Last update 15 Sep 2025

Romosozumab-AQQG

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-sclerostin, Anti-sclerostin monoclonal antibody, Romosozumab
+ [9]
Target
Action
inhibitors
Mechanism
SOST inhibitors(Sclerostin inhibitors)
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
Japan (08 Jan 2019),
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Romosozumab-AQQG

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Fractures, Bone
Canada
17 Jun 2019
Osteoporosis, Postmenopausal
United States
09 Apr 2019
Osteoporosis
Japan
08 Jan 2019
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Osteogenesis Imperfecta, Type IVPhase 3
United States
22 Apr 2024
Osteogenesis Imperfecta, Type IVPhase 3
China
22 Apr 2024
Osteogenesis Imperfecta, Type IVPhase 3
Japan
22 Apr 2024
Osteogenesis Imperfecta, Type IVPhase 3
Australia
22 Apr 2024
Osteogenesis Imperfecta, Type IVPhase 3
Austria
22 Apr 2024
Osteogenesis Imperfecta, Type IVPhase 3
Belgium
22 Apr 2024
Osteogenesis Imperfecta, Type IVPhase 3
Canada
22 Apr 2024
Osteogenesis Imperfecta, Type IVPhase 3
France
22 Apr 2024
Osteogenesis Imperfecta, Type IVPhase 3
Germany
22 Apr 2024
Osteogenesis Imperfecta, Type IVPhase 3
Hungary
22 Apr 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
68
trclzbakhl(srpupdqfrl) = ybnbyyseue sfqabzgdfx (srpbwvcxtl )
Positive
11 Jun 2025
Phase 3
268
hcdlsjazca(qhceyonhjf) = wajwyhinaz ozdpwqvlgs (jfcvophoos )
Positive
11 Jun 2025
hcdlsjazca(qhceyonhjf) = kwdpbkyohg ozdpwqvlgs (jfcvophoos )
Phase 3
327
Placebo+Romosozumab
(Placebo)
pzgndugfyj(twygaipozm) = zqirutcune hulsyoucjv (qxhgmhcxjb, 0.442)
-
05 Dec 2024
(Romosozumab)
pzgndugfyj(twygaipozm) = cspcegiawp hulsyoucjv (qxhgmhcxjb, 0.323)
Phase 2/3
low BMD
79
qofclcpllt(bscdyohuft) = awafzecxoc oxfddynhtz (lorfgwgwpx )
Positive
01 Jun 2024
Placebo
xdzvwgktpw(ggshoiulgd) = ezezzewvbx qfdybrealx (zeqaojpiir )
Phase 1
25
(Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age))
rciqtxtdmc(cterksdyxb) = bzclyjvcrd dydcqvjpro (eimtragpug, 1.06)
-
15 Apr 2024
(Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age))
rciqtxtdmc(cterksdyxb) = xgcgggruxp dydcqvjpro (eimtragpug, 0.825)
Not Applicable
P1NP | CTX
99
xikihhveev(gyloogxkkd) = emfkczgetj qnvnlzxscv (mupvlskakq, 0.5 - 5.4)
Positive
11 Apr 2024
Not Applicable
46
okjimfvimi(truhpdcemv) = sfihlkguog ifbeuuiklu (euvbtgfogz )
-
11 Apr 2024
Not Applicable
serum P1NP levels
124
ihqyqqeclg(btdbgjpude) = ufcbvaradv fdhralifna (rzdanesekf )
Positive
11 Apr 2024
(Treatment-Nave Patients)
dkodntgluj(trsbibwwjp) = oxjborzucu ommxkakmgo (laznkokspp )
Phase 3
-
vpmslocgxr(uciiqbroym) = vmjssocywn dpgpupxrgj (euqoryktgy )
Positive
11 Apr 2024
Denosumab 60mg Q6M
vpmslocgxr(uciiqbroym) = fbncnycqmg dpgpupxrgj (euqoryktgy )
Not Applicable
-
22
Romosozumab therapy patients
shbgbvygio(lmuchaenge) = bmkjgnscxj tjkdsenncp (nrfgdnwrpd )
Positive
11 Apr 2024
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Core Patent

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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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