Durlobactam

XACDURO is an antibacterial drug [see Microbiology (12.4) ].

• XACDURO is a co-packaged product containing sulbactam, a beta-lactam antibacterial and beta lactamase inhibitor, and durlobactam, a beta lactamase inhibitor, indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. ( 1.1 ) Limitations of Use : XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.ICD-10: J18.9

• XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO (sulbactam and durlobactam), or other beta-lactam antibacterial drugs [see Warnings and Precautions (5.1) ] . Known history of severe hypersensitivity to the components of XACDURO (sulbactam and durlobactam), or other beta-lactam antibacterial drugs.contraindicated

Administer XACDURO (1 g of sulbactam, 1 g of durlobactam) every 6 hours by intravenous (IV) infusion over 3 hours in patients with creatinine clearance (CLcr) of 45 to 129 mL/min. ( 2.1 ) Dosing regimen adjustments are recommended for CLcr less than 45 mL/min and CLcr greater than or equal to 130 mL/min. ( 2.2 ) Administer all doses of XACDURO by IV infusion over 3 hours. ( 2.3 ) See full prescribing information for instructions on the preparation of the intravenous solution. ( 2.4 ) 2.1 Recommended Dosage XACDURO is a co-packaged product containing sulbactam for injection and durlobactam for injection. The recommended dosage of XACDURO is 1 gram (g) of sulbactam and 1 g of durlobactam every 6 hours administered by intravenous (IV) infusion over 3 hours in adults with a creatinine clearance (CLcr) of 45 to 129 mL/min. Adjustments to the dosing regimen for XACDURO are recommended for patients with CLcr less than 45 mL/min and for patients with CLcr greater than or equal to 130 mL/min [see Dosage and Administration (2.2) ] . The recommended duration of treatment with XACDURO is 7 to 14 days. The duration of therapy should be guided by the patient's clinical status. 2.2 Dosage in Patients (18 Years of Age and Older) Based on Renal Function See Table 1 for the recommended dosage of XACDURO in patients (18 years of age and older) based on renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

Hypersensitivity Reactions : Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibacterial drugs. Hypersensitivity was observed in patients treated with XACDURO. If an allergic reaction occurs, discontinue XACDURO. ( 5.1 ) Clostridioides difficile -Associated Diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including XACDURO. Evaluate if diarrhea occurs. ( 5.2 ) 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterial drugs. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity and/or a history of sensitivity to multiple allergens. Hypersensitivity was observed in patients treated with XACDURO in clinical trials [see Adverse Reactions (6.1) ] . Before initiating therapy with XACDURO, careful inquiry should be made concerning previous hypersensitivity reactions to carbapenems, penicillins, cephalosporins, other beta lactams, and other allergens. Discontinue XACDURO if an allergic reaction occurs. 5.2 Clostridioides difficile -Associated Diarrhea (CDAD) Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XACDURO, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C.

The following serious adverse reactions are described in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions (5.2) ] The most common adverse reactions (incidence > 10%) were liver test abnormalities, diarrhea, anemia, and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Entasis Therapeutics Inc. at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Clinical trials are conducted under widely varying conditions, therefore adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of durlobactam with or without sulbactam was evaluated in 380 adult subjects across six phase 1 trials, one phase 2 trial in patients with complicated urinary tract infections (cUTIs) including acute pyelonephritis, and one phase 3 trial (also referred to as Trial 1) in adult patients with infections caused by Acinetobacter baumannii-calcoaceticus complex including hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and ventilated pneumonia (VP) [see Clinical Studies (14) ].

8.1 Pregnancy Risk Summary XACDURO There are no available data on the use of XACDURO in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Individual Components of XACDURO Sulbactam: Available published data from case reports and case series with sulbactam use in combination with ampicillin during pregnancy over many decades have not identified a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The published literature reports that sulbactam crosses the human placenta. Reproduction studies have been performed in mice, rats, and rabbits at doses up to ten (10) times the human dose and have revealed no evidence of harm to the fetus due to sulbactam (see Data ). Durlobactam: There are no available data on the use of durlobactam in pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Durlobactam administered to pregnant mice and rats during organogenesis, showed no drug-induced fetal malformations but an increased incidence of skeletal variations was observed in mice at 2- and 4-times the Maximum Recommended Human Dose (MRHD) (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

Metabolism

Sulbactam and durlobactam pharmacokinetics are similar following single- and multiple-dose administrations. The C max and AUC of sulbactam increase in proportion to dose (0.5 times the recommended single dose to 1 g single dose).

