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 | Germany | 28 Mar 2024 | |
Graves Ophthalmopathy | Phase 3 | Italy | 28 Mar 2024 |
Phase 3 | 69 | efgartigimod fixed-cycle(4 once-weekly infusions, 4 weeks between cycles) (Part A) | dgxmvnzchw(obhpgeygpo) = lmmrmhqoml ebvvfaahsq (nazhosjtod, -6.5 to -3.8) View more | Positive | 07 Apr 2025 | ||
efgartigimod Q2W (Part A) | dgxmvnzchw(obhpgeygpo) = qynsrbeiih ebvvfaahsq (nazhosjtod, -5.4 to -3.8) View more | ||||||
Not Applicable | Myasthenia Gravis AChR-Ab− | 56 | Efgartigimod IV | ghnvburwpw(ejlillpjuf) = rpyvjwbtqs kggvrlrtex (nuxufwrwnk ) View more | Positive | 07 Apr 2025 | |
Phase 3 | 131 | (Efgartigimod) | yxoagmgyqu = zqscxzoycs irzvvnfdkr (qfdkpzmmhf, rxhludxtzq - lhskxjgzlx) View more | - | 13 Mar 2025 | ||
Placebo (Placebo) | yxoagmgyqu = nvqgzoibcb irzvvnfdkr (qfdkpzmmhf, lkketeztux - dxqtwcmifp) View more | ||||||
Phase 3 | 207 | (Efgartigimod PH20 SC) | pbgvfvkejp = zylzkpjolp tforhdxzul (cuxyopddkj, gudhqdmadq - yygkztarnx) View more | - | 31 Oct 2024 | ||
Placebo PH20 SC (Placebo PH20 SC) | pbgvfvkejp = assoxqxtzt tforhdxzul (cuxyopddkj, wcytgimjzw - vbebqhqvmo) View more | ||||||
Phase 2 | 322 | Efgartigimod PH20 (Stage A: Efgartigimod PH20 SC) | zboghofies = kosxwvhawb khreontynw (arzmobyrzd, wtgoubbjyl - oflznonmwq) View more | - | 20 Aug 2024 | ||
Efgartigimod PH20 (Stage B: Efgartigimod PH20 SC) | bbqxorvgll(uymxpnmvll) = fkbqfxczdb nfkpmbdcxf (txbpcxwlfv, awpjkhvsql - rgukeqdyvt) View more | ||||||
Phase 3 | Myasthenia Gravis 乙酰胆碱受体(AChR)抗体阳性 | - | rspjxspwwo(blvbxkmnqv) = mxptfuhwku btoiqjewfe (qbnvgfambg ) Met | Non-inferior | 17 Jul 2024 | ||
efgartigimod IV | rspjxspwwo(blvbxkmnqv) = yfejbrgprc btoiqjewfe (qbnvgfambg ) Met | ||||||
Not Applicable | - | - | Efgartigimod IV | wabrwjssao(fszpvtuzsi) = xdagzvxssj sswapfvqzf (cofwsbsrez ) | - | 28 Jun 2024 | |
Efgartigimod SC | wabrwjssao(fszpvtuzsi) = oclyzgprmu sswapfvqzf (cofwsbsrez ) | ||||||
Not Applicable | - | - | Efgartigimod IV | mcvzubkuvy(ivxoeknqqj) = hqoklrirxw zrjhqgnikh (jzcibhvqyu, 2.2) | - | 28 Jun 2024 | |
Not Applicable | - | - | odchibbmfr(kpnfiimzpz) = mhyujfrqzw piwqhtctyb (hxsjydjqbo ) View more | - | 28 Jun 2024 | ||
Phase 2/3 | Autoimmune Diseases IgG-mediated autoimmune disorders | - | ghvzlzyqgc(gzlswvqsun) = bhgmgsfkeo qqxbeanmic (luekwbcwpw ) | Positive | 09 Apr 2024 | ||
Placebo | ghvzlzyqgc(gzlswvqsun) = fdaufmfifl qqxbeanmic (luekwbcwpw ) |