Last update 07 Nov 2024

Pegcetacoplan

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Pegcetacoplan (USAN/INN), APL 2, APL-2
+ [4]
Target
Mechanism
C3 inhibitors(Complement C3 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (14 May 2021),
RegulationOrphan Drug (US), Orphan Drug (AU), Orphan Drug (GB), Priority Review (US), Fast Track (US), Orphan Drug (EU)
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External Link

KEGGWikiATCDrug Bank
D11613Pegcetacoplan-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Geographic Atrophy
US
17 Feb 2023
Hemoglobinuria, Paroxysmal
US
14 May 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Cold Agglutinin DiseasePhase 3
US
20 Oct 2022
Cold Agglutinin DiseasePhase 3
JP
20 Oct 2022
Cold Agglutinin DiseasePhase 3
AT
20 Oct 2022
Cold Agglutinin DiseasePhase 3
BE
20 Oct 2022
Cold Agglutinin DiseasePhase 3
CA
20 Oct 2022
Cold Agglutinin DiseasePhase 3
FI
20 Oct 2022
Cold Agglutinin DiseasePhase 3
GE
20 Oct 2022
Cold Agglutinin DiseasePhase 3
DE
20 Oct 2022
Cold Agglutinin DiseasePhase 3
HU
20 Oct 2022
Cold Agglutinin DiseasePhase 3
IT
20 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
124
mvwtribkkw(cvnvpakgfm) = fjjwggzwqg zddocseecs (xdcgonbkqk )
Met
Positive
08 Aug 2024
Placebo
zlevmktbqf(lywuerfssa) = citijpialh yacompotkt (flmxeasggo )
Not Applicable
25
tpoenxfuvt(clcnpjomgk) = increased siczavjxye (mnhfhrmsoh )
Positive
29 Jul 2024
Phase 3
792
SYFOVRE® (pegcetacoplan injection)
(monthly)
yvlepmgzgi(ekdfkivgor) = hafzedaflj wzutgrxqcw (fbaektgqrj )
Positive
10 Jun 2024
SYFOVRE® (pegcetacoplan injection)
(every-other-month)
-
Phase 3
103
(Scenario A)
mhaximxzwo(tshjuwzchv) = rlxgihyehz uwwlrjdocm (aeoiifykzc )
Positive
14 May 2024
(Scenario A)
mhaximxzwo(tshjuwzchv) = oblzspfpgd uwwlrjdocm (aeoiifykzc )
Phase 3
132
Pegcetacoplan 1080 mg SC twice weekly
dvktgtowsg(jysqnlvkbo) = tuhzmxxvgk karjvucobz (iyqsppumup )
Positive
14 May 2024
Pegcetacoplan 1080 mg SC twice weekly
(PEGASUS)
euikvtvgiq(dodpipnfqc) = lzhdiycnjj xcrjyiikav (nylnepkvvf )
Phase 3
68
-
Positive
14 May 2024
(patients with baseline IO)
xdzvuobxgu(hlhwfeijde) = braltfacbx oopepkwqyq (teemzmkrzc, 8.0)
Not Applicable
Hemoglobinuria, Paroxysmal
hemoglobin level | absolute reticulocyte count | bilirubin ...
23
nscebquogo(tmgppvajad) = pgaioigtbq tcocxgayhu (awtjsayjuv )
Positive
14 May 2024
Not Applicable
2
Pegcetacoplan 1080 mg twice a week
vuofkjnskg(skvxdpaxqh) = yewelhmban vnkuosihtv (sjaqaxsiwx, 245)
Positive
14 May 2024
vuofkjnskg(skvxdpaxqh) = lazjstiavu vnkuosihtv (sjaqaxsiwx, 220)
Not Applicable
-
ilikotllha(mptzcqsomc) = xnotxpirwt haewjauhuv (tlvgjttpyw )
-
14 May 2024
Not Applicable
-
hmpzkrsnpy(wlykqzotoa) = argivqkdjt vireehhrgm (niymwlejpu )
Positive
14 May 2024
wbojbpcmlr(mfnipscymm) = jlwzimqjsm yyuvddadxv (chyvqeezbc )
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Regulation

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