CAYSTON (aztreonam)
CAYSTON (aztreonam) is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with *Pseudomonas aeruginosa*. To reduce the development of drug-resistant bacteria and maintain the effectiveness of the treatment, CAYSTON should only be used in patients known to have *P. aeruginosa* in the lungs. Safety and effectiveness have not been established in pediatric patients under 7 years of age, patients with a predicted FEV1 <25% or >75%, or patients colonized with *Burkholderia cepacia*.
How CAYSTON Works
Aztreonam is a monobactam antibiotic that inhibits bacterial cell wall synthesis. It exhibits potent activity in vitro against Gram-negative aerobic pathogens, including *Pseudomonas aeruginosa*. Aztreonam binds to penicillin-binding protein 3 (PBP3) of susceptible bacteria, which inhibits the third and last stage of bacterial cell wall synthesis. This interference leads to the inhibition of peptidoglycan assembly, resulting in bacterial cell filamentation, lysis, and death. Aztreonam is poorly absorbed systemically when inhaled, allowing for high local concentrations in the lungs.
Details
- Status
- Prescription
- First Approved
- 2010-02-22
- Routes
- INHALATION
- Dosage Forms
- FOR SOLUTION
CAYSTON Approval History
What CAYSTON Treats
1 indicationsCAYSTON is approved for 1 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cystic Fibrosis
CAYSTON Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03867734 results posted | STUDY00003878-02 | Ph 2, Ph 3 | completed | Aztreonam for Pharyngeal Gonorrhea |
| NCT02894684 AZTEC-CF | 2016AZLIND001 | Ph 4 | completed | Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis |
| NCT02276482 results posted | 1986-012 TR701-122, 2014-004023-40 | Ph 3 | completed | Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012) |
| NCT01659866 results posted | STU00059558 EAM-237 | Ph 4 | completed | Antibiotic Prophylaxis for Transrectal Prostate Biopsy |
| NCT03376529 | SPR741-102 | Ph 1 | completed | Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741 |
| NCT01984684 results posted | RX-3341-303 | Ph 3 | completed | Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections |
| NCT01811732 results posted | RX-3341-302 2012-001767-71 | Ph 3 | completed | Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections |
| NCT02202135 results posted | D3720C00001sub | Ph 3 | terminated | Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections. |
| NCT01499277 results posted | D3720C00001 2011-004013-16 | Ph 3 | completed | Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections |
| NCT00633152 results posted | P903-19 | Ph 2 | completed | Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CAYSTON FDA Label Details
Indications & Usage
FDA Label (PDF)CAYSTON is indicated for the treatment of Cystic Fibrosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.