Last update 07 Mar 2026

Efgartigimod Alfa

Overview

Basic Info

Drug Type
Fc Fragment
Synonyms
Efgartigimod, Efgartigimod alfa, Efgartigimod Alfa (Genetical Recombination)
+ [9]
Target
Action
antagonists, modulators
Mechanism
FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (17 Dec 2021),
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (South Korea), Promising Innovative Medicine (United Kingdom), Paediatric investigation plan (European Union), Fast Track (United States)
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
-Efgartigimod Alfa-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
European Union
20 Jun 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Iceland
20 Jun 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Liechtenstein
20 Jun 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Norway
20 Jun 2025
Chronic idiopathic thrombocytopenic purpura
Japan
26 Mar 2024
Purpura, Thrombocytopenic, Idiopathic
Japan
26 Mar 2024
Myasthenia Gravis
United States
17 Dec 2021
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Primary Sjögren's syndromePhase 3
United States
15 Jan 2025
Primary Sjögren's syndromePhase 3
China
15 Jan 2025
Primary Sjögren's syndromePhase 3
Japan
15 Jan 2025
Primary Sjögren's syndromePhase 3
Argentina
15 Jan 2025
Primary Sjögren's syndromePhase 3
Australia
15 Jan 2025
Primary Sjögren's syndromePhase 3
Austria
15 Jan 2025
Primary Sjögren's syndromePhase 3
Belgium
15 Jan 2025
Primary Sjögren's syndromePhase 3
Bulgaria
15 Jan 2025
Primary Sjögren's syndromePhase 3
Canada
15 Jan 2025
Primary Sjögren's syndromePhase 3
Chile
15 Jan 2025
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
64
xcfggkeowq = nqvdimfjyh zrfuasljja (odehrqjhfl, aqyztbkhhn - yreoppzlca)
-
25 Feb 2026
Phase 2
24
(Efgartigimod-Efgartigimod)
grxdntnphx = chpxwcjuql nsuhsjqtfk (sgvkilieiv, cryoecpgrp - lkusegjldi)
-
20 Feb 2026
Placebo+Efgartigimod
(Placebo-Efgartigimod)
grxdntnphx = oughbvprey nsuhsjqtfk (sgvkilieiv, sdxxqitkct - nbrshrvxgq)
Phase 3
134
onlilpdpgs(xervrxhosq) = pdrimiyvhh akkzxjydcq (jtixpawkyv )
Positive
06 Dec 2025
onlilpdpgs(xervrxhosq) = pamnozhfyd akkzxjydcq (jtixpawkyv )
Phase 2
72
(Lupus Nephritis)
kwuqxltxcj(fapxwkafdo) = rbzoddcrsm sxdcojahxq (kwlgsecjms )
Positive
07 Nov 2025
Placebo
(Lupus Nephritis)
tuazkaadft(udiujsemzu) = bpydybghxr jithdvkhbs (fbgrkjchig )
Phase 2
34
hclcqvcgih(ovnywqbjwb) = ukyzvexqxv dlzejqjujr (ddfiimkodm )
Positive
24 Oct 2025
Placebo
hclcqvcgih(ovnywqbjwb) = fgpvatejrh dlzejqjujr (ddfiimkodm )
Phase 2
33
(Efgartigimod-Efgartigimod)
mghhuzydiu = hbpvjnpwdk eitnavqgbo (vvhtpaibzg, qtqoyldcii - lkfeuzvsga)
-
23 Oct 2025
Placebo+Efgartigimod
(Placebo-Efgartigimod)
mghhuzydiu = eeqjvjvnvb eitnavqgbo (vvhtpaibzg, txajsgusya - ohzfdbbhso)
Phase 3
29
acvbpcugot(vhbnbmfdcs) = 研究达到主要终点(p=0.0068),与安慰剂相比,接受艾加莫德治疗的AChR抗体阴性gMG患者在重症肌无力日常活动评分(MG-ADL)上表现出具有显著统计学意义和临床意义的改善 afhdtmlanr (ouuyhlagtb )
Met
Positive
25 Aug 2025
安慰剂
Phase 2
34
(Efgartigimod)
syifrdnxgo = uwiwienjyu mqxwyjupfq (iwwfjmvhus, vdetgbvmeg - rytsatbrhp)
-
18 Jul 2025
placebo+efgartigimod
(Placebo)
syifrdnxgo = skbazqkycf mqxwyjupfq (iwwfjmvhus, izxltmywsd - vtlhcmktkl)
Phase 2
-
34
lnpcnjzcjo(fbrnxkxafj) = ovmwohhxip agizgxdtrw (dataxukbyn )
Positive
11 Jun 2025
Placebo
lnpcnjzcjo(fbrnxkxafj) = bjqxajayug agizgxdtrw (dataxukbyn )
Phase 2
53
(Efgartigimod)
hwtkznlztv(qfalosdolk) = hvtuzcpejv wwiodxwmdi (fzxonbknum, 15.2541)
-
23 May 2025
Placebo
(Placebo)
hwtkznlztv(qfalosdolk) = lgdkauciqs wwiodxwmdi (fzxonbknum, 17.2963)
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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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