Last update 14 Mar 2026

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-
RegulationOrphan Drug (United States), Orphan Drug (European Union), Fast Track (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Locally Advanced Malignant Solid NeoplasmPhase 2
United States
26 Jun 2024
Locally Advanced Malignant Solid NeoplasmPhase 2
France
26 Jun 2024
Locally Advanced Malignant Solid NeoplasmPhase 2
Italy
26 Jun 2024
Locally Advanced Malignant Solid NeoplasmPhase 2
Netherlands
26 Jun 2024
Locally Advanced Malignant Solid NeoplasmPhase 2
Spain
26 Jun 2024
Locally Advanced Malignant Solid NeoplasmPhase 2
United Kingdom
26 Jun 2024
Metastatic Solid TumorPhase 2
United States
26 Jun 2024
Metastatic Solid TumorPhase 2
France
26 Jun 2024
Metastatic Solid TumorPhase 2
Italy
26 Jun 2024
Metastatic Solid TumorPhase 2
Netherlands
26 Jun 2024
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
Colorectal Cancer | Ewing Sarcoma
Last line | Third line
51
Ozekibart + FOLFIRI
(Colorectal Cancer)
uqhixzidfz(gehlikzyps) = Group1: The most common TEAEs included anemia, diarrhea, nausea, and fatigue, with the majority being low-grade. Group2: The most common adverse events were diarrhea, nausea, anemia, and fatigue. nfybyehvjn (okvdecujje )
Positive
23 Oct 2025
(Ewing Sarcoma)
Phase 2/3
206
jhewjcuzsw(yjvavsaxzf) = lejyvazxym rgixiiwffz (xiityxfomr )
Met
Positive
23 Oct 2025
Placebo
jhewjcuzsw(yjvavsaxzf) = tfbopewhac rgixiiwffz (xiityxfomr )
Met
Phase 1
13
Ozekibart 1 mg/kg + FOLFIRI
plkrjtimjo(claqyawfsb) = 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 eklcyckemb (aswjodkxue )
Positive
23 Jan 2025
Phase 1
13
krcziedclc(ntumqvurdb) = ushegvrfcd xyrykkliev (mobhxlzqva )
Positive
02 Nov 2023
Phase 1
Chondrosarcoma
IDH1/IDH2-mutant
-
etqxopxdkd(oxwaeuddyu) = <4 months axvidfgifu (noxqpyayfb )
-
15 Aug 2023
Phase 1
33
ldwjxhocun(jxhpvqaqbt) = increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and increased blood bilirubin and fatigue. nnisokdglf (kprouptehk )
Positive
16 Nov 2022
Phase 2
201
uqqurmugqb(gnqhxvgnjs) = fwgmeffcor dshmeglndz (fzdsephevz )
-
02 Jun 2022
Placebo
uqqurmugqb(gnqhxvgnjs) = qkeyxydnsn dshmeglndz (fzdsephevz )
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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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