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Xacduro (Copackaged) (DURLOBACTAM)
Xacduro works by binding to and inhibiting bacterial beta-lactamases, allowing antibiotics to effectively kill bacteria.
DURLOBACTAM (Xacduro), marketed by Entasis Therapeutics, is a novel antibiotic combination therapy designed to treat Hospital-acquired Bacterial Pneumonia (HABP). Its key strength lies in its mechanism of action, which involves binding to and inhibiting bacterial beta-lactamases, thereby enhancing the efficacy of antibiotics against resistant bacteria. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generic alternatives.
At a glance
| Generic name | DURLOBACTAM |
|---|---|
| Sponsor | Entasis Therap |
| Drug class | beta Lactamase Inhibitor |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Think of Xacduro like a shield that protects antibiotics from the bacteria's defense mechanism. By blocking the bacteria's ability to break down antibiotics, Xacduro allows the antibiotics to reach their target and kill the bacteria. This makes Xacduro an important tool in the fight against antibiotic-resistant bacteria.
Approved indications
- Hospital-acquired Bacterial Pneumonia (HABP)
- Ventilator-associated Bacterial Pneumonia (VABP)
Common side effects
- Liver test abnormalities
- Diarrhea
- Anemia
- Hypokalemia
- Arrhythmia
- Acute kidney injury
- Thrombocytopenia
- Constipation
Serious adverse events
- Anaphylactic shock
- Serious adverse reactions (general)
Drug interactions
- OAT1 inhibitors (e.g., probenecid)
Key clinical trials
- 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 (PHASE2)
- A Study to Assess Sulbactam-durlobactam in Pediatric Patients With Acinetobacter Baumannii-calcoaceticus Complex Infection (PHASE1)
- A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
- Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter Baumannii-calcoaceticus Complex (PHASE3)
- Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers (PHASE1)
- Study to Determine the Excretion and Metabolism of 14C-ETX2514 Administered Intravenously in Healthy Male Subjects (PHASE1)
- Study to Determine and Compare Plasma and Intrapulmonary Concentrations of ETX2514 and Sulbactam in Healthy Subjects (PHASE1)
- Evaluation of the Safety, Tolerability and Pharmacokinetics of Intravenous ETX2514 Administered in Healthy Subjects (PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xacduro (Copackaged) CI brief — competitive landscape report
- Xacduro (Copackaged) updates RSS · CI watch RSS
- Entasis Therap portfolio CI