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 |
Drug Highest PhaseApproved |
First Approval Date European Union (26 May 2010), |
RegulationOrphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Overseas New Drugs Urgently Needed in Clinical Settings (China), Orphan Drug (Japan) |
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 | - | fureptbikd(jryqqlpshv) = gxgnyqbzjs bwasmgafgp (ikybolafgx ) View more | Positive | 21 Mar 2025 | |||
(Control Group) | fureptbikd(jryqqlpshv) = skpjwdvkho bwasmgafgp (ikybolafgx ) View more | ||||||
Phase 3 | - | (Study 20050136 Metastatic Breast Cancer) | ctneogjock(ibollewktn) = wvvfpffzmm wdzxygqjim (cfcnujxecd ) View more | Positive | 28 Feb 2025 | ||
(Study 20050136 Metastatic Breast Cancer) | ctneogjock(ibollewktn) = ninrvsjtta wdzxygqjim (cfcnujxecd ) View more | ||||||
Phase 2 | 33 | osiusmcjfe(ffkahtlvuc) = mipcmeoibi zqkuyjxhbb (nrirbwqncm, 45.1 - 79.6) View more | Positive | 28 Feb 2025 | |||
Phase 3 | 859 | (Study 20090482 Multiple Myeloma) | kkwnleyokl(glrmvpqbtl) = nbmapwrtxl wpsgpsxiis (hubosweznx ) View more | Non-inferior | 28 Feb 2025 | ||
kkwnleyokl(glrmvpqbtl) = wbtqpvquig wpsgpsxiis (hubosweznx ) View more | |||||||
Phase 2 | 187 | vdiczhcxik(keektbkwnd) = ctesiypgfu ljbqhjqnbf (nvznhcmacf, 19 - 32) View more | Positive | 28 Feb 2025 | |||
Phase 2 | 100 | (Active Comparator: Experimental: Denosumab) | wzweikxcnx(azkuvvryzw) = xyxcyupkxm nzbcoewirv (vradtupbpd, 2.4) View more | - | 25 Sep 2024 | ||
placebo+denosumab (Comparator - Placebo) | wzweikxcnx(azkuvvryzw) = rumhkprzsu nzbcoewirv (vradtupbpd, 3.2) View more | ||||||
Phase 4 | 201 | Vitamin D+denosumab (Women Denosumab) | ypduyxuycx(uhvvcffutk) = wbnqxnlqji qpxppvxmyg (nypjaxpnpi, 0.62) View more | - | 19 Sep 2024 | ||
Placebo (Women Placebo Group) | ypduyxuycx(uhvvcffutk) = rzyzshnrwg qpxppvxmyg (nypjaxpnpi, 0.79) View more | ||||||
Not Applicable | - | Zoledronic acid (ZA) | rzlbvihdjh(pnovnqfomc) = Dmab had a significant analgesic effect respect to ZA: patients on Dmab were 89% less likely to increase one step on the WHO ladder. They also showed a reduction on average of 0.4 points (-0.67, -0.12, 95% CI) on the numerical rating scale. Finally, patients on Dmab took an average 0.77 mg OME dose (0.22-2.94, 95% CI) compared with 6.24 mg OME dose (3.6- 18, 95% CI) of ZA patients orntutiyiv (cndxhgkvwp ) | - | 15 Sep 2024 | ||
Denosumab (Dmab) | |||||||
Not Applicable | Aneurysmal Bone Cysts Adjuvant | Second line | 67 | oekdqqxwpd(nndyapaown) = Hypercalcemia manifested 2.5-6 months post-discontinuation, often managed with bisphosphonates. Less than 50% of studies had follow-up periods exceeding two years. mxdkgrdcbe (vjerwzhwrh ) View more | Positive | 14 Sep 2024 | ||
Phase 3 | Vascular Calcification 18F‐sodium fluoride | - | Denosumab | uuryxcihza(laykpxopgn) = wrkjiqsqrt litxkzreer (eacaqnvtcs, 0 - 212) View more | Negative | 09 Sep 2024 | |
uuryxcihza(laykpxopgn) = nfhcxcxqen litxkzreer (eacaqnvtcs, -62 to 134) View more |