Anpheros Search · Treatment

Denosumab

Also known as: Prolia · Xgeva · Jubbonti · Wyost · Xbryk · Obodence · Osenvelt · Stoboclo · Jubereq · Osvyrti

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In short

In the European Union, denosumab is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In the European Union, it is also indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone, and for the treatment of giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity in adults and skeletally mature adolescents. In the United States, denosumab is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, for the treatment of unresectable or high-morbidity giant cell tumor of bone in adults and skeletally mature adolescents, and for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

From: Source: European Medicines Agency (EMA), Prolia — EPAR, 19/08/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA), Xgeva — EPAR, 30/06/2026. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
993449 denosumab
EMA
EMEA/H/C/001120, EMEA/H/C/002173, EMEA/H/C/005964, EMEA/H/C/006378, EMEA/H/C/006468, EMEA/H/C/006424, EMEA/H/C/006157, EMEA/H/C/006156, EMEA/H/C/006398, EMEA/H/C/006399, EMEA/H/C/006437, EMEA/H/C/006436, EMEA/H/C/006534, EMEA/H/C/006199, EMEA/H/C/006376, EMEA/H/C/006377, EMEA/H/C/006152, EMEA/H/C/006526, EMEA/H/C/006269, EMEA/H/C/006507, EMEA/H/C/006268, EMEA/H/C/006435, EMEA/H/C/006434, EMEA/H/C/006239, EMEA/H/C/006722, EMEA/H/C/006490, EMEA/H/C/006734, EMEA/H/C/006238, EMEA/H/C/006552, EMEA/H/C/006492, EMEA/H/C/006626

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

FDA (USA) Bilprevda

1 INDICATIONS AND USAGE Bilprevda 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. ( 1.1 ) 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. ( 1.2 , 14.3 ) Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. ( 1.3 ) 1.1 Multiple Myeloma and Bone Metastasis from Solid Tumors Bilprevda is indicated for the prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. 1.2 Giant Cell Tumor of Bone Bilprevda is indicated for the 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 [see Clinical Trials ( 14.2 )] . 1.3 Hypercalcemia of Malignancy Bilprevda is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Data provided by the U.S. Food and Drug Administration.

Document date: 20260818 · Official document →

EMA (EU) Prolia

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.

Source: European Medicines Agency (EMA), Prolia — EPAR, 19/08/2026. © European Medicines Agency.

Document date: 19/08/2026 · Official document →

EMA (EU) Xgeva

Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone (see section 5.1). Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

Source: European Medicines Agency (EMA), Xgeva — EPAR, 30/06/2026. © European Medicines Agency.

Document date: 30/06/2026 · Official document →

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External resources

Questions

What is Denosumab approved for in the European Union?

Treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women Prolia significantly reduces the risk of vertebral, non vertebral and hip fractures. Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures. (Source: European Medicines Agency (EMA), Prolia — EPAR, 19/08/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Data provided by the U.S. Food and Drug Administration.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Prolia — EPAR, 19/08/2026. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Xgeva — EPAR, 30/06/2026. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →