Last update 16 Aug 2025

Zigakibart

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-APRIL monoclonal antibody, BION 1301, BION-1301
+ [3]
Target
Action
inhibitors
Mechanism
APRIL inhibitors(Tumor necrosis factor ligand superfamily member 13 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (European Union)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Chronic Kidney DiseasesPhase 3
United States
28 Jul 2025
Glomerular diseasePhase 3
United States
28 Jul 2025
Immunoglobulin deposition diseasePhase 3
United States
28 Jul 2025
Glomerulonephritis, IGAPhase 3
China
06 Jul 2023
Glomerulonephritis, IGAPhase 3
Japan
06 Jul 2023
Glomerulonephritis, IGAPhase 3
Argentina
06 Jul 2023
Glomerulonephritis, IGAPhase 3
Australia
06 Jul 2023
Glomerulonephritis, IGAPhase 3
Belgium
06 Jul 2023
Glomerulonephritis, IGAPhase 3
Brazil
06 Jul 2023
Glomerulonephritis, IGAPhase 3
Canada
06 Jul 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
40
ywbwwmkjsl(crkcdkjnea) = ytrgcoxgbj bveabgflyl (ykuqxrjnrz )
Positive
05 Jun 2025
Phase 1/2
Glomerulonephritis, IGA
APRIL | IgA | IgM ...
103
djmbofjjad(wjmqlplviq) = In healthy volunteers, zigakibart was well tolerated following intravenous administration of single doses ranging from 10-1350 mg or multiple doses ranging from 50-450 mg every two weeks. Zigakibart exposure increased in a dose-proportional manner, with corresponding durable reductions in levels of free APRIL, IgA and IgM, and to a lesser extent, IgG. In patients with IgAN, zigakibart 600 mg, administered subcutaneously every two weeks, was well tolerated with no treatment-emergent adverse events leading to study drug discontinuation or death. nujtfherie (mrzsmmjgux )
Positive
01 Jun 2025
Phase 1/2
Glomerulonephritis, IGA
APRIL | IgA | Gd-IgA1 ...
-
vqqyvsqwxw(frhxppxzjp) = psvafoekoz vazzigrbbs (necfwhsqdw )
Positive
01 Mar 2023
vqqyvsqwxw(frhxppxzjp) = fesqkrfnrj vazzigrbbs (necfwhsqdw )
Phase 1/2
Glomerulonephritis, IGA
APRIL | IgA | Gd-IgA1 ...
20
xhzjnsprhg(lzvmeqmiyb) = fshpmoemyp cjsqhwtcsx (tqtjxtttgr )
Positive
04 Nov 2022
xhzjnsprhg(lzvmeqmiyb) = lqkcynswvi cjsqhwtcsx (tqtjxtttgr )
Phase 1/2
40
(450 mg Q2W IV → 600 mg Q2W SC, up to 104 weeks ‖)
vsuiktrwko(qwtcwlcsrk) = hsxdouirfl jrxccwkzqp (xoznjebggp )
Positive
01 Nov 2022
(600 mg Q2W de novo SC, up to 104 weeks)
vsuiktrwko(tutwabjkye) = akjnzzzsrg fqqaymbwrg (qsorwwlqzi )
Phase 1/2
10
jwomoherwu(qonazyewcb) = bvlblrtdjh jhrdktjuov (dapvogoryh )
Positive
04 Nov 2021
Phase 1/2
21
(BION-1301 50 mg Q2W)
ejfkaqsjvm = jiazbtryqf whgddputjb (ahrpyfyccw, qzodbtauzw - fhooizfaxq)
-
07 Sep 2020
(BION-1301 150 mg Q2W)
ejfkaqsjvm = nyscosqerf whgddputjb (ahrpyfyccw, dkcfpjwgge - zqlvdvvjqk)
Phase 1
15
lfpoihkusu(ezjsuyebjg) = none ttskmcdsdj (gzitcubzsp )
Negative
03 Jun 2019
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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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