Xacduro (sulbactam-durlobactam) / ZAI Lab, Innoviva - LARVOL DELTA

In vitro efficacy of sulbactam/durlobactam combined with β-lactam antibiotics in Australian Mycobacterium abscessus isolates. (PubMed, J Antimicrob Chemother) - "Sulbactam/durlobactam significantly increased susceptibility to oral and intravenous β-lactam antibiotics in the form of cefuroxime, cefuroxime/amoxicillin and meropenem against clinical isolates of M. abscessus. This study also found significant differences in susceptibility to β-lactam antibiotics dependent on the culture media used, highlighting that the optimal culture methods for determining MIC in M. abscessus remains uncertain. Future in vivo studies are required to determine whether the in vitro efficacy of the β-lactam combinations studied could result in clinical efficacy for M. abscessus disease."

Journal • Preclinical

The epidemiological and molecular characteristics and sulbactam-durlobactam susceptibility of carbapenem-resistant Acinetobacter baumannii in a Chinese teaching hospital. (PubMed, J Glob Antimicrob Resist) - "The increasing percentage of carbapenem-resistance among A. baumannii, dominated by ST2 and blaOXA-23-positive strains, highlights an urgent need for stricter infection control. Meanwhile, the notable in vitro susceptibility of CRAB to SUL-DUR offers a promising therapeutic alternative for patients infected with CRAB."

Journal • Infectious Disease

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

In vitro activity of cefiderocol and sulbactam-durlobactam against carbapenem-resistant Acinetobacter baumannii clinical isolates collected between 2019 and 2024. (PubMed, Infect Dis (Lond)) - "Among the 159 carbapenem-resistant Acinetobacter baumannii isolates, 72.9% (n = 116) carried the blaOXA-23 gene, 10.7% (n = 17) harboured blaOXA-24/40, and 16.4% (n = 26) did not possess any of the carbapenemase genes included in the testing panel. Cefiderocol and sulbactam-durlobactam exhibited strong in vitro activity against carbapenem-resistant A. baumannii isolates from a single University Hospital and may represent valuable treatment options for patients with limited therapeutic alternatives."

Journal • Preclinical • Infectious Disease

β-Lactam/β-Lactamase Inhibitor Combinations in Sepsis-Associated Acute Kidney Injury and Renal Replacement Therapy. (PubMed, Antibiotics (Basel)) - "This review summarizes PK/PD features, extracorporeal clearance, and practical dosing considerations about ceftolozane-tazobactam, ceftazidime-avibactam, aztreonam-avibactam, cefiderocol, meropenem-vaborbactam, imipenem-relebactam, and newer agents including sulbactam-durlobactam, cefepime-enmetazobactam, and cefepime-taniborbactam. Full-dose initiation during the first 24-48 h, followed by careful adjustment, appears prudent. Therapeutic drug monitoring should be used when available, and institution-specific protocols should be integrated into stewardship programs to improve efficacy and minimize resistance."

Journal • Review • Acute Kidney Injury • Infectious Disease • Nephrology • Pediatrics • Renal Disease • Septic Shock

New Drugs, Old Problems: A Narrative Review of Antibiotic Stewardship Program in the era of novel Gram-negative antibiotics. (PubMed, Clin Microbiol Infect) - "Effective stewardship of new Gram-negative antibiotics requires combining enablement, personalized pharmacology, and selective restriction within multidisciplinary ASPs. Strengthening real-world evidence, digital infrastructure, and standardized outcome measures is essential to guide equitable and sustainable implementation."

Journal • Review • Infectious Disease

Evaluation of sulbactam/durlobactam activity and synergy against highly drug-resistant Acinetobacter baumannii strains. (PubMed, JAC Antimicrob Resist) - "Chequerboard assays revealed consistent synergy between sulbactam/durlobactam and multiple β-lactams and βL/βLI agents, including cefepime, meropenem, cefiderocol, ceftazidime-avibactam, and piperacillin-tazobactam, with ≥95% of strains showing synergistic effects...Combinations with tetracyclines also showed synergy in select strains, particularly against the MBL-carrying isolate. Sulbactam/durlobactam demonstrates strong activity against highly drug-resistant A. baumannii isolates and shows enhanced potency when combined with specific β-lactam and βL/βLI agents. Further investigation of sulbactam/durlobactam-based combination therapy is warranted as a therapeutic strategy for the treatment of carbapenem-resistant A. baumannii infections."

