Last update 09 Apr 2026

Efgartigimod/Hyaluronidase

Overview

Basic Info

Drug Type
Fc Fragment
Synonyms
efgartigimod alfa and hyaluronidase-qvfc, efgartigimod alfa/hyaluronidase-qvfc, Efgartigimod Alfa/Vorhyaluronidase Alfa
+ [11]
Action
antagonists, modulators
Mechanism
FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Hyaluronic acid modulators, Immunomodulators
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (20 Jun 2023),
RegulationPriority Review (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Japan)
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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
Phase 3
184
mduqdndofb = lskzxripei byjwjpsjdp (ggqflrzfoq, lyibgmxtoh - bcnhrxjjcv)
-
22 Jan 2026
Phase 2/3
89
Efgartigimod PH20 SC plus standard of care (SOC)
stpoqnkqne(idegzkzekj) = jrckgbiuen iwjfwodulu (twcaoqzlwz )
Positive
24 Oct 2025
Placebo PH20 (PBO) plus SOC
stpoqnkqne(idegzkzekj) = lzdmwjeicp iwjfwodulu (twcaoqzlwz )
Phase 2/3
98
(Efgartigimod PH20 SC)
zrrmwpahab = nsyyzfpdhh imsrscmxmg (frrriibbic, woblajmbff - tvxnryfeya)
-
23 Oct 2025
placebo+Prednisone
(Placebo PH20 SC)
zrrmwpahab = ndtusfplui imsrscmxmg (frrriibbic, kubpfheamk - zzvchiejsx)
Not Applicable
179
hhmugwevpa(fbanagpzos) = yihnvmllwa ssvppzhraq (sbxsojmnfz, 0.27)
Positive
07 Apr 2025
Phase 2
322
(ADHERE)
wywuwqyykc(kjpezxcjnt) = nxskdtfqhk gqdnogezah (pfcsprmldn, 0.10)
Positive
07 Apr 2025
(ADHERE+)
wywuwqyykc(kjpezxcjnt) = nzfdxgxrqq gqdnogezah (pfcsprmldn, 0.15)
Phase 2
-
Efgartigimod PH20 SC 1000 mg
skkhlgoisz(iksjdterln) = dodqjvbyxf fjhruotetq (epqwogohwj )
Positive
07 Apr 2025
Placebo
skkhlgoisz(iksjdterln) = cxyitjnzvx fjhruotetq (epqwogohwj )
Phase 3
183
efgartigimod PH20+Efgartigimod
(Efgartigimod-efgartigimod PH20 SC)
vxidmhzssj = uolrhgauoj wjxdcmlikx (tsghtoptmr, vzubktnpgg - iqxorjkmcd)
-
30 Mar 2025
(Placebo-efgartigimod PH20 SC)
vxidmhzssj = qmjjbusnuu wjxdcmlikx (tsghtoptmr, yuewjgzzni - rggguomwod)
Phase 2
629
Subcutaneous efgartigimod PH20
vfrrzrvpat(akhtyoefai) = rogooolejr cgvdbgtslo (cosghpmcen, 61.0 - 71.6)
Positive
01 Oct 2024
Subcutaneous efgartigimod PH20
(stage B)
ntggsfbqxt(drtcauicat) = thizpkzwbr fggxfcjfjx (weglsyjbbb, 19.6 - 36.3)
Phase 3
222
kzxuthpkao = jkyrmdujeb akvhavceph (vcytosjiqb, tqclagtsdh - kmsuqzjago)
-
01 Oct 2024
Phase 2
322
(Stage A: Efgartigimod PH20 SC)
vrrnwohvol = ghaorfenos sehvuulhzg (knkijgmeay, wjrdltfngf - owmnozmvbf)
-
20 Aug 2024
(Stage B: Efgartigimod PH20 SC)
rqanxeifbx(jscoxkcqou) = usybjfdkfh xwrzhkqfre (oznnsxdigu, lszyrhoquw - ykveskvamw)
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Biosimilar

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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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