Drugs / Denosumab
Denosumab Clinical Trials
DrugDenosumab is a human monoclonal antibody targeting RANK ligand and is used for osteoporosis, treatment-induced bone loss, bone metastasis-related complications, and giant cell tumor of bone. It is marketed under brands including Prolia and Xgeva. The drug has U.S. approvals since 2010 and remains prescription-only.
Continuously tracked·last revised
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Recruiting Phase 3
| Trial | Phase | Status | Sponsor | Started |
|---|---|---|---|---|
| A Comparative Study to Valuating the Efficacy and Safety of QL1206 and Prolia® NCT07062978 | Phase 3 | Recruiting | Qilu Pharmaceutical Co., Ltd. | Started 2025-06 |
| The DENOCHARCOT Trial NCT04547348 | Phase 3 | Recruiting | Ole Lander Svendsen | Started 2020-11 |
| Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases NCT07043608 | Phase 2 | Recruiting | Kelly Fitzgerald, MD | Started 2026-06 |
| An Exploratory Study of Tislelizumab in Combination with Chemotherapy in Immuno-experienced Patients with EGFR/ALK/ROS1-negative Advanced NSCLC in the Second-line Setting NCT06749886 | Phase 2 | Recruiting | Shanghai Pulmonary Hospital, Shanghai, China | Started 2024-11 |
Recently started
| Trial | Phase | Status | Sponsor | Started |
|---|---|---|---|---|
| Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases NCT07043608 | Phase 2 | Recruiting | Kelly Fitzgerald, MD | Started 2026-06 |
| Romosozumab and Denosumab, Alone or Combined, in Postmenopausal Osteoporosis NCT07283887 | Phase 4 | Recruiting | National Taiwan University Hospital | Started 2025-12 |
| Study to Compare the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of MAB-22 Versus Prolia® NCT06504966 | Phase 3 | Withdrawn | Xentria, Inc. | Started 2025-10 |
Results recently posted
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | 3 | 1 | — | — | 1 | 5 |
| Phase 1 | 1 | 1 | — | 19 | 1 | 3 | — | 7 | 32 |
| Phase 1/2 | 2 | — | 1 | 3 | — | 1 | — | 1 | 8 |
| Phase 2 | 3 | 2 | 4 | 40 | 9 | 2 | — | 5 | 65 |
| Phase 2/3 | — | — | — | 2 | — | 1 | — | 1 | 4 |
| Phase 3 | 2 | 3 | 3 | 50 | 6 | 1 | — | 9 | 74 |
| Phase 4 | 6 | 3 | 10 | 21 | 3 | 1 | 1 | 9 | 54 |
| Not applicable | 1 | — | — | 4 | — | — | — | 2 | 7 |
| Unknown | 3 | — | — | 8 | — | — | — | 5 | 16 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Osteoporosis | — | 5 | 1 | 13 | 1 | 23 | 27 | 1 | 6 | 77 |
| Osteoporosis, Postmenopausal | — | 4 | — | 4 | — | 21 | 11 | 1 | 5 | 46 |
| Bone Diseases, Metabolic | 1 | 1 | — | 3 | 1 | 14 | 4 | 2 | — | 26 |
| Breast Neoplasms | 3 | — | 1 | 9 | — | 9 | 3 | — | — | 25 |
| Neoplasms | — | 1 | 1 | 4 | — | 6 | — | — | — | 12 |
| Fractures, Bone | — | — | — | — | — | 5 | 2 | 1 | 1 | 9 |
| Giant Cell Tumor of Bone | — | — | — | 3 | — | 2 | 2 | — | 2 | 9 |
| Multiple Myeloma | — | — | — | 5 | — | 4 | — | — | — | 9 |
| Prostatic Neoplasms | — | — | — | 2 | — | 6 | 1 | — | — | 9 |
| Neoplasm Metastasis | — | 1 | — | 4 | — | 1 | 1 | — | 1 | 8 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Amgen | 60 | 32 |
| 2 | Massachusetts General Hospital | 9 | 1 |
| 3 | Shenzhen People's Hospital | 7 | 4 |
| 4 | GlaxoSmithKline | 5 | 4 |
| 5 | Luye Pharma Group Ltd. | 5 | 2 |
| 6 | Martin Blomberg Jensen | 5 | 0 |
| 7 | Mabwell (Shanghai) Bioscience Co., Ltd. | 4 | 2 |
| 8 | Qilu Pharmaceutical Co., Ltd. | 4 | 2 |
| 9 | Tuen Mun Hospital | 4 | 0 |
| 10 | 424 General Military Hospital | 3 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Denosumab | 265 |
| 2 | Zoledronic Acid | 34 |
| 3 | Alendronate | 15 |
| 4 | romosozumab | 12 |
| 5 | Teriparatide | 12 |
| 6 | Calcium | 11 |
| 7 | Vitamin D | 8 |
| 8 | QL1206 | 7 |
| 9 | Sodium Chloride | 7 |
| 10 | Diphosphonates | 6 |
Terminations
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT03029442 Terminated | Terminated | Study ended early due to COVID-19 | 2022-10-06 |
| NCT03638128 Terminated | Terminated | The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants | 2022-03-28 |
| NCT02352753 Terminated | Terminated | The study was stopped earlier than planned due to safety concerns about high levels of calcium in the blood of the participants | 2022-03-26 |
| NCT03960554 Terminated | Terminated | Study lost funding | 2021-12-02 |
| NCT03382574 Terminated | Terminated | it was decided that due to lack of accrual on the trial, and low potential for accruing over the near future, the trial will be shut down. | 2021-10-22 |
| NCT02792413 Terminated | Terminated | Modified study and new deposit in RECHMPL21\_0451 | 2020-12-10 |
| NCT03620149 Terminated | Terminated | Poor accrual | 2020-07-30 |
| NCT03408652 Terminated | Terminated | lack of recruitment | 2020-06-22 |
| NCT03457818 Terminated | Terminated | Due to enrollment difficulties compounded by the COVID pandemic. | 2020-06-10 |
| NCT02129699 Terminated | Terminated | Completion of recruitment was not feasible as accrual was slower than anticipated. Even if a benefit for denosumab could be shown, these results would be of very limited clinical impact by the time they would be available | 2020-02-29 |
Evidence
- Results reported
- 66.7%100 of 150 completed
- Published
- 10%15 of 150 completed
- Primary endpoint met
- 79.5%62 of 78 analyses
- Median months to report
- 14
Documents disclosed
Trial profile
- Median enrollment
- 90
- Median duration
- 36.9months
- Countries
- 57
- Study sites
- 2083
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 44
- Phase 1
- 124
- Phase 1/2
- 29
- Phase 2
- 36
- Phase 2/3
- 90
- Phase 3
- 358
- Phase 4
- 62
- Not applicable
- 91
- Unknown
- 261
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Warsaw | Poland | 19 |
| 2 | Boston | United States | 18 |
| 3 | Prague | Czechia | 17 |
| 4 | New York | United States | 16 |
| 5 | Beijing | China | 14 |
| 6 | Montreal | Canada | 13 |
| 7 | Barcelona | Spain | 12 |
| 8 | Houston | United States | 12 |
| 9 | Krakow | Poland | 12 |
| 10 | Toronto | Canada | 12 |