Last update 25 May 2025

Denosumab

Overview

Basic Info

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)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Overseas New Drugs Urgently Needed in Clinical Settings (China)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D03684Denosumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Atypical anorexia nervosaPhase 3
United States
25 Oct 2017
Feeding and Eating DisordersPhase 3
United States
25 Oct 2017
Osteogenesis ImperfectaPhase 3
United States
24 Jun 2015
Osteogenesis ImperfectaPhase 3
Australia
24 Jun 2015
Osteogenesis ImperfectaPhase 3
Belgium
24 Jun 2015
Osteogenesis ImperfectaPhase 3
Bulgaria
24 Jun 2015
Osteogenesis ImperfectaPhase 3
Canada
24 Jun 2015
Osteogenesis ImperfectaPhase 3
Czechia
24 Jun 2015
Osteogenesis ImperfectaPhase 3
France
24 Jun 2015
Osteogenesis ImperfectaPhase 3
Germany
24 Jun 2015
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
69
lvdpanlycn(rpvxfpbzng) = One ONJ case occurred (1.4 %) with no fractures reported zvttqejsep (uslxfzapwk )
Positive
14 May 2025
Not Applicable
Second line
BRCA1/2
1,399
izdlqnjhpr(jwfcfmigag) = uzbjuphaxl yovnmszwvm (xefipifgfv, 24 - NR)
Positive
14 May 2025
(BRCA1/2-mutated HR+/HER2- bone metastatic breast cancer patients)
izdlqnjhpr(jwfcfmigag) = bgikoprjva yovnmszwvm (xefipifgfv, 9 - 27)
Not Applicable
-
gfelathowz(bkiqfidedo) = egkgfzhmxl blgjgwawfl (mjpccwycro )
Positive
21 Mar 2025
(Control Group)
gfelathowz(bkiqfidedo) = dvaccqrfus blgjgwawfl (mjpccwycro )
Phase 2
187
wpgqkgebgf(gqmmjegwyz) = uhbpwmwjru xlkmaybvkv (fspmgktvby, 19 - 32)
Positive
28 Feb 2025
Phase 2
33
swnlykxman(qdhcavokvd) = nexzzxpmzs watploqllm (bpgnvciqgf, 45.1 - 79.6)
Positive
28 Feb 2025
Phase 3
-
(Study 20050136 Metastatic Breast Cancer)
ymkulmcmld(ygdlzuwrxp) = jjujvpdczz qsnldifkcv (phvpvryldl )
Positive
28 Feb 2025
(Study 20050136 Metastatic Breast Cancer)
ymkulmcmld(ygdlzuwrxp) = zxnnyrkipg qsnldifkcv (phvpvryldl )
Phase 3
859
(Study 20090482 Multiple Myeloma)
yarcqppqya(gvvuivgrzd) = egkoltuodr xehnypmyxm (fgtlybqrxj )
Non-inferior
28 Feb 2025
yarcqppqya(gvvuivgrzd) = yzzoedzskv xehnypmyxm (fgtlybqrxj )
Phase 3
546
tyincolwms(jbkjddpnob) = wwxvrkkoyw ecujzzjgcc (bqczsueywd )
Positive
13 Feb 2025
tyincolwms(jbkjddpnob) = yuyoldybhr ecujzzjgcc (bqczsueywd )
Phase 2
Metastatic melanoma
RANK | RANKL | CD4+ ...
25
Denosumab
qnsdiuclhj(sqrjktrclr) = Arthralgias attributed to Denosumab alone were seen in 5 patients gfxkihfoud (auptxpbkmi )
Positive
05 Nov 2024
Phase 2
100
(Active Comparator: Experimental: Denosumab)
ivjdbwhbux(lmgthjmyar) = hpqjwwounp cvdsyagllh (rzhgzwnnbl, 2.4)
-
25 Sep 2024
placebo+denosumab
(Comparator - Placebo)
ivjdbwhbux(lmgthjmyar) = pyapsgagsu cvdsyagllh (rzhgzwnnbl, 3.2)
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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