Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CXA-201 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| CXA-201 as treatment for cUTI | EXPERIMENTAL | CXA-201 IV infusion (1500mg q8) for 7 days |
| Levofloxacin as treatment for cUTI | ACTIVE_COMPARATOR | Levofloxacin IV infusion (750mg qd) for 7 days |
| Name | Type | Description |
|---|---|---|
| CXA-201 | DRUG | CXA-201 IV infusion (1500mg q8) for 7 days |
| Levofloxacin | DRUG | Levofloxacin IV infusion (750mg qd) for 7 days |
Inclusion Criteria: 1. Provide written informed consent prior to any study-related procedure not part of normal medical care (a legally acceptable representative may provide consent if the subject is unable to do so, provided this is approved by local country and institution specific guidelines). 2...
CXA-201 is an investigational small molecule being developed for complicated urinary tract infection and complicated intra-abdominal infection. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
CXA-201 is a small molecule antibiotic, though its specific molecular target has not been disclosed. It is being studied for its efficacy against bacterial infections in complicated urinary tract and intra-abdominal settings.
CXA-201 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy.
CXA-201 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Two Phase 3 trials have been completed, with a total enrollment of over 1,000 patients.
CXA-201 has completed two Phase 3 trials. NCT01345929 compared intravenous CXA-201 to levofloxacin in complicated urinary tract infection, enrolling 558 patients. NCT01445678 compared it to meropenem in complicated intra-abdominal infection, enrolling 494 patients. Both were randomized, double-blind, active-controlled studies.
CXA-201 is not the same as ceftolozane/tazobactam. CXA-201 is a distinct investigational antibiotic being developed by Merck. No alternative names for CXA-201 have been disclosed in the clinical trial data.