Denosumab

also known as Prolia · XGEVA · AMG 162 · QL1206 · TK006 · DMAB · MW031 · 9MW0311 · +13 more

Monoclonal antibody targets TNFSF11 via inhibition

Developed for: osteoporosis · postmenopausal osteoporosis · breast cancer · bone giant cell tumor · female breast carcinoma · metastatic carcinoma in the bone · non-small cell lung carcinoma · drug pseudoallergy
+77 more
· plasma cell myeloma · rheumatoid arthritis · castration-resistant prostate carcinoma · disease of bone structure · glucocorticoid-induced osteoporosis · lytic metastatic bone lesion · osteogenesis imperfecta · spinal cord injury · aneurysmal bone cyst · bone neoplasm · disease related to hematopoietic stem cell transplant · metastatic malignant neoplasm · metastatic melanoma · neurogenic arthropathy · osteoarthritis, hip · osteoarthritis, knee · premenopausal osteoporosis · primary hyperparathyroidism · prostate cancer · type 2 diabetes mellitus · anorexia nervosa · bone disorder · bone resorption disease · breast mucinous carcinoma · breast neoplasm · chondroblastoma · chondromyxoid fibroma · clear cell renal carcinoma · conventional osteosarcoma · corticosteroid-induced osteoporosis · Crohn disease · cutaneous melanoma · cystic fibrosis · disease related to solid organ transplantation · end stage renal failure · estrogen-receptor positive breast cancer · fibrous dysplasia · giant cell reparative granuloma · HER2 positive breast carcinoma · Her2-receptor negative breast cancer · hormone receptor-positive breast cancer · hormone-resistant prostate carcinoma · humoral hypercalcemia of malignancy · idiopathic inflammatory myopathy · immunodeficiency disease · inflammatory breast carcinoma · invasive tubular breast carcinoma · Langerhans cell histiocytosis · lung cancer · male infertility · metabolic bone disorder · metastatic neoplasm · metastatic prostate carcinoma · NAFLD1 · nasopharyngeal carcinoma · osteoblastoma · osteoporosis, childhood- or juvenile-onset, with developmental delay · ovarian carcinoma · plasma cell neoplasm · progesterone-receptor positive breast cancer · renal cell carcinoma · renal osteodystrophy · smoldering plasma cell myeloma · spondylolisthesis · systemic mastocytosis · type 1 diabetes mellitus · urothelial carcinoma · aortic valve stenosis · beta-thalassemia major · bone marrow disorder · bone remodeling disease · carcinoma · gout · McCune-Albright syndrome · osteoarthritis, hand · pelvic muscle wasting · primary osteolysis
Investigated by: Amgen · Shenzhen People's Hospital · National Cancer Institute (NCI) · Daiichi Sankyo · GlaxoSmithKline · Massachusetts General Hospital
+122 more
· James J. Peters Veterans Affairs Medical Center · Jiangsu T-Mab Biopharma Co.,Ltd · Kessler Institute for Rehabilitation · National Taiwan University Hospital · 424 General Military Hospital · Aristotle University Of Thessaloniki · Austrian Breast & Colorectal Cancer Study Group · Columbia University · European Organisation for Research and Treatment of Cancer - EORTC · Luye Pharma Group Ltd. · M.D. Anderson Cancer Center · Mabwell (Shanghai) Bioscience Co., Ltd. · Martin Blomberg Jensen · National Institute of Dental and Craniofacial Research (NIDCR) · National Institutes of Health (NIH) · Peking Union Medical College Hospital · Qilu Pharmaceutical Co., Ltd. · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · University of California, San Francisco · University of Rochester · Washington University School of Medicine · 251 Hellenic Air Force & VA General Hospital · Aalborg University · Aarhus University Hospital · Academic Medical Organization of Southwestern Ontario · Ain Shams University · Albert Einstein Healthcare Network · Alison Stopeck · Alkem Laboratories Ltd · Alliance for Clinical Trials in Oncology · AryoGen Pharmed Co. · Assign Data Management and Biostatistics GmbH · Assistance Publique - Hôpitaux de Paris · Australian and New Zealand Urogenital and Prostate Cancer Trials Group · Bispebjerg Hospital · Bristol-Myers Squibb · CEREMAST · Cancer Trials Ireland · Capital Medical University · Catalan Institute of Oncology · Celgene Corporation · Centre Hospitalier Annecy Genevois · Centre Leon Berard · Children's Hospital of Eastern Ontario · Children's Oncology Group · China Medical University, China · Chinese University of Hong Kong · Chrissy Kistler · City of Hope Medical Center · Creighton University · Dutch Breast Cancer Research Group · ETOP IBCSG Partners Foundation · Elizabeth Shane · Emory University · Enzene Biosciences Ltd. · French Lung Cancer Group · GBG Forschungs GmbH · Gruppo Oncologico del Nord-Ovest · Health Research, Inc. · Hebei Medical University Third Hospital · Hellenic Society for the Study of Bone Metabolism · Hope Rugo, MD · ICES · Indiana University · Innovaderm Research Inc. · Intas Pharmaceutical Limited (Biopharma Division) · Jules Bordet Institute · Kwong Wah Hospital · Kyoto Prefectural University of Medicine · Lambda Therapeutic Research Ltd. · Leiden University Medical Center · Mario Negri Institute for Pharmacological Research · McMaster University · Melanoma and Skin Cancer Trials Limited · all 128 on the full record

Regulatory milestones approvals, filings & regulatory actions · 23 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed drug-induced osteoporosis 2 milestones
Filed	EU (EMA)	—	drug-induced osteoporosis	2023-05-25	“today announced that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review.” novartis.com ↗
Filed	US (FDA)	—	drug-induced osteoporosis	2023-02-06	“today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab.” novartis.com ↗ “Amgen has submitted marketing applications for denosumab in the United States” gsk.com ↗
Filed joint contractures, osteochondromas, and B-cell lymphoma 1 milestone
Filed	China (NMPA)	XGEVA	joint contractures, osteochondromas, and B-cell lymphoma	2023-03-21	“XGEVA In April, a marketing authorization for the treatment of skeletal related events was accepted for review by the Center for Drug Evaluation in China .” amgen.com ↗ “Additionally, a supplemental NDA for XGEVA for an expanded indication in skeletal-related events in China was accepted by the NMPA;” beonemedicines.com ↗ “BA1102（地舒单抗注射液）的上市许可申请已获得中国国家药品监督管理局药品审评中心受理” luye.com ↗
Filed lytic metastatic bone lesion 1 milestone
Filed	Japan (PMDA)	—	lytic metastatic bone lesion	2010-08-25	“it has filed for approval in Japan to manufacture and market AMG 162 (Denosumab), a gene recombinant drug for bone disorders stemming from bone metastases.” daiichisankyo.com ↗
Filed osteoporosis 1 milestone
Filed	Japan (PMDA)	—	osteoporosis	2012-03-23	“today announced that it has filed for approval in Japan to market AMG 162 (denosumab), a gene recombinant drug for osteoporosis.” daiichisankyo.com ↗ “In March 2012, Daiichi Sankyo filed an application in Japan to market denosumab for osteoporosis based on this study.” daiichisankyo.com ↗
Filed plasma cell myeloma 1 milestone
Filed	EU (EMA)	XGEVA	plasma cell myeloma	2017-04-04	“an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for XGEVA ® (denosumab).” amgen.com ↗ “Amgen has submitted marketing applications for denosumab in the United States, European Union” gsk.com ↗
Approved Indication not stated 8 milestones
Label expansions (10)	US (FDA)	PROLIA	—	2010-11-18 – 2025-05-22	fda.gov ↗
Filed	US (FDA)	—	—	2024-05-27	“accepted for review the company’s Biologics License Application (BLA) for FKS518, its biosimilar candidate of Prolia® (denosumab)” fresenius-kabi.com ↗
Filed	EU (EMA)	—	—	2024-05-24	“the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar.” henlius.com ↗
Filed	EU (EMA)	—	—	2023-07-18	“Denosumab biosimilar EMA accepted the marketing authorization applications for proposed biosimilar denosumab for regulatory review.” sandoz.com ↗ “Die EMA hat die Marktzulassungsanträge für das vorgeschlagene Denosumab-Biosimilar zur regulatorischen Prüfung entgegengenommen.” novartis.com ↗ “L’EMA a accepté d’autoriser la commercialisation des indications du biosimilaire denosumab.” novartis.com ↗
Filed	China (NMPA)	—	—	2021-10-14	“地舒单抗注射液（LY06006 / BA6101）的上市许可申请已获得国家药品监督管理局药品审评中心受理” luye.com ↗
Approved	US (FDA)	PROLIA	—	2010-06-01	fda.gov ↗
Approved	EU (EMA)	Prolia	—	2010-05-26	europa.eu ↗
Filed	Other	—	—	—	“Amgen has submitted marketing applications for denosumab in the United States, European Union, Canada, Switzerland, and Australia” gsk.com ↗ “Amgen has submitted marketing applications for denosumab in the United States, European Union, Canada, Switzerland” gsk.com ↗ “Amgen has submitted marketing applications for denosumab in the United States, European Union, Canada” gsk.com ↗

Trials 172 · started per year

today

EU approved 2010

US approved 2010

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

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 Stop: Enrollment
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 · 2 met primary · 1 missed
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	Met primary
Phase 1	NCT04621318	Oct 2020 → Nov 2022	—	Samsung Bioepis Co., Ltd.	Completed	Met primary
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 Stop: Enrollment
Phase 1	NCT02677246	Dec 2016 → Sep 2018	disease related to hematopoietic stem cell transplant	St. Justine's Hospital	Withdrawn	No outcome recorded Stop: Business
Phase 1	NCT02135640	Jul 2014 → Feb 2015	osteoporosis	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT02099461	Apr → Jul 2014	—	Amgen	Completed	Missed primary
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 Stop: Enrollment
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 Stop: Business
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 · 6 met primary · 4 missed
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 Stop: Enrollment
Phase 2	NCT04067726	Aug 2019 → Sep 2025 overdue	—	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 Stop: Enrollment
Phase 2	NCT03457818	Nov 2018 → Jun 2020	osteoporosis, type 2 diabetes mellitus	Mishaela Rubin	Terminated	No outcome recorded Stop: Enrollment
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 Stop: Enrollment
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	Mixed
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	Met primary
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	Missed primary
Phase 2	NCT01864798	Jul 2013 → Jan 2017	breast neoplasm	Jules Bordet Institute	Terminated	Missed primary Stop: Enrollment
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 Stop: Enrollment
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	Met primary
Phase 2	NCT00926380	Jun 2009 → Dec 2016	postmenopausal osteoporosis	Massachusetts General Hospital	Completed	Missed primary
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	Met primary
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	Met primary
Phase 2	NCT00091832	Sep 2004 → Nov 2005	breast cancer, metastatic neoplasm	Amgen	Completed	Missed primary
Phase 2	NCT00095498	Aug 2004 → Apr 2007	rheumatoid arthritis	Amgen	Completed	Met primary
Phase 2	NCT00043186	May 2002 → Apr 2007	osteoporosis	Amgen	Completed	Met primary

