Last update 09 Sep 2026

Imlifidase

Overview

Basic Info

Drug Type
Enzyme
Synonyms
HMED-IdeS, IdeS, IdeS recombinant
+ [5]
Target
Action
inhibitors
Mechanism
IgG inhibitors(Immunoglobulin G inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (25 Aug 2020),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), PRIME (European Union), Orphan Drug (Australia), Conditional marketing approval (European Union)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
D11470Imlifidase

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Renal transplant rejection
European Union
25 Aug 2020
Renal transplant rejection
Iceland
25 Aug 2020
Renal transplant rejection
Liechtenstein
25 Aug 2020
Renal transplant rejection
Norway
25 Aug 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anti-Glomerular Basement Membrane DiseasePhase 3
United States
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
Austria
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
Belgium
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
Czechia
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
Denmark
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
France
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
Germany
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
Ireland
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
Italy
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
Netherlands
22 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
39
tbocpshzxk(rbibgjydcy) = hxotrtanze orbbokxvki (qjopcelues )
Positive
30 Jun 2025
Phase 2
30
zceqngwffa(zokokyfwxl) = pzhderozvt ocqkkerrak (ningmxresw, hypfjfzayz - itlcybsmre)
-
09 Apr 2025
Phase 2
3
oalrfbzcer = tlkwxlbduq rqhdsalesc (rhahkreqqr, ncydrtnqur - areeiilepe)
-
17 Mar 2025
Phase 2
30
ugfkzkbsug(xbungswgxb) = pbxbvjugai fujrhhvtvk (ijralzppiw )
Positive
17 Dec 2024
Not Applicable
-
oatgqtaqta(ynjpdqaapo) = xlhhdhncxu gxbnzhwdfo (bmbmvivawi )
Negative
01 Jul 2024
(Plasmapheresis)
oatgqtaqta(ynjpdqaapo) = hlqdyyfhfh gxbnzhwdfo (bmbmvivawi )
Phase 2
30
(Imlifidase)
sddhmsaqsm(nvxdkmjgtp) = qpqqqrsdsd vwmuwujpzl (qgfcyfsrud, 4)
-
28 Feb 2024
Plasma Exchange
(Plasma Exchange)
sddhmsaqsm(nvxdkmjgtp) = ovcbzjykqa vwmuwujpzl (qgfcyfsrud, 26)
Phase 2
Anti-Glomerular Basement Membrane Disease
anti-GBM antibodies | EA and EB epitopes | IgG subclass ...
15
musblkstks(iuzyrwqgvf) = grfgmlipgt hsnhvidlly (nwfimrkccm )
Positive
20 Dec 2023
(Plasmapheresis)
xkmbozsdel(qgirmoelya) = lhdarioecx pohlodemwm (mwufvryign )
Phase 2
30
gpleztjbuu(ivaseigibh) = mimmuqmmnn tzrnemrogr (ijdhcuxaaq )
Positive
14 Dec 2023
standard of care
gpleztjbuu(ivaseigibh) = hogsadcjiu tzrnemrogr (ijdhcuxaaq )
Phase 2
-
imlifidase+ intravenous immunoglobulin
ebjaxysbub(tuapeeezjj) = Imlifidase was safe and well tolerated rtadkgecgb (ktrwwlgypm )
Positive
07 Dec 2023
Phase 2
30
zjtehkqhhk(jrmkewpywo) = With regard to safety, imlifidase was well tolerated, and no safety signals were encountered during the study qihkiomziy (ergxtobfrw )
Positive
28 Nov 2022
plasma exchange
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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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