Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DFA-02 · 1 trial · 1 indication
Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.
Area under the curve (AUC) of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
| Arm | Type | Description |
|---|---|---|
| DFA-02 | EXPERIMENTAL | Progressive cohorts of 10 subjects (8 active, 2 placebo) receiving 10, 20 , 30 or 40 mL of DFA-02 or matching placebo. |
| DFA-02 placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| DFA-02 | DRUG | Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure |
| Placebo | DRUG | DFA-02 placebo |
Inclusion Criteria: 1. Males and females 18 years of age or older; 2. If female, the patient must be: * postmenopausal (if amenorrheic for \< 1 year, postmenopausal status must be confirmed by an elevated follicle stimulating hormone \[FSH\] level \> 30 mIU/mL; if amenorrheic for \> 1 year, FSH...
DFA-02 is an investigational small molecule being developed for the prevention of surgical site infection. It is being studied in patients undergoing colorectal surgery, a procedure with a high risk of this complication. The drug is currently in Phase 1 clinical development.
DFA-02 is a small molecule, but its specific molecular target has not been disclosed. The drug is being investigated for its potential to prevent surgical site infections, which are typically caused by bacterial contamination during surgery. Its mechanism of action is not publicly detailed.
DFA-02 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in preventing surgical site infections.
DFA-02 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug is not yet approved by regulatory authorities. It remains an investigational agent, and further studies are needed to establish its safety and effectiveness.
DFA-02 has one completed clinical trial, identified as NCT01496352, titled 'DFA-02 in Patients Undergoing Colorectal Surgery.' This Phase 1 study enrolled 30 participants in the United States and was randomized, double-blind, and placebo-controlled. The trial is no longer active.
No alternative names for DFA-02 have been disclosed. The drug is solely identified by its code name DFA-02 in clinical and regulatory contexts. It is not known to be marketed under any other brand or generic name.