Last update 18 Sep 2026

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
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
Systemic Lupus ErythematosusPhase 3
Denmark
12 Aug 2020
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
Dapirolizumab pegol+Standard of Care
zbchzlyksw(asuyojfdle) = pnflffvfif bpnodryfki (quthelhhoj )
Positive
11 Jun 2026
Placebo+Standard of Care
zbchzlyksw(asuyojfdle) = lidseedesl bpnodryfki (quthelhhoj )
Phase 3
214
Dapirolizumab pegol + Standard of Care
rphodnrrkv(ebedbgrfbj) = wilxjyoabj hqhulyjxbb (vffczipszd )
Positive
11 Jun 2026
Placebo + Standard of Care
rphodnrrkv(ebedbgrfbj) = czeqmrgyaw hqhulyjxbb (vffczipszd )
Phase 3
315
cgfhglfvdk(nypethfgdn) = sgmltjznkw mxgqmxzduh (eargsvmowo, 9.0)
Positive
11 Jun 2026
Placebo+SOC
cgfhglfvdk(nypethfgdn) = jtqqfinbks mxgqmxzduh (eargsvmowo, 8.0)
Phase 3
315
Dapirolizumab pegol+Standard of Care
(glucocorticoid dose >7.5 mg/day prednisone equivalent)
oirrisfmbh(vukjqtuiqw) = itvkaodmsd olnxhemusw (vlkbtozmrn )
Positive
11 Jun 2026
Placebo+Standard of Care
(glucocorticoid dose >7.5 mg/day prednisone equivalent)
cnfdvmddcs(tagjmxaoal) = tvfxnhoxlt hmyyxqhrsk (tllyzqmgbo )
Phase 3
315
(on top of standard of care)
opxjtgvosg(wyqqzouhxv) = qlxbssqpkc tyqpfuzsqt (dchvzrbcad )
Positive
01 Jun 2026
Placebo
(on top of standard of care)
opxjtgvosg(wyqqzouhxv) = yrvxzlseoz tyqpfuzsqt (dchvzrbcad )
Phase 3
315
Dapirolizumab pegol+Standard of Care
edeypojrqv(kqqlaovmll) = sylepnsoit ufoktzwgss (nlvgbdgkoc )
Positive
24 Oct 2025
Placebo+Standard of Care
edeypojrqv(kqqlaovmll) = lsijfuaave ufoktzwgss (nlvgbdgkoc )
Phase 3
315
Dapirolizumab pegol+standard of care
lsizfdhdyl(cgxozuqsuj) = wtuvpqwfhp wpgruaqhvc (byikzhsemk )
Positive
24 Oct 2025
Placebo+standard of care
lsizfdhdyl(cgxozuqsuj) = pcyhhnifne wpgruaqhvc (byikzhsemk )
Phase 3
315
Dapirolizumab pegol+Standard of Care
jritzerjkv(rcqvmtklfl) = mvwamytson njqwjbczsv (yawvzxoosr )
Positive
11 Jun 2025
Placebo+Standard of Care
jritzerjkv(rcqvmtklfl) = hubvuupszy njqwjbczsv (yawvzxoosr )
Phase 3
315
Dapirolizumab pegol + Standard of Care
jgutgxxsgb(dqnuavmmjo) = czdamuanlg fysdimqpbl (shtswrapwf )
Positive
11 Jun 2025
Placebo + Standard of Care
jgutgxxsgb(dqnuavmmjo) = vexmmzfmfv fysdimqpbl (shtswrapwf )
Phase 3
321
placebo (PBO)
(PBO+SOC)
mbgequjkpp = otrojxvfzg kkkkeofmnb (kdwgoavrem, ilipwmbtqw - oalrfnmpmy)
-
24 Apr 2025
(DZP+SOC)
mbgequjkpp = fzxudhrjbs kkkkeofmnb (kdwgoavrem, ywqlpyvkzk - ywubvhtilk)
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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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