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Drug

Efgartigimod alfa

Approved · EMA
Late-stage development

Also known as Vyvgart, Vyvgart Hytrulo, efgartigimod.

RxNorm2587717UNII961YV2O515
18
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase IIa, Single-Site, Open-Label Study of Efgartigimod in Patients With IgG4-Related Disease

Clinical trial2026-07-23Status changed to Active, not recruiting · ClinicalTrials.gov

A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP

Clinical trial2026-07-09Results expected Q4 2028 · ClinicalTrials.gov

Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab

Clinical trial2026-07-06Results expected Q3 2027 · ClinicalTrials.gov

Safety and Efficacy of Efgartigimod in Guillain-Barré Syndrome

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

An ISA to Master Protocol ARGX-999-2-MG-2000 for an Exploratory, Phase 2a, Proof-of-Concept Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV as Add-On Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

Clinical trial2026-06-12Results expected Q1 2028 · ClinicalTrials.gov

A Pilot Study of Efgartigimod for Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)

Clinical trial2026-06-11Results expected Q2 2028 · ClinicalTrials.gov

A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis

Clinical trial2026-05-27Results posted · ClinicalTrials.gov

Targeting Collagen VII Antibodies in Bullous Diseases Using Efgartigimod IV (VYVGART)

Clinical trial2026-05-05Results expected Q1 2028 · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

Clinical trial2026-05-01Results expected Q2 2028 · ClinicalTrials.gov

A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia.

Clinical trial2026-03-11Completed · ClinicalTrials.gov

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome (pSS) Who Complete Qualifying Efgartigimod pSS Studies

Clinical trial2026-02-20Results posted · ClinicalTrials.gov

Approval: Vyvgart (EMA)

Regulatory2022-08-10EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Efgartigimod alfa
Aliases & brands
VyvgartVyvgart Hytruloefgartigimod
RxNorm CUI
2587717
UNII
961YV2O515
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2022-08-10
Latest approval
2022-08-10
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2022-08-10Approval
Approval: Vyvgart (EMA)
Indication: Vyvgart is indicated as- an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are antiacetylcholine receptor (AChR)… Show full indication

Vyvgart is indicated as- an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are antiacetylcholine receptor (AChR) antibody positive.- monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

32 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
32
registered trials across all phases
LATEST COMPLETION 2026
18
Active studies
16
Recruiting
15
Late-stage (III+)
11
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 32
Phase 13Phase 1 / 21Phase 213Phase 2 / 33Phase 39Phase 43

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Multicenter, Prospective, Observational, Open-label Study to Evaluate the Benefit of Corticoid Sparing in Elderly With Generalized AntiRAch Myasthenia Gravis Treated With IV or SC Efgartigimod

RecruitingPH IVCentre Hospitalier Universitaire de Nicen=502027

Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod: A Single Arm, Open Label Prospective Cohort Study

RecruitingPH IVUniversity of Colorado, Denvern=202026

Intravenous Human IgG1 Fc Fragment (Efgartigimod) in Myasthenic Crisis

Not yet recruitingPH IVRambam Health Care Campusn=162025

A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants From 12 Years to Less Than 18 Years of Age With Chronic ITP

RecruitingPH II/IIIargenxn=242030

Efficacy and Safety of Nipocalimab vs Efgartigimod for Patients With Generalized Myasthenia Gravis in a Randomized, Open-label, Phase 3b, Interventional Trial Including Within Class Switching From Efgartigimod to Nipocalimab

RecruitingPH IIIJanssen Research & Development, LLCn=1152029

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia.

CompletedPH IIIargenxn=1012026

A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis

CompletedPH IIIargenxn=692025

A Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis

CompletedPH IIargenxn=732025

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome (pSS) Who Complete Qualifying Efgartigimod pSS Studies

CompletedPH IIargenxn=242025

A Phase 1, Open-label, Study to Evaluate the Pharmacokinetics of Efgartigimod IV 10 mg/kg Single Dose Administered in Participants With Renal Impairment

CompletedPH Iargenxn=332024

A Phase 2 Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Patients With Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (POTS)

CompletedPH IIargenxn=532024
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.