Drugs / Denosumab
Regulatory milestones approvals, filings & regulatory actions · 12 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (10) | US (FDA) | PROLIA | — | 2010-11-18 – 2025-05-22 | fda.gov ↗ |
| Approved | US (FDA) | PROLIA | — | 2010-06-01 | fda.gov ↗ |
| Approved | EU (EMA) | Prolia | — | 2010-05-26 | europa.eu ↗ |
Trials 171 · started per year
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT03382574 | Mar 2019 → Oct 2021 | ovarian carcinoma | National Cancer Institute (NCI) | Terminated | No outcome recorded |
| Phase 0 | NCT03691311 | Jul 2018 → Jul 2022 | female breast carcinoma, hormone receptor-positive breast cancer | Catalan Institute of Oncology | Unknown | No outcome recorded |
| Phase 0 | NCT03629717 | Jun → Dec 2018 | female breast carcinoma | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 0 | NCT02900469 | Oct 2016 → Dec 2019 | breast cancer | NYU Langone Health | Completed | No outcome recorded |
| Phase 119 trials | ||||||
| Phase 1 | NCT07085520 | Jul → Oct 2025 overdue | osteoarthritis, knee, osteoporosis | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05299073 | Mar 2022 → Mar 2023 | — | mAbxience Research S.L. | Completed | No outcome recorded |
| Phase 1 | NCT05245669 | Jan 2022 → May 2024 | — | Enzene Biosciences Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06095427 | Mar 2021 → Mar 2023 | — | Luye Pharma Group Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04621318 | Oct 2020 → Nov 2022 | — | Samsung Bioepis Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03487055 | May 2018 → May 2019 | breast cancer | Jiangsu T-Mab Biopharma Co.,Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT03242512 | Aug 2017 → Dec 2018 | osteoporosis | Jiangsu T-Mab Biopharma Co.,Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT03239756 | Jul 2017 → Aug 2018 | breast cancer | Jiangsu T-Mab Biopharma Co.,Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT02444585 | Feb 2017 → Dec 2019 | osteoarthritis, hip | University of Southern California | Withdrawn | No outcome recorded |
| Phase 1 | NCT02677246 | Dec 2016 → Sep 2018 | disease related to hematopoietic stem cell transplant | St. Justine's Hospital | Withdrawn | No outcome recorded |
| Phase 1 | NCT02135640 | Jul 2014 → Feb 2015 | osteoporosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT02099461 | Apr → Jul 2014 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01978483 | Nov 2013 → Jun 2014 | drug allergy, immunodeficiency disease, type IV hypersensitivity disease | Innovaderm Research Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01869686 | Jun → Sep 2013 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01624766 | Jun 2012 → Feb 2021 | metastatic malignant neoplasm | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT01464931 | Nov 2011 → Jan 2013 | impaired renal function disease | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01294397 | Mar 2011 → Jan 2016 | postmenopausal osteoporosis, rheumatoid arthritis | Amgen | Terminated | No outcome recorded |
| Phase 1 | NCT01221727 | Nov 2010 → Jul 2011 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT03822078 | Sep 2003 → Dec 2004 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 1/26 trials | ||||||
| Phase 1/2 | NCT06706414 | Mar 2025 → Aug 2026 overdue | male infertility | Martin Blomberg Jensen | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06524960 | Sep 2024 → Oct 2027 expected | type 1 diabetes mellitus | City of Hope Medical Center | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02418273 | Aug 2019 → Jun 2021 | dermatomyositis, glucocorticoid-induced osteoporosis, juvenile idiopathic arthritis, polyarticular arthritis +2 | Indiana University | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03161756 | Dec 2017 → Dec 2021 | metastatic melanoma | Melanoma and Skin Cancer Trials Limited | Unknown | No outcome recorded |
| Phase 1/2 | NCT02321280 | Feb 2015 → Apr 2018 | Crohn disease | University of Manitoba | Completed | No outcome recorded |
| Phase 1/2 | NCT03415477 | Jan 2014 → Dec 2016 | aneurysmal bone cyst | Peking University People's Hospital | Completed | No outcome recorded |
| Phase 245 trials | ||||||
| Phase 2 | NCT07034391 | May 2025 → Oct 2026 expected | non-small cell lung carcinoma | China Medical University, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06749886 | Nov 2024 → Nov 2026 expected | lung cancer | Shanghai Pulmonary Hospital, Shanghai, China | Recruiting | No outcome recorded |
| Phase 2 | NCT05419050 | Oct 2022 → Jan 2026 | fibrous dysplasia | National Institute of Dental and Craniofacial Research (NIDCR) | Completed | No outcome recorded |
| Phase 2 | NCT04800367 | Mar 2021 → Mar 2027 expected | premenopausal osteoporosis | Columbia University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04231682 | Jul 2020 → Jan 2024 | osteoporosis | Albert Einstein Healthcare Network | Withdrawn | No outcome recorded |
| Phase 2 | NCT03925532 | Dec 2019 → Nov 2022 | disease related to hematopoietic stem cell transplant, osteoporosis | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT03792763 | Sep 2019 → Sep 2023 | plasma cell myeloma | Study Group of Medical Tumour Therapy (AGMT) | Completed | No outcome recorded |
| Phase 2 | NCT03620149 | Sep 2019 → Jul 2020 | bone giant cell tumor | European Organisation for Research and Treatment of Cancer - EORTC | Terminated | No outcome recorded |
| Phase 2 | NCT04067726 | Aug 2019 → Sep 2025 overdue | female breast upper-inner quadrant cancer | Washington University School of Medicine | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03923842 | Jun 2019 → Sep 2021 | nasopharyngeal carcinoma | Gruppo Oncologico del Nord-Ovest | Unknown | No outcome recorded |
| Phase 2 | NCT03571191 | Jun 2019 → Nov 2021 overdue | bone disorder | National Institute of Dental and Craniofacial Research (NIDCR) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03839459 | Apr 2019 → Sep 2022 | smoldering plasma cell myeloma | University of Rochester | Completed | No outcome recorded |
| Phase 2 | NCT03869762 | Jan 2019 | castration-resistant prostate carcinoma, metastatic carcinoma in the bone | Cancer Trials Ireland | Terminated | No outcome recorded |
| Phase 2 | NCT03457818 | Nov 2018 → Jun 2020 | osteoporosis, type 2 diabetes mellitus | Mishaela Rubin | Terminated | No outcome recorded |
| Phase 2 | NCT03669523 | Nov 2018 → Oct 2023 | lytic metastatic bone lesion, non-small cell lung carcinoma | Centre Hospitalier Annecy Genevois | Completed | No outcome recorded |
