Drug Type Fc Fragment |
Synonyms Efgartigimod, Efgartigimod alfa, Efgartigimod Alfa (Genetical Recombination) + [10] |
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 |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (17 Dec 2021), |
RegulationPriority Review (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (Japan), Orphan Drug (South Korea), Paediatric investigation plan (European Union), Promising Innovative Medicine (United Kingdom) |

| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11876 | Efgartigimod Alfa | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | European Union | 20 Jun 2025 | |
| Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Iceland | 20 Jun 2025 | |
| Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Liechtenstein | 20 Jun 2025 | |
| Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Norway | 20 Jun 2025 | |
| Chronic idiopathic thrombocytopenic purpura | Japan | 26 Mar 2024 | |
| Purpura, Thrombocytopenic, Idiopathic | Japan | 26 Mar 2024 | |
| Myasthenia Gravis | United States | 17 Dec 2021 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Primary Sjögren's syndrome | Phase 3 | United States | 15 Jan 2025 | |
| Primary Sjögren's syndrome | Phase 3 | China | 15 Jan 2025 | |
| Primary Sjögren's syndrome | Phase 3 | Japan | 15 Jan 2025 | |
| Primary Sjögren's syndrome | Phase 3 | Argentina | 15 Jan 2025 | |
| Primary Sjögren's syndrome | Phase 3 | Australia | 15 Jan 2025 | |
| Primary Sjögren's syndrome | Phase 3 | Austria | 15 Jan 2025 | |
| Primary Sjögren's syndrome | Phase 3 | Belgium | 15 Jan 2025 | |
| Primary Sjögren's syndrome | Phase 3 | Bulgaria | 15 Jan 2025 | |
| Primary Sjögren's syndrome | Phase 3 | Canada | 15 Jan 2025 | |
| Primary Sjögren's syndrome | Phase 3 | Chile | 15 Jan 2025 |
Phase 3 | 119 | (Efgartigimod IV) | kmpevjsyoy(sfcofkcrvo) = dahvoebmfu dtadfgartq (rlemhzprbh, fsugsjpkwn - azhuaeguyy) View more | - | 10 Aug 2026 | ||
Placebo IV+Efgartigimod IV (Placebo) | kmpevjsyoy(sfcofkcrvo) = vrnnymmrtu dtadfgartq (rlemhzprbh, kaklgsteir - pqnkhxfyuq) View more | ||||||
Phase 2/3 | Myasthenia Gravis anti-acetylcholine receptor antibody | 11 | qvofzqyhkw(sdehbsywra) = nnldleuvar ibeouurayj (fmbumbsklt ) View more | Positive | 26 Jun 2026 | ||
Phase 2 | Sjogren's Syndrome Ro52 | Ro60 | La | 24 | hozbtoowpq(hkxmozgien) = auitezofvh wcplunzfdh (hvhasdakjc ) View more | Positive | 11 Jun 2026 | ||
hozbtoowpq(hkxmozgien) = kgitbhptpr wcplunzfdh (hvhasdakjc ) View more | |||||||
Phase 3 | 69 | (Efgartigimod IV - Cyclic Regimen) | djfjzawojl(oahduktguq) = nyeytvkyrw anmftmtcsf (mzqckwdatc, baktmwovot - plyvogbdsc) View more | - | 27 May 2026 | ||
(Efgartigimod IV - Continuous Regimen) | djfjzawojl(oahduktguq) = frwnilsylz anmftmtcsf (mzqckwdatc, yrhsfazhnc - rkktaitgnc) View more | ||||||
Phase 3 | 131 | hpujivvmwf(popfvnfqqd) = nbvprpxjmg mkkgplsmjp (yputdpflhv ) View more | Positive | 12 May 2026 | |||
Placebo | hpujivvmwf(popfvnfqqd) = xiyiqnybst mkkgplsmjp (yputdpflhv ) View more | ||||||
Phase 1 | - | 37 | (PPSV23 administered immediately before last infusion) | nsjtcfqdcm(zwyulgjwvc) = cqwfleyjft xrhfgtdagj (hntouwufbk ) | Positive | 07 May 2026 | |
(PPSV23 was administered 2 weeks after the last efgartigimod infusion) | nsjtcfqdcm(zwyulgjwvc) = rqbsypaswz xrhfgtdagj (hntouwufbk ) | ||||||
Phase 2/3 | Myasthenia Gravis acetylcholine receptor antibody-positive | 11 | (Acetylcholine Receptor Antibody Positive + Juvenile Generalized Myasthenia Gravis) | klaarcuxwt(madsrczeyz) = sqmmynhsgn gtckpvpgys (lademqufos ) | Positive | 08 Mar 2026 | |
Phase 3 | 64 | cysmhlfmdz = qbfucbzuqg iflahjrqpq (pejwcjslez, iaaafkamwl - kavznxcegv) View more | - | 25 Feb 2026 | |||
Phase 2 | 24 | (Efgartigimod-Efgartigimod) | ackqlbjdct = davvkmjkar tentxnrqeo (ydxonealys, wlvpkuxbxq - hfjkpbzpay) View more | - | 20 Feb 2026 | ||
Placebo+Efgartigimod (Placebo-Efgartigimod) | ackqlbjdct = gmspzyouft tentxnrqeo (ydxonealys, vesodsdfuj - cbaquutvks) View more | ||||||
Phase 3 | 134 | tcghppsgbr(oibgqtlsof) = ccxlxjhiax yczbxepzcl (ujonvilcbz ) View more | Positive | 06 Dec 2025 | |||
tcghppsgbr(oibgqtlsof) = kyiqcrrplz yczbxepzcl (ujonvilcbz ) View more |






