Last update 17 May 2025

Ozekibart

Overview

Basic Info

Drug Type
VHH-Fc
Synonyms
INBRX 109, INBRX-109, JCT-205
Target
Action
agonists
Mechanism
DR5 agonists(Tumor necrosis factor receptor superfamily member 10B agonists)
Inactive Indication-
Originator Organization
Drug Highest PhasePhase 2
First Approval Date-
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
ChondrosarcomaPhase 2
United States
23 Sep 2021
ChondrosarcomaPhase 2
Australia
23 Sep 2021
ChondrosarcomaPhase 2
France
23 Sep 2021
ChondrosarcomaPhase 2
Germany
23 Sep 2021
ChondrosarcomaPhase 2
Ireland
23 Sep 2021
ChondrosarcomaPhase 2
Italy
23 Sep 2021
ChondrosarcomaPhase 2
Netherlands
23 Sep 2021
ChondrosarcomaPhase 2
Spain
23 Sep 2021
ChondrosarcomaPhase 2
United Kingdom
23 Sep 2021
Adenocarcinoma of large intestinePhase 1
United States
10 Oct 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
13
Ozekibart 1 mg/kg + FOLFIRI
gfefdwagwx(hqfhsmqfit) = Ozekibart-related adverse events (AEs) were reported in 85% of pts (grade ≥3, 31%) and led to ozekibart interruption in 3 pts and discontinuation in 1 pt gydggrfpsa (pjfdzrouwk )
Positive
23 Jan 2025
Phase 1
13
posyhysdeh(emyfcfxifl) = fgpweumbig eethhhcbfm (cyclqumuvw )
Positive
02 Nov 2023
Phase 1
Chondrosarcoma
IDH1/IDH2-mutant
-
INBRX-109 3 mg/kg
rouuljpmna(egcvykysrm) = <4 months wcehajkift (wtlrkmpfct )
-
15 Aug 2023
Phase 1
33
ogmfuspamp(penwjbafbx) = increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and increased blood bilirubin and fatigue. eewyzmderl (fmstfiuezd )
Positive
16 Nov 2022
Phase 2
201
rjovvbdbml(nhxxzyerfv) = ozyphmeptd yufpfekfhp (qylgtlfwal )
-
02 Jun 2022
Placebo
rjovvbdbml(nhxxzyerfv) = epwzodijpx yufpfekfhp (qylgtlfwal )
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Translational Medicine

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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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