| Phase 2 | NCT03620019 | Sep 2018 → Apr 2023 | cutaneous melanoma, metastatic melanoma | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT03520231 | Sep 2018 → Dec 2020 | kidney cancer, ureter cancer, urinary bladder cancer, urothelial carcinoma | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 2 | NCT03605199 | Jun 2018 → Jun 2021 | aneurysmal bone cyst, chondroblastoma, chondromyxoid fibroma, giant cell reparative granuloma +1 | Leiden University Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT03532087 | Feb 2018 → Feb 2021 | breast cancer | Dutch Breast Cancer Research Group | Withdrawn | No outcome recorded |
| Phase 2 | NCT03280667 | Dec 2017 → Jun 2023 | clear cell renal carcinoma | Australian and New Zealand Urogenital and Prostate Cancer Trials Group | Unknown | No outcome recorded |
| Phase 2 | NCT03070002 | Oct 2017 → Mar 2018 | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, metastatic carcinoma in the bone, progesterone-receptor positive breast cancer | Northwestern University | Terminated | No outcome recorded |
| Phase 2 | NCT03270020 | Sep 2017 → Jun 2022 | Langerhans cell histiocytosis | Hellenic Society for the Study of Bone Metabolism | Completed | No outcome recorded |
| Phase 2 | NCT02682693 | Feb 2017 → Dec 2019 | HER2 positive breast carcinoma, breast mucinous carcinoma, female breast carcinoma, inflammatory breast carcinoma +1 | GBG Forschungs GmbH | Completed | No outcome recorded |
| Phase 2 | NCT02833610 | Aug 2016 → Mar 2023 | plasma cell myeloma | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02632916 | Aug 2016 → Feb 2020 | osteoporosis | Children's Hospital of Eastern Ontario | Completed | No outcome recorded |
| Phase 2 | NCT02470091 | Nov 2015 → Dec 2019 | conventional osteosarcoma | Children's Oncology Group | Completed | No outcome recorded |
| Phase 2 | NCT02613416 | Nov 2015 → Aug 2021 | breast cancer | Alison Stopeck | Completed | No outcome recorded |
| Phase 2 | NCT02422108 | May 2015 → Feb 2017 | spermatogenic failure, testicular disorder | Martin Blomberg Jensen | Completed | No outcome recorded |
| Phase 2 | NCT01952054 | Feb 2015 → Oct 2018 | breast cancer | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT02049866 | Nov 2014 → Mar 2020 | premenopausal osteoporosis | Elizabeth Shane | Completed | No outcome recorded |
| Phase 2 | NCT01951586 | Dec 2013 → Jul 2016 | non-small cell lung carcinoma | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01864798 | Jul 2013 → Jan 2017 | breast neoplasm | Jules Bordet Institute | Terminated | No outcome recorded |
| Phase 2 | NCT01799798 | Feb 2013 → Jan 2015 | osteogenesis imperfecta | University of Cologne | Completed | No outcome recorded |
| Phase 2 | NCT01545648 | Nov 2012 → Jun 2015 | female breast carcinoma | Hope Rugo, MD | Terminated | No outcome recorded |
| Phase 2 | NCT00896454 | Nov 2009 → Sep 2012 | Hodgkins lymphoma, breast cancer, colon carcinoma, head and neck cancer +8 | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00896532 | Jun 2009 → Feb 2011 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00926380 | Jun 2009 → Dec 2016 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00680992 | Sep 2008 → May 2018 | bone giant cell tumor, giant cell tumor | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00396279 | Jul 2006 → Apr 2008 | bone giant cell tumor | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00293813 | May 2006 → Mar 2008 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00259740 | Nov 2005 → Aug 2007 | plasma cell neoplasm | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00104650 | Jan 2005 → Jan 2008 | bone neoplasm | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00091832 | Sep 2004 → Nov 2005 | breast cancer, metastatic neoplasm | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00095498 | Aug 2004 → Apr 2007 | rheumatoid arthritis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00043186 | May 2002 → Apr 2007 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT05065164 | Sep 2021 → Mar 2023 | drug pseudoallergy | Shenzhen People's Hospital | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT05106517 | Sep 2021 → Mar 2023 | — | Shenzhen People's Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT05058443 | Jan 2020 → Aug 2022 | — | Shenzhen People's Hospital | Completed | No outcome recorded |
| Phase 2/3 | NCT04169698 | Oct 2019 → May 2021 | disease related to solid organ transplantation, osteoporosis | Ain Shams University | Completed | No outcome recorded |
| Phase 358 trials | ||||||
| Phase 3 | NCT06504966 | Oct 2025 → Oct 2027 | osteoporosis | Xentria, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT07062978 | Jun 2025 → Jan 2027 expected | postmenopausal osteoporosis | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06804590 | Nov 2024 → Apr 2026 overdue | postmenopausal osteoporosis | Mabwell (Shanghai) Bioscience Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT06154707 | Feb → Dec 2024 | muscular atrophy, osteoporosis | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase 3 | NCT05853354 | Apr 2023 → Jul 2025 | postmenopausal osteoporosis | Luye Pharma Group Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04711109 | Feb 2023 → Jul 2027 expected | BRCA1-related cancer predisposition, breast carcinoma | Alliance for Clinical Trials in Oncology | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04729621 | Mar 2021 → Dec 2022 | postmenopausal osteoporosis | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 3 | NCT04547348 | Nov 2020 → Oct 2025 overdue | diabetes mellitus, neurogenic arthropathy | Bispebjerg Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05638399 | Jan 2020 → Feb 2023 | spondylolisthesis | Shenzhen People's Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT05215977 | Dec 2019 → Sep 2021 | postmenopausal osteoporosis | Mabwell (Shanghai) Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04034199 | Aug 2019 → Dec 2020 | idiopathic inflammatory myopathy, osteoporosis | Kwong Wah Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT04128163 | Jun 2019 → Aug 2021 | postmenopausal osteoporosis | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT03408652 | Mar 2019 → Jun 2020 | renal cell carcinoma | Centre Leon Berard | Terminated | No outcome recorded |
| Phase 3 | NCT03638128 | Jul 2018 → Mar 2022 | osteogenesis imperfecta | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT03164928 | May 2018 → Dec 2021 | glucocorticoid-induced osteoporosis, osteoporosis, childhood- or juvenile-onset, with developmental delay | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03401060 | Mar 2018 → Mar 2024 | osteoporosis, systemic mastocytosis | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT03292146 | Oct 2017 → Jul 2021 | anorexia nervosa, bone resorption disease | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 3 | NCT03324932 | Sep 2017 → Dec 2023 overdue | female breast carcinoma | Kyoto Prefectural University of Medicine | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03174366 | May 2017 → Jun 2018 | neurogenic arthropathy | Western University of Health Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03293108 | Apr 2017 → Sep 2020 | postmenopausal osteoporosis | AryoGen Pharmed Co. | Unknown | No outcome recorded |
