Last reviewed · How we verify
Cedax (ceftibuten)
Cedax (ceftibuten) is a cephalosporin antibacterial drug, a type of small molecule antibiotic. It was originally developed by Pernix Therapeutics and is currently owned by Burke Therapeutics. Cedax is used to treat various bacterial infections, including acute bacterial bronchitis, acute otitis media, and streptococcal tonsillitis. The drug is off-patent and has no active Orange Book patents, allowing for generic manufacturing. Key safety considerations include the potential for allergic reactions and gastrointestinal side effects.
At a glance
| Generic name | ceftibuten |
|---|---|
| Sponsor | Burke Therap |
| Drug class | Cephalosporin Antibacterial |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1995 |
Approved indications
- Acute bacterial bronchitis
- Acute otitis media
- Haemophilus Influenzae Acute Otitis Media
- Haemophilus Influenzae Chronic Bronchitis
- Infective otitis media
- Moraxella Catarrhalis Acute Otitis Media
- Moraxella Catarrhalis Chronic Bronchitis
- Streptococcal tonsillitis
- Streptococcus Pneumoniae Chronic Bronchitis
- Streptococcus pyogenes infection
- Tonsillitis
Common side effects
- Nausea
- Headache
- Diarrhea
- Dyspepsia
- Dizziness
- Abdominal pain
- Vomiting
- Anorexia
- Constipation
- Dry mouth
- Dyspnea
- Dysuria
Serious adverse events
- Seizures
- Anaphylaxis
- Stevens-Johnson syndrome
- Toxic epidermal necrolysis
- Pseudomembranous colitis
- Aplastic anemia
- Hemolytic anemia
- Agranulocytosis
- Hepatic cholestasis
- Toxic nephropathy
Key clinical trials
- Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Male and Female Participants 18 to ≤55 Years of Age (PHASE1)
- Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination (PHASE1)
- P1, DDI & MAD PK and Safety Study of Xeruborbactam Oral Prodrug in Combo With Ceftibuten in Healthy Participants (PHASE1)
- VNRX-7145 Drug-Drug Interaction in Healthy Adult Volunteers (PHASE1)
- Ceftibuten/VNRX-7145 in Participants With Varying Degrees of Renal Function (PHASE1)
- Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants (PHASE1)
- Subthreshold Micropulse Laser Therapy (SML) in Retinitis Pigmentosa (NA)
- To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults (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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Cedax CI brief — competitive landscape report
- Cedax updates RSS · CI watch RSS
- Burke Therap portfolio CI