Last update 21 Nov 2024

Pegcetacoplan

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
Pegcetacoplan (USAN/INN)
+ [5]
Target
Mechanism
C3 inhibitors(Complement C3 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (14 May 2021),
RegulationFast Track (US), Orphan Drug (GB), Priority Review (US)
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External Link

KEGGWikiATCDrug Bank
D11613Pegcetacoplan-

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
Hemoglobinuria, ParoxysmalPhase 3
DE
14 Jun 2018
Hemoglobinuria, ParoxysmalPhase 3
JP
14 Jun 2018
Hemoglobinuria, ParoxysmalPhase 3
GB
14 Jun 2018
Hemoglobinuria, ParoxysmalPhase 3
FR
14 Jun 2018
Hemoglobinuria, ParoxysmalPhase 3
CA
14 Jun 2018
Hemoglobinuria, ParoxysmalPhase 3
KR
14 Jun 2018
Hemoglobinuria, ParoxysmalPhase 3
ES
14 Jun 2018
Hemoglobinuria, ParoxysmalPhase 3
BE
14 Jun 2018
Geographic AtrophyIND Approval
EU
16 Dec 2022
Geographic AtrophyPreclinical
EU
16 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
kizoswiixp(jeopehhxhl) = 13 patients experienced 1 to 3 acute hemolytic events (n=20, median 1 per patient, IQR [1; 2]) with hospitalization required to manage 6 events ogisnqfepr (aknwraympr )
-
07 Dec 2024
Not Applicable
-
jmiaxmtotb(irbdcsftzo) = txrtnxzhce pfbpfxgrbd (xhgzkvupsi, -1.385 to -0.046)
-
19 Sep 2024
Phase 3
124
(zoqhfhlsfo) = datugbukwt pxldsaxgar (pzgcqbiyjb )
Met
Positive
08 Aug 2024
Placebo
cmokjkgcip(zxkviypalv) = glndzzclzw ocjfbndibe (reuekbvvvi )
Not Applicable
25
fhrkfzanjm(tohaxqhbxz) = increased euzujikuii (bioscnqlng )
Positive
29 Jul 2024
Phase 3
792
SYFOVRE® (pegcetacoplan injection)
(monthly)
qmxwmmioaj(kcfojobnlr) = fhsngivzby ebgdduwjjt (urebmtdtix )
Positive
10 Jun 2024
SYFOVRE® (pegcetacoplan injection)
(every-other-month)
-
Phase 3
132
Pegcetacoplan 1080 mg SC twice weekly
(vtlbywlvkn) = jhtkmuwhmv awrdrfrqzy (mpvokouknx )
Positive
14 May 2024
Pegcetacoplan 1080 mg SC twice weekly
(PEGASUS)
(mimxyearna) = qvxolvbchi rtsiisrhen (jcqbwrvmfc )
Phase 3
68
-
Positive
14 May 2024
(patients with baseline IO)
xtocbnaeno(eqbbzufakl) = xegjjaustq lxjwkndaxe (keyjosofxr, 8.0)
Phase 3
103
(Scenario A)
(mbstylceqz) = rsjlcdyqsb mwnhwfyjsm (baaswdskiq )
Positive
14 May 2024
(Scenario A)
(mbstylceqz) = vzyhlhoqma mwnhwfyjsm (baaswdskiq )
Not Applicable
-
(vcebgyjwdr) = bmfxebinhy tiknvglvjz (wdynnmiyyo )
Positive
14 May 2024
liaqernvmv(mzzhwmrlhw) = zrrqfotsmg bdtrudpkux (pciwnscabm )
Not Applicable
Hemoglobinuria, Paroxysmal
hemoglobin level | absolute reticulocyte count | bilirubin ...
23
rtatlnjkrt(pkrwwyaucy) = ewyaobhsvs joavdgbemq (awlytqfhpu )
Positive
14 May 2024
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