| Phase 3 | NCT03027557 | Mar 2017 → Apr 2019 | parathyroid gland adenoma, parathyroid hyperplasia, primary hyperparathyroidism | Peter Vestergaard | Completed | No outcome recorded |
| Phase 3 | NCT03259152 | May 2016 → May 2019 | bone giant cell tumor | Hebei Medical University Third Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT02352753 | Jun 2015 → Mar 2022 | osteogenesis imperfecta | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT02129699 | Jan 2015 → Feb 2020 | non-small cell lung carcinoma | ETOP IBCSG Partners Foundation | Terminated | No outcome recorded |
| Phase 3 | NCT02051218 | Jul 2014 → Jun 2026 overdue | breast cancer, metastatic carcinoma in the bone, metastatic prostate carcinoma | Swiss Cancer Institute | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02014467 | Jan 2014 → Aug 2015 | postmenopausal osteoporosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01920568 | Aug 2013 → Feb 2015 | disease of bone structure | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01345019 | May 2012 → Jul 2016 | lytic metastatic bone lesion, plasma cell myeloma | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01575873 | Mar 2012 → Jun 2016 | corticosteroid-induced osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01495000 | Jan 2012 → Feb 2013 | postmenopausal osteoporosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01419717 | Nov 2011 → Aug 2018 | — | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01457950 | Nov 2011 → Dec 2012 | postmenopausal osteoporosis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01377467 | Jun 2011 → May 2015 | chronic kidney disease, osteoporosis | Rudolf Wuethrich | Completed | No outcome recorded |
| Phase 3 | NCT01824342 | Jan 2011 → Feb 2014 | castration-resistant prostate carcinoma | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01077154 | Jun 2010 → Aug 2017 | breast cancer | Amgen | Terminated | No outcome recorded |
| Phase 3 | NCT00925600 | Nov 2009 → May 2016 | cataract, osteoporosis, prostate cancer | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00980174 | Oct 2009 → Jun 2011 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00919711 | Sep 2009 → Dec 2011 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00936897 | Jul 2009 → Nov 2011 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00950911 | Jul 2009 → Feb 2012 | bone neoplasm | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00890981 | Jul 2009 → Jun 2010 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00838201 | Feb 2009 → May 2012 | castration-resistant prostate carcinoma | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00680953 | May 2008 → Jun 2012 | osteoporosis | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 3 | NCT00518531 | Sep 2007 → Jun 2009 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00523341 | Aug 2007 → Jul 2015 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00515463 | May 2007 → Mar 2008 | disease of bone structure, osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00556374 | Dec 2006 → Oct 2014 | breast cancer | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00377819 | Sep 2006 → Mar 2008 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00330759 | Jun 2006 → Apr 2009 | lytic metastatic bone lesion | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00325468 | May 2006 → Mar 2011 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00330460 | May 2006 → Nov 2007 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00321620 | Apr 2006 → Oct 2009 | metastatic carcinoma in the bone | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00321464 | Apr 2006 → Jul 2009 | metastatic carcinoma in the bone | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00286091 | Jan 2006 → Jul 2010 | hormone-resistant prostate carcinoma | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00089661 | Oct 2004 → May 2007 | breast cancer, osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00089791 | Aug 2004 → Jun 2008 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00089674 | Aug 2004 → May 2008 | prostate cancer | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00091793 | Aug 2004 → Feb 2009 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 428 trials | ||||||
| Phase 4 | NCT07281586 | Jan 2026 → Dec 2028 expected | osteoporosis | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT07283887 | Dec 2025 → Jul 2026 overdue | osteoporosis | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06588153 | May 2025 → Apr 2027 expected | glucocorticoid-induced osteoporosis | Amgen | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06332014 | Aug 2024 → Jan 2027 expected | osteoporosis | Amgen | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07271771 | May 2024 → Mar 2027 expected | osteoporosis | Aarhus University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06118905 | Feb 2024 → Feb 2029 expected | osteoporosis | Susan L. Greenspan | Recruiting | No outcome recorded |
| Phase 4 | NCT04586660 | Aug 2023 → Mar 2028 expected | bone giant cell tumor | Amgen | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05493761 | Dec 2022 → Jul 2026 overdue | NAFLD1, postmenopausal osteoporosis | Aristotle University Of Thessaloniki | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05559268 | Oct 2022 → Dec 2023 | osteoarthritis, knee | The Affiliated Hospital of Qingdao University | Unknown | No outcome recorded |
| Phase 4 | NCT05096195 | Jun 2022 → Dec 2025 overdue | dialysis disequilibrium syndrome, osteoporosis, renal osteodystrophy | Western University, Canada | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05101018 | Nov 2021 → Jun 2026 overdue | osteoporosis, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05203588 | Oct 2021 → Oct 2022 | osteoporosis | Shanghai Changzheng Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03921060 | Sep 2021 → Jul 2027 expected | cystic fibrosis | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05598606 | Jan 2021 → Jan 2023 | drug pseudoallergy | Shenzhen People's Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04087096 | Aug 2020 → Aug 2024 | disease of bone structure | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03868033 | Apr 2019 → Jul 2023 | osteoporosis | National Taiwan University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02792413 | Nov 2018 → Dec 2020 | osteoporosis | University Hospital, Montpellier | Terminated | No outcome recorded |
