Last update 05 Nov 2024

Blisibimod

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
Blisibimod (USAN/INN), A-623, AMG-623
Target
Mechanism
BAFF inhibitors(B-cell-activating factor/B lymphocyte stimulator inhibitors)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseDiscontinuedPhase 3
First Approval Date-
RegulationOrphan Drug (US)
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External Link

KEGGWikiATCDrug Bank
D10311Blisibimod-

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
NephritisPhase 3
GE
01 Jun 2016
Purpura, Thrombocytopenic, IdiopathicPhase 3-01 Dec 2015
Glomerulonephritis, IGAPhase 3
DE
01 Jun 2013
Glomerulonephritis, IGAPhase 3
KR
01 Jun 2013
Glomerulonephritis, IGAPhase 3
GB
01 Jun 2013
Systemic Lupus ErythematosusPhase 3
BY
01 Feb 2013
Systemic Lupus ErythematosusPhase 3
BR
01 Feb 2013
Systemic Lupus ErythematosusPhase 3
CO
01 Feb 2013
Systemic Lupus ErythematosusPhase 3
GE
01 Feb 2013
Systemic Lupus ErythematosusPhase 3
GT
01 Feb 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
442
hmdygrgeae(ffmyxmcdux) = The SRI-6 primary end point was not met ddczrkpyxh (ybrstcrlxp )
Negative
01 Jun 2018
Placebo
Phase 3
Systemic Lupus Erythematosus
anti-nuclear antibodies | anti-dsDNA | complement C3
442
tigeabtsgy(vxynwjgqfq) = laqaszxnef sqavqmcwqw (ugpimzvzbd )
Negative
14 Jun 2017
Placebo
tigeabtsgy(vxynwjgqfq) = zthaxdfoke sqavqmcwqw (ugpimzvzbd )
Phase 3
Systemic Lupus Erythematosus
anti-double-stranded DNA (dsDNA) | low complement C3 or C4
442
xekkxazqgn(tyhubgbrux) = uarssiuols cfiubdmkuo (cowfeuxpql )
Positive
08 Jun 2016
Phase 2
547
qccnwvlogt(vtfdolxuln) = SRI-5 response rates were not significantly improved in the pooled blisibimod groups duqhblkgmx (bbgftrzwbf )
Positive
01 Sep 2015
Placebo
Phase 1
-
gidwhsdxqz(oesxgtmfqj) = With time, memory B cells reverted to baseline, leading to a calculated 30 % reduction in total B cells by approximately 160 days after the first dose rmptfkcsoh (pqkpoboyvg )
-
20 Aug 2015
Phase 2
Systemic Lupus Erythematosus
anti-double-stranded DNA | anti-nuclear antibodies
547
Blisibimod 200 mg QW
dcwyubhnyz(jlsmhjepvn) = eoxgitrglj qnvqsebcxu (oikdkjlggh )
Positive
10 Jun 2015
Placebo
dcwyubhnyz(jlsmhjepvn) = gfcevfuidb qnvqsebcxu (oikdkjlggh )
Phase 2
Systemic Lupus Erythematosus
anti-double-stranded DNA | SELENA-SLEDAI score ≥6
547
oszhayyrmq(avcrwgcaga) = kdimgwzsvc lmbwtyhivp (nhogtudgey )
Positive
11 Jun 2014
Placebo
oszhayyrmq(avcrwgcaga) = xpayosktnj lmbwtyhivp (nhogtudgey )
Phase 2
Systemic Lupus Erythematosus
proteinuria | renal biomarkers | inflammation biomarkers ...
547
Blisibimod 200 mg monthly SC
hkgojnuyhv(jicdqmfsxh) = Blisibimod was safe and well-tolerated at all dose levels with no meaningful imbalances in serious adverse events or infections between blisibimod and placebo in the PEARL-SC study, and continued to be well-tolerated through the OLE study. qxsmyrpurk (zlunnnbzec )
-
11 Jun 2014
Blisibimod 100 mg weekly SC
Not Applicable
-
jitxfxgjzo(lpzzbzapiu) = no meaningful imbalances in serious adverse events or infections between blisibimod and placebo in the PEARL-SC study, and continued to be well-tolerated through the OLE study lelbhdvphu (gypamktzto )
-
25 Oct 2013
Placebo
Phase 2
Systemic Lupus Erythematosus
anti-double-stranded DNA | anti-nuclear antibodies
547
Blisibimod 100 mg QW
moufpqtnay(xrndlbrnrm) = During the placebo-controlled study, critically low IgG levels (<4g/L) were observed in 1/280 subjects in blisibimod group compared with 0/266 subjects on placebo mobndaojvd (kzirnquoof )
Positive
25 Oct 2013
Blisibimod 200 mg QW
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