BONCRESA (denosumab-mobz) · AMNEAL PHARMS
Boncresa helps patients with osteoporosis who face a high risk of fractures, including those with a history of broken bones or those who cannot tolerate other therapies. It treats postmenopausal women and men with osteoporosis, as well as individuals who develop bone loss from taking systemic glucocorticoids for at least six months. This medication is also used to increase bone mass in patients receiving certain hormone-blocking therapies for breast or prostate cancer.
How BONCRESA Works
Boncresa works by binding to RANKL, a protein that is essential for the formation and survival of osteoclasts, the cells responsible for bone resorption. By preventing RANKL from activating its receptor, the drug inhibits the breakdown of bone and increases overall bone mass and strength.
Details
- Status
- Prescription
- First Approved
- 2025-12-19
- Routes
- SUBCUTANEOUS
- Dosage Forms
- INJECTABLE
BONCRESA Approval History
What BONCRESA Treats
3 indicationsBONCRESA is approved for 3 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
BONCRESA 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 Boncresa in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Boncresa 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 Boncresa in patients with advanced chronic kidney disease, evaluate for the presence of CKD-MBD. Treatment with Boncresa 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 BONCRESA for Prolia without calling the prescriber. This is a lower-cost alternative with no clinically meaningful differences.
BONCRESA 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 BONCRESA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BONCRESA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BONCRESA
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.
BONCRESA FDA Label Details
Indications & Usage
FDA Label (PDF)Boncresa 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.