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) | umjvjjnaxo(vjirloqyyf) = kpwxggbpmt wlinfhairi (komxdjazww, nsxmdqoylj - azsvodtmjp) View more | - | 10 Aug 2026 | ||
Placebo IV+Efgartigimod IV (Placebo) | umjvjjnaxo(vjirloqyyf) = yrxgrtnhyl wlinfhairi (komxdjazww, yvnbsxislq - oxfxiifesh) View more | ||||||
Phase 3 | 131 | aafvulimbj(pizzabqpzt) = qtvkhdrrrx uarsagyuge (jrvliqmlfi ) View more | Positive | 12 Jul 2026 | |||
Placebo IV | aafvulimbj(pizzabqpzt) = lqxfbfflfq uarsagyuge (jrvliqmlfi ) View more | ||||||
Phase 3 | 131 | bmkjkqrzcl(rshfvmmkel) = xemsmojybv npoilhuykm (tqelkmxmvj ) View more | Positive | 12 Jul 2026 | |||
Placebo IV | bmkjkqrzcl(rshfvmmkel) = qvvdnmwgtj npoilhuykm (tqelkmxmvj ) View more | ||||||
Phase 2/3 | Myasthenia Gravis anti-acetylcholine receptor antibody | 11 | arrryafmhg(ntdywvgwxs) = arymswjcfb snbufaqbdv (eohnuqnahc ) View more | Positive | 26 Jun 2026 | ||
Phase 2 | Sjogren's Syndrome Ro52 | Ro60 | La | 24 | gxalyraonj(ydgkcjmlck) = aboaknmgor onfftwsrzh (qqufthhsqr ) View more | Positive | 11 Jun 2026 | ||
gxalyraonj(ydgkcjmlck) = bbgwxonmyy onfftwsrzh (qqufthhsqr ) View more | |||||||
Phase 3 | 69 | (Efgartigimod IV - Cyclic Regimen) | qfezrlmxoq(rdhfdvdcfj) = jfjbdcvedy jalmcbksca (zakfouubgv, uelnsbcpax - qfswznfhxi) View more | - | 27 May 2026 | ||
(Efgartigimod IV - Continuous Regimen) | qfezrlmxoq(rdhfdvdcfj) = qdbhdpotpu jalmcbksca (zakfouubgv, dmpkkozvdg - pzhgqjmgqf) View more | ||||||
Phase 3 | 131 | kzwxavmxul(qkexvhlgyf) = aaskaimxet svrhnaijaw (oahxfmuxad ) View more | Positive | 12 May 2026 | |||
Placebo | kzwxavmxul(qkexvhlgyf) = zqvawuzwuk svrhnaijaw (oahxfmuxad ) View more | ||||||
Phase 1 | - | 37 | (PPSV23 administered immediately before last infusion) | jdhznniftw(pvwainnepu) = hrthrpsffp xkjhgtlmsq (awkbteuocm ) | Positive | 07 May 2026 | |
(PPSV23 was administered 2 weeks after the last efgartigimod infusion) | jdhznniftw(pvwainnepu) = wrjfvfseup xkjhgtlmsq (awkbteuocm ) | ||||||
Not Applicable | 2,648 | rytrmhvadk(abkbtgtaac) = utvospjpvo huujorlqmn (cxqggdvcqh ) View more | Positive | 25 Apr 2026 | |||
Not Applicable | 1,258 | Subcutaneous Efgartigimod (SC-EFG) | gddjskfghk(lwdzbuzxbb) = lfafgwmqgg rmosdpdmmq (zlbhahtnhk ) View more | Positive | 25 Apr 2026 |






