Last reviewed · How we verify
Denosumab (CP2)
Denosumab (CP2) is a RANKL inhibitor (monoclonal antibody) Small molecule drug developed by Amgen. It is currently in Phase 3 development for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of giant cell tumor of bone, Osteoporosis in postmenopausal women and men at high risk of fracture. Also known as: XGEVA®.
Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), blocking osteoclast formation and bone resorption.
Denosumab is a monoclonal antibody that inhibits RANKL (receptor activator of nuclear factor kappa-B ligand), blocking osteoclast formation and bone resorption. Used for Prevention of skeletal-related events in patients with bone metastases from solid tumors, Treatment of giant cell tumor of bone, Osteoporosis in postmenopausal women and men at high risk of fracture.
At a glance
| Generic name | Denosumab (CP2) |
|---|---|
| Also known as | XGEVA® |
| Sponsor | Amgen |
| Drug class | RANKL inhibitor (monoclonal antibody) |
| Target | RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand) |
| Modality | Small molecule |
| Therapeutic area | Oncology, Bone Metabolism |
| Phase | Phase 3 |
Mechanism of action
Denosumab binds to RANKL, a key mediator of osteoclast differentiation and activation. By preventing RANKL from engaging its receptor RANK on osteoclast precursors, the drug suppresses bone resorption and increases bone mineral density. This mechanism makes it effective for conditions characterized by excessive bone loss or osteoclast-mediated bone destruction.
Approved indications
- Prevention of skeletal-related events in patients with bone metastases from solid tumors
- Treatment of giant cell tumor of bone
- Osteoporosis in postmenopausal women and men at high risk of fracture
Common side effects
- Hypocalcemia
- Osteonecrosis of the jaw
- Atypical femoral fractures
- Infections
- Fatigue
Key clinical trials
- Bioequivalence Study of Denosumab CP4 Drug Product and Commercially Available Denosumab CP2 Drug Product (PHASE1)
- A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Denosumab (CP2) CI brief — competitive landscape report
- Denosumab (CP2) updates RSS · CI watch RSS
- Amgen portfolio CI
Frequently asked questions about Denosumab (CP2)
What is Denosumab (CP2)?
How does Denosumab (CP2) work?
What is Denosumab (CP2) used for?
Who makes Denosumab (CP2)?
Is Denosumab (CP2) also known as anything else?
What drug class is Denosumab (CP2) in?
What development phase is Denosumab (CP2) in?
What are the side effects of Denosumab (CP2)?
What does Denosumab (CP2) target?
Related
- Drug class: All RANKL inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting RANKL (Receptor Activator of Nuclear Factor Kappa-B Ligand)
- Manufacturer: Amgen — full pipeline
- Therapeutic area: All drugs in Oncology, Bone Metabolism
- Indication: Drugs for Prevention of skeletal-related events in patients with bone metastases from solid tumors
- Indication: Drugs for Treatment of giant cell tumor of bone
- Indication: Drugs for Osteoporosis in postmenopausal women and men at high risk of fracture
- Also known as: XGEVA®
- Compare: Denosumab (CP2) vs similar drugs
- Pricing: Denosumab (CP2) cost, discount & access