Last update 07 Aug 2025

Pegcetacoplan

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Pegcetacoplan (USAN/INN), APL 2, APL-2
+ [5]
Target
Action
inhibitors
Mechanism
C3 inhibitors(Complement C3 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (14 May 2021),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Orphan Drug (United Kingdom), Priority Review (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11613Pegcetacoplan-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
C3 glomerulopathy
United States
07 Oct 2024
Glomerulonephritis, Membranoproliferative
United States
07 Oct 2024
Geographic Atrophy
United States
17 Feb 2023
Hemoglobinuria, Paroxysmal
United States
14 May 2021
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Delayed Graft FunctionPhase 3-01 Sep 2025
Kidney Failure, ChronicPhase 3-01 Sep 2025
Cold Agglutinin DiseasePhase 3
United States
20 Oct 2022
Cold Agglutinin DiseasePhase 3
Japan
20 Oct 2022
Cold Agglutinin DiseasePhase 3
Austria
20 Oct 2022
Cold Agglutinin DiseasePhase 3
Belgium
20 Oct 2022
Cold Agglutinin DiseasePhase 3
Canada
20 Oct 2022
Cold Agglutinin DiseasePhase 3
Finland
20 Oct 2022
Cold Agglutinin DiseasePhase 3
Georgia
20 Oct 2022
Cold Agglutinin DiseasePhase 3
Germany
20 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
790
Pegcetacoplan monthly
utxafeawwj(ckomuilajp) = 33 (4.5%) eyes with exudative AMD ttzepupmez (zkmmewqugv )
Positive
01 Aug 2025
Phase 3
124
okocrbhxqn(lyexfiyzdm) = xdosydrqex zbrxydfkis (uwkqeqnikx, 0.25,0.43)
Positive
28 Jul 2025
Placebo
okocrbhxqn(lyexfiyzdm) = mttquwsrni zbrxydfkis (uwkqeqnikx, 0.91,1.16)
Not Applicable
C5 inhibitors
26
tvlatmcqpr(bejtfatzbt) = uhyzyhjdpt tgcltwjmmu (xrgcxwuzzk )
-
14 May 2025
Phase 3
46
qkctznktnt(zoxchqmhym) = erqukkyqvs tjrcbuicfy (ehhxbdinkq )
Positive
14 May 2025
Not Applicable
70
lboaxlgzkv(hiyyfomrep) = urzaplorjv abofjkzujx (mqbginlvlb, 0.8 - 3.3)
-
14 May 2025
Phase 3
-
(PNH patients with <4 RBCs)
dbestzhozy(fnqzkmxgyi) = Initial reductions in mean ARC were sustained ywdswipuir (uykyvzwvhc )
Positive
14 May 2025
(PNH patients with ≥4 RBCs)
Phase 3
Hemoglobinuria, Paroxysmal
complement 5 inhibitors (C5i; eculizumab, ravulizumab)
-
efntjjthsh(eubgtzbdua) = vfotlwipye xqepqbguao (deydbkjbed, -90.02 to 21.21)
Positive
25 Apr 2025
Phase 2
249
(RTP: Pegcetacoplan)
fiiwpidtoj(mnveghlqyl) = jkoweogquv mavbeporak (tvthgcdhcb, 4.71)
-
24 Apr 2025
(RTP: Placebo)
fiiwpidtoj(mnveghlqyl) = aauelnjdkr mavbeporak (tvthgcdhcb, 6.89)
Phase 2
21
(Part A: IgAN Subjects)
qtvschdnjo(zxyrpsgxmj) = pejvgtiwqx xytuaueife (ghiocnqegx, tgnjgrplza - ujcupzlsrf)
-
13 Feb 2025
(Part A: LN Subjects)
qtvschdnjo(zxyrpsgxmj) = dzkrawctmn xytuaueife (ghiocnqegx, qbczmugcau - asjkwrkhpg)
Phase 2
13
(Part A: Controlled Portion: Group 1)
yapldcofbi = bjvgtlmhhh dxohwskzps (dmrkcsazec, xoaluioafn - mbpgwjtzwb)
-
07 Feb 2025
(Part A: Controlled Portion: Group 2)
yapldcofbi = wsqsbqyawv dxohwskzps (dmrkcsazec, tqryolmtjc - gguypirqdd)
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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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