denosumab
Trade name: prolia
mAbapproved
Approved
Jun 1, 2010
Denosumab, sold under the brand name Prolia among others, is a human monoclonal antibody used for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone. — Wikipedia
Clinical trial activity
289 trials · 211 clinical orgs · 10 marketing orgs
Phase 1
59
Phase 2
163
Phase 3
89
Phase 4
58
Earliest trial started May 1, 2002 (NCT00043186)
Timeline
2000s
2010s
2020s
- Mar 5, 2024
Sandoz — Marketing Organization
- Feb 13, 2025
Samsung — Marketing Organization
- Feb 28, 2025
Celltrion — Marketing Organization
- Mar 25, 2025
Fresenius — Marketing Organization
- Aug 29, 2025
Shanghai Henlius Biotech — Marketing Organization
- Sep 16, 2025
Biocon Limited — Marketing Organization
- Sep 26, 2025
Hikma — Marketing Organization
- Oct 29, 2025
Accord Research — Marketing Organization
- Dec 19, 2025
Amneal Pharmaceuticals — Marketing Organization
Indications
Studied for
- Alveolar Bone Loss · Phase 4
- Anesthesia · Phase 4
- Anesthesia, Local · Phase 4
- Anorexia · Early Phase 1
- Anorexia Nervosa · Phase 3
- Aortic Stenosis, Subvalvular · Phase 2
- Arthralgia · Phase 4
- Arthritis · Phase 1/Phase 2
- Arthritis, Juvenile · Phase 1/Phase 2
- Arthritis, Rheumatoid · Phase 4
- Arthroplasty, Replacement, Hip · Phase 1
- Bariatric Surgery · Phase 4
- beta-Thalassemia · Phase 3
- Bone Cysts, Aneurysmal · Phase 2
- Bone Density · Phase 4
- Bone Diseases · Phase 4
- Bone Diseases, Metabolic · Phase 4
- Bone Marrow Diseases · Phase 4
- Bone Marrow Transplantation · Phase 1
- Bone Neoplasms · Phase 3
- Bone Resorption · Phase 4
- BRCA1 Protein · Phase 3
- Breast Density · Phase 1
- Breast Diseases · Phase 3
- Breast Neoplasms · Phase 4
- Carcinoma · Phase 3
- Carcinoma, Giant Cell · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Renal Cell · Phase 3
- Carcinoma, Transitional Cell · Phase 2
- Cataract · Phase 3
- Charcot-Marie-Tooth Disease · Phase 4
- Chondroblastoma · Phase 2
- Chronic Kidney Disease-Mineral and Bone Disorder · Phase 4
- Chronic Periodontitis · Phase 3
- Colonic Neoplasms · Phase 2
- Colorectal Neoplasms · Phase 2
- Critical Illness · Phase 2
- Crohn Disease · Phase 1/Phase 2
- Cystic Fibrosis · Phase 4
- Denosumab · Phase 4
- Dental Implantation · Phase 4
- Dermatomyositis · Phase 1/Phase 2
- Diabetes Mellitus · Phase 3
- Diabetes Mellitus, Type 1 · Phase 1/Phase 2
- Diabetes Mellitus, Type 2 · Phase 4
- Dialysis · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drugs, Investigational · Phase 2/Phase 3
- Endocrine Gland Neoplasms · Phase 2
- Feeding and Eating Disorders · Early Phase 1
- Fibroma · Phase 2
- Fibrous Dysplasia of Bone · Phase 4
- Fibrous Dysplasia, Polyostotic · Phase 4
- Fractures, Bone · Phase 4
- Fractures, Compression · Phase 2/Phase 3
- Fractures, Spontaneous · Phase 1/Phase 2
- General Surgery · Phase 2
- Giant Cell Tumor of Bone · Phase 4
- Giant Cell Tumors · Phase 2
- Gingivitis · Phase 1/Phase 2
- Gout · Phase 2
- Granuloma, Giant Cell · Phase 2
- Head and Neck Neoplasms · Phase 2
- Healthy Volunteers · Phase 1
- Hematologic Neoplasms · Phase 3
