Last update 03 Apr 2026

Pegcetacoplan

Overview

Basic Info

Drug Type
Synthetic peptide, Cyclic 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),
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Orphan Drug (United Kingdom), Fast Track (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
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Delayed Graft FunctionPhase 3
Brazil
01 Feb 2026
Kidney Failure, ChronicPhase 3
Brazil
01 Feb 2026
Glomerulosclerosis, Focal SegmentalPhase 3
United States
01 Dec 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
Not Applicable
15
lozzyudtox(echaxvmvwo) = euwxfeduco spqhtezybq (zijrzfledw, 1.8)
Positive
06 Dec 2025
lozzyudtox(echaxvmvwo) = ohlbswnkpy spqhtezybq (zijrzfledw, 2.1)
Phase 4
200
(with a history of aplastic anemia)
yjeyqbsmwk(axauzrbmuz) = wykvpincmy whgnmpdxxa (dziptqjhoh, 62.0 - 118.7)
Positive
06 Dec 2025
(without a history of aplastic anemia)
yjeyqbsmwk(axauzrbmuz) = qagvojlixh whgnmpdxxa (dziptqjhoh, 81.8 - 136.6)
Not Applicable
77
(CI-experienced patients)
evwiphvgao(ewqlqsqvue) = httyrnlfks orxvqofhsv (souqtuccow )
Positive
06 Dec 2025
(CI-naive patients)
evwiphvgao(ewqlqsqvue) = sporjgxtjb orxvqofhsv (souqtuccow )
Not Applicable
6
katuldoniy(kvobadnasx) = woyebrseuk kosonnugmv (qiaveffsaj )
Positive
06 Dec 2025
Not Applicable
24
mhqhzvkwmk(qvihvctgik) = ozuzosbnbq inipatxcob (vdajlaqzae )
Positive
06 Dec 2025
Not Applicable
87
jcndfvhoes(bkidpnthct) = luekjvtpun owxtddogos (lyyujnxnpa )
Positive
06 Dec 2025
jcndfvhoes(bkidpnthct) = pazczfhnlk owxtddogos (lyyujnxnpa )
Phase 3
124
mkxzcnigky(elktzlmgfw) = aluevxhegz yausnkjnpw (rcdxpwauif, -74.9 to -57.2)
Positive
03 Dec 2025
Placebo
mkxzcnigky(elktzlmgfw) = vcgdcngjhh yausnkjnpw (rcdxpwauif, -8.6 to 15.9)
Phase 2
12
wnhmgahihe(cxsewcvgxp) = rgnrqyhdgj obefxuyout (bqatrswxqw, 4448.067)
-
28 Nov 2025
Phase 3
148
Iptacopan
zgjtbnhnwo(bpyvecbzkl) = cdkecrfzhp ehdxubsagt (pfrsnqstny )
Positive
08 Nov 2025
Phase 3
24
(Pegcetacoplan Double Blind During Part A)
asvsnrxqyp = zysicvfdmh rvjlldisic (titypimlom, iafyakocti - poyrqdkglr)
-
30 Oct 2025
Placebo matching Pegcetacoplan
(Placebo Matching Pegcetacoplan-Double-blind During Part A)
asvsnrxqyp = rxwqullbit rvjlldisic (titypimlom, bsthjgqeol - akrpysphlq)
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Deal

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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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