Phase 2/34 trials · 1 met primary
Phase 2/3	NCT05065164	Sep 2021 → Mar 2023	drug pseudoallergy	Shenzhen People's Hospital	Withdrawn	No outcome recorded Stop: Enrollment
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	Met primary
Phase 359 trials · 25 met primary · 4 missed
Phase 3	NCT06504966	Oct 2025 → Oct 2027	osteoporosis	Xentria, Inc.	Withdrawn	No outcome recorded Stop: Business
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	NCT05419427	Nov 2021 → Sep 2024	postmenopausal osteoporosis	Lambda Therapeutic Research Ltd.	Unknown	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 Stop: Enrollment
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	Missed primary
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	Met primary
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	Met primary
Phase 3	NCT03027557	Mar 2017 → Apr 2019	parathyroid gland adenoma, parathyroid hyperplasia, primary hyperparathyroidism	Peter Vestergaard	Completed	Mixed
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	Missed primary Stop: Enrollment
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	Met primary
Phase 3	NCT01920568	Aug 2013 → Feb 2015	disease of bone structure	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01345019	May 2012 → Jul 2016	lytic metastatic bone lesion, plasma cell myeloma	Amgen	Completed	Met primary
Phase 3	NCT01575873	Mar 2012 → Jun 2016	corticosteroid-induced osteoporosis	Amgen	Completed	Met primary
Phase 3	NCT01495000	Jan 2012 → Feb 2013	postmenopausal osteoporosis	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01419717	Nov 2011 → Aug 2018	—	Amgen	Completed	No outcome recorded
Phase 3	NCT01457950	Nov 2011 → Dec 2012	postmenopausal osteoporosis	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01377467	Jun 2011 → May 2015	chronic kidney disease, osteoporosis	Rudolf Wuethrich	Completed	Met primary
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	Missed primary
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	Met primary
Phase 3	NCT00919711	Sep 2009 → Dec 2011	osteoporosis	Amgen	Completed	Met primary
Phase 3	NCT00890981	Jul 2009 → Jun 2010	postmenopausal osteoporosis	Amgen	Completed	Missed primary
Phase 3	NCT00936897	Jul 2009 → Nov 2011	postmenopausal osteoporosis	Amgen	Completed	Met primary
Phase 3	NCT00950911	Jul 2009 → Feb 2012	bone neoplasm	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	Met primary
Phase 3	NCT00518531	Sep 2007 → Jun 2009	osteoporosis	Amgen	Completed	Met primary
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	Met primary
Phase 3	NCT00377819	Sep 2006 → Mar 2008	postmenopausal osteoporosis	Amgen	Completed	Met primary
Phase 3	NCT00330759	Jun 2006 → Apr 2009	lytic metastatic bone lesion	Amgen	Completed	Met primary
Phase 3	NCT00325468	May 2006 → Mar 2011	osteoporosis	Amgen	Completed	No outcome recorded
Phase 3	NCT00330460	May 2006 → Nov 2007	osteoporosis	Amgen	Completed	Met primary
Phase 3	NCT00321620	Apr 2006 → Oct 2009	metastatic carcinoma in the bone	Amgen	Completed	Met primary
Phase 3	NCT00321464	Apr 2006 → Jul 2009	metastatic carcinoma in the bone	Amgen	Completed	Met primary
Phase 3	NCT00286091	Jan 2006 → Jul 2010	hormone-resistant prostate carcinoma	Amgen	Completed	Met primary
Phase 3	NCT00089661	Oct 2004 → May 2007	breast cancer, osteoporosis	Amgen	Completed	Met primary
Phase 3	NCT00089674	Aug 2004 → May 2008	prostate cancer	Amgen	Completed	Met primary
Phase 3	NCT00089791	Aug 2004 → Jun 2008	osteoporosis	Amgen	Completed	Met primary
Phase 3	NCT00091793	Aug 2004 → Feb 2009	postmenopausal osteoporosis	Amgen	Completed	Met primary

Phase 428 trials · 1 met primary · 1 missed
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	Chrissy Kistler	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	Missed primary
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	Met primary
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 Stop: Enrollment
Phase 4	NCT02853539	Jan 2011 → Jul 2016	metabolic bone disorder	Stanley Dudrick's Memorial Hospital	Completed	No outcome recorded

Phase not applicable7 trials · 1 met primary
—	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 overdue	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	Met primary
—	NCT01572545	Apr → Sep 2012	postmenopausal osteoporosis	Aristotle University Of Thessaloniki	Completed	No outcome recorded
Comparator or background therapy98 trials
Phase 0	NCT02554695 Comparator	Oct 2015 → Oct 2016	osteoporosis	Mayo Clinic	Completed	No outcome recorded
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	Met primary
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	Met primary
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	Met primary
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	Met primary
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	Met primary
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	Met primary
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 1/2	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 2	NCT07806331 Comparator	Oct 2026 → Apr 2027 expected	disease of bone structure, postmenopausal osteoporosis	Transcenta Therapeutics (Hangzhou) Co., Ltd.	Not yet recruiting	No outcome recorded
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	Met primary
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	disease of bone structure, spinal cord injury	VA Office of Research and Development	Completed	No outcome recorded
Phase 2	NCT03960554 Comparator	Jan 2020 → Dec 2021	osteoporosis, renal osteodystrophy	Thomas Nickolas, MD MS	Terminated	No outcome recorded Stop: Business
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 Stop: Enrollment
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 3	NCT07056478 Comparator	Jan 2027 → 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	Met primary
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	Met primary
Phase 3	NCT05345691 Comparator	May 2022 → Jun 2024	postmenopausal osteoporosis	Biocon Biologics UK Ltd	Completed	Met primary
Phase 3	NCT05338086 Comparator	Mar 2022 → Dec 2023	postmenopausal osteoporosis	mAbxience Research S.L.	Completed	Met primary
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	Met primary
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	Met primary
Phase 3	NCT04812509 Comparator	Mar 2020 → Apr 2021	bone neoplasm	Mabwell (Shanghai) Bioscience Co., Ltd.	Completed	Met primary
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 Stop: Enrollment
Phase 3	NCT02567279 Comparator	Jun 2016 → Jan 2019	anorexia nervosa	University Hospital, Montpellier	Terminated	No outcome recorded Stop: Enrollment
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	Met primary
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 overdue	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	NCT02760979 Comparator	Jan 2013 → Jan 2014	bone resorption disease	Sant Pau Research Institute	Completed	No outcome recorded
Phase 4	NCT01753856 Comparator	Jan 2013 → Jun 2014	osteoporosis	Eli Lilly and Company	Completed	Met primary
Phase 4	NCT01750086 Comparator	Jan 2013 → Apr 2014	postmenopausal osteoporosis	Massachusetts General Hospital	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
—	NCT05736640 Comparator	Sep 2013 → Sep 2016	—	University of Aarhus	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 105

