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US-licensed Prolia
Prolia is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption.
Prolia is a human monoclonal antibody that targets RANKL, a protein involved in bone resorption. Used for Treatment of osteoporosis in postmenopausal women at high risk of fracture, Treatment of bone loss in patients with hormone ablation for non-metastatic prostate cancer.
At a glance
| Generic name | US-licensed Prolia |
|---|---|
| Sponsor | Celltrion |
| Drug class | Denosumab |
| Target | RANKL |
| Modality | Biologic |
| Therapeutic area | Osteoporosis |
| Phase | Phase 3 |
Mechanism of action
By binding to RANKL, Prolia inhibits the formation of osteoclasts, which are cells responsible for bone breakdown. This leads to an increase in bone mass and a decrease in the risk of fractures. Prolia is administered via subcutaneous injection and has a half-life of approximately 28 days.
Approved indications
- Treatment of osteoporosis in postmenopausal women at high risk of fracture
- Treatment of bone loss in patients with hormone ablation for non-metastatic prostate cancer
Common side effects
- Nausea
- Headache
- Injection site reaction
- Musculoskeletal pain
- Fatigue
Key clinical trials
- A Study to Evaluate the Efficacy, Pharmacodynamics, Safety, and Immunogenicity of FKS518 in Postmenopausal Women With Osteoporosis (PHASE3)
- A Study Comparing the Pharmacokinetic Similarity of MB09 and EU/US-Sourced Xgeva (PHASE1)
- A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis (PHASE3)
- Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects (PHASE1)
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 |