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AMG 162/ Denosumab · 1 trial · 3 indications
Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry.
| Arm | Type | Description |
|---|---|---|
| AMG 162 / Denosumab | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months |
| AMG 162 / Denosumab | DRUG | 60 mg (1.0 mL) administered subcutaneously every six months, beginning on Study Day 1, for a total treatment period of 24 months |
* Histologically or cytologically confirmed adenocarcinoma of the breast * Subjects with early stage disease who are estrogen receptor positive and who have completed their treatment pathway (surgery, chemo-therapy, radiation, and/or hormone therapy) and are currently on or will initiate aromatase i...
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AMG 162 is an investigational small molecule being studied for bone-related conditions including prostate cancer, breast cancer, bone metastases in men with hormone-refractory prostate cancer, low bone mineral density, osteoporosis, and postmenopausal osteoporosis. It is in Phase 3 clinical development and is not yet approved.
AMG 162 is being developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN. The drug is currently in Phase 3 clinical trials for multiple bone-related indications.
AMG 162 is in Phase 3 clinical development. It has completed one Phase 3 trial and is being studied for conditions such as postmenopausal osteoporosis, breast cancer, and bone metastases. The drug remains investigational and has not been approved by regulatory authorities.
AMG 162 has been studied in clinical trials including NCT00089661 for bone loss in breast cancer patients, NCT00091793 for prevention of postmenopausal osteoporosis, and NCT00950911 for bone metastases in advanced cancers. These trials are completed.
Yes, AMG 162 is also known as denosumab. One clinical trial, NCT00306189, is titled 'A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects,' confirming the alternative name.