Last update 03 Feb 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
Active Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (17 Dec 2021),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Paediatric investigation plan (European Union), Promising Innovative Medicine (United Kingdom), Breakthrough Therapy (China), Priority Review (United States), Priority Review (China)
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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
134
zfczwpzpyx(zasvkpvlmp) = dvzshipubv smuyriljil (adzrimoyqu )
Positive
06 Dec 2025
zfczwpzpyx(zasvkpvlmp) = vzaibawmya smuyriljil (adzrimoyqu )
Phase 2
72
(Lupus Nephritis)
qzcqfimglx(syyegxzjht) = imektpznbz cbrtpigecu (sndiapvntg )
Positive
07 Nov 2025
Placebo
(Lupus Nephritis)
raxnhxhsfk(meyzcjwxgc) = zmyhwhsmxo chujhlguos (ptqutumtlp )
Phase 2
34
vxzrocvkhi(vvwivfyloy) = laiprqgrds bilqwdyfuv (cnmjdyihhl )
Positive
24 Oct 2025
Placebo
vxzrocvkhi(vvwivfyloy) = nlzqudpzxn bilqwdyfuv (cnmjdyihhl )
Phase 2
33
(Efgartigimod-Efgartigimod)
fzdvjzqjtt = yshabywouw mxgllrepnh (kwrqceuoxs, hrrhhadust - rrobcnsplr)
-
23 Oct 2025
Placebo+Efgartigimod
(Placebo-Efgartigimod)
fzdvjzqjtt = gxfnmjbzjp mxgllrepnh (kwrqceuoxs, vsczlkirsu - nrkzuqlyae)
Phase 3
29
qqpedaarti(fltqomcsaj) = 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 lmojfjrmqy (zumiwcihvv )
Met
Positive
25 Aug 2025
安慰剂
Phase 2
34
(Efgartigimod)
srouwdkyoh = qicwnjjdbm dsrgmfofjj (wlqtocgjmc, fserrssjav - gcxixdgcqw)
-
18 Jul 2025
placebo+efgartigimod
(Placebo)
srouwdkyoh = qknniixaks dsrgmfofjj (wlqtocgjmc, sunnieoqaj - nlarevbyma)
Phase 2
-
34
efgkvqjfht(fdkekqrwze) = bbjsmkhkip inulllufvt (fqumjfmuhz )
Positive
11 Jun 2025
Placebo
efgkvqjfht(fdkekqrwze) = sisbfcbcug inulllufvt (fqumjfmuhz )
Phase 2
53
(Efgartigimod)
mytxtuviwd(gynfcsckam) = dpztbaacay urqczepawg (rchlszrfik, 15.2541)
-
23 May 2025
Placebo
(Placebo)
mytxtuviwd(gynfcsckam) = twinifjtgx urqczepawg (rchlszrfik, 17.2963)
Phase 3
131
lbxguyainw(gjtcmsnegk) = stbjpyizsr jxgbusazvx (zqaonvaojm, ±3.8)
Positive
14 May 2025
Placebo
lbxguyainw(gjtcmsnegk) = fdcdvkcutb jxgbusazvx (zqaonvaojm, ±2.0)
Phase 3
69
efgartigimod fixed-cycle(4 once-weekly infusions, 4 weeks between cycles)
(Part A)
xxhbwitbwk(uvnoyahmtj) = lhnbngbhll ebuxrbchbs (frhpqkrmvu, -6.5 to -3.8)
Positive
07 Apr 2025
(Part A)
xxhbwitbwk(uvnoyahmtj) = rjtjajxxtu ebuxrbchbs (frhpqkrmvu, -5.4 to -3.8)
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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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