IVIg

Phase 3Small molecule

Argenx

IVIg is one of 47 small molecule programs targeting Neonatal. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

NeonatalRecruiting

Anti-3-Hydroxy-3-Methylglutaryl-Coa Reductase (HMGCR) Immune-Mediated Necrotizing MyopathyRecruiting

PregnancyCompleted

InfantsCompleted

Atrioventricular BlockActive, not recruiting

Kawasaki DiseaseWithdrawn

NeonatalPhase 3

Recruiting

Anti-3-Hydroxy-3-Methylglutaryl-Coa Reductase (HMGCR) Immune-Mediated Necrotizing MyopathyPhase 2

Recruiting

PregnancyPhase 2

Completed

InfantsPreclinical

Completed

Atrioventricular BlockPhase 3

Active, not recruiting

Kawasaki DiseasePhase 3

Withdrawn

Competition

Competitive Landscape

46 competitors in Pregnancy

#DrugCompanyPhaseTrials

Femara

Novartis

Approved

14 2

Bayer Aspirin

Bayer

Approved

8 3

Marinol

Jazz Pharmaceuticals

Approved

1 4

Rayos

RRoxane Laboratories

Approved

7 5

Pifeltro

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Approved

1 6

BEYFORTUS

Sanofi

Phase 3

1 7

Monoferric

PPharmacosmos A/S

Phase 3

1 8

Dihydroartemisinin-Piperaquine

GSK

Phase 3

4 9

Cimzia

UCB

Phase 2

1 10

IVIg

Argenx

Phase 3

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Henoch-Schönlein Purpura

NCT03647852

Q2 2027

Phase 2Recruiting

Anti-3-Hydroxy-3-Methylglutaryl-Coa Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy

NCT06599697

Q1 2028

PreclinicalNot yet recruiting

Kawasaki Disease

NCT07686770

Q1 2029

Phase 3Recruiting

Chronic Inflammatory Demyelinating Polyneuropathy

NCT06290141

Clinical

Trials by Indication[1]

Kawasaki Disease6 trials

Different Doses of IVIG for Kawasaki Disease

Completed·—·Phase 3·NCT02439996·404 enrolled

Efficacy of Immunoglobulin Plus Infliximab for the Early Regression of Coronary Artery Lesion in Kawasaki Disease

Withdrawn·—·Phase 3·NCT04535518

KIDCARE (Kawasaki Disease Comparative Effectiveness Trial)

Completed·UUniversity of California, San Diego·Phase 3·NCT03065244·105 enrolled

Show 3 more trials

Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease

Active, not recruiting·—·Phase 3·NCT04078568·3,208 enrolled

Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial

Completed·FFudan University·Phase 3·NCT02298062·40 enrolled

Efficacy and Safety of Immunoglobulin Plus Firsekibart in Patients With Kawasaki Disease: An Exploratory Randomized Controlled Study

Not yet recruiting·CChildren's Hospital of Fudan University·Preclinical·NCT07686770·90 enrolled

Intravenous5 trials

Post-Poliosyndrome Treated With Intravenous Immunoglobulin (IvIg)

Completed·HHaukeland University Hospital·Phase 2/3·NCT00231439·40 enrolled

Treating Donors With Intravenous Immunoglobulin to Reduce Donor-Derived Infections

Unknown status·SShanghai Changzheng Hospital·Phase 4·NCT05799716·40 enrolled

Antibiotic Treatment and Intravenous Immunoglobulin Trial for PANDAS

Withdrawn·CCNS Onlus·Phase 2·NCT01769027

Show 2 more trials

Intravenous Immunoglobulin (IVIG) Versus Plasma Exchange (PE) for Ventilated Children With Guillain Barre Syndrome (GBS)

Completed·MMansoura University Children Hospital·N/A·NCT01306578·41 enrolled

Intravenous Immunoglobulin (IVIg) for the Treatment of Stiff-Man Syndrome (SMS)

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT00001550·20 enrolled

Immune Thrombocytopenia3 trials

A Trial of Eltrombopag or Intravenous Immune Globulin Before Surgery for Immune Thrombocytopenia Patients

Completed·MMcMaster University·Phase 3·NCT01621204·74 enrolled

A Trial of Antenatal Treatment of Alloimmune Thrombocytopenia

Completed·WWeill Medical College of Cornell University·Phase 2/3·NCT00194987·102 enrolled

Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) in Children

Completed·—·Phase 3·NCT03939637·122 enrolled

Pregnancy3 trials

Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Implantation Failure

Completed·TTabriz University of Medical Sciences·Phase 2·NCT03174964·50 enrolled

Immunomodulatory Effects of IVIg on Pregnancy Rate of Patient With Recurrent Pregnancy Loss

Completed·TTabriz University of Medical Sciences·Phase 2·NCT03174951·50 enrolled

Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

Recruiting·PPeking University People's Hospital·Phase 2·NCT06577909·100 enrolled

Kidney Transplant2 trials

Study in End-stage Renal Disease Patients Awaiting Kidney Transplant to Investigate the Potential Effect of IVIG Treatment on the Pharmacokinetics and Pharmacodynamics of LFG316

Completed· Novartis logo

Novartis·Phase 1·NCT02878616·8 enrolled

IVIg to Treat BK Viremia in Kidney Transplant Recipients

Completed·MMassachusetts General Hospital·Phase 1·NCT02659891·16 enrolled

33 more indications

Chronic Inflammatory Demyelinating Polyneuropathy2 trials

A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

Recruiting· Argenx logo

Argenx·Phase 3·NCT06920004·218 enrolled

A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy

Recruiting· Sanofi logo

Sanofi·Phase 3·NCT06290141·160 enrolled

Long COVID2 trials

RECOVER-AUTONOMIC: A Platform Protocol for Evaluation of Interventions for Autonomic Dysfunction in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

