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Zyvox/ Linezolid

Phase 3FDA approved

Bacterial Infections | Small molecule | Infectious Disease |Pfizer, Inc.|Trials Updated: Aug 14, 2009

Zyvox/ Linezolid development status

FDA approval on record Approved
Highest phase Phase 3

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Zyvox/ Linezolid clinical trials

Zyvox/ Linezolid · 1 trial · 1 indication

Phase 3 1
NCT00035854New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)Bacterial Infections
COMPLETED13 Analytics
PHASE3COMPLETED
New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)
Bacterial InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Investigator's and sponsor's evaluation of patient clinical outcome.

Secondary Endpoints

Pathogen eradication rates, changes in clinical signs and symptoms, body temperature, WBC count, lesion size (for SSSIs) and chest radiograph findings(for HAP).
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Zyvox® / LinezolidDRUG -
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Eligibility Criteria

Age RangeN/A to 17 Years
SexALL
Healthy VolunteersNo
Study Sites21

Other specific inclusion/exclusion criteria may apply. In order to determine eligibility, further examination by the investigator is necessary. Inclusion Criteria: * Hospitalized/chronic care pediatric patients (birth through 17 years) * Known infections due to vancomycin-resistant enterococcus sp...

Countries:United States
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Frequently asked questions about Zyvox/ Linezolid

What is Zyvox used for?

Zyvox, also known as linezolid, is an antibiotic used to treat bacterial infections. It is studied in pediatric patients with infections caused by vancomycin-resistant Enterococcus, a specific bacterium that resists many other antibiotics. Linezolid is a small molecule anti-infective developed by Pfizer, Inc. (NYSE: PFE).

Who makes Zyvox?

Zyvox is developed and manufactured by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the company behind the linezolid brand, and the drug sits within Pfizer's infectious disease portfolio.

What phase is Zyvox in?

Zyvox, or linezolid, has been studied in Phase 3 clinical development for bacterial infections. The Phase 3 trial in the program has completed, and no trials are currently active. Linezolid is a small molecule antibiotic in the infectious disease therapeutic area.

What clinical trials is Zyvox in?

Zyvox has been evaluated in the Phase 3 trial NCT00035854, titled "New Antibiotic to Treat Pediatric Patients With Infections Due to a Specific Bacteria (Vancomycin-Resistant Enterococcus)." The trial enrolled 13 participants in the United States, was randomized, and has completed.

Is Zyvox the same as linezolid?

Yes, Zyvox and linezolid refer to the same antibiotic. Zyvox is the brand name, while linezolid is the generic or international nonproprietary name. Both names describe the same small molecule developed by Pfizer, Inc. for treating bacterial infections.

What does Zyvox target?

Zyvox, or linezolid, is a small molecule antibiotic that targets bacterial infections, specifically infections caused by vancomycin-resistant Enterococcus. Its activity is directed at this resistant bacterium, which is the focus of its Phase 3 pediatric trial NCT00035854.