| Phase 4 | NCT03301857 | Nov 2017 → Jul 2023 | bone giant cell tumor | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT03029442 | Apr 2017 → Dec 2021 | osteoporosis, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT02753283 | Jun 2016 → Aug 2023 | postmenopausal osteoporosis | Susan L. Greenspan | Completed | No outcome recorded |
| Phase 4 | NCT01983475 | Jan 2015 → May 2020 | osteoporosis, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Unknown | No outcome recorded |
| Phase 4 | NCT02156960 | May 2014 → May 2015 | osteoporosis | Shinshu University | Unknown | No outcome recorded |
| Phase 4 | NCT01926158 | Dec 2013 → Feb 2017 | osteoarthritis, hip | Turku University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02130973 | Aug 2013 → Aug 2018 | osteoporosis | Health Research, Inc. | Unknown | No outcome recorded |
| Phase 4 | NCT01770106 | Dec 2012 → Jun 2014 | rheumatoid arthritis | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 4 | NCT01732770 | Nov 2012 → Jan 2015 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT01558115 | Jan 2012 → Oct 2014 | primary hyperparathyroidism | Columbia University | Terminated | No outcome recorded |
| Phase 4 | NCT02853539 | Jan 2011 → Jul 2016 | metabolic bone disorder | Stanley Dudrick's Memorial Hospital | Completed | No outcome recorded |
| Phase not applicable7 trials | ||||||
| — | NCT07063797 | Feb 2026 → Jul 2027 expected | osteoporosis, type 2 diabetes mellitus | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05866029 | May 2023 → Sep 2026 expected | osteoporosis | Peking Union Medical College Hospital | Recruiting | No outcome recorded |
| — | NCT05692297 | Jan 2023 → Dec 2025 | end stage renal failure, osteoporosis | Capital Medical University | Unknown | No outcome recorded |
| — | NCT05662358 | Jan 2021 → Sep 2023 | drug pseudoallergy | Shenzhen People's Hospital | Unknown | No outcome recorded |
| — | NCT05415657 | Jan 2020 → Jan 2023 | drug pseudoallergy | Shenzhen People's Hospital | Completed | No outcome recorded |
| — | NCT01973569 | Oct 2013 → Dec 2015 | rheumatoid arthritis | Daiichi Sankyo | Completed | No outcome recorded |
| — | NCT01572545 | Apr → Sep 2012 | postmenopausal osteoporosis | Aristotle University Of Thessaloniki | Completed | No outcome recorded |
Also used as a comparator or background therapy in 98 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02554695 Comparator | Oct 2015 → Oct 2016 | osteoporosis | Mayo Clinic | Completed | No outcome recorded |
| Phase 121 trials | ||||||
| Phase 1 | NCT06513624 Background | Dec 2024 → Dec 2026 expected | — | National University Hospital, Singapore | Recruiting | No outcome recorded |
| Phase 1 | NCT06310824 Comparator | Jun 2024 → Jul 2025 | — | Xentria, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06361355 Comparator | Nov 2023 → Jun 2024 | — | Taizhou Mabtech Pharmaceutical Co.,Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05876949 Comparator | Jul 2023 → Apr 2024 | — | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 1 | NCT05777109 Comparator | Apr 2023 → Apr 2024 | — | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT05808673 Comparator | Feb 2023 → Jun 2024 | — | Taizhou Mabtech Pharmaceutical Co.,Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT05126784 Comparator | Jun 2022 → Oct 2023 | — | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 1 | NCT05323708 Comparator | Mar 2022 → Oct 2023 | — | Biocon Biologics UK Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06037395 Comparator | Oct 2021 → Oct 2022 | — | Celltrion | Completed | No outcome recorded |
| Phase 1 | NCT04940845 Comparator | Jul 2021 → Jun 2022 | postmenopausal osteoporosis | Shanghai Hansoh Biomedical Co., Ltd | Unknown | No outcome recorded |
| Phase 1 | NCT04673799 Comparator | Feb → Oct 2021 | — | Kunming Pharmaceuticals, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT04973722 Comparator | Dec 2020 → Apr 2021 | — | Luye Pharma Group Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04534582 Comparator | Nov 2020 → Sep 2023 | — | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 1 | NCT04512872 Comparator | Oct 2020 → May 2021 | — | Celltrion | Completed | No outcome recorded |
| Phase 1 | NCT04494373 Comparator | Sep 2020 → Jun 2021 | metastatic carcinoma in the bone | Jiangsu Hansoh Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04798313 Comparator | Jun → Dec 2020 | postmenopausal osteoporosis | Mabwell (Shanghai) Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04198636 Comparator | Dec 2019 → Dec 2020 | — | Luye Pharma Group Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04213105 Comparator | Oct 2019 → Oct 2020 | — | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT03925051 Comparator | Jul 2019 → Mar 2020 | postmenopausal osteoporosis | Shanghai Biomabs Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04798326 Comparator | Jun 2019 → Jan 2020 | bone neoplasm | Mabwell (Shanghai) Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT03651947 Comparator | Aug → Nov 2018 | — | Qilu Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT06374459 Comparator | Jan 2025 → May 2032 expected | hormone receptor-positive breast cancer | Washington University School of Medicine | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06300229 Comparator | Mar 2024 → Jan 2025 | male infertility | Martin Blomberg Jensen | Completed | No outcome recorded |
| Phase 224 trials | ||||||
| Phase 2 | NCT07043608 Background | May 2026 → Feb 2029 expected | clear cell renal carcinoma, metastatic carcinoma in the bone | Kelly Fitzgerald, MD | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07537972 Comparator | May 2026 → May 2029 expected | hepatocellular carcinoma, metastatic carcinoma in the bone | Tongji Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07028268 Comparator | Jun → Dec 2025 overdue | — | Suzhou Suncadia Biopharmaceuticals Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT05278338 Comparator | Apr 2022 → Dec 2023 | postmenopausal osteoporosis | Shanghai JMT-Bio Inc. | Unknown | No outcome recorded |
| Phase 2 | NCT05212337 Comparator | Jan 2022 → Oct 2024 overdue | male infertility | Martin Blomberg Jensen | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04907851 Background | Dec 2021 → Nov 2023 | cancer | Redx Pharma Ltd | Completed | No outcome recorded |
| Phase 2 | NCT04907539 Background | Nov 2021 → Apr 2024 | colorectal cancer | Redx Pharma Ltd | Completed | No outcome recorded |
| Phase 2 | NCT04608630 Comparator | Jul 2021 → Feb 2027 expected | osteoporosis | Australian and New Zealand Intensive Care Research Centre | Recruiting | No outcome recorded |
| Phase 2 | NCT04232657 Comparator | Mar 2021 → Aug 2026 overdue | disease of bone structure, spinal cord injury | VA Office of Research and Development | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03960554 Comparator | Jan 2020 → Dec 2021 | osteoporosis, renal osteodystrophy | Thomas Nickolas, MD MS | Terminated | No outcome recorded |
| Phase 2 | NCT03732495 Background | Jul 2019 → Dec 2022 | differentiated thyroid carcinoma | Centre Leon Berard | Unknown | No outcome recorded |
| Phase 2 | NCT03239080 Comparator | Jun 2017 → May 2020 | rheumatoid arthritis | Chinese University of Hong Kong | Completed | No outcome recorded |
| Phase 2 | NCT02903446 Comparator | Feb 2017 → Mar 2020 | gout | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 2 | NCT03030196 Comparator | Jan 2017 → Jan 2021 | male infertility | Martin Blomberg Jensen | Completed | No outcome recorded |
| Phase 2 | NCT02758132 Comparator | Mar → Sep 2016 | prostate cancer | University of Hawaii | Terminated | No outcome recorded |
| Phase 2 | NCT02771860 Comparator | Mar 2016 → Jun 2019 | osteoarthritis, hand | University Hospital, Ghent | Completed | No outcome recorded |
| Phase 2 | NCT02299817 Comparator | Aug 2015 → Jan 2021 | primary osteolysis | Olof Skoldenberg | Unknown | No outcome recorded |
| Phase 2 | NCT02366130 Background | Feb 2015 → Dec 2020 | breast cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT02132026 Comparator | Nov 2014 → Nov 2019 | aortic valve stenosis | University of Edinburgh | Completed | No outcome recorded |
| Phase 2 | NCT02559648 Comparator | Sep 2014 → Dec 2016 | beta-thalassemia major, osteoporosis | Ersi Voskaridou | Completed | No outcome recorded |
| Phase 2 | NCT01630941 Comparator | Aug 2012 → Jan 2017 | osteoarthritis, hip | Hans Mallmin | Completed | No outcome recorded |
| Phase 2 | NCT01358669 Comparator | Dec 2011 → Jan 2019 | — | Sheffield Teaching Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 2 | NCT00887965 Background | Jun 2009 → Jun 2010 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00306189 Comparator | Jan 2006 → Jun 2007 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 321 trials | ||||||
| Phase 3 | NCT07056478 Comparator | Jan 2026 → Jan 2028 expected | pelvic muscle wasting | Prince of Wales Hospital, Shatin, Hong Kong | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06314698 Comparator | Apr → Dec 2024 overdue | disease of bone structure, plasma cell myeloma | RenJi Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05813665 Comparator | Apr 2023 → Jun 2028 expected | bone giant cell tumor | Shanghai JMT-Bio Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05395091 Comparator | Aug 2022 → May 2024 | postmenopausal osteoporosis | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 3 | NCT05405725 Comparator | Jul 2022 → Jul 2024 | postmenopausal osteoporosis | Enzene Biosciences Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT05352516 Comparator | Jun 2022 → Dec 2023 | postmenopausal osteoporosis | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 3 | NCT05345691 Comparator | May 2022 → Jun 2024 | postmenopausal osteoporosis | Biocon Biologics UK Ltd | Completed | No outcome recorded |
| Phase 3 | NCT05338086 Comparator | Mar 2022 → Dec 2023 | postmenopausal osteoporosis | mAbxience Research S.L. | Completed | No outcome recorded |
| Phase 3 | NCT05419427 Comparator | Nov 2021 → Sep 2024 | postmenopausal osteoporosis | Lambda Therapeutic Research Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT05087030 Comparator | Sep 2021 → Oct 2023 | postmenopausal osteoporosis | Gedeon Richter Plc. | Completed | No outcome recorded |
| Phase 3 | NCT04757376 Comparator | Jun 2021 → May 2023 | postmenopausal osteoporosis | Celltrion | Completed | No outcome recorded |
| Phase 3 | NCT04934072 Comparator | Jun 2021 → Aug 2023 | postmenopausal osteoporosis | Fresenius Kabi SwissBioSim GmbH | Completed | No outcome recorded |
| Phase 3 | NCT04859569 Comparator | Apr 2021 → Dec 2022 | metastatic carcinoma in the bone | Luye Pharma Group Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT04591275 Comparator | Mar 2021 → Nov 2024 | postmenopausal osteoporosis | Shanghai Biomabs Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04664959 Comparator | Nov 2020 → Jun 2022 | postmenopausal osteoporosis | Samsung Bioepis Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04812509 Comparator | Mar 2020 → Apr 2021 | bone neoplasm | Mabwell (Shanghai) Bioscience Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04550949 Comparator | Apr 2019 → Mar 2021 | bone neoplasm | Qilu Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT03040765 Comparator | May 2018 → Apr 2019 | beta-thalassemia major, osteoporosis | Hamad Medical Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT02567279 Comparator | Jun 2016 → Jan 2019 | anorexia nervosa | University Hospital, Montpellier | Terminated | No outcome recorded |
| Phase 3 | NCT02157948 Comparator | May 2014 → Jul 2015 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01575834 Background | Mar 2012 → Dec 2015 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 428 trials | ||||||
| Phase 4 | NCT06938152 Comparator | Apr 2025 → Apr 2029 expected | postmenopausal osteoporosis | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06720350 Comparator | Jan 2025 → Oct 2026 expected | postmenopausal osteoporosis | Marmara University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06472050 Comparator | Aug 2024 → Dec 2025 | osteoporosis, poisoning | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06643780 Comparator | Apr 2024 → Apr 2027 expected | pelvic muscle wasting | Prince of Wales Hospital, Shatin, Hong Kong | Recruiting | No outcome recorded |
| Phase 4 | NCT06272227 Background | Feb 2024 → Sep 2025 | muscular atrophy | Yonsei University | Unknown | No outcome recorded |
| Phase 4 | NCT05884372 Background | Aug 2023 → Jul 2025 | postmenopausal osteoporosis | Xi'an Honghui Hospital | Completed | No outcome recorded |
| Phase 4 | NCT05966064 Comparator | Jun 2023 → Dec 2027 expected | McCune-Albright syndrome, fibrous dysplasia | Natasha Appelman-Dijkstra | Recruiting | No outcome recorded |
| Phase 4 | NCT05666310 Comparator | Feb 2023 → Jan 2026 overdue | muscular atrophy, osteoporosis | Nami Safai Haeri | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05010590 Comparator | Mar 2022 → Oct 2027 expected | postmenopausal osteoporosis | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05091086 Comparator | Nov 2021 → Dec 2025 overdue | osteoporosis | National Taiwan University Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04467983 Comparator | Feb 2021 → Sep 2026 expected | postmenopausal osteoporosis | Hospital for Special Surgery, New York | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04549207 Comparator | Oct 2020 → Apr 2025 overdue | breast cancer, castration-resistant prostate carcinoma | Ottawa Hospital Research Institute | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04177940 Comparator | Aug 2020 → Jul 2024 | osteoporosis | University of Alabama at Birmingham | Completed | No outcome recorded |
| Phase 4 | NCT04026256 Comparator | Sep 2019 → Apr 2022 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04085419 Comparator | May 2019 → May 2023 | osteoporosis, primary hyperparathyroidism | University Medical Centre Ljubljana | Unknown | No outcome recorded |
| Phase 4 | NCT03623633 Comparator | Nov 2018 → Feb 2023 overdue | postmenopausal osteoporosis | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
| Phase 4 | NCT03005678 Comparator | Apr 2017 → Nov 2019 | osteoporosis | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT03472846 Comparator | Mar 2017 → Sep 2022 | postmenopausal osteoporosis, type 2 diabetes mellitus | Medical University of Vienna | Completed | No outcome recorded |
| Phase 4 | NCT02721433 Comparator | Aug 2016 → Sep 2019 | breast cancer, metastatic neoplasm, prostate cancer | Ottawa Hospital Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT02499237 Comparator | Jul 2015 → Nov 2018 | postmenopausal osteoporosis | 424 General Military Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02101164 Comparator | Nov 2014 | disease of bone structure, neoplasm | Amgen | Withdrawn | No outcome recorded |
| Phase 4 | NCT02176382 Comparator | Aug 2014 → Feb 2020 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04241211 Comparator | Jan 2014 → Dec 2018 | — | Seoul National University Bundang Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01750086 Comparator | Jan 2013 → Apr 2014 | postmenopausal osteoporosis | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01753856 Comparator | Jan 2013 → Jun 2014 | osteoporosis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 4 | NCT02760979 Comparator | Jan 2013 → Jan 2014 | bone resorption disease | Sant Pau Research Institute | Completed | No outcome recorded |
| Phase 4 | NCT01734824 Comparator | May 2012 → Sep 2015 | bone marrow disorder, bone remodeling disease | Medical University of Vienna | Suspended | No outcome recorded |
| Phase 4 | NCT01465568 Comparator | Dec 2011 → Apr 2014 | osteoporosis | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05736640 Comparator | Sep 2013 → Sep 2016 | — | University of Aarhus | Completed | No outcome recorded |
Press releases naming this drug 46 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-03-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com ↗ |
| 2026-03-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com ↗ |
| 2025-11-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva receives European Commission approvals for PONLIMSI® (denosumab) Biosimilar to Prolia® and DEGEVMA® (denosumab) Biosimilar to Xgeva® tevapharm.com ↗ |
| 2025-11-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva receives European Commission approvals for PONLIMSI® (denosumab) Biosimilar to Prolia® and DEGEVMA® (denosumab) Biosimilar to Xgeva® tevapharm.com ↗ |
| 2025-09-19 | Organon and Co | European Commission (EC) Approves Henlius and Organon’s BILDYOS® (denosumab) and BILPREVDA® (denosumab), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively organon.com ↗ |
| 2025-09-02 | Organon and Co | US Food and Drug Administration (FDA) Approves Henlius and Organon’s BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively organon.com ↗ |
| 2024-10-30 | Organon and Co | US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab) organon.com ↗ |
| 2024-10-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA tevapharm.com ↗ |
| 2024-05-24 | Organon and Co | European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 organon.com ↗ |
| 2024-04-08 | Organon and Co | Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints organon.com ↗ |
| 2023-05-25 | Novartis Pharmaceuticals | Sandoz Marketing Authorization Applications for proposed biosimilar denosumab accepted by EMA novartis.com ↗ |
| 2023-05-08 | Amgen | NEW DATA FROM AMGEN'S PROLIA® (DENOSUMAB) DEMONSTRATES SIGNIFICANT REDUCTION IN OSTEOPOROTIC FRACTURE RISK COMPARED TO ALENDRONATE amgen.com ↗ |
| 2023-02-06 | Novartis Pharmaceuticals | Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA novartis.com ↗ |
| 2022-09-19 | Novartis Pharmaceuticals | Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial novartis.com ↗ |
| 2022-06-13 | Organon and Co | Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta® (Pertuzumab) and Prolia®/Xgeva® (Denosumab) Biosimilar Candidates organon.com ↗ |
| 2019-07-22 | Novartis Pharmaceuticals | Sandoz announces first patient enrolled in clinical study for proposed biosimilar denosumab in osteoporosis novartis.com ↗ |
| 2018-06-08 | Amgen | European Commission Approves Prolia® (denosumab) for Patients With Glucocorticoid-Induced Osteoporosis amgen.com ↗ |
| 2018-05-21 | Amgen | FDA Approves Prolia® (Denosumab) For Glucocorticoid-Induced Osteoporosis amgen.com ↗ |
| 2018-04-27 | Amgen | Amgen Receives Positive CHMP Opinion To Expand Use Of Prolia® (denosumab) To Patients With Glucocorticoid-Induced Osteoporosis amgen.com ↗ |
| 2018-04-03 | Amgen | European Commission Approves Expanded Indication For Amgen's XGEVA® (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma amgen.com ↗ |
| 2018-02-23 | Amgen | Amgen Receives Positive Opinion Expanding Use Of XGEVA® (denosumab) To Cover Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma In Europe amgen.com ↗ |
| 2018-02-08 | Amgen | Results From Phase 3 XGEVA® (Denosumab) Study In Patients With Multiple Myeloma Published In The Lancet Oncology amgen.com ↗ |
| 2018-02-02 | Daiichi Sankyo | Daiichi Sankyo Announces Update on Amgen Inc.’s Phase 3 Clinical Trial Evaluating Denosumab as Adjuvant Breast Cancer Treatment daiichisankyo.com ↗ |
| 2018-01-05 | Amgen | FDA Approves XGEVA® (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma amgen.com ↗ |
| 2017-10-09 | Amgen | FDA Accepts Supplemental Biologics License Application For Prolia® (Denosumab) In Glucocorticoid-Induced Osteoporosis amgen.com ↗ |
| 2017-09-08 | Amgen | Amgen Highlights The Latest EVENITY™ (Romosozumab) And Prolia® (Denosumab) Research At The American Society For Bone And Mineral Research Annual Meeting amgen.com ↗ |
| 2017-07-31 | Amgen | Amgen Submits Supplemental Biologics License Application For Prolia® (denosumab) In Glucocorticoid-Induced Osteoporosis amgen.com ↗ |
| 2017-06-19 | Amgen | FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA® (denosumab) To Include Multiple Myeloma Patients amgen.com ↗ |
| 2017-06-04 | Amgen | Amgen Presents New Data From Phase 3 XGEVA® (Denosumab) Study In Patients With Multiple Myeloma At ASCO 2017 amgen.com ↗ |
| 2017-04-04 | Amgen | Amgen Submits Applications In The US And Europe To Expand Current Indication For XGEVA® (denosumab) To Include Patients With Multiple Myeloma amgen.com ↗ |
| 2017-03-03 | Amgen | Amgen Presents New Data From Phase 3 XGEVA® (denosumab) Study In Multiple Myeloma Patients At The 16th International Myeloma Workshop amgen.com ↗ |
| 2017-03-01 | Amgen | Amgen To Present New KYPROLIS® (Carfilzomib) And XGEVA® (Denosumab) Data At The 16th International Myeloma Workshop amgen.com ↗ |
| 2016-10-20 | Amgen | Amgen Announces Positive Top-Line Results From XGEVA® (Denosumab) Phase 3 Trial For Delay Of Bone Complications In Multiple Myeloma Patients amgen.com ↗ |
| 2016-09-23 | Daiichi Sankyo | Daiichi Sankyo Announces Application in Japan for Additional Indication for Anti-RANKL Antibody, Denosumab daiichisankyo.com ↗ |
| 2016-08-29 | Amgen | Amgen Announces Positive Top-Line Results From Phase 3 Study Of Prolia® (Denosumab) In Patients Receiving Glucocorticoid Therapy amgen.com ↗ |
| 2016-03-30 | Daiichi Sankyo | Daiichi Sankyo Announces Phase 3 Clinical Trial Results for AMG 162 (denosumab) Rheumatoid Arthritis Treatment daiichisankyo.com ↗ |
| 2015-12-14 | Amgen | Amgen Reacquires All Product Rights To Prolia® (denosumab), XGEVA® (denosumab) And Vectibix® (panitumumab) From GSK In 48 Countries amgen.com ↗ |
| 2015-10-12 | Amgen | New Data Show Consistent Safety Profile For Up To 10 Years With Prolia® (Denosumab) In Postmenopausal Women With Osteoporosis amgen.com ↗ |
| 2015-10-11 | Amgen | New Data Show Greater Bone Mineral Density Gains With Prolia® (Denosumab) Compared With Zoledronic Acid amgen.com ↗ |
| 2015-06-01 | Amgen | Amgen Presents Phase 3 Data At ASCO Showing Prolia® (Denosumab) Significantly Reduced Bone Fractures In Breast Cancer Patients Receiving Aromatase Inhibitors amgen.com ↗ |
| 2014-12-08 | Amgen | FDA Approves Amgen's XGEVA® (Denosumab) For The Treatment Of Hypercalcemia Of Malignancy Refractory To Bisphosphonate Therapy amgen.com ↗ |
| 2012-10-15 | Daiichi Sankyo | Positive Phase 3 Study Results for Denosumab on Fracture Risk in Japanese Patients with Osteoporosis Presented at ASBMR daiichisankyo.com ↗ |
| 2012-03-23 | Daiichi Sankyo | Daiichi Sankyo Files for Approval in Japan to Market AMG 162 (denosumab), a Treatment for Osteoporosis daiichisankyo.com ↗ |
| 2011-05-24 | Daiichi Sankyo | Daiichi Sankyo and AstraZeneca Announce a Co-Promotion Agreement in Japan for Denosumab, a Treatment of Bone Disorders stemming from Bone Metastasis daiichisankyo.com ↗ |
| 2010-08-25 | Daiichi Sankyo | Daiichi Sankyo Files for Approval to Manufacture and Market AMG 162 (Denosumab) in Japan daiichisankyo.com ↗ |
| 2007-07-12 | Daiichi Sankyo | Amgen Grants Daiichi Sankyo Exclusive Rights to Develop and Commercialize Denosumab in Japan daiichisankyo.com ↗ |
Evidence & citations 27 cited values
Every value below carries the sentence it was read from. 283 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Denosumab | “Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing the RANKL/RANK interaction from occurring and...” NCT03869762 ↗240“Denosumab, a fully human monoclonal antibody that inhibits RANK Ligand (RANKL), is a novel bone-targeted agent with a distinct mechanism of action relative to the...” PMID 22975218 ↗ Sep 2012 “A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Clinical Efficacy, Safety, and Immunogenicity of Denosumab Injection 9MW0311 With Prolia® in...” NCT06804590 ↗ “CONTEXT: Denosumab is an investigational fully human monoclonal antibody against receptor activator of nuclear factor-kappaB ligand, a mediator of osteoclastogenesis and...” PMID 18381571 ↗ Apr 2008 “Denosumab is a human IgG2 monoclonal antibody against receptor activator of nuclear factor kappa-B ligand (RANKL) for the treatment of osteoporosis and bone loss.” PMID 39700054 ↗ Dec 2024 “This is a randomized, double-blind and placebo-controlled trial to evaluate the efficacy of denosumab on the biologic incorporation of cementless hip prosthesis.” NCT01926158 ↗ “The active ingredient of Xgeva® is denosumab,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.” NCT04550949 ↗ “120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.” NCT00950911 ↗ “QL1206 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.” NCT07062978 ↗ “AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42” NCT00325468 ↗ “CMAB807, a biosimilar to denosumab (Prolia®), which is the only approved RANKL inhibitor for the treatment of osteoporosis.” PMID 35140619 ↗ Jan 2022 “QL1206 is the first denosumab biosimilar and needs to be compared with denosumab in a phase III trial.” PMID 36802320 ↗ Feb 2023 “ENZ215 Injection:- 60 mg Denosumab (ENZ215) will be administered subcutaneously on day 1.” NCT05245669 ↗ “The Treatment of Osteoporosis Using a Combination of Teriparatide (Forteo) and Denosumab” NCT02130973 ↗ “Switch from Denosumab 60 mg administered subcutaneously (SC) to weekly oral alendronate” NCT04177940 ↗ “United States-licensed reference denosumab (US-denosumab) in healthy male Asian adults” PMID 38349618 ↗ Feb 2024 “TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)” NCT04729621 ↗ “postmenopausal women without type 2 diabetes mellitus treated with denosumab” NCT03472846 ↗ “The primary PK parameter endpoints are AUC0-last and Cmax for denosumab.” NCT05299073 ↗ “Post-change CMAB807X versus Xgeva® #Denosumab# in healthy male subjects” NCT05808673 ↗ “versus Prolia #Denosumab# in healthy male subjects after a single dose” NCT06361355 ↗ “HS-20090 is a proposed biosimilar candidate of Denosumab (Xgeva®).” PMID 36112084 ↗ Sep 2022 “MW031 is a biosimilar candidate of denosumab (Prolia®).” PMID 36892190 ↗ Mar 2023 “100 mg AMG 162 (denosumab) SC every 6 months” NCT00306189 ↗ “The active ingredient of Xgeva® is denosumab” NCT04812509 ↗ “Denosumab Injection (Prolia®)” NCT05352516 ↗ “AMG 162 / Denosumab” NCT00089661 ↗ “Denosumab” NCT05058443 ↗ “Denosumab” NCT04549207 ↗ “Denosumab” NCT06588153 ↗ “Denosumab” NCT07043608 ↗ |
| Known as | 9MW0311 | “A Randomized, Double-blind, Parallel-group, Phase III Study to Compare the Clinical Efficacy, Safety, and Immunogenicity of Denosumab Injection 9MW0311 With Prolia® in...” NCT06804590 ↗ |
| Known as | AMG 162 | “An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation...” NCT00838201 ↗8“AMG 162; 60 mg/mL of Denosumab given to all subjects at Screening/Day 1, Month 6, Month 12, Month 18, Month 24, Month 30, Month 36 and Month 42” NCT00325468 ↗ “This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).” NCT00095498 ↗ “Treatment With Denosumab (AMG 162) and Alendronate Sodium” NCT00293813 ↗ “Denosumab (AMG 162)” NCT00377819 ↗ |
