Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Xilonix · 2 trials · 4 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo administered intravenously every 2 weeks |
| Xilonix | ACTIVE_COMPARATOR | Xilonix administered intravenously every 2 weeks |
| open label-Xilonix | EXPERIMENTAL | Open label-Xilonix |
| Name | Type | Description |
|---|---|---|
| Xilonix | BIOLOGICAL | - |
| Placebo | BIOLOGICAL | - |
Inclusion Criteria: 1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have failed both an oxaliplatin (oxaliplatin may have been in the adjuvant setting) and an i...
Xilonix is an investigational monoclonal antibody being studied for pyoderma gangrenosum, a rare inflammatory skin condition, and for symptomatic colorectal cancer, including advanced colorectal cancer with cachexia. It is not approved by the FDA and remains in clinical development.
Xilonix is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational monoclonal antibody and has not received regulatory approval.
Xilonix has completed a Phase 2 trial in pyoderma gangrenosum and a Phase 3 trial in symptomatic colorectal cancer. Both trials are completed, and the drug is still considered investigational, meaning it has not been approved by the FDA.
Xilonix has been studied in two completed trials: NCT01965613, a Phase 2 open-label study in pyoderma gangrenosum with 10 participants in the United States, and NCT02138422, a Phase 3 study in symptomatic colorectal cancer with 276 participants in Poland.
No alternative names for Xilonix have been reported. The drug is known only as Xilonix in clinical trials and is being developed by Johnson & Johnson.