denosumab
denosumab: sourced relationships with 1 company · 10 clinical trials tracked · 1 FDA decision.
denosumab evidence translation
What we can confirm
1 FDA record · 10 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 evidence2 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| AMGEN INC (AMGN) Reported 2010-06-01 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (10)
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.
Romosozumab to Improve Bone Mineral Density and Architecture in Chronic SCI
Primary endpoint: Change in vBMD at the Distal Femur, measured by pQCT after 12 months of romosozumab treatment
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
A Randomised, Open-label Phase III Trial Evaluating the Addition of Denosumab to Standard First-line Anticancer Treatment in Advanced NSCLC
Primary endpoint: Overall Survival
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with denosumab?
denosumab has dated SEC/FDA relationship records for AMGEN INC.
How many clinical trials involve denosumab?
BioSniper tracks 10 clinical trials involving denosumab.
What is denosumab's latest FDA decision?
The most recent tracked FDA decision for denosumab is Approval, dated June 1, 2010.