Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 223 · 2 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
| AMG 223 | EXPERIMENTAL | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
| 2 | ACTIVE_COMPARATOR | 30 subjects will be randomized on Day -1 |
| 1 | EXPERIMENTAL | 30 subjects will be randomized on Day -1 |
| Name | Type | Description |
|---|---|---|
| AMG 223 | DRUG | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
| Placebo | DRUG | 1.0 g TID orally 3.0 g TID orally 4.0 g TID orally 5.0 g TID orally |
| Renagel® (sevelamer hydrochloride) | DRUG | 2g Renagel® (2 x 800 mg capsules + 1 x 400 mg capsule) TID on Days 1 through 7 |
Inclusion Criteria: * Maintenance hemodialysis 3 times a week for at least 3 months prior to screening * Single pool Kt/V at least 1.2 or urea reduction ratio at least 65% * Serum phosphorus level of 3.5 to 6.5 mg/dL inclusive at screening * No change(s) in type or dose of non-investigational phosp...
AMG 223 is an investigational small molecule being studied for use in End Stage Renal Disease and Chronic Kidney Disease with hyperphosphatemia, as well as in Healthy Volunteers. It is being developed by Amgen Inc. (NASDAQ: AMGN) and is currently in Phase 2 clinical development.
AMG 223 is a small molecule being developed for nephrology indications, specifically for hyperphosphatemia in chronic kidney disease. Its molecular target has not been disclosed in available information, so its precise mechanism of action is not specified.
AMG 223 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 2 clinical trials for End Stage Renal Disease and related conditions.
AMG 223 is in Phase 2 clinical development. It has completed one Phase 2 trial and one Phase 1 trial. The drug is investigational and has not been approved by regulatory authorities for any indication.
AMG 223 has been studied in two completed trials. NCT00530114 was a Phase 2 study in 167 subjects with chronic kidney disease on hemodialysis with hyperphosphatemia. NCT00756860 was a Phase 1 study in 66 healthy volunteers comparing AMG 223 to sevelamer HCL.
AMG 223 is not the same as sevelamer. In a Phase 1 trial, AMG 223 was compared directly against sevelamer HCL (Renagel) to evaluate their effects in healthy volunteers. AMG 223 is a separate investigational compound being developed by Amgen.