| Known as | DEMAB | “Denosumab(DEMAB, a medication approved for osteoporosis, acts on molecular targets shared between muscle and bone.” NCT06118905 ↗ |
| Known as | DEN | “SB16 is a biosimilar to reference denosumab (DEN).” PMID 37870163 ↗ Nov 2023 |
| Known as | Denosumab-Ref | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05419427 ↗ |
| Known as | DMAb | “It is uncertain whether the risk of vertebral fracture (VF) and multiple vertebral fractures (MVFs; ≥2 VFs) after denosumab (DMAb) discontinuation is related to treatment duration.” PMID 36088628 ↗ Oct 20221“Denosumab (DMAB) Discontinuation And Switching In Glucocorticoid-Induced Osteoporosis (GIOP): A Pilot Study” NCT04177940 ↗ |
| Known as | DNM | “Denosumab (DNM) is a fully human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand (RANKL) that has been licensed for the treatment of...” PMID 30381400 ↗ Nov 2018 |
| Known as | ENZ215 | “ENZ215 Injection:- 60 mg Denosumab (ENZ215) will be administered subcutaneously on day 1.” NCT05245669 ↗ |
| Known as | EU sourced Prolia | “EU sourced Prolia Injection:- 60 mg Denosumab (EU sourced Prolia) will be administered subcutaneously on day 1.” NCT05245669 ↗ |
| Known as | EU-DEN | “This study aimed to evaluate the pharmacokinetic (PK), pharmacodynamic (PD) similarity, comparable safety, and immunogenicity between LY06006, European Union-sourced denosumab...” PMID 39582128 ↗ Nov 2024 |
| Known as | LY06006 | “This study aimed to evaluate the pharmacokinetic (PK), pharmacodynamic (PD) similarity, comparable safety, and immunogenicity between LY06006, European Union-sourced denosumab...” PMID 39582128 ↗ Nov 2024 |
| Known as | Mai Lishu | “Denosumab injection (Mai Lishu), 60 mg subcutaneous injection, once every six months, combined with eldecalcitol soft capsules (Gai Sheng Yuan), 0.75 μg/capsule, take one...” NCT07063797 ↗ |
| Known as | MB09 | “MB09 (Denosumab Biosimilar)” NCT05299073 ↗ |
| Known as | MW031 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04798313 ↗ |
| Known as | Prolia | “A Randomised, Parallel, Single-Dose, Subcutaneous Injection, Phase I Clinical Study Of HLX14 Versus Prolia® (Denosumab) In Chinese Healthy Adult Male Subjects For Comparison In...” NCT04534582 ↗48“Compare the Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of Denosumab (SB16, EU Sourced Prolia®, and US Sourced Prolia®) in Healthy Male Subjects” NCT04621318 ↗ “This study aimed to compare the efficacy and safety of the biosimilar denosumab candidate (Arylia) to the originator product (Prolia®) in postmenopausal osteoporotic patients.” PMID 35773713 ↗ Jun 2022 “Prolia® Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.” NCT07062978 ↗ “Patients were administered 60mg of denosumab (Prolia) subcutaneously once 6months from the day on before 3months to after 3months about surgery.” NCT04241211 ↗ “Prolia (denosumab) is a recombinant fully human IgG2 monoclonal antibody to RANKL developed to be administered as a subcutaneous injection.” NCT05395091 ↗ “1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection plus intravenous placebo every 6 months (Q6M)” NCT05598606 ↗ “The purpose of this study is to demonstrate similar efficacy and safety between TVB-009 and Prolia® (denosumab)” NCT04729621 ↗ “Maintaining bone mineral density (BMD) after discontinuing denosumab (Prolia) is a major clinical challenge” NCT07281586 ↗ “Participants with glucocorticoid-induced osteoporosis (GIOP) will receive Prolia® every 6 months (Q6M).” NCT06588153 ↗ “as one of the pediatric studies that were a condition of registration for Prolia (denosumab).” PMID 42319705 ↗ Jun 2026 “Denosumab (Prolia) for prevention of bone loss after stopping teriparatide” NCT02049866 ↗ “versus Prolia #Denosumab# in healthy male subjects after a single dose” NCT06361355 ↗ “1 ml (60 mg) of denosumab (Prolia; Amgen, Inc) subcutaneous injection” NCT05662358 ↗ “alternating use of Prolia (Denosumab) and Aclasta (Zoledronic acid)” NCT05091086 ↗ “Denosumab 60 mg/ml Injectable Solution [Prolia]” NCT05203588 ↗ “Denosumab 60 MG/ML Injectable Solution [Prolia]” NCT05559268 ↗ “Denosumab 60 MG/ML Prefilled Syringe [Prolia]” NCT04085419 ↗ “Denosumab 60 MG/ML Prefilled Syringe [Prolia]” NCT04800367 ↗ “Drug: Denosumab 60 mg/ml [Prolia]” NCT05638399 ↗ “Denosumab (Prolia) Sub study” NCT03921060 ↗ “Denosumab 60 mg/ml [Prolia]” NCT05058443 ↗ “Denosumab 60 mg/ml [Prolia]” NCT04169698 ↗ “Denosumab 60 MG [Prolia]” NCT03292146 ↗ “Prolia® (Denosumab)” NCT04664959 ↗ “Denosumab (Prolia)” NCT06720350 ↗ “Denosumab (Prolia)” NCT07056478 ↗ “Denosumab (Prolia)” NCT03029442 ↗ “Denosumab (Prolia)” NCT06706414 ↗ |
| Known as | QL1206 | “QL1206 Denosumab injection(60 mg) was administered subcutaneously once every 6 months for a maximum of 2 consecutive doses throughout the trial.” NCT07062978 ↗ |
| Known as | SB16 | “SB16 is a biosimilar to reference denosumab (DEN).” PMID 37870163 ↗ Nov 2023 |
| Known as | TK006 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03239756 ↗ |
| Known as | TVB-009 | “TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)” NCT04729621 ↗ |
| Known as | US-DEN | “This study aimed to evaluate the pharmacokinetic (PK), pharmacodynamic (PD) similarity, comparable safety, and immunogenicity between LY06006, European Union-sourced denosumab...” PMID 39582128 ↗ Nov 2024 |
| Known as | US-denosumab | “United States-licensed reference denosumab (US-denosumab) in healthy male Asian adults” PMID 38349618 ↗ Feb 2024 |
| Known as | Xgeva | “Denosumab, a drug used in millions of patients worldwide under trade names Prolia® and Xgeva®, inhibits the RANKL pathway and is used to treat osteoporosis and bone metastases.” NCT06706414 ↗17“Denosumab, a drug used in millions of patients worldwide under trade names Prolia® and Xgeva®, inhibits the RANKL pathway” NCT06300229 ↗ “Denosumab, a drug used in millions of patients worldwide under trade names Prolia® and Xgeva®, inhibits the RANKL pathway” NCT05212337 ↗ “Xgeva® injection (120mg) by subcutaneous injection once on the first day” NCT04198636 ↗ “Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]” NCT03792763 ↗ “Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]” NCT03691311 ↗ “Denosumab 70 MG/ML [Xgeva]” NCT03270020 ↗ “Denosumab (XGEVA®)” NCT03669523 ↗ |
| Action | Inhibit | “Denosumab, a human monoclonal antibody against RANKL, reversibly inhibits osteoclast-mediated bone resorption” PMID 20533525 ↗ Oct 2010 |
| Modality | Monoclonal antibody | “Denosumab is a fully human monoclonal antibody” PMID 18495508 ↗ May 2008 |
| Route | Subcutaneous | “subcutaneously administered denosumab” PMID 16495394 ↗ Feb 2006 |
| Target | TNFSF11 | “a clinically available antibody against RANKL” NCT02682693 ↗ |