Last reviewed · How we verify
Unasyn (SULBACTAM)
Unasyn (Sulbactam) is a beta-lactamase inhibitor developed by Pfizer, targeting the serine beta-lactamase-like protein LACTB, mitochondrial. It is a small molecule modality, FDA-approved in 1986 for various bacterial infections, including peritonitis, cholangitis, and hospital-acquired pneumonia. Unasyn is a commercial product, with its ownership and patent status still held by Pfizer. Key safety considerations include its short half-life of 1.1 hours. As a beta-lactamase inhibitor, Unasyn works by preventing bacterial enzymes from breaking down beta-lactam antibiotics, thereby enhancing their effectiveness.
At a glance
| Generic name | SULBACTAM |
|---|---|
| Sponsor | Pfizer |
| Drug class | beta Lactamase Inhibitor |
| Target | Serine beta-lactamase-like protein LACTB, mitochondrial |
| Modality | Small molecule |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 1986 |
Approved indications
- Bacterial peritonitis
- Bacteroides Gynecological Infections
- Bacteroides Peritonitis
- Cholangitis
- E. Coli Gynecological Infections
- E. Coli Peritonitis
- Female genital tract infection
- Hospital-acquired bacterial pneumonia caused by acinetobacter baumannii-calcoaceticus complex
- Infection caused by carbapenem-resistant acinetobacter baumannii-calcoaceticus complex
- Infection due to Enterobacteriaceae
- Infection due to Escherichia coli
- Infection due to Staphylococcus aureus
- Infection of skin AND/OR subcutaneous tissue
- Infectious disease of abdomen
- Inflammatory Disease of Female Pelvic Organs
- Intra-Abdominal E. Coli Abscess
- Klebsiella Pneumoniae Peritonitis
- Rhinoscleroma
- Skin and Skin Structure Acinetobacter Infection
- Skin and Skin Structure Bacteroides Fragilis Infection
Common side effects
- Pain at IM injection site
- Diarrhea
- Pain at IV injection site
- Thrombophlebitis
- Rash
- Itching
- Nausea
- Vomiting
- Candidiasis
- Fatigue
- Malaise
- Headache
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)
- Short Versus Standard of Care Antibiotic Duration for Children Hospitalized for CAP (PHASE4)
- A Study to Assess the Safety and Risk of Hypersensitivity Reactions of Sulbactam-durlobactam in Adults With Acinetobacter Baumannii-calcoaceticus (ABC) Complex Infection
- Assessing Role of Probiotics in Children Aged 6-36 Months Treated for Pneumonia (NA)
- Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients (NA)
- Therapeutic Options for CRAB (PHASE4)
- Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (PHASE3)
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:
- Unasyn CI brief — competitive landscape report
- Unasyn updates RSS · CI watch RSS
- Pfizer portfolio CI