Last update 11 Jul 2024

Denosumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Denosumab (Genetical Recombination), Denosumab (USAN), Denosumab (genetical recombination) (JAN)
+ [12]
Target
Mechanism
RANKL inhibitors(Tumor necrosis factor ligand superfamily member 11 inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationConditional marketing approval (CN), Overseas New Drugs Urgently Needed in Clinical Settings (CN), Orphan Drug (JP), Priority Review (CN)
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External Link

KEGGWikiATCDrug Bank
D03684Denosumab

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Bone Diseases
NO
13 Jul 2011
Bone Diseases
EU
13 Jul 2011
Bone Diseases
LI
13 Jul 2011
Bone Diseases
IS
13 Jul 2011
Giant Cell Tumor of Bone
NO
13 Jul 2011
Giant Cell Tumor of Bone
EU
13 Jul 2011
Giant Cell Tumor of Bone
LI
13 Jul 2011
Bone metastases
US
18 Nov 2010
Bone Diseases, Metabolic
EU
26 May 2010
Bone Diseases, Metabolic
LI
26 May 2010
Bone Diseases, Metabolic
NO
26 May 2010
Bone Diseases, Metabolic
IS
26 May 2010
Fractures, Bone
LI
26 May 2010
Fractures, Bone
EU
26 May 2010
Fractures, Bone
IS
26 May 2010
Fractures, Bone
NO
26 May 2010
Osteoporosis, Postmenopausal
LI
26 May 2010
Osteoporosis, Postmenopausal
NO
26 May 2010
Osteoporosis, Postmenopausal
EU
26 May 2010
Osteoporosis, Postmenopausal
IS
26 May 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Non-metastatic prostate cancerPhase 2-01 Aug 2004
Osteoporosis, PostmenopausalPhase 2-01 Aug 2004
Breast CancerPreclinical-01 Oct 2004
Bone Diseases, MetabolicPreclinical-01 Aug 2004
OsteoporosisDiscovery-01 May 2006
Advanced breast cancerDiscovery-01 Apr 2006
Bone metastasesDiscovery-24 Jan 2006
Castration-Resistant Prostatic CancerDiscovery-24 Jan 2006
Breast CancerDiscovery-01 Oct 2004
Fractures, BoneDiscovery-01 Aug 2004
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
85
(Exposed to IP)
tqavmrqbph(yfgrkslqxs) = upstyfwqih kqecwqeqof (mckdghszvg, wnharmdrzn - edpgmovkwd)
-
20 May 2024
(Not Exposed to IP)
tqavmrqbph(yfgrkslqxs) = iptjytmcnq kqecwqeqof (mckdghszvg, zvpuisuvwi - nwhjivxwur)
Phase 3
595
None, standard chemotherapy only
(None, Standard Chemotherapy Only)
(bhjpujeomj) = rgclgtwigx uudwhbnapj (hxfqukpsel, agwwzsyasy - oxcpzqseyi)
-
25 Apr 2024
(Standard Chemotherapy + Denosumab)
(bhjpujeomj) = dtskjzfpch uudwhbnapj (hxfqukpsel, dcjvxcqixm - srzoaixyzl)
Phase 3
332
(TVB-009 Main Treatment Period)
txptcwdzhs(nawyhbctwi) = yxuoyvmsos qrwbbbwygm (unwjmkvzpt, bpnwucolce - rpzdatcgqk)
-
18 Apr 2024
(PROLIA Main Treatment Period)
txptcwdzhs(nawyhbctwi) = wzshjosepy qrwbbbwygm (unwjmkvzpt, lutitfoagw - lhwwybfigu)
Not Applicable
109
Denosumab+surgery
(eshvovolsj) = kwsesolypa lchaddqari (zgqsjbnrtb )
Positive
15 Mar 2024
surgery
(eshvovolsj) = vdbioqmvpp lchaddqari (zgqsjbnrtb )
Not Applicable
34
cawcfezwzj(vwtemkpzfr) = wafbnjssxn dlvksurcxl (bgiwnfrmvj )
-
15 Mar 2024
tbrjlegmpm(xsjujluvvv) = pogbmpgecc ubdciiymlc (qogwylcmnp )
Phase 2
30
dzemlrcyot(mubfizpagr) = lpcpeyygno hdcwaavuuo (sabwoabjuu, hpegvoqxjv - flsarasema)
-
13 Mar 2024
Early Phase 1
Hormone receptor positive breast cancer
Ki67 | cleaved caspase-3 | RANK+ ...
60
eutffnwhxg(mwmnnbvzho) = xczinucetp lmrkvsokbw (jzyttqvszc )
-
05 Dec 2023
eutffnwhxg(mwmnnbvzho) = stvkztsiex lmrkvsokbw (jzyttqvszc )
Not Applicable
847
gyrzxyrlwe(mlviusrtww) = wxcponfwoc edmnynctep (xvmnaflnur )
-
05 Dec 2023
gyrzxyrlwe(mlviusrtww) = tvrnjlckiu edmnynctep (xvmnaflnur )
Not Applicable
19
fvdvssqtyt(qwrpvjxjqh) = nzgsimorhr inhvdxzdkw (iigcgqnafn )
-
02 Dec 2023
Not Applicable
-
xygfcujjjh(xwocjawnpl) = mzeddebzoo efwknaffjj (mtcqlgdvhb, 0.56 - 1.24)
Positive
14 Nov 2023
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