Recent Updates
Recently added Catalysts

Radezolid

Phase 2

Community-Acquired Pneumonia (CAP) | Small molecule | Infectious Disease |CorMedix Inc.|Last Updated: May 12, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment158

FDA Designations

No designations recorded

Clinical trial landscape

Radezolid · 2 trials · 6 indications

Phase 2 2
NCT00646958Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin InfectionsInfectious Skin Diseases
COMPLETED150 Analytics
NCT00640926Safety and Efficacy Study of Oxazolidinone to Treat PneumoniaCommunity-Acquired Pneumonia (CAP)
COMPLETED158 Analytics
PHASE2COMPLETED
Safety and Efficacy Study of Oxazolidinones to Treat Uncomplicated Skin Infections
Infectious Skin DiseasesUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of Oxazolidinone to Treat Pneumonia
Community-Acquired Pneumonia (CAP)Unlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With a Clinical Response of Cure
Test of Cure (TOC), day 10-20

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.

Clinical Cure in the Clinically Evaluable (CE) Population at Test of Cure (TOC)
Study days 14-38

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.

Secondary Endpoints

Number of Patients With Per-Patient Microbiologic Response of Eradicated
Test of Cure (TOC), day 10-20
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRadezolid 450 mg PO QD
2EXPERIMENTALRadezolid 450 mg PO BID
3ACTIVE_COMPARATORLinezolid 600 mg PO BID

Interventions

NameTypeDescription
RadezolidDRUG450mg PO QD
LinezolidDRUG600mg PO BID
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites19

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 ...

Countries:United StatesCanadaRussia
Unlock Eligibility Criteria

Frequently asked questions about Radezolid

What is Radezolid used for?

Radezolid is an investigational small molecule antibiotic being studied for the treatment of community-acquired pneumonia (CAP) and infectious skin diseases, including bacterial skin infections, staphylococcal skin infections, streptococcal infections, and abscesses. It is being developed by CorMedix Inc. (CRMD) and is currently in Phase 2 clinical development.

What does Radezolid target?

Radezolid is an oxazolidinone antibiotic, a class of drugs that works by inhibiting bacterial protein synthesis. It is being studied for use against bacterial infections, including those affecting the skin and respiratory tract. The specific molecular target of Radezolid has not been disclosed in the available clinical trial information.

Who makes Radezolid?

Radezolid is being developed by CorMedix Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol CRMD. The company is conducting clinical trials to evaluate the safety and efficacy of Radezolid for the treatment of infectious diseases.

What phase is Radezolid in?

Radezolid is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 2 clinical trials have been completed, one for community-acquired pneumonia and one for uncomplicated skin infections, but Radezolid remains in the clinical development stage.

What clinical trials has Radezolid been in?

Radezolid has been studied in two completed Phase 2 clinical trials. The first, NCT00640926, evaluated its safety and efficacy in treating community-acquired pneumonia in 158 participants across the United States, Canada, and Russia. The second, NCT00646958, studied its use in uncomplicated skin infections in 150 participants in the United States.

Is Radezolid the same as an oxazolidinone antibiotic?

Radezolid is an oxazolidinone antibiotic, a class of synthetic antibacterial agents. It is being studied for its potential to treat bacterial infections, including community-acquired pneumonia and skin infections. Radezolid is distinct from other oxazolidinones like linezolid, though it shares the same class mechanism of action.