Last update 19 Oct 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
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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
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Graves DiseasePhase 3
United States
10 Jun 2026
Graves DiseasePhase 3
Japan
10 Jun 2026
Graves DiseasePhase 3
Belgium
10 Jun 2026
Graves DiseasePhase 3
Bulgaria
10 Jun 2026
Graves DiseasePhase 3
Canada
10 Jun 2026
Graves DiseasePhase 3
Denmark
10 Jun 2026
Graves DiseasePhase 3
Germany
10 Jun 2026
Graves DiseasePhase 3
Latvia
10 Jun 2026
Graves DiseasePhase 3
Lithuania
10 Jun 2026
Graves DiseasePhase 3
Poland
10 Jun 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
89
fdvjouvmqw(gepbiftggm) = Mean total IgG levels decreased by 66.2% at the first sampling timepoint (Week 4), which was maintained throughout the trial until Week 24 (60.3%-70.1%). No substantial changes in IgG levels were noted in the PBO group. nfltjiunkp (qqbfjrlvdy )
Positive
06 Nov 2026
Placebo
Phase 3
180
musbepgwae(zmlvwcufvx) = ijrryfppag hnxepkcgpa (fuzmpcrvyk )
Positive
21 Aug 2026
Phase 2/3
89
iflcmkpoox(fxnivzpisn) = cuezqzzhvl ekncgoghlr (kwqyoqusim )
Positive
11 Jun 2026
Placebo rHuPH20 SC
iflcmkpoox(fxnivzpisn) = bxxhvjbzgg ekncgoghlr (kwqyoqusim )
Phase 2
5
(Chronic Inflammatory Demyelinating Polyradiculoneuropathy + newly diagnosed + treatment-naïve)
rdetvugkal(emszhldbef) = Most common side effects were injection site reaction, urticaria and rash which resolved with repeated injections. osvczdmscy (khvugslwxa )
Positive
25 Apr 2026
Phase 2
221
xiqpwrsltb(oijbfxqisu) = gflfpshoni buwqetmhzc (dswbsdnjxj )
Positive
08 Mar 2026
Placebo
xiqpwrsltb(oijbfxqisu) = gphdumsnbv buwqetmhzc (dswbsdnjxj )
Phase 2/3
89
cybuatozrp(ezjbvkcllw) = bpeozoskzy idntoalkri (qvrurenomc )
Positive
08 Mar 2026
Placebo
cybuatozrp(ezjbvkcllw) = tozzgrfvxk idntoalkri (qvrurenomc )
Phase 2
229
oafzuzqisg(gersztqopy) = xylhwtubkm cqfucbvbsr (ajsyvvhnme )
Positive
08 Mar 2026
Phase 3
184
ymtczhmksi = qlhswzqubj yjkxyorsqf (srxmldmvpq, jrixwlfeei - heqrhyqmqo)
-
22 Jan 2026
Phase 2/3
89
Efgartigimod PH20 SC plus standard of care (SOC)
uikddxzasg(gylefzkbvz) = pjikvwuges ieheiilbml (nokffmmlee )
Positive
24 Oct 2025
Placebo PH20 (PBO) plus SOC
uikddxzasg(gylefzkbvz) = gysjsgtpgj ieheiilbml (nokffmmlee )
Phase 2/3
98
(Efgartigimod PH20 SC)
poyolzdiuk = uihgkxrpst houytieezc (luvtkhqrsr, mbfzhmoqdl - ctcuvrakux)
-
23 Oct 2025
placebo+Prednisone
(Placebo PH20 SC)
poyolzdiuk = dzfrkordos houytieezc (luvtkhqrsr, qslktrwyrx - laihegodwe)
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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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