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AMG 162 - Prolia
AMG 162, also known as Prolia, is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption.
AMG 162, also known as Prolia, is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption. Used for Treatment of osteoporosis in postmenopausal women, Treatment of bone loss in patients with glucocorticoid-induced osteoporosis.
At a glance
| Generic name | AMG 162 - Prolia |
|---|---|
| Also known as | denosumab |
| Sponsor | Amgen |
| Drug class | RANKL inhibitor |
| Target | RANKL |
| Modality | Small molecule |
| Therapeutic area | Bone disorders |
| Phase | Phase 2 |
Mechanism of action
By binding to RANKL, Prolia inhibits its interaction with its receptor, RANK, on the surface of osteoclasts, thereby reducing bone resorption and increasing bone density. This mechanism of action is particularly relevant in the treatment of osteoporosis and other bone-related disorders.
Approved indications
- Treatment of osteoporosis in postmenopausal women
- Treatment of bone loss in patients with glucocorticoid-induced osteoporosis
Common side effects
- Back pain
- Pain in extremity
- Musculoskeletal pain
Key clinical trials
- Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma (PHASE2)
- A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China (PHASE4)
- Bone Loss Prevention With Zoledronic Acid or Denosumab in Critically Ill Adults (PHASE2)
- Romosozumab/Denosumab Study for Premenopausal IOP (PHASE2)
- A Study of Denosumab in Multiple Myeloma Patients With Renal Insufficiency (PHASE2)
- Contribution of Bone to Urine Citrate
- The Comparison of Ibandronate and Zoledronic Acid After Denosumab Discontinuation (PHASE4)
- Evaluation of Efficacy and Safety of Prolia in Subjects of Male Osteoporosis in Mainland China (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- AMG 162 - Prolia CI brief — competitive landscape report
- AMG 162 - Prolia updates RSS · CI watch RSS
- Amgen portfolio CI