Last reviewed · How we verify
Bethkis®
Bethkis is an inhaled antibiotic that delivers tobramycin directly to the lungs to kill Pseudomonas aeruginosa bacteria in cystic fibrosis patients.
Bethkis is an inhaled antibiotic that delivers tobramycin directly to the lungs to kill Pseudomonas aeruginosa bacteria in cystic fibrosis patients. Used for Cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection.
At a glance
| Generic name | Bethkis® |
|---|---|
| Sponsor | Mylan Inc. |
| Drug class | Aminoglycoside antibiotic |
| Target | Bacterial 30S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Pulmonary |
| Phase | FDA-approved |
Mechanism of action
Tobramycin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. The inhaled formulation allows high local concentrations in the respiratory tract while minimizing systemic exposure, making it particularly effective for treating chronic Pseudomonas aeruginosa lung infections in cystic fibrosis.
Approved indications
- Cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection
Common side effects
- Cough
- Wheezing
- Dyspnea
- Bronchospasm
- Tinnitus
- Voice alteration
Key clinical trials
- A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection (PHASE1, PHASE2)
- Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients (PHASE3)
- Efficacy and Safety of Stimulan® for the Treatment of Diabetic Foot Osteomyelitis. The BIG D-FOOT Study (NA)
- Evaluating the Use of ProKera Plus® in the Management of Bacterial Corneal Ulcers (NA)
- Observational Study in Cystic Fibrosis Patients Using TOBI® PODHALER® or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs
- Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules (PHASE4)
- DPI-Tobra-Kind Cyclops® in Children With Cystic Fibrosis (PHASE1, PHASE2)
- Patients Response to Early Switch To Oral:Osteomyelitis Study (EARLY_PHASE1)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Bethkis® CI brief — competitive landscape report
- Bethkis® updates RSS · CI watch RSS
- Mylan Inc. portfolio CI