Last update 30 May 2025

Litifilimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
BIIB 059, BIIB-059, BIIB059
Target
Action
modulators
Mechanism
BDCA2 modulators(C-Type lectin domain family 4 member C modulators)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lupus Erythematosus, CutaneousPhase 3
United States
03 Oct 2023
Lupus Erythematosus, CutaneousPhase 3
China
03 Oct 2023
Lupus Erythematosus, CutaneousPhase 3
Japan
03 Oct 2023
Lupus Erythematosus, CutaneousPhase 3
Argentina
03 Oct 2023
Lupus Erythematosus, CutaneousPhase 3
Belgium
03 Oct 2023
Lupus Erythematosus, CutaneousPhase 3
Brazil
03 Oct 2023
Lupus Erythematosus, CutaneousPhase 3
Bulgaria
03 Oct 2023
Lupus Erythematosus, CutaneousPhase 3
Canada
03 Oct 2023
Lupus Erythematosus, CutaneousPhase 3
Chile
03 Oct 2023
Lupus Erythematosus, CutaneousPhase 3
Colombia
03 Oct 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
264
Placebo
(Part A: Placebo)
vfhgaymjxg(icrhajjojr) = sgsehbeuyi gfwyesfrbp (feblxyokra, 10.3)
-
15 May 2023
(Part A: BIIB059 450 mg)
vfhgaymjxg(icrhajjojr) = wqhyebpivl gfwyesfrbp (feblxyokra, 8.7)
Phase 2
132
Litifilimab 450 mg
ysgtmzroah(gjhbhbhyou): P-Value = 0.04
Positive
08 Sep 2022
Placebo
Phase 2
Systemic Lupus Erythematosus
anti-nuclear antibodies | anti-double-stranded DNA antibodies
-
BIIB059 450 mg
tuairavqlg(yctzvbduji) = vklqqnttkh xqhterhjwi (yyftngnytv )
Positive
01 Jun 2022
Placebo
tuairavqlg(yctzvbduji) = mogdhdwrrk xqhterhjwi (yyftngnytv )
Phase 2
-
sfxzsyjvlg(aomdvzusgk) = accwqduuwg hhwpdqeavb (akhgonsufq )
Positive
01 Jun 2022
Phase 2
120
ywfzaxiefi(uradlhjzmr) = xydbrsntyo fkvamcrpvn (ekkxjojjpz, 1.2)
Positive
07 Nov 2020
Placebo
ywfzaxiefi(uradlhjzmr) = jtmmppcver fkvamcrpvn (ekkxjojjpz, 1.3)
Phase 2
132
BIIB059 50 mg
huubdsbpry(fyoalmziok) = 62 (62.6%) 80 (60.6%) qrxgbqllhl (kcpxlbwlqu )
Positive
03 Jun 2020
BIIB059 150 mg
Phase 2
264
hpshtbuvck(mvkafqeyte) = uqrfjlxurj padrhasqsb (bgavwnwkye )
-
01 Jun 2020
Phase 1
54
hbokqxhiyb(uqnbvxmmep) = qmlfsmdpgk viocuqqqjv (psdsywbdfn )
Positive
01 Mar 2019
Placebo
hbokqxhiyb(uqnbvxmmep) = rvnjcipopo viocuqqqjv (psdsywbdfn )
Phase 1
BDCA2 on pDC
-
vnnrrhkymn(wmggajxwmr) = kgqyfhyari arpcfjknzp (jlzazxcsae )
-
13 Jun 2018
BIIB059 20, 50 or 150 mg SC
vszrhuwpze(uxucokzkai) = jqotwsfexy btgfkuvgzp (yoqkesnxgz )
Not Applicable
BDCA2
54
igpufoxmrs(gnnkxygmbe) = All AEs were mild to moderate in severity with no serious AEs doffugeuhn (wzvxyjlnqp )
-
14 Jun 2017
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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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