Vyvgart

(Efgartigimod)

ApprovedMonoclonal antibody

Efgartigimod is used to treat generalized myasthenia gravis, a condition where the immune system attacks muscles and causes weakness and fatigue. It works by reducing harmful antibodies that interfere with muscle function.[2] Vyvgart is currently approved and in use across 16 indications[4].[1]

Vyvgart is one of 229 antibody fragment programs targeting Chronic Inflammatory Demyelinating Polyneuropathy. It is currently in Approved.

Indications

Total Trials

Active Trials

228

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Chronic Inflammatory Demyelinating PolyneuropathyCompleted

Immune ThrombocytopeniaCompleted

Immune Thrombocytopenia (ITP)Recruiting

Igg4 Related DiseaseActive, not recruiting

Generalized Myasthenia GravisActive, not recruiting

Myasthenia Gravis, GeneralizedRecruiting

MyositisEnrolling by invitation

AcuteNot yet recruiting

Myasthenia GravisRecruiting

Thrombotic Thrombocytopenic PurpuraRecruiting

Chronic Inflammatory Demyelinating PolyneuropathyPhase 2

Completed

Immune ThrombocytopeniaPhase 3

Completed

Immune Thrombocytopenia (ITP)Preclinical

Recruiting

Igg4 Related DiseasePhase 2

Active, not recruiting

Generalized Myasthenia GravisPhase 3

Active, not recruiting

Myasthenia Gravis, GeneralizedApproved

Recruiting

MyositisPhase 3

Enrolling by invitation

AcutePhase 2

Not yet recruiting

Myasthenia GravisApproved

Recruiting

Thrombotic Thrombocytopenic PurpuraPhase 2

Recruiting

Showing 10 of 16 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Vyvgart

Argenx

Approved

1 2

Dexilant

Takeda

Preclinical

2 3

Levulan

Sun Pharmaceutical Industries, Inc.

Preclinical

1 4

Theo-Dur

Pfizer

Preclinical

1 5

Lamprene

Novartis

Preclinical

1 6

Foscavir

CClinigen, Inc.

Preclinical

6 7

Hivid

CConrado Roberto Hoffmann Filho

Preclinical

6 8

Norpramin

VValidus Pharmaceuticals

Preclinical

1 9

Brevibloc

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 10

Barhemsys

Tibotec Pharmaceuticals, Ireland

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Not yet recruiting

ART

NCT07011589

Phase 3Active, not recruiting

Immune Thrombocytopenia

NCT04812925

N/ANot yet recruiting

Myasthenia Gravis

NCT06827587

Phase 2/3Not yet recruiting

Treatment

NCT06885762

Post-ApprovalRecruiting

Myasthenia Gravis

NCT06860633

Q1 2027

Phase 3Recruiting

Myasthenia Gravis

NCT06765161

Clinical

Trials by Indication[1]

Myasthenia Gravis13 trials

Efficacy and Safety of Efgartigimod Sequential Therapy with Telitacicept in Generalized Myasthenia Gravis

Not yet recruiting·FFirst Affiliated Hospital of Wenzhou Medical University·N/A·NCT06827587·60 enrolled

Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

Completed· Argenx logo

Argenx·Phase 3·NCT04818671·184 enrolled

An Open-label Study to Investigate the Clinical Efficacy of Different Dosing Regimens of Efgartigimod IV in Patients With Generalized Myasthenia Gravis

Completed· Argenx logo

Argenx·Phase 3·NCT04980495·69 enrolled

Show 10 more trials

Perioperative Efgartigimod for Thymoma and Myasthenia Gravis

Not yet recruiting·SShanghai Zhongshan Hospital·Phase 2·NCT06221501·30 enrolled

Efgartigimod in IVIG Dependent Myasthenia Gravis Patients

Recruiting·CClinique Neuro-Outaouais·Phase 3·NCT06765161·30 enrolled

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

Recruiting· Argenx logo

Argenx·Phase 2/3·NCT04833894·12 enrolled

Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis

Enrolling by invitation· Argenx logo

Argenx·Phase 2/3·NCT05374590·12 enrolled

Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

Completed· Argenx logo

Argenx·Phase 3·NCT04735432·110 enrolled

A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

Recruiting· Argenx logo

Argenx·Phase 4·NCT06909214·30 enrolled

Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod

Recruiting·UUniversity of Colorado, Denver·Phase 4·NCT06860633·20 enrolled

Seronegative Myasthenia Gravis - Efgartigimod IV

Recruiting·UUniversity Health Network, Toronto·Phase 3·NCT06587867·30 enrolled

A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis

Recruiting· Argenx logo

Argenx··NCT07294170·70 enrolled

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

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT07217587·115 enrolled

Immune Thrombocytopenia6 trials

A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

Completed· Argenx logo

Argenx·Phase 3·NCT04225156·101 enrolled

A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

Completed· Argenx logo

Argenx·Phase 3·NCT04188379·131 enrolled

A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Completed· Argenx logo

Argenx·Phase 3·NCT04687072·207 enrolled

Show 3 more trials

A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

Recruiting· Argenx logo

Argenx·Phase 3·NCT06544499·69 enrolled

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Active, not recruiting· Argenx logo

