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Suprax (CEFIXIME)
Suprax works by inhibiting the bacterial enzyme 1-phosphatidylinositol 4,5-bisphosphate phosphodiesterase gamma-1, disrupting bacterial cell wall synthesis.
Suprax (Cefixime) is a third-generation cephalosporin antibiotic, originally developed by Hoechst Marion Roussel and currently owned by Lederle. It targets the bacterial enzyme 1-phosphatidylinositol 4,5-bisphosphate phosphodiesterase gamma-1, inhibiting bacterial cell wall synthesis. Suprax is a small molecule modality, FDA-approved in 1989 for various bacterial infections, including respiratory, urinary, and sexually transmitted infections. It has a bioavailability of 47% and a half-life of 3.2 hours. Suprax is off-patent, with multiple generic manufacturers available.
At a glance
| Generic name | CEFIXIME |
|---|---|
| Sponsor | Lederle |
| Drug class | cefixime |
| Target | 1-phosphatidylinositol 4,5-bisphosphate phosphodiesterase gamma-1 |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1989 |
Mechanism of action
Cefixime is semisynthetic cephalosporin antibacterial drug see Microbiology( 12.4)].
Approved indications
- Acute bacterial bronchitis
- Acute exacerbation of chronic bronchitis
- Acute gonococcal cervicitis
- Acute gonococcal urethritis
- Acute otitis media
- Bronchitis
- Escherichia coli urinary tract infection
- Gonorrhea
- Haemophilus Influenzae Acute Otitis Media
- Haemophilus Influenzae Bronchitis
- Haemophilus Influenzae Chronic Bronchitis
- Infective otitis media
- Moraxella Catarrhalis Acute Otitis Media
- Pharyngitis
- Proteus urinary tract infection
- Streptococcal tonsillitis
- Streptococcus Pneumoniae Bronchitis
- Streptococcus Pneumoniae Chronic Bronchitis
- Streptococcus pyogenes infection
- Tonsillitis
Common side effects
- Diarrhea
- Gastrointestinal events
- Loose or frequent stools
- Abdominal pain
- Dyspepsia
- Flatulence
- Nausea
- Vomiting
- Anaphylactic/anaphylactoid reactions
- Skin rashes
- Urticaria
- Drug fever
Key clinical trials
- Optimizing the Diagnostic Approach to Cephalosporin Allergy Testing (PHASE2)
- Efficacy of Immunization With 4C-MenB in Preventing Experimental Urethral Infection With Neisseria Gonorrhoeae (PHASE2)
- A Platform Trial for Gram Negative Bloodstream Infections (NA)
- The Azithromycin and Cefixime Treatment of Typhoid in South Asia Trial (ACT-South Asia Trial) (PHASE4)
- 3-day IV Antibiotic Treatment Versus 3-day IV Followed by 7-day Oral Antibiotic Treatment for AP in Children (PHASE4)
- Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder (PHASE4)
- Periodic Presumptive Treatment vs. doxyPEP for STI Control in Kenyan MSM (PHASE4)
- Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9233112 | 2028-12-14 | Formulation |
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:
- Suprax CI brief — competitive landscape report
- Suprax updates RSS · CI watch RSS