Journal • Infectious Disease • Pneumonia • Respiratory Diseases

Management of extensively drug-resistant Acinetobacter baumannii bacteremia with cefiderocol and sulbactam-durlobactam: a case report. (PubMed, ASM Case Rep) - "He completed a 14-day course of FDC and SUD with clinical resolution and was discharged home. This case demonstrates the potential efficacy of FDC combined with SUD in treating XDR A. baumannii bacteremia, highlighting the need for further research into combination therapy regimens for XDR A. baumannii."

Journal • Gastroenterology • Hepatology • Infectious Disease • Pneumonia • Respiratory Diseases

Evaluation of sulbactam-durlobactam disk diffusion and broth microdilution methods for Acinetobacter baumannii. (PubMed, Int J Antimicrob Agents) - "The disk diffusion method (10/10μg) accurately detects the susceptibility of A. baumannii to sulbactam-durlobactam. This method is characterised by its simplicity, economy, and ease of result interpretation, making it suitable for use in routine clinical microbiology laboratories."

Journal

Comparative in vitro analysis of sulbactam-durlobactam against extensively drug resistant (XDR) and non-XDR carbapenem-resistant Acinetobacter baumannii (CRAB) clinical isolates collected from a tertiary care facility in North India. (PubMed, Eur J Clin Microbiol Infect Dis) - "The MIC distribution ranged from≤0.25 to ≥128 µg/mL.SUL-DUR showed promising in vitro activity against CRAB, but with reduced efficacy in XDR strains, particularly respiratory isolates. High concordance between BMD and DD supports the utility of disk diffusion in resource-limited settings."

Journal • Preclinical

In vitro efficacy of sulbactam-durlobactam combined with β-lactam antibiotics in Australian Mycobacterium abscessus isolates (WBC 2025) - " Sulbactam-durlobactam significantly lowered the MICs of M. abscessus to meropenem, cefuroxime, and cefuroxime-amoxicillin to MICs comparable to those of imipenem and imipenem-relebactam. Sulbactam-durlobactam significantly increased susceptibility to oral and intravenous β-lactam antibiotics in the form of cefuroxime, amoxicillin and meropenem against clinical isolates of M. abscessus . Further research is required to determine if the in vitro data correlates with clinical efficacy with the optimal culture methods for determining MIC in M. abscessus remaining uncertain."

Preclinical

Resistance of Acinetobacter baumannii Complex Clinical Isolates to Sulbactam-Durlobactam: A Systematic Review of Data from In Vitro Studies. (PubMed, Pathogens) - "The low proportion of sulbactam-durlobactam resistance among A. baumannii complex isolates supports the consideration of the use of this new antibiotic for its approved indications."

Journal • Preclinical • Review • Infectious Disease • Pneumonia • Respiratory Diseases

Successful Treatment of OXA-23 Acinetobacter baumannii Pneumonia with Sulbactam-Durlobactam in a Liver Transplant Recipient. (PubMed, Infect Drug Resist) - "Initial treatment with polymyxin B and eravacycline produced unsatisfactory results and worsened renal dysfunction during treatment. Later, administration of sulbactam-durlobactam (SUL-DUR) combined with meropenem resulted in significant clinical improvement...This case highlights the difficulty of managing OXA-23-producing Acinetobacter baumannii in liver transplant patients, especially those with kidney impairment. SUL-DUR showed effective therapy with a much lower risk of nephrotoxicity compared to previously used agents."

Journal • Infectious Disease • Nephrology • Pneumonia • Renal Disease • Respiratory Diseases • Transplantation

Turning the Tide Against Carbapenem-resistant Acinetobacter baumannii: Advancing Care With Sulbactam-Durlobactam. (PubMed, Open Forum Infect Dis) - No abstract available

Journal

Critical Care Management of Pan-Resistant Acinetobacter Osteomyelitis Requiring Novel Antibiotic Therapy (ASA 2025) - "Due to the high cost, IV-only administration, and Q6H dosing of sulbactam-durlobactam, discharge planning was complex, necessitating LTACH placement. This case highlights challenges in perioperative management, antimicrobial stewardship, and post-ICU transitions for patients requiring emerging antimicrobials."

CNS Disorders • Critical care • Diabetes • Infectious Disease • Inflammation • Metabolic Disorders • Septic Shock

In Vitro Activity and Resistance Mechanisms of Sulbactam/Durlobactam Against Acinetobacter baumannii Clinical Isolates in China (2019-2020). (PubMed, Clin Microbiol Infect) - "Despite SUL-DUR's strong efficacy against CRAB, the emergence of PBP3 mutations and NDM variants highlights the need for vigilant resistance monitoring. This study underscores the importance of integrated surveillance and mechanistic research to optimize SUL-DUR use in China and preserve its therapeutic effectiveness."

