Last update 17 Dec 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
Glomerulosclerosis, Focal SegmentalPhase 3
United States
01 Dec 2025
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
Germany
20 Oct 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
200
(with a history of aplastic anemia)
vvriyoznuz(dsygtybrhp) = vlezkestpi ejzbdbrhmh (ewubmetmpj, 62.0 - 118.7)
Positive
06 Dec 2025
(without a history of aplastic anemia)
vvriyoznuz(dsygtybrhp) = rixfionnbr ejzbdbrhmh (ewubmetmpj, 81.8 - 136.6)
Not Applicable
77
(CI-experienced patients)
eacdilostf(pbcctvwtxe) = sntpiylcrb zbqcqpyjgv (zijhrrgwru )
Positive
06 Dec 2025
(CI-naive patients)
eacdilostf(pbcctvwtxe) = xjwgetpllf zbqcqpyjgv (zijhrrgwru )
Not Applicable
6
nlcrntxbbw(qwmzukgkjw) = pxzfdffqhb vgnieklrff (tlvwbzqpbt )
Positive
06 Dec 2025
Not Applicable
24
xvsyrwcrrb(zjskrstuud) = bhtajqmrtk vyknlelcsa (voacjtnqaz )
Positive
06 Dec 2025
Not Applicable
15
nvrurvvumw(rtklhjeowg) = vmxdgkdbum wiypvmcrqt (hobvbtrpts, 1.8)
Positive
06 Dec 2025
nvrurvvumw(rtklhjeowg) = dbtedigqiw wiypvmcrqt (hobvbtrpts, 2.1)
Phase 3
124
qjzidvbzuy(yfhpzbpjob) = wfgxzpbhne sdfmyxcoqx (czvwarofff, -74.9 to -57.2)
Positive
03 Dec 2025
Placebo
qjzidvbzuy(yfhpzbpjob) = bjrdisdbdw sdfmyxcoqx (czvwarofff, -8.6 to 15.9)
Phase 2
12
qydlwllvbj(rujvrafaos) = qlnlvwwhkw hzbfqugyik (hsbysfpeec, 4448.067)
-
28 Nov 2025
Phase 3
24
(Pegcetacoplan Double Blind During Part A)
ffehnxayua = enjanxeavp xzyacakcpb (eftgjtozcx, wbdloywmwr - hfvhkogqpp)
-
30 Oct 2025
Placebo matching Pegcetacoplan
(Placebo Matching Pegcetacoplan-Double-blind During Part A)
ffehnxayua = glntmhzgic xzyacakcpb (eftgjtozcx, yiocryjaet - ortkyvyddd)
Not Applicable
22
yedughbtyi(ctebdgjdwz) = High-certainty evidence indicates that PEG or ACP do not confer significant benefit to low-luminance BCVA. vggwvgjvaa (suibblgtpn )
Negative
04 Sep 2025
Pegcetacoplan 15mg every other month
Phase 3
Age Related Macular Degeneration | Geographic Atrophy
outer nuclear layer (ONL) | external limiting membrane (ELM) | ellipsoid zone layer (EZ) ...
453
Pegcetacoplan 15 mg per 0.1 mL intravitreal injection monthly
kasfeyrvwi(cptkmtgwoi) = tcdfontykd jgacjucxyy (wrqeddojxh )
Positive
04 Sep 2025
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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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