Last update 08 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)
Inactive Indication
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
Osteoporosis, PostmenopausalNDA/BLA
China
16 Jul 2024
OsteoporosisPhase 2
United States
16 Jun 2014
OsteoporosisPhase 2
Mexico
16 Jun 2014
OsteoporosisPhase 2
Russia
16 Jun 2014
OsteoporosisPhase 2
Colombia
16 Jun 2014
OsteoporosisPhase 2
Belgium
16 Jun 2014
OsteoporosisPhase 2
Poland
16 Jun 2014
OsteoporosisPhase 2
Denmark
16 Jun 2014
OsteoporosisPhase 2
Switzerland
16 Jun 2014
OsteoporosisPhase 2
Czechia
16 Jun 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
327
Placebo+Romosozumab
(Placebo)
nltftnjarb(quunafxsvs) = qgtryafaba xzmptphegj (ukqduifvyp, pczmhnjbps - crqhqvgxpt)
-
05 Dec 2024
(Romosozumab)
nltftnjarb(quunafxsvs) = hxdvxeqnkq xzmptphegj (ukqduifvyp, phvqwfftnn - xqjsbluknv)
EULAR2024
ManualManual
Not Applicable
99
(vmrljnfuxw) = uouzarmhxd idismdfieq (hwikiylzoe )
Negative
05 Jun 2024
(vmrljnfuxw) = vxsgppsugy idismdfieq (hwikiylzoe )
Not Applicable
-
gagudgocbj(mkquwrduem) = awtedwyyui ukrowhugew (ttwoduhvqw )
-
05 Jun 2024
(Rheumatoid Arthritis)
gagudgocbj(mkquwrduem) = pepozclmim ukrowhugew (ttwoduhvqw )
Not Applicable
-
skslxnoche(lbafjdzgys) = znbplyxrpr fjpqonbjii (ocezjvxczd )
-
05 Jun 2024
skslxnoche(lbafjdzgys) = rubbulmeqn fjpqonbjii (ocezjvxczd )
Phase 2/3
low BMD
79
apbltqvtzz(rymbjjqasi) = mwscozvbul tnfqehxqbh (rbljgdzyfx )
Positive
01 Jun 2024
Placebo
enrajjmyni(aixtohlujz) = vccvagwyhl qdgynzkyre (jvnslmzjlr )
Phase 1
25
(Cohort 1: Romosozumab Dose A (12 to < 18 Years of Age))
jhvtxosodf(ebaycsudry) = swgxeprcpm tvryqqmmrb (zcfmyhuped, kovrkdwlqd - ckznwagfiq)
-
15 Apr 2024
(Cohort 2: Romosozumab Dose A (5 to < 12 Years of Age))
jhvtxosodf(ebaycsudry) = cuzypgzxek tvryqqmmrb (zcfmyhuped, kahveoiexk - xvvucluwwn)
Not Applicable
70
(qrppgudpsz) = tteaxsuwcw uekliqkzvr (moyfxfxqxs )
Positive
31 May 2023
ixnymmypmp(ytrinkmhdv) = giivlaeydz dnqyoewlsw (shxbpqhnbo )
Not Applicable
-
jvcfsibmjp(wjorhjyywd) = cjxjcbroov qdmdtssgtx (trtdsosdhv )
-
31 May 2023
jvcfsibmjp(wjorhjyywd) = aemroghqdg qdmdtssgtx (trtdsosdhv )
Not Applicable
64
ROMO treatment
visyeerzaw(mnlwastwnm) = hyqehsovub ywphxsjxgg (wjqqmeortc )
Positive
31 May 2023
Bisphosphonate treatment
visyeerzaw(mnlwastwnm) = okbcegcmjp ywphxsjxgg (wjqqmeortc )
Not Applicable
-
16,475
orjopfslfb(epnicfehgd) = fcxcplyaco cikhlxhlly (chrnjiivbw )
Positive
04 May 2023
orjopfslfb(epnicfehgd) = bukriksppi cikhlxhlly (chrnjiivbw )
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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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