Clinical • Journal • Preclinical

Pharmacokinetic drug evaluation of co-packaged sulbactam for injection and durlobactam for injection for the treatment of Acinetobacter baumannii-calcoaceticus complex in HABP/VABP. (PubMed, Expert Opin Drug Metab Toxicol) - "Sulbactam/durlobactam (S/D) pairs sulbactam's intrinsic anti-Acinetobacter activity with the broad Ambler class A/C/D β-lactamase inhibitor durlobactam, creating the first agent targeting CRAB...Notably, S/D is inappropriate for isolates harboring class B metallo-β-lactamases and/or certain penicillin-binding proteins-3 (PBP3) mutations, those with S/D minimum inhibitory concentration (MIC) ≥4 mcg/mL and in populations with data gaps. Pharmacovigilance, studies of use in broader populations, and cost-effectiveness will be critical to maximize its clinical and stewardship value."

Journal • PK/PD data • Review • CNS Disorders • Infectious Disease • Pneumonia • Respiratory Diseases

It is time to go beyond the association between colistin and meropenem for invasive carbapenem-resistant Acinetobacter baumannii infections. (PubMed, Clin Infect Dis) - No abstract available

Journal • Infectious Disease

Sulbactam-durlobactam combination therapy for carbapenem-resistant Acinetobacter baumannii sepsis with cutaneous involvement in an infant with acute monocytic leukemia: A case report. (PubMed, Front Pharmacol) - "Sulbactam-durlobactam (SUL-DUR) is a novel antibiotic, but its use in children and infants has not been reported. We reported the first case of an infant with acute leukemia successfully treated with SUL-DUR for CRAb sepsis with cutaneous involvement."

Journal • Acute Myelogenous Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Septic Shock

Pharmacokinetics of sulbactam-durlobactam in patients with Acinetobacter baumannii ventriculitis: a report of two cases. (PubMed, Antimicrob Agents Chemother) - "Penetration into the central nervous system was estimated (by cerebrospinal fluid [CSF]/serum area under the curve [AUC] ratios at steady state) for sulbactam (0.47-0.64) and durlobactam (0.27-0.3), respectively. In view of mostly constant CSF concentrations, single CSF levels at steady state may offer a more convenient and clinically applicable approach for monitoring therapy."

Journal • PK/PD data • Infectious Disease

Sulbactam-durlobactam improves cephalosporin and carbapenem susceptibility and time-kill effect against Mycobacterium abscessus. (PubMed, Microbiol Spectr) - "The fold reduction in MICs was as follows: amoxicillin 94, ceftriaxone 103, cefuroxime 69, cefdinir 19, cefalexin 74, imipenem 23, meropenem 37, tebipenem 89, and faropenem 74. We show that sulbactam/durlobactam (Sul/Dur) can improve the kill effect of several β-lactam antibiotics that, otherwise, due to observed high minimum inhibitory concentration, deem ineffective. Based on our findings, we propose imipenem that is already included in the MAB-LD treatment recommendations and ceftriaxone that achieves very high lung concentration, to test with Sul/Dur as a double β-lactam-β-lactamase backbone regimen to advance the therapy for MAB-LD."

Journal • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases

From clinical trials to daily practice: how to adequately administer sulbactam-durlobactam? alone or combined with imipenem? (PubMed, Curr Opin Infect Dis) - "Combination therapy of SUL-DUR with carbapenems remains the preferred strategy in critically ill or high-risk patients. Future trials should specifically evaluate the comparative efficacy of monotherapy vs. combination regimens and establish which could be the best companion in the treatment of CRAB infections."

Journal • Infectious Disease

Management of MDR/XDR severe infections in the critically ill. (PubMed, Curr Opin Crit Care) - "Optimal management of serious infections by MDR/XDR pathogens requires up-to-date knowledge of evolving treatment options and resistance mechanisms. Further high-quality clinical trials are needed to guide evidence-based therapy."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases

Characterizing a Sulbactam-Durlobactam Challenge Set of Acinetobacter baumannii Surveillance Isolates with Rapid Genotypic Testing (Carba-R) and Whole Genome Sequencing (IDWeek 2025) - No abstract available

Whole genome sequencing • Infectious Disease

Population Pharmacokinetics (PPK) Analysis of Sulbactam-Durlobactam (SUD) to Support Dose Selection for Evaluation in a Clinical Trial in Pediatric Patients with Acinetobacter Baumannii-Calcoaceticus Complex (ABC) Infections (IDWeek 2025) - No abstract available

Clinical • PK/PD data • Infectious Disease