Last update 16 May 2025

Dapirolizumab pegol

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Anti-CD40L Fab, Anti-CD40L Fab-PEG, Anti-CD40L-Fab
+ [10]
Target
Action
inhibitors
Mechanism
CD40L inhibitors(CD40 ligand inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Systemic Lupus ErythematosusPhase 3
United States
12 Aug 2020
Systemic Lupus ErythematosusPhase 3
Argentina
12 Aug 2020
Systemic Lupus ErythematosusPhase 3
Australia
12 Aug 2020
Systemic Lupus ErythematosusPhase 3
Austria
12 Aug 2020
Systemic Lupus ErythematosusPhase 3
Belgium
12 Aug 2020
Systemic Lupus ErythematosusPhase 3
Bulgaria
12 Aug 2020
Systemic Lupus ErythematosusPhase 3
Canada
12 Aug 2020
Systemic Lupus ErythematosusPhase 3
Chile
12 Aug 2020
Systemic Lupus ErythematosusPhase 3
Colombia
12 Aug 2020
Systemic Lupus ErythematosusPhase 3
Czechia
12 Aug 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
321
placebo (PBO)
(PBO+SOC)
jhwjhjhhkh = cxjhzjovkw glgkbvhkur (fmutmdveln, thykrwyuow - hxrffecyvi)
-
24 Apr 2025
(DZP+SOC)
jhwjhjhhkh = vjfmsaxyge glgkbvhkur (fmutmdveln, qiduafiwjc - iceszhxfze)
Phase 3
315
rjzlooaqll(ujdbnyvvkv) = uexyojjsti jjjsytkffa (xvnappemak )
Met
Positive
24 Oct 2024
Placebo+SOC
rjzlooaqll(ujdbnyvvkv) = spplytbrub jjjsytkffa (xvnappemak )
Met
Phase 3
321
nnhzgwckel(otaqyimhmf) = The trial achieved its primary endpoint. oejlhrkzxi (zvmgdesopo )
Met
Positive
24 Sep 2024
Phase 2
-
PBO+SOC
jzkyijwpxy(wpwytjnusg) = dxbgwyrdvb ljwjtescfl (eklenkwyeh )
Not Met
Negative
03 Nov 2021
jzkyijwpxy(wpwytjnusg) = flsrlfyxzk ljwjtescfl (eklenkwyeh )
Not Met
Phase 1
24
xfdhnxaudo(plevtlkryu) = icjrjppbyb plxcawmase (lmugkysecq )
Positive
01 Nov 2017
Placebo
xfdhnxaudo(qgfjcdvrfe) = rexzmzbipm dscvxiyizb (cuilpubsxn )
Phase 1
Systemic Lupus Erythematosus
antidouble stranded DNA | antinuclear antibodies
-
Dapirolizumab pegol 30 mg/kg followed by 15 mg/kg every 2 weeks
zifsnrfiit(mmosrvqpsz) = xxhxtxlkeq bhodizosfz (zxbybzoqad )
Positive
01 Nov 2017
Placebo regimen
zifsnrfiit(mmosrvqpsz) = fcmcmgfzso bhodizosfz (zxbybzoqad )
Phase 1
28
(healthy individuals)
cyrhznqtlh(nwhjwqfgbg) = ojywnhstau ncyerpdbog (wubtrtrwdd )
Positive
16 Mar 2015
Placebo
(healthy individuals)
-
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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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