OZILTUS (denosumab-mobz) · AMNEAL PHARMS
Oziltus is a RANK ligand inhibitor used to prevent skeletal-related events in patients with multiple myeloma and those with bone metastases from solid tumors. It is also indicated for the treatment of giant cell tumor of bone in adults and skeletally mature adolescents when the tumor is unresectable or surgery would cause severe morbidity. Additionally, the drug is used to treat hypercalcemia of malignancy in patients whose condition has not responded to bisphosphonate therapy.
How OZILTUS Works
Oziltus binds to RANKL, a protein essential for the formation, function, and survival of osteoclasts, which are the cells responsible for bone resorption. By blocking RANKL, the drug prevents the activation of the RANK receptor on the surface of osteoclasts and their precursors, thereby modulating the release of calcium from bone. In giant cell tumors of bone, this inhibition disrupts the signaling that contributes to osteolysis and tumor growth.
Details
- Status
- Prescription
- First Approved
- 2025-12-19
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
OZILTUS Approval History
What OZILTUS Treats
4 indicationsOZILTUS is approved for 4 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Myeloma
- Bone Metastasis
- Giant Cell Tumor of Bone
- Hypercalcemia of Malignancy
Pharmacists can substitute OZILTUS for Prolia without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
OZILTUS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in OZILTUS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OZILTUS treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OZILTUS FDA Label Details
Indications & Usage
FDA Label (PDF)Oziltus is a RANK ligand (RANKL) inhibitor indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Oziltus is indicated for the prevention of skeletal-related events in patients with multiple myeloma a...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.