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BONCRESA (DENOSUMAB-MOBZ)
BONCRESA (generic name: DENOSUMAB-MOBZ) is a RANK Ligand Inhibitor [EPC] drug developed by AMNEAL PHARMS LLC. It is currently FDA-approved.
Denosumab binds to RANKL, preventing it from activating RANK on osteoclasts, reducing bone resorption and increasing bone mass.
BONCRESA is a monoclonal antibody that inhibits tumor necrosis factor ligand superfamily member 11. It is classified as an inhibitor and works by blocking the action of tumor necrosis factor ligand superfamily member 11.
At a glance
| Generic name | DENOSUMAB-MOBZ |
|---|---|
| Sponsor | AMNEAL PHARMS LLC |
| Drug class | RANK Ligand Inhibitor [EPC] |
| Target | RANKL |
| Therapeutic area | Other |
| Phase | FDA-approved |
Mechanism of action
Denosumab works by binding to RANKL, a protein crucial for the formation and function of osteoclasts, which are cells that break down bone. By blocking RANKL from interacting with its receptor RANK, Denosumab inhibits osteoclast activity, leading to decreased bone resorption and increased bone mass and strength.
Approved indications
Boxed warnings
- 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)
Common side effects
- Back pain
- Pain in extremity
- Musculoskeletal pain
- Hypercholesterolemia
- Cystitis
- Vertigo
- Upper respiratory tract infection
- Edema peripheral
- Sciatica
- Bone pain
- Abdominal pain upper
- Anemia
Serious adverse events
- Hypocalcemia
- Nonfatal serious adverse events
- All-cause mortality
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BONCRESA CI brief — competitive landscape report
- BONCRESA updates RSS · CI watch RSS
- AMNEAL PHARMS LLC portfolio CI
Frequently asked questions about BONCRESA
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Related
- Drug class: All RANK Ligand Inhibitor [EPC] drugs
- Target: All drugs targeting RANKL
- Manufacturer: AMNEAL PHARMS LLC — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing