23 completed, 8 unknown, 4 withdrawn, 3 recruiting. 40 Phase 1, 8 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 40 | Completed 23, Unknown 8, Withdrawn 4, Recruiting 3, Not yet recruiting 1, Terminated 1 |
| Phase 2 | 8 | Completed 4, Recruiting 2, Unknown 1, Withdrawn 1 |
Follow Denosumab: new trials by email Literature Review of Denosumab trials Research Report on Denosumab
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Clinical Study Evaluating the Dermal Safety of Soluble Denosumab Microneedle Patches Microneedle with 0.24mg Denosumab, Saline Microneedle Patch, Microneedle with 1.2mg Denosumab - Osteoarthritis, Osteoarthritis (OA) of the Knee | Phase 1 | Not yet recruiting | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | 12 | 2025-07-31 | 2025-07-25 |
| Denosumab for Type 1 Diabetes Denosumab, Placebo - Type 1 Diabetes | Phase 1 / Phase 2 | Recruiting | City of Hope Medical Center | 45 | 2025-05-05 | 2026-10-20 |
| NT-NOA - Novel Treatment of Some Men With Non-Obstructive Azoospermia Denosumab (Prolia), Letrozole (Aromatase Inhibitors) - Infertility, Male | Phase 1 / Phase 2 | Completed | Martin Blomberg Jensen | 16 | 2025-03-01 | 2026-10-21 |
| Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis Zumsemetinib, Capecitabine, Zoledronic acid - Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer | Phase 1 / Phase 2 | Recruiting | Washington University School of Medicine | 152 | 2025-01-30 | 2026-10-13 |
| ETC-159 In Combination With Pembrolizumab In Advanced MSS/pMMR Ovarian Cancers ETC-159, Pembrolizumab, Denosumab / Zoledronic Acid - With MSS/pMMR Advanced, Platinum-resistant Ovarian Cancer | Phase 1 | Recruiting | National University Hospital, Singapore | 16 | 2024-12-09 | 2025-07-25 |
| NAPO - Novel Approach for Oligospermia Denosumab, sodium chloride - Infertility, Male | Phase 1 / Phase 2 | Completed | Martin Blomberg Jensen | 42 | 2024-03-01 | 2025-12-19 |
| Study of CMAB807 Post-change in Manufacturing Site and Prolia in Healthy Volunteers Post-change CMAB807, Prolia - Healthy Volunteers | Phase 1 | Completed | Taizhou Mabtech Pharmaceutical Co.,Ltd | 128 | 2023-11-02 | 2024-11-07 |
| AVT03 With Xgeva in Healthy Male Subjects AVT03, Denosumab - This is a Phase I Study Conducted in Healthy Volunteers | Phase 1 | Completed | Alvotech Swiss AG | 208 | 2023-07-21 | 2025-05-15 |
| Comparing of the PK, PD, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults HS-20090, Xgeva® - Healthy | Phase 1 | Unknown | Jiangsu Hansoh Pharmaceutical Co., Ltd. | 180 | 2023-04-20 | 2023-08-23 |
| Study of CMAB807X Pre- and Post-change in Manufacturing Site and Xgeva® in Healthy Volunteers Post-change CMAB807X, Pre-change CMAB807X, Xgeva® - Healthy Volunteers | Phase 1 | Withdrawn | Taizhou Mabtech Pharmaceutical Co.,Ltd | 2023-02-01 | 2024-04-09 | |
| AVT03 With Prolia in Healthy Male Subjects AVT03, Prolia - Healthy Male Subjects | Phase 1 | Completed | Alvotech Swiss AG | 209 | 2022-06-29 | 2024-05-29 |
| Comparison of Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Bmab 1000 and Prolia® in Normal Healthy Volunteers: DENARIUS: DENosumab Pharmacokinetic equivAlence tRIal in Healthy volUnteerS Bmab 1000, Prolia® - Healthy Volunteers | Phase 1 | Completed | Biocon Biologics UK Ltd | 190 | 2022-03-09 | 2024-04-17 |
