Last update 31 May 2024

Avacopan

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
CCX 168, CCX-168, CCX168
+ [2]
Target
Mechanism
C5AR1 antagonists(C5a anaphylatoxin chemotactic receptor antagonists)
Inactive Organization-
Drug Highest PhaseApproved
RegulationOrphan Drug (US), Orphan Drug (EU), PRIME (EU), Orphan Drug (AU)
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Structure

Molecular FormulaC33H35F4N3O2
InChIKeyPUKBOVABABRILL-YZNIXAGQSA-N
CAS Registry1346623-17-3

External Link

KEGGWikiATCDrug Bank
D11093--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
US
07 Oct 2021
Granulomatosis With Polyangiitis
JP
27 Sep 2021
Microscopic Polyangiitis
JP
27 Sep 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hidradenitis SuppurativaPhase 2
US
21 Dec 2018
C3 glomerulopathyPhase 2
US
29 Sep 2017
C3 glomerulopathyPhase 2
BE
29 Sep 2017
C3 glomerulopathyPhase 2
CA
29 Sep 2017
C3 glomerulopathyPhase 2
DK
29 Sep 2017
C3 glomerulopathyPhase 2
FR
29 Sep 2017
C3 glomerulopathyPhase 2
DE
29 Sep 2017
C3 glomerulopathyPhase 2
IE
29 Sep 2017
C3 glomerulopathyPhase 2
IT
29 Sep 2017
C3 glomerulopathyPhase 2
NL
29 Sep 2017
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
anti-proteinase 3 (PR3) positive | anti-myeloperoxidase positive
330
sxzzfnysmu(wraatoqexu) = zwwxezqhkp fvjkzeiddb (cignbrwhaw )
Positive
12 Nov 2023
sxzzfnysmu(wraatoqexu) = xadelwhsua fvjkzeiddb (cignbrwhaw )
Phase 2
42
Placebo
(Placebo BID Plus Standard of Care)
gbiprajjev(epnzcjcfdl) = mjzhnnhirr sesxtrrovt (swjmadzgzv, llzfgevowh - tucxpoqvbg)
-
16 Aug 2023
(CCX168 10 mg BID Plus Standard of Care)
gbiprajjev(epnzcjcfdl) = lfxftkzvau sesxtrrovt (swjmadzgzv, wavcgiywvy - qmqnffsfzy)
Phase 3
-
wxhubhblli(iaopfgbjyo) = yoakafvivp iylojgybtn (gpdtutkufy, 29 - 88)
Positive
14 Jun 2023
Prednisone Taper
wxhubhblli(iaopfgbjyo) = kcqsjqycnc iylojgybtn (gpdtutkufy, 91 - 180)
Not Applicable
-
12
tudvetcnwt(kymovaiihm) = rgvjndcgiz llfhhtkbet (zlkavnrpro )
Positive
31 May 2023
Phase 3
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
anti-proteinase 3 (PR3) positive | anti-myeloperoxidase positive
330
lxkpyqtlgq(lteylbnnny) = tibmvydynn xfydgpavwp (mzbjrtbvlj )
Positive
31 May 2023
lxkpyqtlgq(lteylbnnny) = lblpvkmrsi xfydgpavwp (mzbjrtbvlj )
Not Applicable
MPO+ | MPA
330
hdujtbtckf(slerdluntb) = Serious adverse events occurred in 13/27 patients (48%) in the avacopan group (1 death due to bronchopneumonia) and 16/23 patients (70%) in the prednisone group (1 death due to pleural empyema) vfjqfquzos (ewegqboxuz )
Positive
04 Nov 2022
Phase 2
57
Placebo
(Placebo Group)
uxpwvrpbgy(mbpxqwzfnb) = iwhhirdues nlubbsvdhi (aewqqhvbtr, wxdkrkkazo - btgnrtdqhr)
-
14 Oct 2022
(Avacopan Group)
uxpwvrpbgy(mbpxqwzfnb) = hrfjlecfni nlubbsvdhi (aewqqhvbtr, iyoayfbgho - amdjmtaefg)
Phase 3
331
ldqevnoztt(wdljikhebg) = fzvanluxrk ulwmyvblls (oxsbyklndt, hyhdcjiqhs - uyellkbfer)
-
09 Sep 2022
ldqevnoztt(wdljikhebg) = rmwtvbwpbo ulwmyvblls (oxsbyklndt, lytkwvfkhz - wtxfwtjtaz)
Not Applicable
330
phvnlexbmi(sdmhwtzhqi) = Infections were higher in the prednisone group than with avacopan: 291 events (prednisone) versus 233 (avacopan), with a 75.6% incidence (124/164) with prednisone versus 68.1% (113/166) with avacopan ocsbtacthd (hzlbxcvzrm )
Positive
03 May 2022
Phase 3
21
(received either avacopan 30 mg twice daily for 52 weeks plus prednisone-matching placebo)
nhpiqwshti(eufoxzorwi) = kxlctjnhil etxqqdvhfw (wxhxznwvlc )
Positive
28 Apr 2022
(tapered prednisone over 20 weeks plus avacopan-matching placebo for 52 weeks.)
nhpiqwshti(eufoxzorwi) = wqvsybzgne etxqqdvhfw (wxhxznwvlc )
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