Argenx·Phase 3·NCT04812925·173 enrolled

A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP)

Withdrawn· Argenx logo

Argenx·Phase 3·NCT04274452

Chronic Inflammatory Demyelinating Polyneuropathy3 trials

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

Active, not recruiting· Argenx logo

Argenx·Phase 2·NCT04280718·229 enrolled

Pre-Approval Access for Efgartigimod PH20 SC in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Available· Argenx logo

Argenx··NCT04777734

A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves)

Completed· Argenx logo

Argenx·Phase 2·NCT04281472·322 enrolled

Generalized Myasthenia Gravis3 trials

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

Recruiting· Argenx logo

Argenx·Phase 2·NCT07284420·70 enrolled

An Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod PH20 SC in Participants From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis

Recruiting· Argenx logo

Argenx·Preclinical·NCT06392386·12 enrolled

A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

Active, not recruiting· Argenx logo

Argenx·Phase 3·NCT06298552·119 enrolled

COVID-192 trials

Open Label Extension of Efgartigimod in Adults With Post-COVID-19 POTS

Terminated· Argenx logo

Argenx·Phase 2·NCT05918978·33 enrolled

Efficacy and Safety Study of Efgartigimod in Adults With Post-COVID-19 POTS

Completed· Argenx logo

Argenx·Phase 2·NCT05633407·53 enrolled

24 more indications

ART2 trials

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

Not yet recruiting·MM. Peter Marinkovich·Phase 1/2·NCT07011589·18 enrolled

A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

Recruiting· Argenx logo

Argenx··NCT06298565·680 enrolled

Primary Sjögren's Syndrome2 trials

Open-Label Extension Study to Evaluate the Safety of Efgartigimod in Adult Patients With Primary Sjögren's Syndrome

Completed· Argenx logo

Argenx·Phase 2·NCT06203457·24 enrolled

A Study of the Efficacy and Safety of Efgartigimod in Patients With Primary Sjögren's Syndrome

Recruiting· Argenx logo

Argenx·Phase 3·NCT06684847·580 enrolled

Pemphigus2 trials

A Study to Assess the Efficacy and Safety of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)

Completed· Argenx logo

Argenx·Phase 3·NCT04598451·222 enrolled

A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod PH20 SC in Adults With Pemphigus (Vulgaris or Foliaceus)

Terminated· Argenx logo

Argenx·Phase 3·NCT04598477·183 enrolled

Bullous Pemphigoid2 trials

A Phase 3 Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

Terminated· Argenx logo

Argenx·Phase 3·NCT05681481·64 enrolled

A Phase 2/3 Study of Efgartigimod PH20 SC in Adult Participants With Bullous Pemphigoid

Completed· Argenx logo

Argenx·Phase 2/3·NCT05267600·98 enrolled

Primary Sjögren's Syndrome (pSS)1 trial

A Study of the Safety and Effectiveness of Efgartigimod in Patients With Primary Sjögren's Syndrome (pSS)

Completed· Argenx logo

Argenx·Phase 2·NCT05817669·34 enrolled

Acute1 trial

FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack

Not yet recruiting·TTianjin Medical University General Hospital·Phase 2·NCT06497374·63 enrolled

Treatment1 trial

Efgartigimod for the Treatment of Guillain-Barré Syndrome

Not yet recruiting·ZZhongming Qiu·Phase 2/3·NCT06885762·20 enrolled

Thrombotic Thrombocytopenic Purpura1 trial

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

Recruiting·UUniversity of Minnesota·Phase 2·NCT06831058·15 enrolled

Concentration1 trial

A Study to Test How Kidney Problems Influence the Blood Concentrations of Efgartigimod

Completed· Argenx logo

Argenx·Phase 1·NCT05927415·33 enrolled

Phase 11 trial

A Phase 1 Bioequivalence Study of Efgartigimod PH20 SC Administered Via a Prefilled Syringe Versus a Vial+Syringe Presentation in Healthy Adults

Completed· Argenx logo

Argenx·Phase 1·NCT05817435·120 enrolled

Membranous Nephropathy1 trial

A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients with Primary Membranous Nephropathy (ZL-1103-014)

Terminated· Argenx logo

Argenx·Phase 2·NCT05810961·8 enrolled

Intravenous1 trial

A Phase 1 Study to Compare the Safety and Effect of Efgartigimod as an Intravenous Infusion With the Effect of Efgartigimod as a Subcutaneous Injection in Healthy Volunteers

Completed· Argenx logo

Argenx·Phase 1·NCT04564066·54 enrolled

Lupus Nephritis1 trial

A Study to Assess Effectiveness and Safety of Efgartigimod in Chinese Patients With Lupus Nephritis (ZL-1103-013)

