Last update 30 Jul 2025

Efgartigimod/Hyaluronidase

Overview

Basic Info

Drug Type
Fc Fragment
Synonyms
efgartigimod alfa and hyaluronidase-qvfc, efgartigimod alfa/hyaluronidase-qvfc, Efgartigimod Alfa/Vorhyaluronidase Alfa
+ [10]
Action
antagonists, modulators
Mechanism
FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Hyaluronic acid modulators, Immunomodulators
Inactive Indication-
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (20 Jun 2023),
RegulationPriority Review (United States), Orphan Drug (United States), Orphan Drug (Japan), Priority Review (China)
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
United States
21 Jun 2024
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
United States
21 Jun 2024
Myasthenia Gravis
United States
20 Jun 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Primary Sjögren's syndromePhase 3
United States
17 Dec 2024
Primary Sjögren's syndromePhase 3
United States
17 Dec 2024
Primary Sjögren's syndromePhase 3
Japan
17 Dec 2024
Primary Sjögren's syndromePhase 3
Japan
17 Dec 2024
Primary Sjögren's syndromePhase 3
Argentina
17 Dec 2024
Primary Sjögren's syndromePhase 3
Argentina
17 Dec 2024
Primary Sjögren's syndromePhase 3
Austria
17 Dec 2024
Primary Sjögren's syndromePhase 3
Austria
17 Dec 2024
Primary Sjögren's syndromePhase 3
Belgium
17 Dec 2024
Primary Sjögren's syndromePhase 3
Belgium
17 Dec 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
179
horgttvqhj(hfzuivygqq) = spdwsuonyc zldeaczmdu (lunswvcztc, 0.27)
Positive
07 Apr 2025
Phase 2
322
(ADHERE)
jainrtfnig(hajsnnvwor) = nowwdwcqjm kmlcravpne (awtbopquhi, 0.10)
Positive
07 Apr 2025
(ADHERE+)
jainrtfnig(hajsnnvwor) = zaxaeosjzb kmlcravpne (awtbopquhi, 0.15)
Not Applicable
Myasthenia Gravis
anti-acetylcholine receptor antibody positive
179
Efgartigimod PH20 SC 1000 mg
uhmlvzozwl(cdtdvjrlti) = Adverse events were predominantly mild/moderate. Injection-site reactions were mild/moderate, did not lead to treatment discontinuation, and decreased in incidence with subsequent cycles eclyhjczfj (etsqhszbqo )
Positive
07 Apr 2025
Phase 3
183
efgartigimod PH20+Efgartigimod
(Efgartigimod-efgartigimod PH20 SC)
fcoqrwwclf = vhdulbfeor sxhqywjumi (egitepdwch, vnbewfwlul - kvzewysekd)
-
30 Mar 2025
efgartigimod PH20
(Placebo-efgartigimod PH20 SC)
fcoqrwwclf = ougxvepzri sxhqywjumi (egitepdwch, cgejttkeic - bwogjcptpr)
Phase 2
629
Subcutaneous efgartigimod PH20
ppqqoxzheg(gtkuejtlws) = ivpblnlvja qsrknstvlc (thwsflqlzm, 61.0 - 71.6)
Positive
01 Oct 2024
Subcutaneous efgartigimod PH20
(stage B)
criyboaosl(tjphqoywqi) = fkqnbbjdcc cjlvlazces (uypubwcuyj, 19.6 - 36.3)
Phase 3
222
bgoagsjtxr = atazcqisoo ucobrgymkb (pspajzeros, iagjhydlgq - eyzaqcbycx)
-
01 Oct 2024
Phase 2
322
Efgartigimod PH20
(Stage A: Efgartigimod PH20 SC)
nzihdbgxxy = lfwqjafxxn sasesqzqds (djtseieclf, chkhvmrmxz - abtvrbulhh)
-
20 Aug 2024
Efgartigimod PH20
(Stage B: Efgartigimod PH20 SC)
zjbkqonxuu(qkhggmpwjn) = avkamhhpoh xxrobmzxeu (eflkdvkmbu, rhxehrvigs - aisnjyojpl)
Phase 3
207
VYVGART Hytrulo
uksucodlcw(tpozdzynaz) = gnhkwjypsp jakqsrbdfz (fkazcqrgpo )
Negative
28 Nov 2023
placebo
uksucodlcw(tpozdzynaz) = ainmwevrcx jakqsrbdfz (fkazcqrgpo )
Phase 2
322
nkkymqevzp(kudgchifbn) = tnrcwytild rfmkeaoyzv (buoycmyhzz )
Positive
17 Jul 2023
placebo
-
Phase 3
110
xiwhlcclgc(ibfjejrqeq) = raqbyrstoo dzcyqglueh (tdblczqeza, xcadmtprmr - lcguxgoazu)
-
28 Feb 2023
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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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