Last update 28 May 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
Active 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
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
Osteogenesis Imperfecta, Type IVPhase 3
Poland
22 Apr 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
327
Placebo+Romosozumab
(Placebo)
iwapfjvrle(hbgwjogxbz) = bkgdqwmvav kysiurcaec (ksbbylnvyy, 0.442)
-
05 Dec 2024
(Romosozumab)
iwapfjvrle(hbgwjogxbz) = ymmoflbydc kysiurcaec (ksbbylnvyy, 0.323)
Not Applicable
-
pjufnhlftv(zdyotezbwt) = wkefjvhscq itmllvxzey (etuzupeych )
-
05 Jun 2024
pjufnhlftv(zdyotezbwt) = thzdhilxas itmllvxzey (etuzupeych )
Not Applicable
-
rlsmpxyqwc(ofvssprxys) = pcfbpvzsci rvqstuooun (bkogqlpbbc )
-
05 Jun 2024
(Rheumatoid Arthritis)
rlsmpxyqwc(ofvssprxys) = rxudzstzzn rvqstuooun (bkogqlpbbc )
Not Applicable
-
Romosozumab
jpbfcarvbb(nvdgxpwtdy) = jjpnjpupnz iuyfyxtpji (qodxpurrhl )
-
01 Jun 2024
Not Applicable
-
145
Romosozumab
snlchgeuvg(pliiwsbcyp) = pdehztnkai osbczwssix (wprrjtlhxo )
-
01 Jun 2024
Romosozumab
(Drug-naive group)
snlchgeuvg(pliiwsbcyp) = gudeiznjwd osbczwssix (wprrjtlhxo )
Not Applicable
-
cgilssjjdl(ykhmbkkgjd) = Romosozumab was the only medication added recently, leading to a suspicion that it might be the causative factor for thrombocytopenia. Consequently, Romosozumab was discontinued. Subsequent complete blood count revealed a return of the normal platelet count. zegrwysrbu (tiapmvnasr )
-
01 Jun 2024
Phase 2/3
low BMD
79
ljeavxmfke(wdbludkqgm) = bowwrdvcjv exnwqqdwup (vvidlvyxbm )
Positive
01 Jun 2024
Placebo
uheqyhopgq(yfgoojlyec) = ywvynwqdau htanbfbycm (npvcxdmroi )
Phase 1
25
(Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age))
oablupnrsh(uuwcuuhvkj) = dlclroxnry zeglirwjli (jbecvtyuql, 1.06)
-
15 Apr 2024
(Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age))
oablupnrsh(uuwcuuhvkj) = xcmyvdsmdn zeglirwjli (jbecvtyuql, 0.825)
Not Applicable
6
Romosozumab 210 mg sc/28d
megnydvgqp(vbeqhpkzjt) = reported in the vicinity of the therapy performed for a single patient tsazfhpsim (gonzexjvdl )
Positive
11 Apr 2024
Phase 3
-
Romosozumab 210mg monthly
jkbbrrqfsf(oizolohxvb) = vqaighdvyr komnxuuopw (exgoizuqlv )
Positive
11 Apr 2024
Denosumab 60mg Q6M
jkbbrrqfsf(oizolohxvb) = hoikwxhpab komnxuuopw (exgoizuqlv )
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Deal

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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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