Completed· Argenx logo

Argenx·Phase 2·NCT05810948·73 enrolled

Optic Neuritis1 trial

Efgartigimod for the Treatment of Acute Optic Neuritis

Recruiting·—·Phase 2·NCT06453694·20 enrolled

AIN1 trial

Evaluating Efgartigimod in Patients With Guillain-Barré Syndrome

Withdrawn·CChafic Karam·Phase 2·NCT05701189

Effectiveness1 trial

Real-World Efgartigimod Effectiveness in CIDP: A Prospective Study

Recruiting· Argenx logo

Argenx··NCT07264426·200 enrolled

Immune Response1 trial

Immune Response to PNEUMOVAX 23 in Healthy Adults Receiving Efgartigimod IV

Completed· Argenx logo

Argenx·Phase 1·NCT05163834·36 enrolled

Pregnancy1 trial

A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.

Recruiting· Argenx logo

Argenx··NCT06299748·279 enrolled

Adult1 trial

A Study to Assess Adults With CIDP Transitioning From IVIg to Efgartigimod PH20 SC

Active, not recruiting· Argenx logo

Argenx·Phase 4·NCT06637072·23 enrolled

Stiff-Person syndrome1 trial

Efgartigimod for Stiff Person Syndrome (ESPS)

Not yet recruiting·UUniversity of South Florida·Phase 2·NCT06528392·10 enrolled

Myasthenia Gravis, Generalized1 trial

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

Recruiting·CCentre Hospitalier Universitaire de Nice·Approved·NCT07072988·50 enrolled

Immune Thrombocytopenia (ITP)1 trial

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

Recruiting· Argenx logo

Argenx·Preclinical·NCT07194850·24 enrolled

IgG4 Related Disease1 trial

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

Active, not recruiting·SStanford University·Phase 2·NCT07025330·5 enrolled

Myositis1 trial

A Phase 3, Single-Arm, Multicenter, Open-label Extension of Study ARGX-113-2007 to Investigate the Long-term Safety, Tolerability, and Efficacy of Efgartigimod PH20 SC in Participants Aged 18 Years and Older With Active Idiopathic Inflammatory Myopathy

Enrolling by invitation· Argenx logo

Argenx·Phase 3·NCT05979441·240 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 17, 2021

VYVGART

NDA BLA761195

Dec 17, 2021

VYVGART

BLA BLA761195

Jun 20, 2023

VYVGART HYTRULO

NDA BLA761304

Dec 12, 2023

VYVGART

NDA BLA761195

Dec 12, 2023

VYVGART HYTRULO

NDA BLA761304

Jun 21, 2024

VYVGART HYTRULO

NDA BLA761304

Jun 21, 2024

VYVGART HYTRULO

NDA BLA761304

Jul 24, 2024

VYVGART

NDA BLA761195

Aug 8, 2024

VYVGART HYTRULO

NDA BLA761304

Aug 8, 2024

VYVGART

NDA BLA761195

Apr 10, 2025

VYVGART HYTRULO

NDA BLA761304

Oct 17, 2025

VYVGART HYTRULO

NDA BLA761304

Oct 17, 2025

VYVGART

NDA BLA761195

Feb 26, 2026

VYVGART HYTRULO

NDA BLA761304

May 8, 2026

VYVGART HYTRULO

NDA BLA761304

May 8, 2026

VYVGART

NDA BLA761195

Sources

References

[1]
ClinicalTrials.gov — 55 trial records for Efgartigimod. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Vyvgart drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Efgartigimod compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Efgartigimod. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA BLA761304). U.S. Food & Drug Administration.
[6]
PubMed — 1 publication indexed for Efgartigimod. U.S. National Library of Medicine.
[7]
SEC EDGAR — Argenx company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Fcrn Antagonist[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Argenx

Key Publications[6]

Efgartigimod in Generalized Myasthenia Gravis: ADAPT Phase 3

Lancet NeurolJun 17, 2022DOI: 10.1016/S1474-4422(22)00173-0

Vyvgart

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Myasthenia Gravis13 trials

Immune Thrombocytopenia6 trials

Chronic Inflammatory Demyelinating Polyneuropathy3 trials

Generalized Myasthenia Gravis3 trials

COVID-192 trials

ART2 trials

Primary Sjögren's Syndrome2 trials

Pemphigus2 trials

Bullous Pemphigoid2 trials

Primary Sjögren's Syndrome (pSS)1 trial

Acute1 trial

Treatment1 trial

Thrombotic Thrombocytopenic Purpura1 trial

Concentration1 trial

Phase 11 trial

Membranous Nephropathy1 trial

Intravenous1 trial

Lupus Nephritis1 trial

Optic Neuritis1 trial

AIN1 trial

Effectiveness1 trial

Immune Response1 trial

Pregnancy1 trial

Adult1 trial

Stiff-Person syndrome1 trial

Myasthenia Gravis, Generalized1 trial

Immune Thrombocytopenia (ITP)1 trial

IgG4 Related Disease1 trial

Myositis1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Key Publications[6]

Related News