- Hematopoietic Stem Cell Transplantation · Phase 2
- Histiocytosis, Langerhans-Cell · Phase 2
- Hodgkin Disease · Phase 2
- Hyperparathyroidism, Primary · Phase 4
- Hyperplasia · Phase 3
- Hypersensitivity, Delayed · Phase 1
- Immunosuppression Therapy · Phase 1
- Infertility · Phase 2
- Infertility, Male · Phase 2
- Inflammatory Breast Neoplasms · Phase 2
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 1
- Kidney Neoplasms · Phase 2
- Kidney Transplantation · Phase 2/Phase 3
- Lung Neoplasms · Phase 2
- Lupus Erythematosus, Systemic · Phase 1/Phase 2
- Lymphoma · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Mastocytosis, Systemic · Phase 3
- Melanoma · Phase 2
- Mobility Limitation · Phase 2
- Multiple Myeloma · Phase 3
- Myositis · Phase 3
- Nasopharyngeal Carcinoma · Phase 2
- Neoplasm Metastasis · Phase 4
- Neoplasms · Phase 4
- Non-alcoholic Fatty Liver Disease · Phase 4
- Osteoarthritis · Phase 2
- Osteoarthritis, Hip · Phase 4
- Osteoarthritis, Knee · Phase 4
- Osteoblastoma · Phase 2
- Osteogenesis Imperfecta · Phase 3
- Osteolysis · Phase 2
- Osteoporosis, Postmenopausal · Phase 4
- Osteoporotic Fractures · Phase 4
- Osteosarcoma · Phase 2
- Ovarian Neoplasms · Phase 1
- Pain · Phase 2
- Parathyroid Neoplasms · Phase 3
- Pharmacokinetics · Phase 1
- Pharmacological and Toxicological Phenomena · Phase 3
- Postmenopause · Phase 3
- Procedural Sedation · Phase 3
- Prostatic Neoplasms · Phase 4
- Prostatic Neoplasms, Castration-Resistant · Phase 3
- Quality of Life · Phase 4
- Renal Insufficiency, Chronic · Phase 3
- Sarcopenia · Phase 4
- Smoldering Multiple Myeloma · Phase 2
- Spermatozoa · Phase 2
- Spinal Cord Injuries · Phase 4
- Spinal Injuries · Phase 4
- Spondylolisthesis · Phase 3
- Testis · Phase 2
- Thyroid Neoplasms · Phase 2
- Ultraviolet Rays · Phase 1
- Ureteral Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 2
- Vasculitis · Phase 1/Phase 2
- Zoledronic Acid · Phase 4
Mechanism of action
TNFSF11 inhibitor
- Tumor necrosis factor ligand superfamily member 11Immunity, passive
TNFSF11 immunity, passive
Approval history
- approvedJun 1, 2010
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaDenosumab ↗
- NCATS4EQZ6YO2HI ↗
- ChEMBLCHEMBL1237023 ↗
Also known as
- amg162
- amg 162
- amg 162
- amg 162
- amg 162
- amg 162
- amg 162
- amg-162
- denosumab
- denosumab
- denosumab
- denosumab
- denosumab
- denosumab
- denosumab
- denosumab
- prolia
- prolia
- prolia
- prolia, ranmark xgeva
- xgeva
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07281586 | Phase 4 | Jan 1, 2026 | National Taiwan University |
| NCT07056478 | Phase 3 | Jan 1, 2026 | City University of Hong Kong |
| NCT07283887 | Phase 4 | Dec 3, 2025 | National Taiwan University |
| NCT07198633 | Phase 1/Phase 2 (Phase 2) | Oct 31, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT07104110 | Phase 1/Phase 2 (Phase 2) | Oct 31, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT06504966 | Phase 3 | Oct 31, 2025 | Xentria, Inc. |
| NCT07063797 | N/A | Aug 1, 2025 | Chinese Academy of Medical Sciences |
