Drug Type Fc Fragment |
Synonyms efgartigimod alfa and hyaluronidase-qvfc, efgartigimod alfa/hyaluronidase-qvfc, Efgartigimod Alfa/Vorhyaluronidase Alfa + [11] |
Target |
Action antagonists, modulators |
Mechanism FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Hyaluronic acid modulators, Immunomodulators |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
License 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) |

| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Graves Disease | Phase 3 | United States | 10 Jun 2026 | |
| Graves Disease | Phase 3 | Japan | 10 Jun 2026 | |
| Graves Disease | Phase 3 | Belgium | 10 Jun 2026 | |
| Graves Disease | Phase 3 | Bulgaria | 10 Jun 2026 | |
| Graves Disease | Phase 3 | Canada | 10 Jun 2026 | |
| Graves Disease | Phase 3 | Denmark | 10 Jun 2026 | |
| Graves Disease | Phase 3 | Germany | 10 Jun 2026 | |
| Graves Disease | Phase 3 | Latvia | 10 Jun 2026 | |
| Graves Disease | Phase 3 | Lithuania | 10 Jun 2026 | |
| Graves Disease | Phase 3 | Poland | 10 Jun 2026 |
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 ) View more | Positive | 21 Aug 2026 | |||
Phase 2/3 | 89 | iflcmkpoox(fxnivzpisn) = cuezqzzhvl ekncgoghlr (kwqyoqusim ) View more | Positive | 11 Jun 2026 | |||
Placebo rHuPH20 SC | iflcmkpoox(fxnivzpisn) = bxxhvjbzgg ekncgoghlr (kwqyoqusim ) View more | ||||||
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 ) View more | Positive | 08 Mar 2026 | |||
Placebo | xiqpwrsltb(oijbfxqisu) = gphdumsnbv buwqetmhzc (dswbsdnjxj ) View more | ||||||
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 ) View more | Positive | 08 Mar 2026 | |||
Phase 3 | 184 | ymtczhmksi = qlhswzqubj yjkxyorsqf (srxmldmvpq, jrixwlfeei - heqrhyqmqo) View more | - | 22 Jan 2026 | |||
Phase 2/3 | 89 | Efgartigimod PH20 SC plus standard of care (SOC) | uikddxzasg(gylefzkbvz) = pjikvwuges ieheiilbml (nokffmmlee ) View more | Positive | 24 Oct 2025 | ||
Placebo PH20 (PBO) plus SOC | uikddxzasg(gylefzkbvz) = gysjsgtpgj ieheiilbml (nokffmmlee ) View more | ||||||
Phase 2/3 | 98 | (Efgartigimod PH20 SC) | poyolzdiuk = uihgkxrpst houytieezc (luvtkhqrsr, mbfzhmoqdl - ctcuvrakux) View more | - | 23 Oct 2025 | ||
placebo+Prednisone (Placebo PH20 SC) | poyolzdiuk = dzfrkordos houytieezc (luvtkhqrsr, qslktrwyrx - laihegodwe) View more |






