denosumab
denosumab: developed by 1 company · 8 clinical trials tracked · 1 FDA decision.
denosumab evidence translation
What we can confirm
1 FDA record · 8 tracked trials
What it means
What to watch
Prepared research question
How could denosumab → AMGN affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 1 study sponsors
Related indications
Study sponsors
Development Pipeline (1)
| Company | Phase |
|---|---|
| AMGEN INC (AMGN) | Approved |
Clinical Trials (8)
A Phase 4 Single-arm Open-label Study for the Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China
Primary endpoint: Change from Baseline in Lumbar Spine BMD Percentage
A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
Primary endpoint: Number of participants with adverse events (Phase Ib only)
A Phase 1/2 Prospective, Randomized, Double-blind, Placebo-controlled Multi-center Clinical Trial to Determine the Safety and Efficacy of Denosumab in Improving Beta Cell Function and Glycemic Control Among Patients With Type 1 Diabetes
Primary endpoint: Primary safety endpoint
Efficacy of Sequential Denosumab After Teriparatide for 6 Months Compared With Denosumab Monotherapy in Reducing Risk of Osteoporotic Fractures in Patients With New Fractures: a Multicenter Randomized Controlled Trial (STAND Study)
Primary endpoint: The main study：The incidence of new vertebral fractures
A Randomized, Double-blind, Parallel-group, Active-controlled Study to Compare the Efficacy, Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Enzene Denosumab (ENZ215) and Prolia® in Postmenopausal Women With Osteoporosis
Primary endpoint: To Evaluate the Efficacy of ENZ215 When Compared to Prolia in Patients With Postmenopausal Osteoporosis, in Terms of Change in Bone Mineral Density (BMD) at Lumbar Spine.
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Primary endpoint: Bone mineral density changes at total hip and lumbar spine
Denosumab for Smoldering Multiple Myeloma
Primary endpoint: Proportion of Subjects With a Downgraded Risk of Progression of Smoldering Multiple Myeloma if the Risk Category Decreases.
Phase 2 Study of Denosumab in Combination With a PD-1 Inhibitor in Subjects With Stage III/IV Melanoma
Primary endpoint: The Antitumor Effect of Denosumab Alone as Represented by the Change in Recent Thymic Emigrant Cells in Peripheral Blood
FDA Decisions1 records
Frequently asked questions
Who is developing denosumab?
denosumab is being developed by AMGEN INC.
How many clinical trials involve denosumab?
BioSniper tracks 8 clinical trials involving denosumab.
What is denosumab's latest FDA decision?
The most recent tracked FDA decision for denosumab is Approval for 1 INDICATIONS AND USAGE Prolia is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture ( 1.1 ) to increase bone mass in men with osteoporosis at high risk for fracture ( 1.2 ) of glucocorticoid-induced osteoporosis in men and women at high risk for fracture ( 1.3 ) to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer ( 1.4 ) to increase bone mass in w, dated June 1, 2010.