Date	Issuer	Release
2026-09-28	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Continues Biosimilar Momentum with U.S. FDA Approval of DEGEVMA™ (denosumab-adet), a Biosimilar to Xgeva® (denosumab) tevapharm.com ↗ Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has approved DEGEVMA™ (denosumab-adet) as a biosimilar to Xgeva® (denosumab).
2026-05-28	Luye Pharma Group Ltd.	Regulatory 博安生物地舒单抗注射液博洛加®新适应症在中国获批，用于治疗实体肿瘤骨转移和多发性骨髓瘤 luye.com ↗ 博安生物宣布，中国国家药品监督管理局已批准博洛加®（地舒单抗注射液120mg）的新增适应症补充申请，用于实体肿瘤骨转移患者或多发性骨髓瘤患者的治疗，以延迟或降低骨相关事件（病理性骨折、脊髓压迫、骨放疗或骨手术）的发生风险.
2026-04-20	Samsung Bioepis Co., Ltd.	Results 삼성바이오에피스, 유럽 국제 학회(WCO-IOF-ESCEO)서 골다공증 치료제 후속 연구 결과 발표 samsungbioepis.com ↗ 분석 결과에 따르면, 인구학적 특성과 질환 특성 변수를 감안했을 경우에도 SB16과 오리지널 의약품은 하위군의 치료에서 일관된 효과를 보였고 이로써 임상 3상 결과와 마찬가지로 두 의약품의 생물학적 유사성을 재확인할 수 있었다.
2026-04-07	Apotex Inc.	Regulatory Apotex Strengthens Osteoporosis Care in Canada with Health Canada's Approval of DENOZA™, a Denosumab Biosimilar apotex.com ↗ Apotex Inc. ("Apotex" or the "Company"), the largest Canadian based global pharmaceutical company, today announced that Health Canada has approved DENOZA™ (denosumab injection), a biosimilar to Prolia®, for its authorized indications.
2026-03-30	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory 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 ↗
2026-03-24	Shanghai Henlius Biotech	Regulatory Health Canada Approves Henlius’ BILDYOS® (Denosumab Injection) and TUZEMTY® (Denosumab Injection), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively henlius.com ↗ The approvals in Canada mark another significant regulatory milestone of the products following prior approvals in the U.S., EU and the UK, as well as a key milestone in our collaboration with Organon
2025-12-22	Impax Laboratories, LLC	Regulatory Amneal Announces FDA Approval of Denosumab Biosimilars Referencing Prolia® and XGEVA® amneal.com ↗
2025-12-02	Shanghai Henlius Biotech	Regulatory Henlius’ Denosumab HLX14 New Drug Application Accepted by NMPA henlius.com ↗
2025-11-25	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva receives European Commission approvals for PONLIMSI® (denosumab) Biosimilar to Prolia® and DEGEVMA® (denosumab) Biosimilar to Xgeva® tevapharm.com ↗ the European Commission (EC) has granted marketing authorizations for its two denosumab biosimilar candidates – PONLIMSI, a biosimilar to Prolia®1 and DEGEVMA, a biosimilar to Xgeva®, following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) earlier this year.
2025-11-25	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva receives European Commission approvals for PONLIMSI® (denosumab) Biosimilar to Prolia® and DEGEVMA® (denosumab) Biosimilar to Xgeva® tevapharm.com ↗ Following the positive opinions of the Committee for Medicinal Products for Human Use (CHMP), the European Commission has granted marketing authorizations for Teva’s biosimilars PONLIMSI and DEGEVMA expanding access to important bone health treatments across Europe
2025-11-12	Shanghai Henlius Biotech	Regulatory The UK Medicines and Healthcare Products Regulatory Agency Approves BILDYOS® (denosumab) and BILPREVDA® (denosumab), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively henlius.com ↗
2025-10-30	Celltrion	Regulatory U.S. FDA grants interchangeability designation to Celltrion's denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) celltrion.com ↗ The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 29, 2025
2025-09-29	Roxane Laboratories	Regulatory Hikma and Richter receive FDA approval for denosumab biosimilars EnobyTM (denosumab- qbde) and XtrenboTM (denosumab- qbde) referencing Prolia® and Xgeva® respectively hikma.com ↗
2025-09-29	Gedeon Richter Ltd.	Regulatory Richter and Hikma receive FDA approval for denosumab biosimilars Enoby™ and Xtrenbo™, referencing Prolia® and Xgeva®, respectively gedeonrichter.com ↗ The FDA approval of Enoby TM , originally known as RGB-14-P and Xtrenbo TM , originally known as RGB-14-X, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Hikma to the FDA.
2025-09-19	Organon and Co	Regulatory European Commission (EC) Approves Henlius and Organon’s BILDYOS® (denosumab) and BILPREVDA® (denosumab), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively organon.com ↗ Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for BILDYOS® (denosumab) injection 60 mg/mL and BILPREVDA® (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.
2025-09-19	Shanghai Henlius Biotech	Regulatory European Commission (EC) Approves Henlius and Organon’s BILDYOS® (denosumab) and BILPREVDA® (denosumab), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively henlius.com ↗
2025-09-19	Alvotech Swiss AG	Regulatory Alvotech Announces Marketing Approval in Japan of Three New Biosimilars alvotech.com ↗
2025-09-02	Organon and Co	Regulatory 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 ↗ Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.
2025-09-02	Shanghai Henlius Biotech	Regulatory 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 henlius.com ↗ Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.
2025-07-07	Biocon Biologics UK Ltd	Regulatory Biocon Biologics Receives MHRA UK Approval for Vevzuo® and Evfraxy®, Denosumab Biosimilars bioconbiologics.com ↗ Vevzuo® is authorized for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.
2025-07-02	Shanghai Henlius Biotech	Regulatory Henlius Receives New EMA GMP Certification, Accelerating European Market Entry of Two Biosimilar Candidates henlius.com ↗ According to the GMP mutual recognition system among European Union (EU) member states, it marks that the related production lines have met the EU GMP standards.
2025-07-02	Fresenius Kabi	Regulatory mAbxience Announces European Commission Approval of Denosumab Biosimilars mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, is pleased to announce that the European Commission has granted approval for its denosumab biosimilars Denbrayce® and Izamby®. fresenius-kabi.com ↗ mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, is pleased to announce that the European Commission has granted approval for its denosumab biosimilars Denbrayce® and Izamby®.
2025-07-01	Gedeon Richter Ltd.	Regulatory Richter receives European Commission approval for Junod® and Yaxwer®, its biosimilar denosumab products for bone disease and osteoporosis gedeonrichter.com ↗ Gedeon Richter announces today that the European Commission (EC) granted marketing authorization for Junod® and Yaxwer®, its biosimilar denosumab products.
2025-05-30	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스, 엑스지바 바이오시밀러 국내 품목허가 획득 samsungbioepis.com ↗ 삼성바이오에피스(대표이사 김경아 사장)가 지난 30일 식품의약품안전처로부터 골질환 치료제 엑스브릭®(Xbryk®, 엑스지바 바이오시밀러, 성분명 데노수맙)의 품목허가를 획득했다.
2025-05-27	Fresenius Kabi	Regulatory Denosumab CHMP Positive Opinion fresenius.com ↗ Fresenius announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for its denosumab biosimilar candidates for the treatment of osteoporosis and other bone-related conditions.
2025-05-27	Fresenius Kabi	Regulatory Fresenius Receives Positive CHMP Opinion for their Denosumab Biosimilar Candidates Fresenius announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of its biosimilar candidates to Prolia® (denosumab) and Xgeva® (denosumab). fresenius-kabi.com ↗ Fresenius announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for the marketing authorization of its biosimilar candidates to (1)Prolia® (denosumab) and (2)Xgeva® (denosumab).
2025-05-21	Hanmi Pharmaceutical Company Limited	Results 한미약품 “출시 앞둔 ‘ 오보덴스’ , 한국인 포함 3상서 우수한 효과 확인” hanmi.co.kr ↗ 임상에 참여한 환자의 국가별 하위 그룹 분석 결과, 한국인에서도 오리지널 제제와 유사한 유효성을 보인 것으로 확인됐다.
2025-04-26	Biocon Biologics UK Ltd	Regulatory Biocon Biologics Receives Positive CHMP Opinions for Biosimilar Denosumab in Europe bioconbiologics.com ↗ the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the approval of its denosumab biosimilars candidates
2025-04-25	Gedeon Richter Ltd.	Regulatory Richter Receives Positive Opinion from CHMP for Marketing Authorisation for Junod® and Yaxwer®, its Biosimilar Denosumab Products for Bone Disease and Osteoporosis gedeonrichter.com ↗
