Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Cefazolin in Dextrose Injection is a cephalosporin antibacterial indicated for: • Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved : ( 1 ) ο Respiratory tract infections ( 1.1 ); ο Urinary tract infections ( 1.2 ); ο Skin and skin structure infections ( 1.3 ); FDA label
Cefazolin · 1 trial · 1 indication
Cefazolin in plasma.
Cefazolin in plasma
Treatment Emergent Adverse Events (TEAEs)
| Arm | Type | Description |
|---|---|---|
| 3 g cefazolin | EXPERIMENTAL | Healthy adult subjects weighing ≥120 kg. (g=grams) |
| 2 g cefazolin | ACTIVE_COMPARATOR | Healthy adult subjects weighing \<120 kg. (g=grams) |
| Name | Type | Description |
|---|---|---|
| Cefazolin | DRUG | Cefazolin Injection - 2 g/100 mL or 3 g/150 mL |
Inclusion Criteria: * Subject provides informed consent (approved by an Institutional Review Board \[IRB\]) before any study specific evaluation is performed. * Subject is between the ages of 18 and 55 years (both inclusive). * A female subject is eligible to participate if she is not pregnant, bre...
Cefazolin is a small molecule drug being developed by Baxter International Inc. (ticker: BAX). It is in Phase 1 clinical development. The specific medical conditions it is intended to treat have not been disclosed. One Phase 1 trial of Cefazolin has been completed.
Cefazolin is being developed by Baxter International Inc., which trades under the ticker symbol BAX. Baxter is the sponsor of the clinical program for this drug candidate.
Cefazolin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
Cefazolin has been studied in one completed Phase 1 trial, NCT05309304, titled "Cefazolin PK Study 3g vs 2g." The trial enrolled 24 healthy adult volunteers in the United States and used an active-controlled design.
Cefazolin is an investigational drug in Phase 1 clinical development and is not FDA approved for the studied use. Its development is being conducted by Baxter International Inc. under ticker BAX.