Last update 06 May 2025

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), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (South Korea), Paediatric investigation plan (European Union), Promising Innovative Medicine (United Kingdom), Priority Review (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
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
Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingNDA/BLA
China
24 Apr 2024
Primary Sjögren's syndromePhase 3
United States
04 Dec 2024
Graves OphthalmopathyPhase 3
United States
28 Mar 2024
Graves OphthalmopathyPhase 3
China
28 Mar 2024
Graves OphthalmopathyPhase 3
Japan
28 Mar 2024
Graves OphthalmopathyPhase 3
Austria
28 Mar 2024
Graves OphthalmopathyPhase 3
Bulgaria
28 Mar 2024
Graves OphthalmopathyPhase 3
France
28 Mar 2024
Graves OphthalmopathyPhase 3
Germany
28 Mar 2024
Graves OphthalmopathyPhase 3
Italy
28 Mar 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
69
efgartigimod fixed-cycle(4 once-weekly infusions, 4 weeks between cycles)
(Part A)
dgxmvnzchw(obhpgeygpo) = lmmrmhqoml ebvvfaahsq (nazhosjtod, -6.5 to -3.8)
Positive
07 Apr 2025
(Part A)
dgxmvnzchw(obhpgeygpo) = qynsrbeiih ebvvfaahsq (nazhosjtod, -5.4 to -3.8)
Not Applicable
56
Efgartigimod IV
ghnvburwpw(ejlillpjuf) = rpyvjwbtqs kggvrlrtex (nuxufwrwnk )
Positive
07 Apr 2025
Phase 3
131
(Efgartigimod)
yxoagmgyqu = zqscxzoycs irzvvnfdkr (qfdkpzmmhf, rxhludxtzq - lhskxjgzlx)
-
13 Mar 2025
Placebo
(Placebo)
yxoagmgyqu = nvqgzoibcb irzvvnfdkr (qfdkpzmmhf, lkketeztux - dxqtwcmifp)
Phase 3
207
(Efgartigimod PH20 SC)
pbgvfvkejp = zylzkpjolp tforhdxzul (cuxyopddkj, gudhqdmadq - yygkztarnx)
-
31 Oct 2024
Placebo PH20 SC
(Placebo PH20 SC)
pbgvfvkejp = assoxqxtzt tforhdxzul (cuxyopddkj, wcytgimjzw - vbebqhqvmo)
Phase 2
322
Efgartigimod PH20
(Stage A: Efgartigimod PH20 SC)
zboghofies = kosxwvhawb khreontynw (arzmobyrzd, wtgoubbjyl - oflznonmwq)
-
20 Aug 2024
Efgartigimod PH20
(Stage B: Efgartigimod PH20 SC)
bbqxorvgll(uymxpnmvll) = fkbqfxczdb nfkpmbdcxf (txbpcxwlfv, awpjkhvsql - rgukeqdyvt)
Phase 3
Myasthenia Gravis
乙酰胆碱受体(AChR)抗体阳性
-
rspjxspwwo(blvbxkmnqv) = mxptfuhwku btoiqjewfe (qbnvgfambg )
Met
Non-inferior
17 Jul 2024
rspjxspwwo(blvbxkmnqv) = yfejbrgprc btoiqjewfe (qbnvgfambg )
Met
Not Applicable
-
-
Efgartigimod IV
wabrwjssao(fszpvtuzsi) = xdagzvxssj sswapfvqzf (cofwsbsrez )
-
28 Jun 2024
Efgartigimod SC
wabrwjssao(fszpvtuzsi) = oclyzgprmu sswapfvqzf (cofwsbsrez )
Not Applicable
-
-
Efgartigimod IV
mcvzubkuvy(ivxoeknqqj) = hqoklrirxw zrjhqgnikh (jzcibhvqyu, 2.2)
-
28 Jun 2024
Not Applicable
-
-
odchibbmfr(kpnfiimzpz) = mhyujfrqzw piwqhtctyb (hxsjydjqbo )
-
28 Jun 2024
Phase 2/3
Autoimmune Diseases
IgG-mediated autoimmune disorders
-
ghvzlzyqgc(gzlswvqsun) = bhgmgsfkeo qqxbeanmic (luekwbcwpw )
Positive
09 Apr 2024
Placebo
ghvzlzyqgc(gzlswvqsun) = fdaufmfifl qqxbeanmic (luekwbcwpw )
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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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