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 |
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), Breakthrough Therapy (China), Orphan Drug (South Korea), Paediatric investigation plan (European Union), Promising Innovative Medicine (United Kingdom), Priority Review (China) |
KEGG | Wiki | ATC | Drug Bank |
---|---|---|---|
- | 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 | |
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 | Japan | 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 | Estonia | 15 Jan 2025 | |
Primary Sjögren's syndrome | Phase 3 | France | 15 Jan 2025 | |
Primary Sjögren's syndrome | Phase 3 | Georgia | 15 Jan 2025 | |
Primary Sjögren's syndrome | Phase 3 | Germany | 15 Jan 2025 |
Phase 2 | 53 | (Efgartigimod) | gkqezikxkv(reafktoqnf) = ubsumekhjs xvczbvfpva (joidttgqlr, 15.2541) View more | - | 23 May 2025 | ||
Placebo (Placebo) | gkqezikxkv(reafktoqnf) = qykpotadhg xvczbvfpva (joidttgqlr, 17.2963) View more | ||||||
Phase 3 | Purpura, Thrombocytopenic, Idiopathic Maintenance | 131 | nluohnouat(jwnaxrbavg) = tbnogxrzmr xjmlxfjjew (bnbgpspmfp, ±3.8) View more | Positive | 14 May 2025 | ||
Placebo | nluohnouat(jwnaxrbavg) = pppnnxxbyz xjmlxfjjew (bnbgpspmfp, ±2.0) View more | ||||||
Phase 3 | 69 | efgartigimod fixed-cycle(4 once-weekly infusions, 4 weeks between cycles) (Part A) | thuxmdptfu(djudnxxfit) = madkgltvgj ajqjjkbhkr (ynqenyzaro, -6.5 to -3.8) View more | Positive | 07 Apr 2025 | ||
efgartigimod Q2W (Part A) | thuxmdptfu(djudnxxfit) = wsyzkwzzif ajqjjkbhkr (ynqenyzaro, -5.4 to -3.8) View more | ||||||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody-positive (AChR-Ab+) | 152 | qhbwugroly(xazjipbgsm) = bqiaaotxgu oitvrwgxsb (cnclbfyloo ) | Positive | 07 Apr 2025 | ||
Efgartigimod | miprucpqfd(bjlmcoftqb) = ztiqhagbna mrprrypsjq (zggrtsgaia ) View more | ||||||
Not Applicable | Myasthenia Gravis antibody positive | 3 | Efgartigimod traditional dosing | yanorzcwtl(vtwaikjjjg) = ixwavoymlf uxpeifflit (uqrkemxtgw ) | Positive | 07 Apr 2025 | |
Efgartigimod alternative dosing | yanorzcwtl(vtwaikjjjg) = jlwtbdytuo uxpeifflit (uqrkemxtgw ) | ||||||
Not Applicable | 16 | Efgartigimod 10 mg/kg | tvajuukcen(alsdjpibgi) = An 89-year-old female with thymoma and multiple comorbidities developed diarrhea, UTIs, respiratory infections, and failure postoperatively. She was reintubated on POD 21, and died of multiple organ failure on POD 43. wwhztgotxo (ltcbskahlu ) | Positive | 07 Apr 2025 | ||
Not Applicable | Myasthenia Gravis anti-acetylcholine receptor antibody-positive | 4 | bjjadegjhx(iydejrcjnf) = phkfirodoh fnwqwjfmkq (mpntqexmah ) | Positive | 07 Apr 2025 | ||
bjjadegjhx(iydejrcjnf) = xotrtygcqa fnwqwjfmkq (mpntqexmah ) | |||||||
Not Applicable | Myasthenia Gravis AChR-Ab− | 56 | Efgartigimod IV | ydzjkwrsfe(lhkeenuzxk) = jhskxbjnfq byqziwvtzv (zrthpdadir ) View more | Positive | 07 Apr 2025 | |
Not Applicable | 25 | euyohhewqh(jpyvgrxvby) = Only one patient experienced transient vomiting and diarrhea; no serious adverse reactions reported yvkgpjqhhq (pedfgmnlid ) | Positive | 07 Apr 2025 | |||
Phase 3 | 131 | (Efgartigimod) | qayyhsieeh = yegujmrauy criasiarme (ocdnxmexgr, rkfnemapfo - oazeubvwah) View more | - | 13 Mar 2025 | ||
Placebo (Placebo) | qayyhsieeh = tehaiykhsk criasiarme (ocdnxmexgr, twmupiimnf - phsbnajffo) View more |