There is no information on the clinical signs and symptoms associated with an overdose of XACDURO. Neurological adverse reactions, including convulsions, may occur with the attainment of high CSF levels of beta-lactams. Sulbactam and durlobactam are removed by hemodialysis [see Clinical Pharmacology (12.3) ]. No clinical information is available on the use of hemodialysis to treat overdosage.

• May 23, 2023NDANDA216974Entasis Therap

1. 1Off Label Use533%
2. 2Death427%
3. 3Drug Ineffective213%
4. 4Pneumonia Acinetobacter213%
5. 5Acute Kidney Injury16.7%
6. 6Blood Pressure Abnormal16.7%
7. 7Cardiac Disorder16.7%
8. 8Cardiac Failure Acute16.7%
9. 9Cardiac Failure Chronic16.7%
10. 10Condition Aggravated16.7%
11. 11Delirium16.7%
12. 12Diarrhoea16.7%
13. 13Drug Ineffective For Unapproved Indication16.7%
14. 14Dysbiosis16.7%
15. 15Enteritis16.7%

The 9 most recently updated of 9 ClinicalTrials.gov registrations naming Durlobactam as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Sulbactam-Durlobactam in CRAB Infection: A Real-World Cohort Study
  Recruiting · Observational · 200 enrolled · Sichuan Provincial People's Hospital
  NCT07601711updated 2026-05-22
• A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
  Recruiting · Observational · 100 enrolled · Innoviva Specialty Therapeutics
  NCT06746883updated 2026-05-22
• Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial
  Not yet recruiting · Phase 2 · Interventional · 300 enrolled · The University of Queensland
  NCT07485010updated 2026-03-20
• A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection
  Recruiting · Phase 1 · Interventional · 48 enrolled · Innoviva Specialty Therapeutics
  NCT06801223updated 2026-03-03
• Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex
  Completed · Phase 3 · Interventional · 207 enrolled · Entasis Therapeutics
  NCT03894046updated 2023-02-01
• Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects
  Completed · Phase 1 · Interventional · 8 enrolled · Entasis Therapeutics
  NCT04018950updated 2019-08-30
• Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers
  Completed · Phase 1 · Interventional · 32 enrolled · Entasis Therapeutics
  NCT03985410updated 2019-08-30
• Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy Subjects
  Completed · Phase 1 · Interventional · 30 enrolled · Entasis Therapeutics
  NCT03303924updated 2017-11-09
• Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects
  Completed · Phase 1 · Interventional · 124 enrolled · Entasis Therapeutics
  NCT02971423updated 2017-06-05

Frequently asked questions

How does Durlobactam work?

XACDURO is an antibacterial drug [see Microbiology (12.4) ].

What is Durlobactam used for?

According to FDA labeling, Durlobactam carries indications including: XACDURO is a co-packaged product containing sulbactam, a beta-lactam antibacterial and beta lactamase inhibitor, and durlobactam, a beta lactamase inhibitor, indicated in patients 18 years of age and older for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP), caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex. ( 1.1 ) Limitations of Use : XACDURO is not indicated for the treatment of HABP/VABP caused by pathogens other than susceptible isolates of Acinetobacter baumannii-calcoaceticus complex.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Durlobactam?

Durlobactam is classified as beta Lactamase Inhibitor, beta Lactamase Inhibitors.

What are the brand names for Durlobactam?

Durlobactam is marketed under brand names including Xacduro.

What are the contraindications for Durlobactam?

Durlobactam labeling lists contraindications including: XACDURO is contraindicated in patients with a history of known severe hypersensitivity to the components of XACDURO (sulbactam and durlobactam), or other beta-lactam antibacterial drugs [see Warnings and Precautions (5.1) ] . Known history of severe hypersensitivity to the components of XACDURO (sulbactam and durlobactam), or other beta-lactam antibacterial drugs.. Always consult the full prescribing information and a clinician.