Last update 03 Jul 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
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (17 Dec 2021),
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Orphan Drug (South Korea), Paediatric investigation plan (European Union), Promising Innovative Medicine (United Kingdom), 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
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
Japan
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
Estonia
15 Jan 2025
Primary Sjögren's syndromePhase 3
France
15 Jan 2025
Primary Sjögren's syndromePhase 3
Georgia
15 Jan 2025
Primary Sjögren's syndromePhase 3
Germany
15 Jan 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
53
(Efgartigimod)
gkqezikxkv(reafktoqnf) = ubsumekhjs xvczbvfpva (joidttgqlr, 15.2541)
-
23 May 2025
Placebo
(Placebo)
gkqezikxkv(reafktoqnf) = qykpotadhg xvczbvfpva (joidttgqlr, 17.2963)
Phase 3
131
nluohnouat(jwnaxrbavg) = tbnogxrzmr xjmlxfjjew (bnbgpspmfp, ±3.8)
Positive
14 May 2025
Placebo
nluohnouat(jwnaxrbavg) = pppnnxxbyz xjmlxfjjew (bnbgpspmfp, ±2.0)
Phase 3
69
efgartigimod fixed-cycle(4 once-weekly infusions, 4 weeks between cycles)
(Part A)
thuxmdptfu(djudnxxfit) = madkgltvgj ajqjjkbhkr (ynqenyzaro, -6.5 to -3.8)
Positive
07 Apr 2025
(Part A)
thuxmdptfu(djudnxxfit) = wsyzkwzzif ajqjjkbhkr (ynqenyzaro, -5.4 to -3.8)
Not Applicable
Myasthenia Gravis
anti-acetylcholine receptor antibody-positive (AChR-Ab+)
152
qhbwugroly(xazjipbgsm) = bqiaaotxgu oitvrwgxsb (cnclbfyloo )
Positive
07 Apr 2025
Efgartigimod
miprucpqfd(bjlmcoftqb) = ztiqhagbna mrprrypsjq (zggrtsgaia )
Not Applicable
Myasthenia Gravis
antibody positive
3
Efgartigimod traditional dosing
yanorzcwtl(vtwaikjjjg) = ixwavoymlf uxpeifflit (uqrkemxtgw )
Positive
07 Apr 2025
Efgartigimod alternative dosing
yanorzcwtl(vtwaikjjjg) = jlwtbdytuo uxpeifflit (uqrkemxtgw )
Not Applicable
Myasthenia Gravis | Muscle Weakness
AChR antibody positive
16
Efgartigimod 10 mg/kg
tvajuukcen(alsdjpibgi) = An 89-year-old female with thymoma and multiple comorbidities developed diarrhea, UTIs, respiratory infections, and failure postoperatively. She was reintubated on POD 21, and died of multiple organ failure on POD 43. wwhztgotxo (ltcbskahlu )
Positive
07 Apr 2025
Not Applicable
Myasthenia Gravis
anti-acetylcholine receptor antibody-positive
4
bjjadegjhx(iydejrcjnf) = phkfirodoh fnwqwjfmkq (mpntqexmah )
Positive
07 Apr 2025
bjjadegjhx(iydejrcjnf) = xotrtygcqa fnwqwjfmkq (mpntqexmah )
Not Applicable
56
Efgartigimod IV
ydzjkwrsfe(lhkeenuzxk) = jhskxbjnfq byqziwvtzv (zrthpdadir )
Positive
07 Apr 2025
Not Applicable
25
euyohhewqh(jpyvgrxvby) = Only one patient experienced transient vomiting and diarrhea; no serious adverse reactions reported yvkgpjqhhq (pedfgmnlid )
Positive
07 Apr 2025
Phase 3
131
(Efgartigimod)
qayyhsieeh = yegujmrauy criasiarme (ocdnxmexgr, rkfnemapfo - oazeubvwah)
-
13 Mar 2025
Placebo
(Placebo)
qayyhsieeh = tehaiykhsk criasiarme (ocdnxmexgr, twmupiimnf - phsbnajffo)
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Clinical Trial

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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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