OMNIvance (xeruborbactam) / Brii Biosci, Shionogi - LARVOL DELTA

Activity of novel antibiotics against dual metallo-Beta-lactamase producing Enterobacter hormaechei clinical isolates. (PubMed, JAC Antimicrob Resist) - "Our findings indicate that E. hormaechei clinical isolates co-producing NDM and VIM metallo-carbapenemases exhibited susceptibility to all tested novel BL/BLIs, including aztreonam/avibactam, cefepime/taniborbactam and cefepime/zidebactam. The combination of cefiderocol and xeruborbactam restored the activity of cefiderocol."

Journal • Infectious Disease

Activity of cefiderocol/xeruborbactam against NDM-producing Escherichia coli isolates with PBP3 insertions and decreased susceptibility or resistance to aztreonam/avibactam, cefiderocol, and cefepime/taniborbactam (ESCMID Global 2026) - No abstract available

Comparative activity of cefepime/taniborbactam and cefiderocol/xeruborbactam against producers of KPC variants conferring resistance to ceftazidime/avibactam and cefiderocol (ESCMID Global 2026) - No abstract available

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

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

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

Tricyclic boronic acids as broad-spectrum serine and metallo-β-lactamase inhibitors with in vitro activity against acinetobacter baumannii: a patent evaluation (us 2025/0223303). (PubMed, Expert Opin Ther Pat) - "This article concisely reviews structurally novel xeruborbactam-inspired tricyclic boronates (reported in US 2025/0223303) with promising inhibitory activities in vitro. By introducing novel thioether-based C5 sidechains onto the previously optimized bicyclic boronate core, the inventors explored novel chemical space yielding SBL/MBL inhibitors with seemingly improved activities against carbapenem-resistant (CR) Escherichia coli, Klebsiella pneumoniae, and, importantly, Acinetobacter baumannii, when used in combination with meropenem and/or biapenem (at least with respect to taniborbactam, i.e. boronate inhibitor in late-stage clinical development). Due to the major societal importance of β-lactams for modern medicine, and the clearly demonstrated clinical potential of functionalized cyclic boronates as potent dual-acting SBL/MBL inhibitors when used in combination therapies, there is ample opportunity and scope for continued investigation of this pharmacophore,..."

Journal • Preclinical • Review • Infectious Disease • Pneumonia

Susceptibilities of cefiderocol, meropenem-xeruborbactam, cefepime-taniborbactam, aztreonam-avibactam, and sulbactam-durlobactam against imipenem-non-susceptible Gram-negative bacilli in Taiwan. (PubMed, Int J Infect Dis) - " Cefiderocol was highly effective, whereas novel β-lactam/β-lactamase inhibitors activity varied by species and carbapenemase types. PBP3 alterations reduced FTB and AZA activity in INS-EC."

Journal • Infectious Disease • Pneumonia

A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Qpex Biopharma, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease

Fused 3D boron heterocycles via EnT catalysis: synthesis, modification and validation as beta-lactamase inhibitors. (PubMed, Chem Sci) - "Crucially, the resulting 3D architectures mimic structural motifs found in the potent β-lactamase inhibitor Xeruborbactam. The biological relevance of these frameworks was validated by NMR titration, pK a analysis, and co-crystallisation with serine β-lactamase CTX-M-14, revealing enantiospecific binding and a well-defined hydrogen bonding network. These results establish a versatile platform for the synthesis of functionalised boron heterocycles with direct translational potential in medicinal chemistry."

Journal

A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Qpex Biopharma, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease

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

Classification and applicability of new beta-lactamase inhibitors. (PubMed, Rev Esp Quimioter) - "This non-exhaustive minireview describes the main characteristics of the new beta-lactamase inhibitors (enmetazobactam, avibactam, relebactam, durlobactam, zidebactam, nacubactam, vaborbactam, taniborbactam, and xeruborbactam), their spectrum of inhibition, their activity in combination with different beta-lactams, the main resistance mechanisms that can compromise their activity and the main applications of the different beta-lactam-beta-lactamase inhibitor combinations depending on the type of beta-lactamase/carbapenemase and the microorganism involved."

Journal • Review

Contribution of mutational resistance mechanisms and acquired β-lactamases to cefiderocol/xeruborbactam susceptibility in Pseudomonas aeruginosa. (PubMed, Antimicrob Agents Chemother) - "Xeruborbactam was assessed in combination with cefiderocol and cefepime at 4 and 8 mg/L and compared with taniborbactam. Importantly, xeruborbactam restored susceptibility in 78% of 99 cefiderocol-resistant P. aeruginosa strains, reducing the MIC90 from 64 to 4 mg/L. Cefiderocol/xeruborbactam shows promising activity against P. aeruginosa."

