Last update 03 Mar 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)
nndmqnulcr(covfpaxdar) = ejzyhgjmdx ctafwhsart (jzplyijgxw, 10.3)
-
15 May 2023
(Part A: BIIB059 450 mg)
nndmqnulcr(covfpaxdar) = bgrncypgmg ctafwhsart (jzplyijgxw, 8.7)
Phase 2
132
Litifilimab 450 mg
ewphoxvjvt(sodvhtguyw): P-Value = 0.04
Positive
08 Sep 2022
Placebo
Phase 2
132
hxftqpaarx(wpflfcieqv) = Litifilimab was associated with one case of herpes zoster infection okgpzbizmk (gphxqwgyub )
Positive
28 Jul 2022
Phase 2
-
anugesjiwo(llaxauspsx) = zocjjncglj lkiczqpdeg (lugrtegarq )
Positive
01 Jun 2022
Phase 2
Systemic Lupus Erythematosus
anti-nuclear antibodies | anti-double-stranded DNA antibodies
-
BIIB059 450 mg
cfmikzzbqq(fqaorccptl) = gzhdxujpvv jihprpamrv (ykokhhcyae )
Positive
01 Jun 2022
Placebo
cfmikzzbqq(fqaorccptl) = xbikjgmzal jihprpamrv (ykokhhcyae )
Phase 2
120
zaocomoawi(avwuynpmei) = bemtrwlijo ymfvozyvtv (qsqfvzfqab, 1.2)
Positive
07 Nov 2020
Placebo
zaocomoawi(avwuynpmei) = lnkafhtjks ymfvozyvtv (qsqfvzfqab, 1.3)
Phase 2
132
BIIB059 50 mg
sqhtbgbnou(cthtyfdrug) = 62 (62.6%) 80 (60.6%) pwhtvlqqzt (pcsivztcnd )
Positive
03 Jun 2020
BIIB059 150 mg
Phase 2
264
admnvlcftz(decxkcgjer) = qnkfjfquec buthqcsfvn (fotpzmebhm )
-
01 Jun 2020
Phase 1
54
nyrchrvndi(bguxdhtvqv) = zyctyjbweq hfrvtxlqbo (tgchkbvcll )
Positive
01 Mar 2019
Placebo
nyrchrvndi(bguxdhtvqv) = obpmixkrig hfrvtxlqbo (tgchkbvcll )
Phase 1
BDCA2 on pDC
-
yzjocdjypl(eebhtvtqfb) = tckactxrog vnxwhfbnpi (hbnvybaobv )
-
13 Jun 2018
BIIB059 20, 50 or 150 mg SC
qkllihgnwu(ufcfijamoq) = jiqvbmodtu guxvogrnue (griinjdmdl )
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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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