| NCT07085520 | Phase 1 | Jul 31, 2025 | Huazhong University of Science and Technology |
| NCT07062978 | Phase 3 | Jun 27, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT07028268 | Phase 2 | Jun 24, 2025 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| NCT07034391 | Phase 2 | May 12, 2025 | China Medical University |
| NCT06588153 | Phase 4 | Apr 10, 2025 | Amgen |
| NCT06938152 | Phase 4 | Apr 8, 2025 | National Taiwan University |
| NCT06720350 | Phase 4 | Jan 15, 2025 | Marmara University |
| NCT06374459 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2024 | Aclaris Therapeutics, Inc., Department of Defense, Washington University in St. Louis |
| NCT06513624 | Phase 1 | Nov 30, 2024 | A*Star, National University of Singapore |
| NCT06749886 | Phase 2 | Nov 19, 2024 | Huazhong University of Science and Technology |
| NCT06804590 | Phase 3 | Nov 16, 2024 | Mabwell |
| NCT06706414 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2024 | University of Copenhagen |
| NCT06472050 | Phase 4 | Sep 30, 2024 | Tuen Mun Hospital, Hong Kong |
Showing 20 of 289 trials
Page 1 / 15
Organizations
Research & Development (211)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Amgen | For profit | 84 | 59 | 4 | 2002 |
| Harvard University | Academic/Hospital | 10 | 9 | 4 | 2009 |
| Department of Veteran Affairs | Government | 8 | 5 | 3 | 2012 |
| Qilu Pharmaceutical Co., Ltd. | For profit | 8 | 8 | 3 | 2018 |
| Luye Pharma | For profit | 7 | 7 | 2 | 2018 |
| Shenzhen University | Academic/Hospital | 7 | 7 | 3 | 2020 |
| University of Copenhagen | Academic/Hospital | 6 | 6 | 2 | 2015 |
| Columbia University | Academic/Hospital | 5 | 5 | 2 | 2012 |
| Daiichi Sankyo | For profit | 5 | 2 | 2 | 2006 |
| GlaxoSmithKline | For profit | 5 | 5 | 2 | 2011 |
| Kessler Institute for Rehabilitation | Academic/Hospital | 5 | 0 | 2 | 2015 |
| Mabwell | For profit | 5 | 5 | 2 | 2019 |
| National Taiwan University | Academic/Hospital | 5 | 5 | 1 | 2019 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 4 | 2 | 3 | 2021 |
| Hellenic Army | Academic/Hospital | 4 | 1 | 3 | 2012 |
| Huazhong University of Science and Technology | Academic/Hospital | 4 | 3 | 3 | 2021 |
| Jiao Tong University | Academic/Hospital | 4 | 2 | 2 | 2019 |
| Leiden University | Academic/Hospital | 4 | 2 | 2 | 2018 |
| National Cancer Institute (NCI) | Government | 4 | 3 | 3 | 2015 |
| University of Texas at Houston | Academic/Hospital | 4 | 3 | 2 | 2012 |
211 organizations
Page 1 / 11
Marketing (11)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Oct 29, 2025 |
| Amgen | For profit | MKTG | Jun 1, 2010 |
| Amgen | For profit | NDA | Jun 2, 2010 |
| Amneal Pharmaceuticals | For profit | MKTG | Dec 19, 2025 |
| Biocon Limited | For profit | MKTG | Sep 16, 2025 |
| Celltrion | For profit | MKTG | Feb 28, 2025 |
| Fresenius | For profit | MKTG | Mar 25, 2025 |
| Hikma | For profit | MKTG | Sep 26, 2025 |
| Samsung | For profit | MKTG | Feb 13, 2025 |
| Sandoz | For profit | MKTG | Mar 5, 2024 |
| Shanghai Henlius Biotech | For profit | MKTG | Aug 29, 2025 |