BLASUBCUTANEOUSINJECTABLE4 Generics Approved
Approved
Jun 2010
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
66
Data completeness
6/8 — Strong
PROLIA (denosumab) by Amgen is rank ligand blocking activity [moa]. Approved for rank ligand inhibitor [epc]. First approved in 2010.
Drug data last refreshed 16h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROLIA (denosumab) is a monoclonal antibody that blocks RANK ligand to inhibit osteoclast formation and bone resorption. It is indicated for treatment of osteoporosis in postmenopausal women and men, prevention of skeletal-related events in patients with bone metastases, and giant cell tumor of bone. The drug works by binding to and neutralizing RANK ligand, a key mediator of bone loss.
$673MPart D
LOE ApproachingPROLIA faces significant competitive pressure with LOE approaching; commercial teams are likely transitioning to defensive positioning and cost-efficiency strategies as biosimilar and generic alternatives enter the market.
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 (66)
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
Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia®
Started Oct 2025
0Osteoporosis
A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches
Started Jul 2025
12 enrolled
OsteoarthritisOsteoarthritis (OA) of the KneeOsteoporosis+2 more
A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia®
Started Jun 2025
278 enrolled
Postmenopausal Women With Osteoporosis at High Risk of Fracture
A Study for the Evaluation of Efficacy and Safety of Prolia® in Participants With Glucocorticoid-induced Osteoporosis in Mainland China
Started May 2025
102 enrolled
Glucocorticoid-induced Osteoporosis
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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.