TheraRadar
Data updated: May 26, 2026

WYOST (denosumab-bbdz)

RANK Ligand Blocking Activity
Oncology Approved 2024-03-05

Wyost (denosumab-bbdz) is a RANK ligand inhibitor used to manage bone-related complications in oncology patients. It is indicated to prevent skeletal-related events in individuals with multiple myeloma or bone metastases from solid tumors. Additionally, the drug is used for patients with hypercalcemia of malignancy that has not responded to bisphosphonate therapy and for certain cases of giant cell tumor of bone.

Source: FDA Label • Novartis • RANK Ligand Inhibitor

How WYOST Works

Wyost functions by binding to RANKL, a protein necessary for the formation and survival of osteoclasts, which are the cells responsible for bone resorption. By preventing RANKL from activating its receptor (RANK) on the surface of osteoclasts and their precursors, the drug inhibits the breakdown of bone and the subsequent release of calcium. This modulation of osteoclast activity helps address bone pathology and tumor growth associated with various malignancies.

1
Indication
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Phase 3 Trials
2
Years on Market

Details

Status
Prescription
First Approved
2024-03-05
Patent Cliff
2025

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Routes
SUBCUTANEOUS
Dosage Forms
INJECTABLE

Companies

Active Ingredient: DENOSUMAB-BBDZ

WYOST Approval History

2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2024 to 2025
Oct 2025 SUPPL
Label · Labeling
Oct 2024 SUPPL
Label · Labeling
Mar 2024 ORIGINAL
Update

What WYOST Treats

4 indications

WYOST is approved for 4 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Multiple Myeloma
  • Bone Metastasis
  • Giant Cell Tumor of Bone
  • Hypercalcemia of Malignancy
Source: FDA Label
Auto-substitute OK for Prolia

Pharmacists can substitute WYOST for Prolia without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.

WYOST Competitive Set

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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 WYOST's indications

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Phase 3 candidates targeting molecules with no FDA-approved drug, in indications WYOST treats. First-in-class if their pivotal trials read out positive.

Drugs Similar to WYOST

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BILPREVDA
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SHANGHAI HENLIUS BIOTECH
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Multiple MyelomaBone MetastasisGiant Cell Tumor of Bone +1 more
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Active Pipeline

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Key Completed Trials

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Trial Timeline

Full development history with FDA approval milestones

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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.

WYOST FDA Label Details

Indications & Usage

FDA Label (PDF)

WYOST is indicated for the treatment of Multiple Myeloma; Bone Metastasis; Giant Cell Tumor of Bone; Hypercalcemia of Malignancy.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.