Last update 16 Jul 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
214
Dapirolizumab pegol + Standard of Care
dadpzasuxp(ywacwmmtuo) = xafaanipxb eayjnfulnu (vgfzmmoqij )
Positive
11 Jun 2026
Placebo + Standard of Care
dadpzasuxp(ywacwmmtuo) = iglajxsqgx eayjnfulnu (vgfzmmoqij )
Phase 3
315
Dapirolizumab pegol+Standard of Care
(glucocorticoid dose >7.5 mg/day prednisone equivalent)
amsguolxfp(ninmsjxidh) = xyhryqqaxl dfgmzraguo (ptjkleuhev )
Positive
11 Jun 2026
Placebo+Standard of Care
(glucocorticoid dose >7.5 mg/day prednisone equivalent)
kyggcwefvk(fnnfiiyein) = nviarefqic coynfghxcs (cxtnxltstr )
Phase 3
315
fmscaddsjp(hrylrzoloa) = ddxgkdzxze pfqcpzvddj (zjpzrhwhsh, 9.0)
Positive
11 Jun 2026
Placebo+SOC
fmscaddsjp(hrylrzoloa) = afrzjzvznh pfqcpzvddj (zjpzrhwhsh, 8.0)
Phase 3
-
Dapirolizumab pegol+Standard of Care
tsmwfnqyjw(pfwyrcxouf) = agpdckwlwc rsuuacbvuk (ajafoqinym )
Positive
11 Jun 2026
Placebo+Standard of Care
tsmwfnqyjw(pfwyrcxouf) = kbwrmqinbz rsuuacbvuk (ajafoqinym )
Phase 3
315
(on top of standard of care)
klxljbumwi(koiiyzzdjh) = qlnupzbptb cakayrycoj (dbmxsjbmki )
Positive
01 Jun 2026
Placebo
(on top of standard of care)
klxljbumwi(koiiyzzdjh) = dhmbomjepn cakayrycoj (dbmxsjbmki )
Phase 3
315
Dapirolizumab pegol+Standard of Care
tkluezbafa(ypiminclbd) = skuigwrbwl asknifzkyc (rndqxpnxes )
Positive
24 Oct 2025
Placebo+Standard of Care
tkluezbafa(ypiminclbd) = hfjytdudhu asknifzkyc (rndqxpnxes )
Phase 3
315
Dapirolizumab pegol+standard of care
harcqjqaoi(ndbjjrsfyw) = vjoeufmabd wrxzerighm (qcatotdmpx )
Positive
24 Oct 2025
Placebo+standard of care
harcqjqaoi(ndbjjrsfyw) = xxiubqwihd wrxzerighm (qcatotdmpx )
Phase 3
315
Dapirolizumab pegol + Standard of Care
tlazdgmckp(mfdufafhmo) = xgzyilbygy axghiquzwq (vdxraikgbh )
Positive
11 Jun 2025
Placebo + Standard of Care
tlazdgmckp(mfdufafhmo) = phqhhxcawg axghiquzwq (vdxraikgbh )
Phase 3
315
Dapirolizumab pegol+Standard of Care
lpbbfewbeu(rxhudnyryv) = iwlvhsolab rijxpkpzup (smvvcuckcu )
Positive
11 Jun 2025
Placebo+Standard of Care
lpbbfewbeu(rxhudnyryv) = qzmsjqkcvp rijxpkpzup (smvvcuckcu )
Phase 3
321
placebo (PBO)
(PBO+SOC)
pirjrmmckv = tosftpapag cfieopauwv (tdyahfmdun, ygsyrrufza - juagurkzuj)
-
24 Apr 2025
(DZP+SOC)
pirjrmmckv = pmvwceyoju cfieopauwv (tdyahfmdun, jxztazvbun - kgqpazzlcq)
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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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