2025-04-15	NPO Petrovax	Regulatory The first-ever biosimilar of original medicine for osteoporosis treatment has been approved in the Russian Federation petrovax.com ↗ The Ministry of Health of Russia has granted marketing authorization for Forsedeno ® (INN denosumab), the country’s first-ever biosimilar of the original targeted medicine used to treat osteoporosis.
2025-04-06	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스, 프롤리아 바이오시밀러 국내 품목허가 승인 samsungbioepis.com ↗ 삼성바이오에피스(대표이사 김경아 사장)가 식품의약품안전처로부터 골다공증 등의 치료제 오보덴스®(Obodence®, 프롤리아 바이오시밀러, 성분명 데노수맙)의 국내 품목허가를 획득했다고 6일 밝혔다.
2025-03-26	Fresenius Kabi	Regulatory Fresenius Receives FDA approval for their Denosumab Biosimilars and Secures Global Settlement fresenius.com ↗ Fresenius today announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the U.S. Food and Drug Administration (FDA).
2025-03-26	Fresenius Kabi	Regulatory Fresenius receives FDA approval for their Denosumab biosimilars and secures global settlement agreement Fresenius announced that the Biologics License Application (BLA) for the denosumab biosimilars Conexxence® (denosumab-bnht) and Bomyntra® (denosumab-bnht) of its operating company Fresenius Kabi has been approved by the FDA. fresenius-kabi.com ↗ Conexxence® (denosumab-bnht) and Bomyntra®(denosumab-bnht) received FDA approval for all indications of the reference products: Prolia®* (denosumab) and Xgeva®*(denosumab) respectively.
2025-03-18	Alvotech Swiss AG	Regulatory Alvotech and Dr. Reddy’s Announce FDA acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva® alvotech.com ↗ The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this biosimilar medication to more patients throughout the U.S.,
2025-03-04	Celltrion	Regulatory Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA® celltrion.com ↗ Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively for all indications of reference products.
2025-03-03	Impax Laboratories, LLC	Regulatory Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA amneal.com ↗
2025-02-19	Celltrion	Regulatory Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars celltrion.com ↗ Celltrion gains simultaneous regulatory approval of two monoclonal antibody biosimilars across three treatments – Eydenzelt® (aflibercept), Stoboclo® and Osenvelt® (denosumab) in the EU market
2025-02-16	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스, 골질환 치료제 2종 미국·유럽 품목허가 획득 samsungbioepis.com ↗ 삼성바이오에피스(대표이사 김경아 사장)가 미국 식품의약국(FDA: Food and Drug Administration)과 유럽 집행위원회(EC: European Commission)로부터 골질환 치료제 프롤리아∙엑스지바(Prolia & Xgeva, 성분명 데노수맙)1) 바이오시밀러 제품 2종의 품목허가를 각각 획득했다고 16일 밝혔다.
2024-12-16	Celltrion	Regulatory Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union celltrion.com ↗ Stoboclo (60 mg solution for injection in pre-filled syringe) and Osenvelt (120 mg solution for injection in vial) have been recommended for approval for all indications of the reference products Prolia® and Xgeva®, respectively.
2024-12-12	Roxane Laboratories	Regulatory Hikma and Richter announce FDA submission acceptance for Denosumab biosimilar products hikma.com ↗ FDA has accepted for review our application for Denosumab, an important biosimilar needed by a growing number of patients across the US
2024-11-19	Celltrion	Results Celltrion presents additional data from phase III randomized controlled trials to further support biosimilarity for CT-41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocilizumab) at ACR Convergence 2024 celltrion.com ↗ The results further support the biosimilarity between CT-P41 and reference denosumab in treating women with PMO.
2024-11-17	Samsung Bioepis Co., Ltd.	Regulatory 삼성바이오에피스, 내분비계/종양 질환 치료제 2종(種) 유럽 허가 권고 samsungbioepis.com ↗ 삼성바이오에피스(대표이사 고한승 사장)가 유럽 의약품청(EMA: European Medicines Agency) 산하 약물사용 자문위원회(CHMP: Committee for Medicinal Products for Human Use)로부터 프롤리아(Prolia)와 엑스지바(Xgeva)1)의 바이오시밀러 오보덴스™와 엑스브릭™(Obodence™ & Xbryk™, 프로젝트명 SB16, 성분명 데노수맙)의 품목허가 긍정 의견(positive opinion)을 획득했다고 17일 밝혔다.
2024-11-13	Alvotech Swiss AG	Regulatory Alvotech Reports Financial Results for the First Nine Months of 2024 alvotech.com ↗ Alvotech announced that the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for AVT03, a proposed biosimilar to Prolia® and Xgeva® (denosumab) and an MAA for AVT05, a proposed biosimilar to Simponi® (golimumab).
2024-10-08	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory Teva Prolia® (Denosumab) Biosimilar Candidate is Accepted for Review by U.S. FDA and EU EMA tevapharm.com ↗ Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Prolia® (denosumab).
2024-07-19	Gedeon Richter Ltd.	Regulatory Richter Announces Submission to EMA for Biosimilar Denosumab in Multiple Indications gedeonrichter.com ↗ Gedeon Richter Plc. (“Richter”) announces today that the European Medicines Agency (EMA) has accepted Richter’s two marketing authorization applications (MAAs) for its proposed biosimilar to denosumab.
2024-07-11	Fresenius Kabi	Regulatory Fresenius Announces EMA Acceptance for Review of Denosumab Biosimilar Candidates fresenius.com ↗ Fresenius, via its operating company Fresenius Kabi, announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Applications (MAAs) for its biosimilar candidates of Prolia® (denosumab) and Xgeva® (denosumab).
2024-07-11	Fresenius Kabi	Regulatory Fresenius Announces EMA Validation of Marketing Authorization Application for Denosumab Biosimilar Candidates European Medicines Agency has accepted for review the Marketing Authorization Applications for the biosimilar candidates of Prolia® (denosumab) and Xgeva® (denosumab) fresenius-kabi.com ↗ Fresenius, via its operating company Fresenius Kabi, announced that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Applications (MAAs) for its biosimilar candidates of Prolia® (denosumab) and Xgeva® (denosumab).
2024-07-02	Alvotech Swiss AG	Results Alvotech Announces Positive Topline Results from Confirmatory Patient Study for AVT03, a Proposed Biosimilar for Prolia® and Xgeva® alvotech.com ↗ Positive topline results demonstrate clinical similarity between AVT03 and the reference biologic, Prolia® (denosumab)
2024-05-27	Luye Pharma Group Ltd.	Regulatory 博安生物肿瘤领域地舒单抗注射液博洛加®在中国获批上市 luye.com ↗
2024-05-27	Fresenius Kabi	Regulatory Fresenius Announces FDA Acceptance for Review of Denosumab Biosimilar Application fresenius.com ↗ Fresenius, via its Operating Company Fresenius Kabi, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab).
2024-05-27	Fresenius Kabi	Regulatory Fresenius Announces U.S. FDA Acceptance for Review of Biologics License Application for Denosumab Biosimilar Candidate U.S. Food and Drug Administration has accepted for Review of Biologics License Application for our Denosumab Biosimilar Candidate fresenius-kabi.com ↗ Fresenius Kabi, an operating company of Fresenius, announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for FKS518, its biosimilar candidate of Prolia® (denosumab) and Xgeva® (denosumab).
2024-05-24	Organon and Co	Regulatory European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 organon.com ↗ Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar.
2024-05-24	Shanghai Henlius Biotech	Regulatory European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 henlius.com ↗ Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has validated the marketing authorization applications (MAAs) for HLX14, an investigational Prolia® and Xgeva® (denosumab) biosimilar.
2024-05-22	Sandoz	Regulatory Sandoz receives European Commission approval for Wyost® and Jubbonti®, the first and only biosimilars of denosumab in Europe sandoz.com ↗
2024-03-05	Sandoz	Regulatory Sandoz receives FDA approval for first and only denosumab biosimilars sandoz.com ↗ Sandoz, the global leader in generic and biosimilar medicines, today announced that the US Food and Drug Administration (FDA) approved Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz), the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines.
