OSPOMYV (denosumab-dssb) · SAMSUNG BIOEPIS CO LTD
Ospomyv is a RANK ligand inhibitor indicated to treat osteoporosis and increase bone mass in patients at high risk for fracture. It is used for postmenopausal women and men with osteoporosis, as well as individuals with glucocorticoid-induced osteoporosis. The medication is also approved for patients undergoing specific hormonal therapies for cancer, including men with nonmetastatic prostate cancer and women with breast cancer.
How OSPOMYV Works
Ospomyv 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 tissue. This process decreases bone resorption and increases bone mass and strength in both cortical and trabecular bone.
Details
- Status
- Prescription
- First Approved
- 2025-02-13
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
OSPOMYV Approval History
What OSPOMYV Treats
4 indicationsOSPOMYV is approved for 4 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
OSPOMYV Boxed Warning
SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m 2 ), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported [see Warnings and Precautions (5.1) ] . The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increase...
WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m 2 ), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported [see Warnings and Precautions (5.1) ] . The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients [see Warnings and Precautions (5.1) ] . Prior to initiating Ospomyv in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Ospomyv in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ] . WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE See full prescribing information for complete boxed warning. Patients with advanced chronic kidney disease are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resulting in hospitalization, life-threatening events and fatal cases have been reported. ( 5.1 ) The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia. ( 5.1 ) Prior to initiating Ospomyv in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Ospomyv in these patients should be supervised by a healthcare provider with expertise in the diagnosis and management of CKD-MBD. ( 2.2 ), ( 5.1 )
Pharmacists can substitute OSPOMYV for Prolia without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
OSPOMYV 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 OSPOMYV's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OSPOMYV treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OSPOMYV
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.
OSPOMYV FDA Label Details
Indications & Usage
FDA Label (PDF)Ospomyv is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer 1.1 Treatment of Postmenopausal Women with Osteoporosis at ...
WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease (eGFR <30 mL/min/1.73 m 2 ), including dialysis-dependent patients, are at greater risk of severe hypocalcemia following denosumab products administration. Severe hypocalcemia resultin...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.