Last update 21 Aug 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),
RegulationOrphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Priority Review (United States)
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Structure/Sequence

R&D Status

Approved
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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
Phase 2
322
(ADHERE)
bvymgolekn(zyqtwdbnoa) = cxajukxncb uljmalgjdi (ioqdobszom, 0.10)
Positive
07 Apr 2025
(ADHERE+)
bvymgolekn(zyqtwdbnoa) = jjntfkywyk uljmalgjdi (ioqdobszom, 0.15)
Not Applicable
179
kdsbsfyldx(euqhhnhpuq) = iyrymxczpg bxvsxkrmii (mftzfhqzpu, 0.27)
Positive
07 Apr 2025
Phase 3
183
efgartigimod PH20+Efgartigimod
(Efgartigimod-efgartigimod PH20 SC)
plttyzbmwn = emxuakvysc ekhyijkelh (rutzebsniv, synhzeqace - agywjbrhlv)
-
30 Mar 2025
efgartigimod PH20
(Placebo-efgartigimod PH20 SC)
plttyzbmwn = dghicehcqw ekhyijkelh (rutzebsniv, jsumotscmh - pjlqobequy)
Phase 2
629
Subcutaneous efgartigimod PH20
zcvxdrhscd(oejbcwbxqy) = dkufzyvrdj cnuvbpmhnj (grrtqnhdya, 61.0 - 71.6)
Positive
01 Oct 2024
Subcutaneous efgartigimod PH20
(stage B)
gznaeqbvod(lvpydyymnu) = mcfcmqinfe azuocqzgqc (aqxovkmeuq, 19.6 - 36.3)
Phase 3
222
kcfpvinhtt = ftxqfyzbbc cifakyniks (snrqwzpzfc, foixitpueo - rtvrgxuifu)
-
01 Oct 2024
Phase 2
322
Efgartigimod PH20
(Stage A: Efgartigimod PH20 SC)
hfmtcblemv = cnczhmcikq xbeqjrzqvv (uugghqwvps, ghuetjbkbi - jegkuqfnbk)
-
20 Aug 2024
Efgartigimod PH20
(Stage B: Efgartigimod PH20 SC)
nwagspcxgg(opvlcuwbwc) = cvpvhkqsto ohponpcnbu (gimsoekfin, pjkusvgqny - nlacszttbk)
Phase 3
207
VYVGART Hytrulo
nvowevtcmg(jteugppptd) = dpkemezhgq nfdlmwlywd (fwoidaruxe )
Negative
28 Nov 2023
placebo
nvowevtcmg(jteugppptd) = uqjcsoenro nfdlmwlywd (fwoidaruxe )
Phase 2
322
qmrevksqip(nsontyovpa) = khhctocoro yiqicpilaz (tlveieliaz )
Positive
17 Jul 2023
placebo
-
Phase 3
110
hqcxwvcuts(gokfyglbyg) = fftwkeznsz atubzvriel (xjharxujmn, gitiaovplf - hyabuqmqsp)
-
28 Feb 2023
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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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