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Also known as [14C]NXL104
NXL104 · 1 trial · 1 indication
Eradication: a uropathogen found at entry at \>10\^5 CFU/mL was reduced to \<10\^4 CFU/mL
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | NXL/104 ceftazidime |
| 2 | ACTIVE_COMPARATOR | comparator 4 x daily |
| Name | Type | Description |
|---|---|---|
| NXL104/ceftazidime | DRUG | 125mg/500mg TID |
| Imipenem/Cilastatin | DRUG | 4 x daily |
Inclusion Criteria: * Acute pyelonephritis or other complicated urinary tract infection due to gram negative pathogens Exclusion Criteria: * ileal loops or vesicoureteral reflux * complete obstruction of any portion of urinary tract, perinephric or intrarenal abscess. * fungal urinary tract infec...
NXL104 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE) for the treatment of complicated urinary tract infections. It has been studied in a Phase 2 clinical trial and is not described as an approved product. It is also known as [14C]NXL104 and NXL104/ceftazidime.
NXL104 is being studied for complicated urinary tract infections, an infectious disease indication. Its clinical development has focused on adults 18 years and older with this condition. The Phase 2 program evaluated it in a randomized, active-controlled study comparing NXL104/ceftazidime against a comparator.
Pfizer, Inc., which trades under the ticker PFE, is the developer of NXL104. The company sponsored the Phase 2 clinical trial of NXL104/ceftazidime in complicated urinary tract infections. No other developer or partnership is associated with the asset in its clinical program.
NXL104 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The study was randomized and active-controlled, enrolling 137 adults with complicated urinary tract infections across the United States, Jordan, and Lebanon. NXL104 is investigational and not an approved therapy.
NXL104 has been evaluated in one completed Phase 2 trial, NCT00690378, titled a comparative study of NXL104/Ceftazidime versus comparator in adults with complicated urinary tract infections. The trial enrolled 137 participants, was randomized and active-controlled, and included sites in the United States, Jordan, and Lebanon.