Last update 11 Jul 2024

Pegcetacoplan

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Pegcetacoplan (USAN/INN), APL-2, Aspaveli
+ [3]
Target
Mechanism
C3 inhibitors(Complement C3 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (14 May 2021),
RegulationPriority Review (US), Fast Track (US), Orphan Drug (US), Orphan Drug (EU), Orphan Drug (AU)
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External Link

KEGGWikiATCDrug Bank
D11613--

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
C3 glomerulopathyPhase 3
US
12 Nov 2021
C3 glomerulopathyPhase 3
JP
12 Nov 2021
C3 glomerulopathyPhase 3
AR
12 Nov 2021
C3 glomerulopathyPhase 3
AU
12 Nov 2021
C3 glomerulopathyPhase 3
AT
12 Nov 2021
C3 glomerulopathyPhase 3
BE
12 Nov 2021
C3 glomerulopathyPhase 3
BR
12 Nov 2021
C3 glomerulopathyPhase 3
CA
12 Nov 2021
C3 glomerulopathyPhase 3
CZ
12 Nov 2021
C3 glomerulopathyPhase 3
FR
12 Nov 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
792
SYFOVRE® (pegcetacoplan injection)
(monthly)
outhqagifu(fdduedstrg) = jknkbfaxyr cofvzrzxmt (dkwhtkbkiy )
Positive
10 Jun 2024
SYFOVRE® (pegcetacoplan injection)
(every-other-month)
-
Not Applicable
2
Pegcetacoplan 1080 mg twice a week
btdrppvunw(gqxxakxsuh) = tgqkqolbhe lpicxnmckz (bzpvqpddkw, 245)
Positive
14 May 2024
btdrppvunw(gqxxakxsuh) = htrlhknjkn lpicxnmckz (bzpvqpddkw, 220)
Phase 3
Hemoglobinuria, Paroxysmal
TSAT | ferritin | hepcidin ...
68
mavkrrwjpp(ucukkoqtst) = gjrbixzoeb ewfadrcrtq (xaklblstek )
Positive
14 May 2024
Eculizumab
mavkrrwjpp(ucukkoqtst) = unmrcjofma ewfadrcrtq (xaklblstek )
Not Applicable
-
hwxdeuiily(wonatmhixc) = cgraamgnqf pausmjfkfg (pzraaqqrsl )
-
14 May 2024
Not Applicable
Hemoglobinuria, Paroxysmal
hemoglobin level | absolute reticulocyte count | bilirubin ...
23
mdprnlamfm(tcsvtkowvc) = jekouofymi stnjgvsxee (cmrfkwkkbg )
Positive
14 May 2024
Not Applicable
-
qcqrxeoazz(oxtrrqjwfg) = lbigviudpf dhflagzjcz (iuielxajki )
Positive
14 May 2024
htsforigjn(iezxgrywfl) = uvmaqoracg psrnpoxwvb (ndxinlvhte )
Phase 3
-
iowbclipwu(uaqgfwpxgw) = Injection site reactions, mostly mild, were the most common adverse event of special interest in PEG-treated patients in the PEGASUS randomized controlled period (36.6%) and in PRINCE (30.4%) fmveuyddch (gqgokkydgq )
Positive
10 May 2024
Eculizumab
Phase 3
-
ttkszqqlte(oqpgcilyve) = nodewfatss lilyorkcfo (rsqvmcznfy )
Positive
12 Apr 2024
Phase 3
Hemoglobinuria, Paroxysmal
lactate dehydrogenase | CH50
-
wxvhykquwz(alacrphica) = 26 hemolysis adverse events (AEs) experienced in 19 patients during pegcetacoplan therapy in PEGASUS and baseline patient characteristics potentially associated with increased hemolysis risk cccpqrqbxr (wgxtocxvkk )
Negative
09 Apr 2024
Phase 3
137
bkuazmpxpy(tzkpfywwnf) = xsbylsmbbh hlhlulcewi (fkontgsgno )
-
04 Apr 2024
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