AUKELSO (denosumab-kyqq) · BIOCON BIOLOGICS INC
Aukelso is a RANK ligand inhibitor used to prevent skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors. It is also indicated for the treatment of hypercalcemia of malignancy in cases where the condition has not responded to bisphosphonate therapy. Additionally, the drug is used to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical intervention would result in severe morbidity.
How AUKELSO Works
Aukelso binds to RANKL, a protein essential for the formation, function, and survival of osteoclasts, which are the cells responsible for bone resorption. By preventing RANKL from activating its receptor on the surface of osteoclasts and their precursors, the drug inhibits the breakdown of bone and the release of calcium. This process modulates bone pathology and osteolysis in patients where tumor signaling otherwise stimulates excessive osteoclast activity.
Details
- Status
- Prescription
- First Approved
- 2025-09-16
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AUKELSO Approval History
What AUKELSO Treats
4 indicationsAUKELSO 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 AUKELSO for Prolia without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
AUKELSO 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 AUKELSO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AUKELSO 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.
AUKELSO FDA Label Details
Indications & Usage
FDA Label (PDF)Aukelso 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 Aukelso 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.