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Also known as RX-1741
Radezolid · 2 trials · 6 indications
To qualify as a Cure, participants were required to fulfill the following criteria: all systemic signs and symptoms of uSSSI present at screening were improved or resolved; no further antibiotic therapy was necessary for treatment of uSSSI; and there was no worsening or appearance of new signs and symptoms of uSSSI.
Patients were considered cured if all systemic signs and symptoms of CAP present at screening were improved or resolved and no further antibiotic therapy was necessary. In addition, the follow-up chest X-ray was to be either stable or improved.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Radezolid 450 mg PO QD |
| 2 | EXPERIMENTAL | Radezolid 450 mg PO BID |
| 3 | ACTIVE_COMPARATOR | Linezolid 600 mg PO BID |
| Name | Type | Description |
|---|---|---|
| Radezolid | DRUG | 450mg PO QD |
| Linezolid | DRUG | 600mg PO BID |
Inclusion Criteria: * Adult patients with uSSSI * Adult (men and women) ≥18 years * Females must be post-menopausal for at least 1 year or surgically sterile * Sexually active males must use a barrier method of birth control during and for 30 days after the study * Acceptable clinical diagnoses of ...
Radezolid is an investigational small-molecule antibiotic being developed for community-acquired pneumonia (CAP) and infectious skin diseases, including bacterial skin infections, staphylococcal skin infections, streptococcal infections, and abscesses. It is in Phase 2 clinical development and has not been approved by the FDA.
Radezolid is being developed by CorMedix Inc., which trades on the Nasdaq under the ticker CRMD. The company is the sponsor of the clinical program evaluating the drug in infectious disease indications.
Radezolid is in Phase 2 clinical development. It has completed one Phase 2 trial and has no active trials at this time. It is an investigational drug and has not received FDA approval.
Radezolid has been studied in two completed Phase 2 trials. NCT00646958 evaluated oxazolidinones for uncomplicated skin infections in the United States, enrolling 150 patients. NCT00640926 evaluated an oxazolidinone for community-acquired pneumonia in the United States, Canada, and Russia, enrolling 158 patients.
No, Radezolid is not FDA approved. It remains an investigational drug in Phase 2 clinical development for community-acquired pneumonia and infectious skin diseases, with one completed Phase 2 trial and no active trials.