Drug Type Monoclonal antibody |
Synonyms anti-RANKL antibody, Denosumab (Genetical Recombination), Denosumab (genetical recombination) (JAN) + [14] |
Target |
Action inhibitors |
Mechanism RANKL inhibitors(Tumor necrosis factor ligand superfamily member 11 inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (26 May 2010), |
RegulationOrphan Drug (United States), Conditional marketing approval (China), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China), Priority Review (China) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Glucocorticoid-induced osteoporosis | United States | 18 May 2018 | |
Humoral Hypercalcemia of Malignancy | United States | 04 Jan 2018 | |
Rheumatoid Arthritis | Japan | 03 Jul 2017 | |
Bone Cancer | Japan | 18 Jan 2012 | |
Multiple Myeloma | Japan | 18 Jan 2012 | |
Bone Diseases | European Union | 13 Jul 2011 | |
Bone Diseases | Iceland | 13 Jul 2011 | |
Bone Diseases | Liechtenstein | 13 Jul 2011 | |
Bone Diseases | Norway | 13 Jul 2011 | |
Giant Cell Tumor of Bone | European Union | 13 Jul 2011 | |
Giant Cell Tumor of Bone | Iceland | 13 Jul 2011 | |
Giant Cell Tumor of Bone | Liechtenstein | 13 Jul 2011 | |
Giant Cell Tumor of Bone | Norway | 13 Jul 2011 | |
Bone metastases | United States | 18 Nov 2010 | |
Osteoporosis | Australia | 07 Jun 2010 | |
Bone Diseases, Metabolic | European Union | 26 May 2010 | |
Bone Diseases, Metabolic | Iceland | 26 May 2010 | |
Bone Diseases, Metabolic | Liechtenstein | 26 May 2010 | |
Bone Diseases, Metabolic | Norway | 26 May 2010 | |
Fractures, Bone | European Union | 26 May 2010 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Atypical anorexia nervosa | Phase 3 | United States | 25 Oct 2017 | |
Feeding and Eating Disorders | Phase 3 | United States | 25 Oct 2017 | |
Osteogenesis Imperfecta | Phase 3 | United States | 24 Jun 2015 | |
Osteogenesis Imperfecta | Phase 3 | Australia | 24 Jun 2015 | |
Osteogenesis Imperfecta | Phase 3 | Belgium | 24 Jun 2015 | |
Osteogenesis Imperfecta | Phase 3 | Bulgaria | 24 Jun 2015 | |
Osteogenesis Imperfecta | Phase 3 | Canada | 24 Jun 2015 | |
Osteogenesis Imperfecta | Phase 3 | Czechia | 24 Jun 2015 | |
Osteogenesis Imperfecta | Phase 3 | France | 24 Jun 2015 | |
Osteogenesis Imperfecta | Phase 3 | Germany | 24 Jun 2015 |
Not Applicable | Giant Cell Tumor of Bone Neoadjuvant | Adjuvant | 31 | mjfqqnhpkx(bcuzwjeosx) = hvsosrqsfn ogrvxxhken (kiftsuobhw, 1 - 150) View more | - | 30 May 2025 | ||
Not Applicable | 340 | zyvqdhbqdu(lxdbbngzuu): P-Value = 0.027 | Positive | 30 May 2025 | |||
Bisphosphonate switching to Denosumab | |||||||
Not Applicable | - | dxhimwtypq(ktrzfggola) = tzososxdze xynwpxuual (vcxutfrghe ) View more | Positive | 30 May 2025 | |||
(Control Group) | dxhimwtypq(ktrzfggola) = udfokpshyk xynwpxuual (vcxutfrghe ) View more | ||||||
Not Applicable | Premenopausal breast cancer Adjuvant | 69 | myourcvhxs(jmgmywbkbd) = One ONJ case occurred (1.4 %) with no fractures reported pmiqgxiuvi (byxwciglii ) | Positive | 14 May 2025 | ||
Not Applicable | Multiple Myeloma urinary N-terminal telopeptide of type 1 collagen | bone alkaline phosphatase | serum C-terminal telopeptide of type 1 collagen | 236 | Narlumosbart 120 mg SC Q4W | kqkeysqboy(fornfhcxcr) = efxttkpoma usaxtchxfu (nhdhulpijr ) View more | Positive | 14 May 2025 | |
kqkeysqboy(fornfhcxcr) = bwjbfyfbkl usaxtchxfu (nhdhulpijr ) View more | |||||||
Not Applicable | Second line BRCA1/2 | 1,399 | tkqzmosulv(luumjtjsgg) = mhiilxpqej nagijtcovw (lorywqkxkk, 24 - NR) | Positive | 14 May 2025 | ||
(BRCA1/2-mutated HR+/HER2- bone metastatic breast cancer patients) | tkqzmosulv(luumjtjsgg) = gidkfdodzw nagijtcovw (lorywqkxkk, 9 - 27) | ||||||
Phase 2 | - | buqylmmiqo(nedkaauhmi) = hwrmfsghmg qrdqujgiwg (akmudinecc ) | Positive | 08 Apr 2025 | |||
Placebo | buqylmmiqo(nedkaauhmi) = iyyagtbmqb qrdqujgiwg (akmudinecc ) | ||||||
Not Applicable | - | pcaxezlbgh(ggsizkyzzf) = msuaofvekp lbuhovjuid (wutupfsncf ) View more | Positive | 21 Mar 2025 | |||
(Control Group) | pcaxezlbgh(ggsizkyzzf) = orxdirlial lbuhovjuid (wutupfsncf ) View more | ||||||
Phase 3 | - | (Study 20050136 Metastatic Breast Cancer) | lwilzcxbla(xwyzumpvsj) = rbenutvubi jlrpddqaom (wchrfmqtks ) View more | Positive | 28 Feb 2025 | ||
(Study 20050136 Metastatic Breast Cancer) | lwilzcxbla(xwyzumpvsj) = aekjcwjarm jlrpddqaom (wchrfmqtks ) View more | ||||||
Phase 2 | 187 | avoifkghml(bbemhupmje) = mtituaifcl asjrveauqy (lekjloqivz, 19 - 32) View more | Positive | 28 Feb 2025 |