BLASUBCUTANEOUSINJECTABLE4 Generics Approved
Approved
Jun 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
6/8 — Strong
XGEVA (denosumab) by Amgen is rank ligand blocking activity [moa]. Approved for rank ligand inhibitor [epc]. First approved in 2010.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XGEVA (denosumab) is a monoclonal antibody that blocks RANK ligand, inhibiting osteoclast formation and bone resorption. It is indicated for prevention of skeletal-related events in patients with bone metastases from solid tumors and giant cell tumor of bone. The drug works by suppressing the biological activity that drives bone destruction in cancer and certain bone disorders.
$46MPart D
LOE ApproachingXGEVA faces significant competitive pressure (30) with LOE approaching; commercial teams should expect defensive positioning and focused retention strategies as biosimilars and generic denosumab entrants gain traction.
Mechanism of Action
RANK Ligand Blocking Activity
Pharmacologic Class:
RANK Ligand Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study on the Intervention Effect of Denosumab on High-Risk Patients With Osteoporotic Fractures in Type 2 Diabetes
Started Feb 2026
358 enrolled
Type 2 DiabetesOsteoporosisFractures
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Started Jul 2025
12 enrolled
OsteoarthritisOsteoarthritis (OA) of the KneeOsteoporosis+2 more
Narlumosbart Compared With Denosumab in Patients With Multiple Myeloma Bone Disease
Started Apr 2024
478 enrolled
Multiple MyelomaBone Diseases
Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes
Started Feb 2024
86 enrolled
SarcopeniaOsteoporosisDenosumab
Single or Repeat Zoledronate Versus Alendronate Following Denosumab (EUROpean Denosumab Effects Consolidation Study)
Started Nov 2023
122 enrolled
Osteoporosis, Postmenopausal
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.