Journal • PER1

Efficacy of cefiderocol in combination with xeruborbactam versus taniborbactam against cefiderocol-resistant NDM-producing Pseudomonas aeruginosa. (PubMed, Antimicrob Agents Chemother) - "One isolate that was unresponsive to taniborbactam carried multiple copies of blaNDM-1. These findings highlight the species-specific limitations of xeruborbactam in P. aeruginosa."

Journal

Sporadic cefiderocol resistance in Escherichia coli from the United Arab Emirates involves multifactorial mechanisms reversible by novel beta-lactamase inhibitors. (PubMed, Sci Rep) - "Zidebactam, with intrinsic antibacterial activity, caused the most significant reduction in CFDC minimum inhibitory concentrations (MICs), while the activity of other inhibitors (taniborbactam and xeruborbactam) was dependent on the genetic makeup of the strains, especially mutations in the siderophore-iron uptake genes. Our findings underscore the importance of genomic surveillance in deciphering antibiotic resistance mechanisms. Novel BLIs and partner antibiotics could be added weapons in the fight against MDR bacteria; thus, we recommend using combinations with novel BLIs as innovative therapeutic options to combat the emerging threat of CFDC resistance, after proper validation of their in vivo efficacy."

Journal • Infectious Disease

Structural Insights into the Role of the Stereochemistry of the Cyclopropyl Ring in the Inhibitory Activity of Xeruborbactam against SME-1 Class A Carbapenemase. (PubMed, Biochemistry) - "In the molecular dynamics, xeruborbactam stabilized SME-1 more than its isomer, which is consistent with our experimental findings. These results together show the strong inhibitory profile of xeruborbactam and highlight the importance of stereochemistry in the design of next-generation β-lactamase inhibitors and diagnostics for AMR."

Journal

A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Renal Disease

Phase 1, randomized, double-blind, placebo-controlled, ascending single- and multiple-dose study of the safety, tolerability, and pharmacokinetics of intravenous xeruborbactam (QPX7728) in healthy adult subjects. (PubMed, Antimicrob Agents Chemother) - "Significant accumulation was noted with 8-hourly dosing. Xeruborbactam at doses up to 1,000 mg daily for 7-10 days was well tolerated, with no serious or life-threatening AEs."

Clinical • Journal • P1 data • PK/PD data • Pain

Pharmacodynamic Assessment of Combination of Cefiderocol with Xeruborbactam in Murine Thigh Infection Model (IDWeek 2025) - No abstract available

PK/PD data • Preclinical • Infectious Disease

Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=8 | Completed | Sponsor: Qpex Biopharma, Inc. | Active, not recruiting ➔ Completed

Trial completion

Antibiotics and non-traditional antimicrobial agents for carbapenem-resistant Acinetobacter baumannii in Phase 1, 2, and 3 clinical trials. (PubMed, Expert Opin Investig Drugs) - "Specifically, 9 antibiotics are in Phase 1 (R-327, xeruborbactam/QPX-7728, upleganan/SPR-206, MRX-8, QPX-9003, zifanocycline/KBP-7072, apramycin/EBL-1003, zosurabalpin/RG-6006, and ANT-3310), two in Phase 2 (BV-100, OMN-6), and two in Phase 3 (zidebactam/WCK-5222, funobactam/XNW-4107) clinical trials...In particular, two monoclonal antibodies (TRL-1068, CMTX-101), a phage therapy (Phagebank), an immune-modulating agent (recombinant human plasma gelsolin/Rhu-pGSN), a microbiome-modulating agent (SER-155), and an engineered cationic antibiotic peptide (PLG-0206). Several agents with promising characteristics against CRAB infections are in clinical development (Phases 1, 2, and 3). The urgent need for therapeutic options against CRAB infections necessitates optimizing efforts and time for introducing successfully studied agents into clinical practice."

Journal • Review • Infectious Disease • GSN

Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Qpex Biopharma, Inc.

New P1 trial

A DDI Study to Investigate PK and Safety of Cefiderocol in Combination With Xeruborbactam in Healthy Adult Participants (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Qpex Biopharma, Inc. | N=40 ➔ 60

Enrollment change • Infectious Disease

Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Qpex Biopharma, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open