2024-02-01	Shanghai Henlius Biotech	Results Henlius Announces Successful Completion of Phase 1 PK Similarity Clinical Study of Denosumab HLX14 henlius.com ↗ The results of this study suggest that HLX14 had highly similar PK and PD, as well as comparable safety, tolerability, and immunogenicity to the reference drugs from different sources.
2023-10-16	Samsung Bioepis Co., Ltd.	Results 삼성바이오에피스, 골격계 질환 치료제 임상 데이터 최초 공개 samsungbioepis.com ↗ SB16과 오리지널 의약품 간 차이는 사전에 정의한 동등성 기준4)을 만족하여 두 그룹 간 효능이 동등한 것으로 확인됐다.
2023-07-12	Fresenius Kabi	Results Fresenius Kabi’s denosumab biosimilar candidate shows positive clinical trial results fresenius.com ↗ Fresenius Kabi announced today that its biosimilar candidate FKS518, a denosumab biosimilar candidate for the US reference product Prolia®*, successfully met its primary and secondary objectives in a recently conducted clinical trial on pharmacokinetic similarity.
2023-05-25	Sandoz	Regulatory Sandoz Marketing Authorization Applications for proposed biosimilar denosumab accepted by EMA sandoz.com ↗ Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review.
2023-05-25	Novartis Pharmaceuticals	Regulatory Sandoz Marketing Authorization Applications for proposed biosimilar denosumab accepted by EMA novartis.com ↗ Basel, May 25, 2023 — Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the European Medicines Agency (EMA) has accepted the marketing authorization applications (MAA) for proposed biosimilar denosumab for regulatory review.
2023-05-08	Amgen	Results NEW DATA FROM AMGEN'S PROLIA® (DENOSUMAB) DEMONSTRATES SIGNIFICANT REDUCTION IN OSTEOPOROTIC FRACTURE RISK COMPARED TO ALENDRONATE amgen.com ↗ Treatment with Prolia was also associated with greater reductions in fracture risk over time.
2023-03-21	Luye Pharma Group Ltd.	Regulatory 博安生物肿瘤领域地舒单抗注射液BA1102在华上市申请获受理 luye.com ↗ 博安生物自主开发的肿瘤领域生物类似药——BA1102（地舒单抗注射液）的上市许可申请已获得中国国家药品监督管理局药品审评中心受理.
2023-02-06	Sandoz	Regulatory Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA sandoz.com ↗ Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab.
2023-02-06	Novartis Pharmaceuticals	Regulatory Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA novartis.com ↗ Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for proposed biosimilar denosumab.
2023-01-18	BeOne Medicines	Regulatory BeiGene Announces Expansion of Coverage on China’s National Reimbursement Drug List beonemedicines.com ↗ KYPROLIS® (carfilzomib), a proteosome inhibitor licensed-in from Amgen, is included for the first time and XGEVA® (denosumab), a RANKL inhibitor and another Amgen asset, successfully renewed this year.
2022-11-11	Luye Pharma Group Ltd.	Regulatory 首个国产地舒单抗注射液！博优倍®获批上市 luye.com ↗ 2022年11月10日，绿叶制药集团宣布，其控股子公司博安生物自主研制的地舒单抗注射液（博优倍®）正式获得国家药品监督管理局的上市批准，用于骨折高风险的绝经后妇女的骨质疏松症；在绝经后妇女中，本品可显著降低椎体、非椎体和髋部骨折的风险.
2022-10-18	Luye Pharma Group Ltd.	Results 博安生物地舒单抗I期临床生物等效性研究结果发表于《Expert Opinion on Investigational Drugs》 luye.com ↗
2022-09-19	Sandoz	Results Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial sandoz.com ↗ Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announces further progress on its biosimilar pipeline, with the release of positive results from the integrated ROSALIA Phase I/III clinical trial study for its proposed biosimilar denosumab.
2022-09-19	Novartis Pharmaceuticals	Results Sandoz announces further progress on its biosimilar pipeline, with release of positive results for denosumab integrated Phase I/III clinical trial novartis.com ↗ Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announces further progress on its biosimilar pipeline, with the release of positive results from the integrated ROSALIA Phase I/III clinical trial study for its proposed biosimilar denosumab.
2021-10-14	Luye Pharma Group Ltd.	Regulatory 博安生物地舒单抗注射液在华上市申请获受理 luye.com ↗ 绿叶制药集团宣布，其控股子公司博安生物开发的地舒单抗注射液（LY06006 / BA6101）的上市许可申请已获得国家药品监督管理局药品审评中心受理.
2020-12-27	BeOne Medicines	Regulatory BeiGene Announces Inclusion of Three Innovative Oncology Products in China National Reimbursement Drug List (NRDL) beonemedicines.com ↗ The NRDL’s inclusion of tislelizumab, BRUKINSA, and XGEVA will help expand access to these high-quality oncology treatments across China and alleviate the financial burden for many cancer patients and their families.
2020-11-19	BeOne Medicines	Regulatory BeiGene Announces the Approval of XGEVA® (Denosumab) in China for the Prevention of Skeletal-Related Events in Patients With Bone Metastases From Solid Tumors and in Patients With Multiple Myeloma beonemedicines.com ↗ BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, today announced that the China National Medical Products Administration (NMPA) has approved XGEVA® (denosumab) for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and in patients with multiple myeloma (MM).
2018-06-08	Amgen	Regulatory European Commission Approves Prolia® (denosumab) for Patients With Glucocorticoid-Induced Osteoporosis amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has approved a new indication for Prolia ® (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
2018-05-21	Amgen	Regulatory FDA Approves Prolia® (Denosumab) For Glucocorticoid-Induced Osteoporosis amgen.com ↗
2018-04-27	Amgen	Regulatory Amgen Receives Positive CHMP Opinion To Expand Use Of Prolia® (denosumab) To Patients With Glucocorticoid-Induced Osteoporosis amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Prolia ® (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.
2018-04-03	Amgen	Regulatory European Commission Approves Expanded Indication For Amgen's XGEVA® (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the European Commission (EC) has approved an expanded indication for XGEVA ® (denosumab) for the prevention of skeletal-related events in adults with advanced malignancies involving bone.
2018-02-23	Amgen	Regulatory 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 ↗ Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion to expand the current indication for XGEVA ® (denosumab) to cover skeletal-related events in patients with multiple myeloma.
2018-02-08	Amgen	Results Results From Phase 3 XGEVA® (Denosumab) Study In Patients With Multiple Myeloma Published In The Lancet Oncology amgen.com ↗ In this study, XGEVA successfully met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95 percent CI: 0.85-1.14).
2018-02-02	Daiichi Sankyo	Results Daiichi Sankyo Announces Update on Amgen Inc.’s Phase 3 Clinical Trial Evaluating Denosumab as Adjuvant Breast Cancer Treatment daiichisankyo.com ↗ The trial did not meet its primary endpoint of bone metastasis-free survival.
2018-01-05	Amgen	Regulatory FDA Approves XGEVA® (denosumab) For The Prevention Of Skeletal-Related Events In Patients With Multiple Myeloma amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved the supplemental Biologics License Application (sBLA) for XGEVA ® (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
2017-10-09	Amgen	Regulatory FDA Accepts Supplemental Biologics License Application For Prolia® (Denosumab) In Glucocorticoid-Induced Osteoporosis amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted for review the supplemental Biologics License Application (sBLA) for Prolia ® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP).
2017-09-08	Amgen	Results Amgen Highlights The Latest EVENITY™ (Romosozumab) And Prolia® (Denosumab) Research At The American Society For Bone And Mineral Research Annual Meeting amgen.com ↗ Prolia presentations will include new analyses from the Phase 3 FREEDOM study and its seven-year extension, including one that demonstrates 10-year continued nonvertebral fracture reduction.
2017-07-31	Amgen	Regulatory Amgen Submits Supplemental Biologics License Application For Prolia® (denosumab) In Glucocorticoid-Induced Osteoporosis amgen.com ↗ Amgen (NASDAQ:AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration ( FDA ) for Prolia ® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP).
