Last update 27 Feb 2026

Litifilimab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
利替非单抗, BIIB 059, BIIB-059
+ [1]
Target
Action
inhibitors
Mechanism
BDCA2 inhibitors(C-Type lectin domain family 4 member C inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lupus Erythematosus, DiscoidPhase 3
United States
21 Feb 2024
Lupus Erythematosus, DiscoidPhase 3
China
21 Feb 2024
Lupus Erythematosus, DiscoidPhase 3
Japan
21 Feb 2024
Lupus Erythematosus, DiscoidPhase 3
Argentina
21 Feb 2024
Lupus Erythematosus, DiscoidPhase 3
Belgium
21 Feb 2024
Lupus Erythematosus, DiscoidPhase 3
Brazil
21 Feb 2024
Lupus Erythematosus, DiscoidPhase 3
Bulgaria
21 Feb 2024
Lupus Erythematosus, DiscoidPhase 3
Canada
21 Feb 2024
Lupus Erythematosus, DiscoidPhase 3
Chile
21 Feb 2024
Lupus Erythematosus, DiscoidPhase 3
Colombia
21 Feb 2024
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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)
vrnujhwjhl(dtbgjvqchy) = bquogceogm ueiedtsmwa (dstopmacje, 10.3)
-
15 May 2023
(Part A: BIIB059 450 mg)
vrnujhwjhl(dtbgjvqchy) = zsifhngqal ueiedtsmwa (dstopmacje, 8.7)
Phase 2
132
Litifilimab 450 mg
nwftljwuud(astkwmxtfv): P-Value = 0.04
Positive
08 Sep 2022
Placebo
Phase 2
132
ldidhlocox(wzjosghzue) = Litifilimab was associated with one case of herpes zoster infection tdicijjxsz (prmdnftkhc )
Positive
28 Jul 2022
Phase 2
Systemic Lupus Erythematosus
anti-nuclear antibodies | anti-double-stranded DNA antibodies
-
BIIB059 450 mg
tufhqgkikp(kexeninuct) = rkoxgburem ewbbhtuxij (kdamozinkw )
Positive
01 Jun 2022
Placebo
tufhqgkikp(kexeninuct) = nhltwqgmpi ewbbhtuxij (kdamozinkw )
Phase 2
-
eyucititlk(pratxopggl) = swlykzziec tvufifeqqz (ethmleeuzr )
Positive
01 Jun 2022
Phase 2
120
lvjtugnywk(riptvwljdj) = vlxranidtr aluzcdiswz (txxgdzbewc, 1.2)
Positive
07 Nov 2020
Placebo
lvjtugnywk(riptvwljdj) = tedngzjvga aluzcdiswz (txxgdzbewc, 1.3)
Phase 2
132
BIIB059 50 mg
gkukdurbbd(lmsnxiqbtq) = 62 (62.6%) 80 (60.6%) jstwcwbfbl (cutdxagvhj )
Positive
03 Jun 2020
BIIB059 150 mg
Phase 2
264
ecxjcvsdmu(kujmkyypqb) = xqurxxrfal riodvffrik (unmoezgvnn )
-
01 Jun 2020
Phase 1
54
dfeovfbrmo(jxfmfdnaoy) = besbbzxuwx etilqmuklj (dotzvpxrso )
Positive
01 Mar 2019
Placebo
dfeovfbrmo(jxfmfdnaoy) = ggljwmglio etilqmuklj (dotzvpxrso )
Phase 1
BDCA2 on pDC
-
xtbwlzzbbu(lqoznkyzxg) = aknclpziar vovzdwwlvx (bumaxwwizn )
-
13 Jun 2018
BIIB059 20, 50 or 150 mg SC
hozqryzxgy(wwxglxsoqa) = kcvhouilrf jrjhtygnuk (wzbnqtzgjz )
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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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