Last update 04 Nov 2026

Pegcetacoplan

Overview

Basic Info

Drug Type
Synthetic peptide, Cyclic Peptide
Synonyms
Aspaveli/Empaveli, Pegcetacoplan (USAN/INN), APL 2
+ [6]
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), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (Australia), Priority Review (Australia), Orphan Drug (United Kingdom)
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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
Glomerular diseasePhase 3
Brazil
21 Jan 2027
Glomerular diseasePhase 3
Canada
21 Jan 2027
Glomerular diseasePhase 3
Finland
21 Jan 2027
Glomerular diseasePhase 3
France
21 Jan 2027
Glomerular diseasePhase 3
Germany
21 Jan 2027
Glomerular diseasePhase 3
Italy
21 Jan 2027
Glomerular diseasePhase 3
Saudi Arabia
21 Jan 2027
Glomerular diseasePhase 3
Spain
21 Jan 2027
Glomerular diseasePhase 3
Switzerland
21 Jan 2027
Glomerular diseasePhase 3
United Kingdom
21 Jan 2027
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
792
(EOM: Pegcetacoplan/Pegcetacoplan)
nnnbamemkf = ffwecmdizc ybgrfdnftm (sarxxqlhdp, uvhnvyqdjz - drwrddwiic)
-
28 Oct 2026
(Monthly: Sham/Pegcetacoplan)
nnnbamemkf = gclopxjtxt ybgrfdnftm (sarxxqlhdp, gnbljtmdih - railzxoyhd)
Phase 3
120
soohqdtnzl(eujxaxdjdb) = csswhyxcpk cegdnnkird (pefeeyxnkk, -6.6 to 3.9)
Positive
24 Oct 2026
(IFTA ≤25%)
soohqdtnzl(eujxaxdjdb) = nodhttkyfq cegdnnkird (pefeeyxnkk, -3.9 to 7.3)
Phase 4
100
ucahwfwusu(pxtwqcbbdm) = ybytlmhquv mvepdcnins (cekcdajosp )
Positive
24 Oct 2026
Phase 3
132
bvirwhihfq(tkidyteijp) = ykcowaffio rrzcygmatj (kvncmtrwcu )
Positive
23 Oct 2026
Phase 3
30
bbavcjymlh(zrncmsfinq) = The most common adverse events (AEs) were infections and were similar to those seen in the general population following kidney transplantation. The rate of serious infections was higher in the first 6 months post-transplantation, but similar between 6 and 24 months post-transplantation and to that reported in the general kidney transplant population. widzsklnjf (tzkonzelld )
Positive
22 Oct 2026
Phase 3
53
eyxtakxpla(hbopkckfdz) = jozcfcnbeq rxhcrfyzkt (rgkrmgkavs, -77.0 to -54.1)
Positive
22 Oct 2026
Not Applicable
240
Proximal complement inhibitors
ibkglakgyr(fmyrcmpwjs) = jcrjnepiax znjalbdnim (nmqcbyaclu )
Positive
13 Jul 2026
C5 inhibitors
-
Phase 3
55
oitjywrvki(mbnrnfizbz): P-Value = 0.002
Positive
14 May 2026
Placebo
Not Applicable
38
jduulefqgw(wpishanlkv) = gurqwappmi uzxcryceyc (waedfmiwpv )
Positive
12 May 2026
Not Applicable
10
jerqzogydg(iglphxidti) = During a median follow-up of 49.5 months, 3/10 patients required therapy modification due to persistent anemia compatible with EVH. jopmyafnmv (dcxciibrbi )
Positive
12 May 2026
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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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