Approval Probability
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Label indication ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia ( 1.1 ); Community-acquired pneumonia ( 1.2 ); Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis ( 1.3 ); FDA label
Also known as Zyvox
linezolid · 6 trials · 7 indications
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
The time corresponding to the beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for ventricular rate (VR) using the QT and VR from each electrocardiogram by Fridericia's formula (QTcF = QT divided by cube root of VR in seconds). A measure of dispersion is not available.
| Arm | Type | Description |
|---|---|---|
| A. | EXPERIMENTAL | Patients will be stratified according to the use of prophylactic antibiotics. Both groups may receive open-label gram-negative coverage with either ceftazidime, aztreonam, and/or aminoglycosides (gentamicin, tobramycin, amikacin). Subjects will receive study medication intravenously every 12 hours for 7 to 28 days. |
| B. | EXPERIMENTAL | - |
| Arm A | ACTIVE_COMPARATOR | - |
| Arm B | PLACEBO_COMPARATOR | - |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | - |
| Cohort 1: 900 mg linezolid | EXPERIMENTAL | - |
| Cohort 1: 1200 mg linezolid | EXPERIMENTAL | - |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | - |
| Cohort 2: 600 mg linezolid | EXPERIMENTAL | - |
| Cohort 2: 1200 mg linezolid | EXPERIMENTAL | - |
| Cohort 2: 400 mg Moxifloxacin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| linezolid | DRUG | - |
| Vancomycin | DRUG | - |
| Oxacillin | DRUG | - |
| Dicloxacillin | DRUG | - |
| Placebo | DRUG | 500 mg oral placebo twice daily for 4.5 days |
| Linezolid 900 mg | DRUG | Intravenous, 900 mg linezolid, single dose |
| Linezolid 1200 mg | DRUG | Intravenous, 1200 mg linezolid, single dose |
| Linezolid 600 mg | DRUG | Intravenous, 600 mg linezolid, single dose |
| Moxifloxacin 400 mg | DRUG | Oral, 400 mg moxifloxacin, single dose |
Inclusion Criteria: * infection due to methicillin-resistant Staphylococcus aureus Exclusion Criteria: * hypersensitivity to linezolid
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
Linezolid is an antibiotic studied for treating bacterial infections, including Gram positive infections, nosocomial infections, burns, and febrile neutropenia. It has been evaluated for infections caused by methicillin resistant Staphylococcus aureus. It is a small molecule infectious disease therapy developed by Pfizer, Inc.
Linezolid is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the company associated with the clinical development program for this antibiotic across its infectious disease indications.
Linezolid has been studied in Phase 3 clinical development. A completed Phase 3 trial evaluated it for infections caused by methicillin resistant Staphylococcus aureus in Japan. The program also includes completed Phase 1 studies, and the drug is investigational rather than approved based on this development record.
Linezolid has been evaluated in completed trials including NCT00150332, a Phase 3 study of infections caused by methicillin resistant Staphylococcus aureus in Japan, and NCT01544673, a Phase 1 study of neutrophil and monocyte function in healthy males. Other completed studies include NCT00795145 on QTc interval and NCT00255996 on pharmacokinetics in burns patients.
Linezolid has been studied in bacterial infections, Gram positive infections, nosocomial infections, burns, and febrile neutropenia. Its Phase 3 trial focused on infections caused by methicillin resistant Staphylococcus aureus. The clinical program includes both healthy volunteer studies and patient studies across these infectious disease conditions.