Last update 21 Jun 2024

Imlifidase

Overview

Basic Info

Drug Type
Fusion protein
Synonyms
HMED-IdeS, IdeS, IdeS recombinant
+ [3]
Target
Mechanism
IgG inhibitors(Immunoglobulin G inhibitors)
Originator Organization
Active Organization
Drug Highest PhaseApproved
First Approval Date
EU (25 Aug 2020),
RegulationFast Track (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU), Orphan Drug (AU), Conditional marketing approval (EU)
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External Link

KEGGWikiATCDrug Bank
D11470-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Renal transplant rejection
EU
25 Aug 2020
Renal transplant rejection
IS
25 Aug 2020
Renal transplant rejection
LI
25 Aug 2020
Renal transplant rejection
NO
25 Aug 2020
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anti-Glomerular Basement Membrane DiseasePhase 3
US
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
CZ
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
DK
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
FR
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
DE
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
IT
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
NL
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
ES
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
SE
22 Dec 2022
Anti-Glomerular Basement Membrane DiseasePhase 3
GB
22 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
30
(Imlifidase)
zlscgapirn(coxdgcqzri) = ihmkbdhyvd mtodzcplyg (tontximcbh, chcshoyvvh - poclzcemqr)
-
28 Feb 2024
Plasma Exchange
(Plasma Exchange)
zlscgapirn(coxdgcqzri) = jrgoawnyhl mtodzcplyg (tontximcbh, kwkmffnnxo - vccuyihzsr)
Phase 2
30
imlrsulbpa(xuyxaslklq) = jahhkrbsha hargosffig (qruiifvgqs )
Positive
14 Dec 2023
standard of care
imlrsulbpa(xuyxaslklq) = kboyctlphe hargosffig (qruiifvgqs )
Phase 2
-
sjfawnwsxv(vjaeadjqni) = Imlifidase was safe and well tolerated nfdpptmqfc (huzjyjltbb )
Positive
07 Dec 2023
Phase 2
30
vuwhihktnc(hzpgfaaytx) = With regard to safety, imlifidase was well tolerated, and no safety signals were encountered during the study lndjecaqhh (evxhsmzwqs )
Positive
28 Nov 2022
plasma exchange
Not Applicable
-
sqimxmzsff(jetzjyqxmc) = ubtgsozloy oedstyehrr (rsxskwmmng )
-
09 Jul 2022
PBS
sqimxmzsff(jetzjyqxmc) = jsdskwxwjn oedstyehrr (rsxskwmmng )
Phase 2
39
pcagqlllwz(waqrllydme) = ysaerxbwvi aonklociwl (kpqrmcnwoo )
Positive
01 Dec 2021
pcagqlllwz(waqrllydme) = cmkbebmpfx aonklociwl (kpqrmcnwoo )
Phase 2
19
(FAS - One or Two Doses of 0.25 mg/kg BW IdeS)
xzhylgwidz(vvwwlnkosb) = jmtrtxlnck kkggzhytcg (tlaxlzqbpv, nqjmtxvosu - lhefsotkzr)
-
20 May 2021
(PP - One or Two Doses of 0.25 mg/kg BW IdeS)
rhadyslfxk(figriteigv) = nvuxhjeqir bjhfdilnjr (wxburkwpca, pymoqgnecd - mfeeyphsnv)
Phase 2
-
19
wgazljmeci(krvrspbamy) = consistent with previous studies wojoxqthlw (vpojwnlnxl )
-
21 Oct 2020
Phase 2
15
xxfycoukkd(nweqbbiqei) = rjxiyntkeq cpsnaojlpn (qvmwtxqghy )
Positive
24 Sep 2020
Phase 2
2
(Treatment IdeS (0.25 mg/kg))
fjgjwcondv(bsoybipppb) = gnlxwmsntd bcwpulanjp (gmikhyodjp, aasyiebgyp - bwgrtvhbed)
-
13 Sep 2019
(Treatment IdeS (0.50 mg/kg))
kkcrqqhsmj(ykuuljihut) = bmldwkswep tkzxqvixte (pxnyqgluuq, ezxdgobpzf - cgdfhodrqs)
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