2017-07-03	Daiichi Sankyo	Regulatory Daiichi Sankyo Obtains Approval for Additional Indication for PRALIA® Subcutaneous Injection 60mg Syringe daiichisankyo.com ↗ Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has obtained approval in Japan for an additional indication for “inhibition of the progression of bone erosion associated with rheumatoid arthritis” for PRALIA® Subcutaneous Injection 60 mg Syringe (generic name: denosumab).
2017-06-21	Amgen	Results Amgen To Present New Data At 22nd Congress of the European Hematology Association amgen.com ↗ This analysis demonstrated an improved delay in time to first skeletal-related event for the XGEVA treated patients.
2017-06-19	Amgen	Regulatory FDA Accepts Amgen's Supplemental Biologics License Application To Expand Indication For XGEVA® (denosumab) To Include Multiple Myeloma Patients amgen.com ↗ Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has accepted the XGEVA ® (denosumab) supplemental Biologics License Application (sBLA) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
2017-06-04	Amgen	Results Amgen Presents New Data From Phase 3 XGEVA® (Denosumab) Study In Patients With Multiple Myeloma At ASCO 2017 amgen.com ↗ The study met its primary endpoint, demonstrating XGEVA is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95 percent CI: 0.85, 1.14; p =0.01).
2017-04-04	Amgen	Regulatory Amgen Submits Applications In The US And Europe To Expand Current Indication For XGEVA® (denosumab) To Include Patients With Multiple Myeloma amgen.com ↗ Amgen (NASDAQ:AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration ( FDA ) and an application for a variation to the marketing authorization to the European Medicines Agency (EMA) for XGEVA ® (denosumab).
2017-03-03	Amgen	Results Amgen Presents New Data From Phase 3 XGEVA® (denosumab) Study In Multiple Myeloma Patients At The 16th International Myeloma Workshop amgen.com ↗ In this study, XGEVA ® (denosumab) met the primary endpoint, demonstrating non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma (HR=0.98, 95 percent CI: 0.85, 1.14; p= 0.01).
2017-03-01	Amgen	Results Amgen To Present New KYPROLIS® (Carfilzomib) And XGEVA® (Denosumab) Data At The 16th International Myeloma Workshop amgen.com ↗ XGEVA demonstrated non-inferiority to zoledronic acid in delaying bone complications in patients with multiple myeloma.
2016-10-20	Amgen	Results Amgen Announces Positive Top-Line Results From XGEVA® (Denosumab) Phase 3 Trial For Delay Of Bone Complications In Multiple Myeloma Patients amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that a Phase 3 study evaluating XGEVA ® (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority (hazard ratio = 0.98, 95 percent CI, 0.85 - 1.14) in delaying the time to first on-study skeletal-related event (SRE) in patients with multiple myeloma.
2016-09-23	Daiichi Sankyo	Regulatory Daiichi Sankyo Announces Application in Japan for Additional Indication for Anti-RANKL Antibody, Denosumab daiichisankyo.com ↗ Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced that it has applied for additional indication of denosumab (product name: PRALIA® subcutaneous injection 60mg syringe) for rheumatoid arthritis-related treatment.
2016-08-29	Amgen	Results Amgen Announces Positive Top-Line Results From Phase 3 Study Of Prolia® (Denosumab) In Patients Receiving Glucocorticoid Therapy amgen.com ↗ Amgen (NASDAQ: AMGN) today announced positive top-line results from the primary analysis conducted in a Phase 3 randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia ® (denosumab) compared with risedronate in patients receiving glucocorticoid treatment.
2016-03-30	Daiichi Sankyo	Results Daiichi Sankyo Announces Phase 3 Clinical Trial Results for AMG 162 (denosumab) Rheumatoid Arthritis Treatment daiichisankyo.com ↗ In this study, denosumab showed excellent effects in preventing structural joint damage.
2015-10-12	Amgen	Results New Data Show Consistent Safety Profile For Up To 10 Years With Prolia® (Denosumab) In Postmenopausal Women With Osteoporosis amgen.com ↗ In this final analysis, treatment with Prolia ® (denosumab) for up to 10 years showed that the overall incidence of adverse events (AEs) and serious AEs remained consistent over the duration of the study with a low fracture incidence.
2015-10-11	Amgen	Results New Data Show Greater Bone Mineral Density Gains With Prolia® (Denosumab) Compared With Zoledronic Acid amgen.com ↗ The change from baseline in lumbar spine BMD at 12 months – the primary endpoint – in the denosumab group was significantly greater than that in the zoledronic acid group: 3.2 percent vs. 1.1 percent, respectively ( p <0.0001).
2015-06-01	Amgen	Results Amgen Presents Phase 3 Data At ASCO Showing Prolia® (Denosumab) Significantly Reduced Bone Fractures In Breast Cancer Patients Receiving Aromatase Inhibitors amgen.com ↗ The trial met its primary endpoint of time from randomization to first clinical fracture (HR=0.5, 95 percent CI 0.39-0.65, p <0.0001).
2014-12-08	Amgen	Regulatory FDA Approves Amgen's XGEVA® (Denosumab) For The Treatment Of Hypercalcemia Of Malignancy Refractory To Bisphosphonate Therapy amgen.com ↗ Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration ( FDA ) has approved a new indication for XGEVA ® (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.
2014-05-23	Daiichi Sankyo	Regulatory Daiichi Sankyo Receives Approval in Japan for Additional Indication Related to RANMARKⓇ for Treatment of Giant Cell Tumor of Bone daiichisankyo.com ↗ Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has received approval in Japan for partial modification to RANMARKⓇ(subcutaneous injection 120mg) (JAN: denosumab (genetic recombination)), a gene recombinant drug to treat giant cell tumor of bone (hereafter, GCTB).
2013-08-29	Daiichi Sankyo	Regulatory Daiichi Sankyo Submits Application to Manufacture and Market RANMARK® for Treatment of Giant Cell Tumor Of Bone in Japan daiichisankyo.com ↗ Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced that it has filed an application for approval in Japan to manufacture and market RANMARK® (subcutaneous injection 120 mg) (INN: Denosumab (genetic recombination)), a gene recombinant drug to treat giant cell tumor of bone(hereafter, GCTB).
2013-03-25	Daiichi Sankyo	Regulatory Daiichi Sankyo Receives Approval in Japan for Manufacture and Marketing of PRALIA(R), a New Treatment for Osteoporosis daiichisankyo.com ↗ Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), announced today that it has received approval from Japan’s Ministry of Health, Labour and Welfare to manufacture and market the osteoporosis treatment PRALIA® subcutaneous injection 60mg syringe (INN: Denosumab; genetic recombination) for the treatment of osteoporosis.
2012-10-15	Daiichi Sankyo	Results Positive Phase 3 Study Results for Denosumab on Fracture Risk in Japanese Patients with Osteoporosis Presented at ASBMR daiichisankyo.com ↗ Denosumab significantly reduced the incidence of new or worsening VFXs (3.6%) compared to placebo (10.3%); hazard ratio [HR]=0.343; 95% CI:0.194, 0.606; p=0.0001).
2012-03-23	Daiichi Sankyo	Regulatory Daiichi Sankyo Files for Approval in Japan to Market AMG 162 (denosumab), a Treatment for Osteoporosis daiichisankyo.com ↗ Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced that it has filed for approval in Japan to market AMG 162 (denosumab), a gene recombinant drug for osteoporosis.
2012-01-18	Daiichi Sankyo	Regulatory Daiichi Sankyo Receives Approval in Japan to Market RANMARK(R), a Treatment for Bone Complications Stemming from Multiple Myeloma and Bone Metastases from Solid Tumors daiichisankyo.com ↗ Daiichi Sankyo Co., Ltd. (hereafter, Daiichi Sankyo) today announced that it has received approval in Japan to market RANMARK (denosumab), a treatment for bone complications stemming from multiple myeloma and bone metastases from solid tumors.
2010-08-25	Daiichi Sankyo	Regulatory Daiichi Sankyo Files for Approval to Manufacture and Market AMG 162 (Denosumab) in Japan daiichisankyo.com ↗ Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo), today announced that it has filed for approval in Japan to manufacture and market AMG 162 (Denosumab), a gene recombinant drug for bone disorders stemming from bone metastases.