| Comparing of the Pharmacokinetic, Safety and Immunogenicity of HS-20090-2 Injection and Prolia® in Healthy Adults HS-20090-2, Prolia - Postmenopausal Osteoporosis | Phase 1 | Unknown | Shanghai Hansoh Biomedical Co., Ltd | 174 | 2021-07-26 | 2021-08-25 |
| A Pharmacokinetic Similarity Study in Healthy Male Subjects to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Immunogenicity of LY06006 Versus US-Prolia and EU-Prolia by Single-dose Subcutaneous Injection LY06006 (Denosumab Biosimilar), US-Prolia (Denosumab), EU-Prolia - Healthy | Phase 1 | Completed | Shandong Boan Biotechnology Co., Ltd | 300 | 2021-03-09 | 2026-10-19 |
| Comparing of the Pharmacokinetics, Immunogenicity and Safety of MV088 and Prolia® in Healthy Adults. MV088 injection, Prolia® injection - Healthy | Phase 1 | Unknown | Kunming Pharmaceuticals, Inc. | 144 | 2021-02-22 | 2020-12-17 |
| A Study to Evaluate LY06006 and Prolia in Healthy Adults LY06006, Prolia - Healthy Adults | Phase 1 | Unknown | Luye Pharma Group Ltd. | 168 | 2020-12-09 | 2021-07-22 |
| Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity Study of SB16 in Healthy Male Subjects Denosumab - Healthy | Phase 1 | Completed | Samsung Bioepis Co., Ltd. | 168 | 2020-10-19 | 2022-11-28 |
| Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of HS-20090 and Xgeva® in Healthy Adults HS-20090, Xgeva® - Bone Metastasis From Solid Tumors | Phase 1 | Unknown | Jiangsu Hansoh Pharmaceutical Co., Ltd. | 154 | 2020-09-01 | 2020-08-04 |
| Comparing of the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of MW031 and Prolia® in Healthy Adults MW031, Prolia® - Osteoporosis, Postmenopausal | Phase 1 | Completed | Mabwell (Shanghai) Bioscience Co., Ltd. | 120 | 2020-06-02 | 2021-03-15 |
| A Study to Evaluate LY01011 and Xgeva® in Healthy Adults LY01011, Xgeva 120 MG in 1.7 ML Injection - Healthy Adults | Phase 1 | Unknown | Luye Pharma Group Ltd. | 168 | 2019-12-16 | 2019-12-13 |
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Osteoporosis (6) · Osteoporosis, Postmenopausal (4) · Arthritis (2) · Infertility, Male (2) · Neoplasms (2) · Recurrence (2) · Arthritis, Juvenile (1) · Arthritis, Rheumatoid (1) · Bone Cysts, Aneurysmal (1) · Bone Diseases, Metabolic (1) · Bone Neoplasms (1) · Breast Neoplasms (1) · Crohn Disease (1) · Dermatitis, Allergic Contact (1) · Dermatomyositis (1)
Amgen (7) · Alvotech Swiss AG (2) · Jiangsu Hansoh Pharmaceutical Co., Ltd. (2) · Luye Pharma Group Ltd. (2) · Mabwell (Shanghai) Bioscience Co., Ltd. (2) · Martin Blomberg Jensen (2) · Qilu Pharmaceutical Co., Ltd. (2) · Taizhou Mabtech Pharmaceutical Co.,Ltd (2) · Biocon Biologics UK Ltd (1) · City of Hope Medical Center (1) · GlaxoSmithKline (1) · Indiana University (1) · Innovaderm Research Inc. (1) · Kunming Pharmaceuticals, Inc. (1) · M.D. Anderson Cancer Center (1)
China (12) · United States (12) · Canada (3) · Australia (2) · Denmark (2) · South Africa (2) · France (1) · Germany (1) · New Zealand (1) · Poland (1) · Singapore (1) · United Kingdom (1)
Felicitas Bullo (2) · Hu Wei, Doctor (2) · Charles N Bernstein, MD (1) · Christian F.S. Jensen, MD, PhD. (1) · Cynthia X Ma, M.D., Ph.D. (1) · Donald Longjohn, MD (1) · Dong Liu, PhD (1) · Edward Ebramzadeh, PhD (1) · Erik Imel, MD (1) · Filip Janku (1) · Fouad Kandeel, MD, PhD (1)
PMID 24277854, PMID 29933364, PMID 33951424, PMID 35140619, PMID 36045484, PMID 36112084, PMID 36892190, PMID 37870163, PMID 39280787, PMID 39582128, PMID 40357744, PMID 40357869, PMID 42643157
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