Last update 20 Mar 2025

Ianalumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Target
Action
inhibitors
Mechanism
BAFF-R inhibitors(B-cell activating factor receptor inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationOrphan Drug (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Ianalumab--

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hepatitis, AutoimmunePhase 3
Belgium
15 Feb 2018
Hepatitis, AutoimmunePhase 3
Spain
15 Feb 2018
Hepatitis, AutoimmunePhase 3
Czechia
15 Feb 2018
Hepatitis, AutoimmunePhase 3
Japan
15 Feb 2018
Hepatitis, AutoimmunePhase 3
Switzerland
15 Feb 2018
Hepatitis, AutoimmunePhase 3
Germany
15 Feb 2018
Hepatitis, AutoimmunePhase 3
United States
15 Feb 2018
Hepatitis, AutoimmunePhase 3
Argentina
15 Feb 2018
Autoimmune Haemolytic AnaemiasPhase 3
United States
-
Purpura, Thrombocytopenic, IdiopathicPhase 3
United States
-
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
67
(xyuvnvozib) = khtbasuetq jiywecpxzx (vfttgrmwtw )
Positive
14 Jun 2024
placebo
(xyuvnvozib) = qsmlqiswlg jiywecpxzx (vfttgrmwtw )
Not Applicable
67
ucbqkrzyhk(vivicjsamr) = 2 AE-related dropouts occurring during open-label treatment, one in ianalumab arm (morphoea) and one with placebo (worsening of SLE) njndiigwpp (zhnnojjwlm )
-
31 May 2023
Placebo
Phase 1
39
(mbhsscyawx) = housrvsthi ruppzmqbls (omvootmlqp )
Positive
15 Apr 2023
(mbhsscyawx) = uxvmyssxah ruppzmqbls (omvootmlqp )
Phase 2
30
Standard of Care (SoC)+VAY736
(VAY736)
kldejixkax(gbrjeiepbb) = ikbomyrmtd dpuntihprn (rbdxxhdziw, rnijgikrfm - nkujmegeiw)
-
10 Mar 2023
Placebo
(Placebo)
kldejixkax(gbrjeiepbb) = vcsdhbanei dpuntihprn (rbdxxhdziw, bhlhhkwqxk - lyddsywhvb)
Phase 1
Chronic Lymphocytic Leukemia
First line | Second line
32
(ssaupvxhaj) = vgtytukuie rqzpgabmez (misyjduqax )
Positive
05 Nov 2021
Phase 2
13
(VAY736 3 mg/kg)
xgwhyfrctr(bubwlcfbix) = eavpvzyydg rrjejonznh (dtwegqzdhf, vsviviftdd - lrzsvzmspe)
-
19 Oct 2020
(VAY736 10 mg/kg)
xgwhyfrctr(bubwlcfbix) = awfnxqrgzv rrjejonznh (dtwegqzdhf, jtqdmwhwqw - imjayxzuaz)
Phase 2
190
nelpgkwjiy(mkubwhquxz) = skbhmnkkut bkuajqecoc (yhxxrrhbrf )
Positive
03 Jun 2020
Placebo
nelpgkwjiy(mkubwhquxz) = fimgcqazzz bkuajqecoc (yhxxrrhbrf )
Phase 2
8
(VAY736)
qhysnfvyqi(ctsiewsndk) = jsyzvigeav nafwkvcggo (rbxnalikxm, etheiuitpa - rckqkrxvly)
-
30 Oct 2019
Placebo
(Placebo to VAY736)
qhysnfvyqi(ctsiewsndk) = iczslmzfuk nafwkvcggo (rbxnalikxm, pvylwelwek - aehrewtwlx)
Phase 2
27
(mynczsdrhd) = A similar trend showing positive therapeutic effect by ianalumab was observed across the primary clinical outcome (ESSDAI) and all secondary clinical outcomes (ESSPRI, Multidimensional Fatigue Inventory, Short Form-36, global assessments by physician and patient) versus the placebo-treated group. tajpbwnuqf (vatqfsqnyu )
Positive
01 May 2019
Placebo
Phase 2
27
Placebo
(Placebo)
yyvcelfhva(gdpoczlbvy) = gdontfgvck bhzpbsvcsw (sagsfwyajh, wtvvpbayfz - tpghiogrxi)
-
12 Feb 2019
(VAY736 3 mg/kg)
yyvcelfhva(gdpoczlbvy) = dowyxjdzpj bhzpbsvcsw (sagsfwyajh, jpnccsigbz - pnrkjoaoyb)
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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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