All press releases naming this drug 154 releases

Date	Issuer	Release
Show all 154 releases opens the full record — a long page

Evidence & citations 26 cited values

Every value below carries the sentence it was read from. 284 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 ↗ 241 “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 Show 231 more sources
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 ↗ NCT00306189 ↗ NCT00104650 ↗ NCT00089661 ↗ NCT00089674 ↗
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	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 2022 1 “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 NCT05215977 ↗ 1 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 Show 38 more sources
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 ↗ 4 “Drug: QL1206” NCT04128163 ↗ NCT04550949 ↗ NCT04213105 ↗ NCT03651947 ↗
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 ↗ 2 NCT03242512 ↗ NCT03487055 ↗
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” NCT05212337 ↗ “Denosumab, a drug used in millions of patients worldwide under trade names Prolia® and Xgeva®, inhibits the RANKL pathway” NCT06300229 ↗ “Xgeva® injection (120mg) by subcutaneous injection once on the first day” NCT04198636 ↗ “Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]” NCT03691311 ↗ “Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]” NCT03792763 ↗ “Denosumab 70 MG/ML [Xgeva]” NCT03270020 ↗ “Denosumab (XGEVA®)” NCT03669523 ↗ NCT05777109 ↗ NCT03869762 ↗ NCT04550949 ↗ Show 7 more sources
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 ↗