access Program studies provides a potential new broad-spectrum therapy for patients with resistant, refractive or deep-seated invasive yeast or mold infections. Ceftibuten-ledaborbactam is a new oral beta-lactam/beta-lactamase inhibitor combination, offering an effective treatment for complicated urinary tract Infections caused by resistant Gram-negative bacteria, enabling patients to receive therapy outside the hospital and supporting more flexible, patient-centered care."

Infectious Disease • Nephrology

Impact of acquired broad-spectrum β-lactamases on susceptibility to oral cephalosporin (ceftibuten) and oral carbapenem (tebipenem) in combination with new β-lactamase inhibitors ledaborbactam and xeruborbactam in Escherichia coli (ESCMID Global 2026) - No abstract available

Combination therapy

Ceftibuten in combination with avibactam, ledaborbactam and xeruborbactam: comparative activity against isogenic E. coli strains and a nationwide collection of carbapenemase-producing Enterobacterales (ESCMID Global 2026) - No abstract available

Combination therapy

New-generation antibiotics and non-antibiotic strategies against carbapenemase-producing Enterobacterales: More focus on metallo-β-lactamase producers. (PubMed, Int J Antimicrob Agents) - "Continued monitoring of resistance trends and the development of innovative therapeutic strategies is warranted in the ongoing battle against CPE harboring blaMBL."

Journal • Review • Infectious Disease

Exploring the activity of a novel orally bioavailable β-lactam-β-lactamase inhibitor combination, ceftibuten-ledaborbactam, against Enterobacterales-carrying blaOXA-48. (PubMed, Microbiol Spectr) - "In this study, we compared the in vitro antimicrobial activity of ceftibuten-ledaborbactam with that of other oral antibiotics, including tebipenem, sulopenem, ceftibuten-clavulanic acid, amoxicillin-clavulanic acid, and levofloxacin, against OXA-48-producing Enterobacterales. Our results show that ceftibuten-ledaborbactam has the most potent activity, with an MIC90 of 0.5 mg/L."

Journal

VNRX-7145-106: Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination (clinicaltrials.gov) - P1 | N=46 | Recruiting | Sponsor: Basilea Pharmaceutica | Active, not recruiting ➔ Recruiting

Enrollment open

P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants (clinicaltrials.gov) - P1 | N=53 | Completed | Sponsor: Qpex Biopharma, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Jan 2025 | Trial primary completion date: Dec 2025 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease

Association between Targeted Therapy and Survival in Patients with MDS (ASH 2024) - "Targeted therapy was recorded if patients had claims for ivosidenib (IDH1), enasidenib (IDH2), luspatercept (SF3B1), or cedaxuridine (TP53) in the Symphony administrative claims data. In addition, our study confirms that a significant number of biomarker-positive MDS patients do not receive targeted therapies, highlighting challenges such as disparities in access to care and provider awareness. Addressing these issues is essential to ensure all eligible patients benefit from advancements in targeted therapies, ultimately improving survival and quality of life."

Clinical • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • IDH1 • IDH2 • SF3B1 • TP53

P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants (clinicaltrials.gov) - P1 | N=71 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Trial primary completion date: Aug 2025 ➔ Dec 2025

Trial primary completion date • Infectious Disease

Dilution susceptibility testing method evaluation for the combination of ceftibuten and avibactam against Enterobacterales. (PubMed, J Clin Microbiol) - "During anti-infective development, it is important to delineate the variables for susceptibility testing so that clinicians can confidently evaluate whether an infecting organism is resistant or susceptible to a potential therapy. This study evaluated dilution susceptibility testing methods for ceftibuten in combination with avibactam against targeted organisms (Enterobacterales) and found that broth and agar dilution testing methods agree, and this combination is recalcitrant to most variations, aside from low pH and inoculum size, in standard test parameters."

Journal • Infectious Disease • Nephrology

ETIOLOGY OF URINARY TRACT INFECTIONS IN NEONATES AND BACTERIAL RESISTANCE IN CROATIA. (PubMed, Acta Clin Croat) - "Most commonly prescribed empirical antibiotics included ceftriaxone (31.1%) and the ampicillin-gentamicin combination (10.7%)...In this study, Escherichia coli frequently exhibited antibiotic resistance to ampicillin, amoxicillin, trimethoprim-sulfamethoxazole, and gentamicin. For UTIs attributed to Klebsiella pneumoniae, the prevailing bacterial resistance was observed against gentamicin, ceftibuten, ampicillin, cefazolin, and piperacillin. The predominance of Escherichia coli as the most common pathogen causing UTI was consistent with global trends. Founded on continuous differences in bacterial resistance, this study can serve as a basis for comprehending local resistance patterns of pathogens causing neonatal UTI, highlighting the need of additional prospective research."

Journal • Retrospective data • Cardiovascular • Hypertension • Infectious Disease • Nephrology • Pneumonia • Septic Shock

VNRX-7145-106: Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination (clinicaltrials.gov) - P1 | N=46 | Active, not recruiting | Sponsor: Venatorx Pharmaceuticals, Inc. | Trial completion date: Sep 2025 ➔ Jun 2026 | Trial primary completion date: Aug 2025 ➔ Jun 2026

Trial completion date • Trial primary completion date

Human Antimicrobial Use in Bangladesh: Five-Year Trend Analysis Including COVID-19 Pandemic Era. (PubMed, Antibiotics (Basel)) - " To achieve the global target of 70% use of Access category antibiotics by 2030, the use of Watch-group antibiotics, like cefixime, azithromycin, ciprofloxacin, levofloxacin, and ceftibuten, needs to be reduced through investing in and strengthening stewardship programs and eliminating self-medication in Bangladesh. The findings of this study provide useful information to policymakers to tackle AMR in Bangladesh."

Journal • Infectious Disease • Novel Coronavirus Disease