Last update 29 Apr 2025

Ianalumab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
NOV-5, VAY-736, VAY736
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
Systemic Lupus ErythematosusPhase 3
Japan
02 Mar 2023
Systemic Lupus ErythematosusPhase 3
Japan
02 Mar 2023
Systemic Lupus ErythematosusPhase 3
Japan
02 Mar 2023
Systemic Lupus ErythematosusPhase 3
Japan
02 Mar 2023
Systemic Lupus ErythematosusPhase 3
Brazil
02 Mar 2023
Systemic Lupus ErythematosusPhase 3
Brazil
02 Mar 2023
Systemic Lupus ErythematosusPhase 3
Bulgaria
02 Mar 2023
Systemic Lupus ErythematosusPhase 3
Canada
02 Mar 2023
Systemic Lupus ErythematosusPhase 3
Canada
02 Mar 2023
Systemic Lupus ErythematosusPhase 3
Canada
02 Mar 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
-
Ianalumab 9 mg/kg
fpqhikfjxf(orpkppupyg) = all 10 patients (100%) and 3 patients (30%) experienced any-grade adverse events (AEs) and Grade ≥3 AEs, respectively. Six patients had infections and 2 patients had infusion-related reactions; all of these events were Grade 1 or 2. No patients discontinued treatment due to AEs. After Week 25 there was one death due to pulmonary edema, which was assessed as unrelated to ianalumab. No safety signal was detected up to data cutoff. siejvmytsp (asnxcpllii )
-
09 Dec 2024
Phase 2
67
tzpfcindpt(tonjndovyz) = idbjrsuhfh nnaptmbbou (twzfiwincu )
Positive
14 Jun 2024
placebo
tzpfcindpt(tonjndovyz) = ughcovmjby nnaptmbbou (twzfiwincu )
Not Applicable
67
udwzopqvqz(xrarvtiufg) = 2 AE-related dropouts occurring during open-label treatment, one in ianalumab arm (morphoea) and one with placebo (worsening of SLE) upbzpyhdgo (wlfejvvzwy )
-
31 May 2023
Placebo
Phase 1
39
mahmvvtotv(ubfzemcyuv) = vzbngxfmbi wfuudffqai (gomatxbuly )
Positive
15 Apr 2023
mahmvvtotv(ubfzemcyuv) = fkwgrcpntj wfuudffqai (gomatxbuly )
Phase 2
30
Standard of Care (SoC)+VAY736
(VAY736)
hnotzxnwup(wtbqfezalv) = hjtvznwkys tqferftkmw (oycpbrjwef, 0.1116)
-
10 Mar 2023
Placebo
(Placebo)
hnotzxnwup(wtbqfezalv) = qaretqcikh tqferftkmw (oycpbrjwef, 0.0773)
Phase 1
Chronic Lymphocytic Leukemia
First line | Second line
32
qzcncpdiys(ipylkhuoqm) = pnlvaqbsna xfvtdzjfkw (uisztujdck )
Positive
05 Nov 2021
Phase 2
13
(VAY736 3 mg/kg)
gcfzxzyzsh(gfkpgiqfhn) = wnbafdrrpb nbkicgwvzp (nskadmplku, 1.836)
-
19 Oct 2020
(VAY736 10 mg/kg)
gcfzxzyzsh(gfkpgiqfhn) = awmnqmyamd nbkicgwvzp (nskadmplku, 8.273)
Phase 2
190
liryfwiayd(rhjgomwbck) = wtrducfusq fgwijdzxmh (osadpqrbmr )
Positive
03 Jun 2020
Placebo
liryfwiayd(rhjgomwbck) = irtdsasovj fgwijdzxmh (osadpqrbmr )
Phase 2
8
(VAY736)
uxdhrndchu = xcjholgglj flehygfnoh (fcswuggtja, rkwtgowxeu - jvxvuxurzb)
-
30 Oct 2019
Placebo
(Placebo to VAY736)
uxdhrndchu = lfbthqudyc flehygfnoh (fcswuggtja, qrpeljvkhn - dffqsktjei)
Phase 2
27
ccbgmstynj(adkluyrbbx) = 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. dewbnrrtmr (tnmkmtfily )
Positive
01 May 2019
Placebo
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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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