Sold as Prolia, Xgeva. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Denosumab (sold as Prolia, Xgeva), first approved Jun 1, 2010, with 10 new uses approved and 0 published complete response letters.
| Program | Updated |
|---|---|
| Prolia REMSLetters to doctors | Jun 9, 2025 |
| Romosozumab and Denosumab Combination Therapy for OsteoporosisPostmenopausal Osteoporosis · Massachusetts General Hospital | Phase 4 | Not yet recruiting | Nov 2, 2026 |
| Cartilage Biomarker Response to Acute Mechanical Loading in Women With Knee Osteoarthritis: Comparison by Antiresorptive Treatment StatusKnee Osteoarthritis · Sisli Hamidiye Etfal Training and Research Hospital | — | Recruiting | Oct 20, 2026 |
| Study of TST002 Injection in Postmenopausal Women With Osteoporosis or Low Bone MassPostmenopausal Osteoporosis, Low Bone Mass · Transcenta Therapeutics (Hangzhou) Co., Ltd. | Phase 2 | Not yet recruiting | Sep 8, 2026 |
| Sequential Treatment With Romosozumab Followed by Denosumab vs. Zoledronic Acid for Gains in HIP BMDOsteoporosis in Post-menopausal Women · Sahlgrenska University Hospital | Phase 4 | Not yet recruiting | Aug 19, 2026 |
| Romosozumab Versus Denosumab In Glucocorticoid-induced Osteoporosis: An Extended Observation Of a Clinical Trial at 6 YearsGlucocorticoid-Associated Osteopenia and Osteoporosis · Tuen Mun Hospital | Phase 4 | Not yet recruiting | Aug 11, 2026 |
| Early Warning and Risk Prediction of Medication-Related Osteonecrosis of the JawMedication-related Osteonecrosis of the Jaw (MRONJ) · Hospital of Stomatology, Wuhan University | — | Not yet recruiting | Jul 9, 2026 |
| Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone MetastasesBreast Cancer, Stage IV Breast Cancer · West China Hospital | Not applicable | Not yet recruiting | Jul 7, 2026 |
| Clinical Relevance of Modifying RANKL Signaling During FolliculogenesisFemale Infertility, NF-κB Ligand · Peter Humaidan | Not applicable | Recruiting | Apr 22, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jun 1, 2010 | Prolia, XgevaBLA 125320 · New molecular entity | Amgen | 50 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Amgen