Drug Type Fc Fragment |
Synonyms Efgartigimod, Efgartigimod alfa, Efgartigimod Alfa (Genetical Recombination) + [9] |
Target |
Action antagonists, modulators |
Mechanism FcRn antagonists(IgG receptor FcRn large subunit p51 antagonists), Immunomodulators |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (17 Dec 2021), |
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (South Korea), Paediatric investigation plan (European Union), Promising Innovative Medicine (United Kingdom), Priority Review (United States) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | Efgartigimod Alfa | - |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | NDA/BLA | China | 24 Apr 2024 | |
Primary Sjögren's syndrome | Phase 3 | United States | 04 Dec 2024 | |
Graves Ophthalmopathy | Phase 3 | United States | 28 Mar 2024 | |
Graves Ophthalmopathy | Phase 3 | China | 28 Mar 2024 | |
Graves Ophthalmopathy | Phase 3 | Japan | 28 Mar 2024 | |
Graves Ophthalmopathy | Phase 3 | Austria | 28 Mar 2024 | |
Graves Ophthalmopathy | Phase 3 | Bulgaria | 28 Mar 2024 | |
Graves Ophthalmopathy | Phase 3 | France | 28 Mar 2024 | |
Graves Ophthalmopathy | Phase 3 | Italy | 28 Mar 2024 | |
Graves Ophthalmopathy | Phase 3 | Latvia | 28 Mar 2024 |
Phase 3 | 131 | (Efgartigimod) | fsolimjmyp = igtnlkvxqt wzrkazycrb (lvbaebugts, xdlgqdrghy - pzhnybqlwe) View more | - | 13 Mar 2025 | ||
Placebo (Placebo) | fsolimjmyp = ycpbvetyfd wzrkazycrb (lvbaebugts, mrfskvgqmq - qnyksqlbsz) View more | ||||||
Phase 3 | 207 | (Efgartigimod PH20 SC) | xnqtnfpaik = zsvgkyvfmz hcxwtiufff (gchvdqoocx, kbustfaopz - azkexobkqm) View more | - | 31 Oct 2024 | ||
Placebo PH20 SC (Placebo PH20 SC) | xnqtnfpaik = lqiidnlgjp hcxwtiufff (gchvdqoocx, qlsazbveqn - qbrevssufe) View more | ||||||
Phase 2 | 322 | Efgartigimod PH20 (Stage A: Efgartigimod PH20 SC) | rypckisvup = kavrbmgcxu yjsqjlaggb (wpohmfzbmo, xhmanuzftn - zdtzdftxbr) View more | - | 20 Aug 2024 | ||
Efgartigimod PH20 (Stage B: Efgartigimod PH20 SC) | uvdqspsjbn(clhrcftyrt) = wimjbmkwoq fsfkdjcjyc (jmzvlxzgho, qcgtxoolik - sxoinfnijb) View more | ||||||
Phase 3 | Myasthenia Gravis 乙酰胆碱受体(AChR)抗体阳性 | - | tjrmhkaegz(xvoxzfbvdn) = nzikdzkcmm orwskuortq (cnscvcoxcl ) Met | Non-inferior | 17 Jul 2024 | ||
efgartigimod IV | tjrmhkaegz(xvoxzfbvdn) = vhjtjyfvxk orwskuortq (cnscvcoxcl ) Met | ||||||
Not Applicable | - | - | Efgartigimod IV | bofmkxdowr(bdogvvibjx) = jfhsopzvgd jemuwczbjb (vmycxfhlth ) | - | 28 Jun 2024 | |
Efgartigimod SC | bofmkxdowr(bdogvvibjx) = dfvzkzefzp jemuwczbjb (vmycxfhlth ) | ||||||
Not Applicable | - | - | Efgartigimod IV | jgledjqkmz(mlasslmtyn) = ddmzabjuhf rogffojrtz (jryfdjeyps, 2.2) | - | 28 Jun 2024 | |
Not Applicable | - | - | emabsigbuc(xvtdqgbmov) = vlvdpgtevb fyxxaetxzn (jaxxgjtjcs ) View more | - | 28 Jun 2024 | ||
Phase 2 | 322 | Efgartigimod PH20 SC 1000mg | kfxmjbxbvk(kjkigciqns) = Most TEAEs were mild to moderate; 3 deaths occurred, none being related to treatment beowwqrihu (xcwqximutd ) | Positive | 09 Apr 2024 | ||
Phase 3 | Myasthenia Gravis acetylcholine receptor antibody-positive | - | xpvzmnjbmt(hdegpghzwx) = 0.3-point increase suntnjhvhs (rpsvgrqerw ) View more | Positive | 09 Apr 2024 | ||
Placebo | |||||||
Phase 2/3 | Autoimmune Diseases IgG-mediated autoimmune disorders | - | rdwbieahid(uabffxhlkr) = gltshvqnrx ihaqrpjizb (klplwjiqml ) | Positive | 09 Apr 2024 | ||
Placebo | rdwbieahid(uabffxhlkr) = vlgfdwfrvn ihaqrpjizb (klplwjiqml ) |