Completed·KKanecia Obie Zimmerman·Phase 2·NCT06305780·381 enrolled

RECOVER-AUTONOMIC (IVIG): Randomized Trial of the Effect of IVIG Versus Placebo on Long COVID Symptoms

Completed·KKanecia Obie Zimmerman·Phase 2·NCT06305793·200 enrolled

First-line Treatment1 trial

Etoposide in the First-line Treatment of Adult EBV-HLH

Unknown status·—·Phase 3·NCT03742115·90 enrolled

Randomised Controlled Trial1 trial

Immunoglobulin for Necrotizing Soft Tissue Infections: a Randomised Controlled Trial

Completed·AAnders Perner·Phase 2·NCT02111161·100 enrolled

Epilepsy1 trial

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

Terminated·EEmory University·Phase 2·NCT01545518·20 enrolled

Multiple Sclerosis1 trial

Maximizing Outcome of Multiple Sclerosis Transplantation

Terminated·NNorthwestern University·Phase 3·NCT03342638·66 enrolled

Neonatal sepsis1 trial

Intravenous Immunoglobulin in Prevention of Preterm Neonatal Sepsis

Completed·HHormozgan University of Medical Sciences·Phase 3·NCT02954926·92 enrolled

Neuropathy1 trial

A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy

Recruiting· Argenx logo

Argenx·Phase 3·NCT06742190·115 enrolled

Efficacy1 trial

Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG

Unknown status·AAzidus Brasil·Phase 3·NCT06089122·50 enrolled

Infants1 trial

Post-bypass Prophylactic IVIG in Infants and Neonates

Completed·UUniversity of Alabama at Birmingham·N/A·NCT02043379·50 enrolled

Systemic Sclerosis1 trial

Cardiac Safe Transplants for Systemic Sclerosis

Terminated·NNorthwestern University·Phase 2/3·NCT03593902·9 enrolled

Melanoma1 trial

IVIG in the Treatment of Metastatic Cancers of the Prostate, Colon and Melanoma

Unknown status·GGammaCan·Phase 2·NCT00294476·30 enrolled

Pneumonia1 trial

Intravenous Immunoglobulin (IVIG, Bioven) Efficacy Assess for COVID-19 / SARS-CoV-2 Severe Pneumonia Complex Treatment

Completed·BBiopharma Plasma LLC·Phase 3·NCT04500067·76 enrolled

NMO Spectrum Disorder1 trial

Autologous Transplant To End NMO Spectrum Disorder

Withdrawn·NNorthwestern University·Phase 2/3·NCT03829566

Single Dose1 trial

Single Dose Study of ANX005 in Healthy Volunteers

Terminated·AAnnexon, Inc.·Phase 1·NCT03010046·27 enrolled

Cerebellar Ataxia1 trial

Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia

Completed·UUniversity of South Florida·Phase 2·NCT01350440·5 enrolled

Hypophosphatasia1 trial

Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa (STRENSIQ®) for Hypophosphatasia

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 4·NCT06015750

Lung Transplantation1 trial

Intravenous Immunoglobulin (IVIG) in Lung Transplantation

Completed·—·Phase 2·NCT00115778·11 enrolled

Desensitization1 trial

Renal Function in Highly Sensitized Patients 1 Year After Desensitization With Imlifidase Prior to DD Kidney Tx

Completed·HHansa Biopharma AB·Phase 3·NCT04935177·64 enrolled

Pediatric1 trial

A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)

Unknown status·IIMMUNOe Research Centers·Phase 4·NCT03348618·21 enrolled

COVID-191 trial

IVIG in Patients With Severe COVID-19 Requiring Mechanical Ventilation

Unknown status·SSharp HealthCare·Phase 4·NCT04616001·10 enrolled

Myasthenia Gravis1 trial

Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis

Completed·UUniversity Health Network, Toronto·Phase 4·NCT01179893·87 enrolled

Henoch-Schönlein Purpura1 trial

Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Recruiting·—·N/A·NCT03647852·150 enrolled

Biomarkers1 trial

The Effects Of Therapeutic Plasma Exchange (TPE) On Age Related Biomarkers And Epigenetics

Active, not recruiting·DDobri Kiprov·Phase 3·NCT06534450·40 enrolled

Treatment1 trial

IVIG (Gamunex-C) Treatment Study for POTS Subjects

Completed·UUniversity of Texas Southwestern Medical Center·Phase 1/2·NCT03919773·30 enrolled

Immune Checkpoint Inhibitor1 trial

Harnessing Allo-immunity to Enhance Immune Checkpoint Inhibitor Responses in Advanced NSCLC

Withdrawn·VVA Office of Research and Development·Phase 1/2·NCT06064279

Cutaneous Lupus Erythematosus1 trial

IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

Completed·UUniversity of California, Irvine·Phase 1·NCT01841619·16 enrolled

Neonatal Infection1 trial

Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection

Completed·NNICHD Neonatal Research Network·Phase 2/3·NCT01203345·2,416 enrolled

CIDP1 trial

Transcriptome Analysis of the Peripheral Blood in CIDP

Unknown status·AAssistance Publique - Hôpitaux de Paris·N/A·NCT02404298·50 enrolled

Neonatal1 trial

Multicenter, Open-Label, Randomized Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT06533098·50 enrolled

Atrioventricular Block1 trial

Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)

Active, not recruiting·NNYU Langone Health·Phase 3·NCT04474223·1,300 enrolled

Kidney1 trial

Intravenous Immunoglobulins for Prevention of BKV Infection in Kidney Transplant Recipients According to BKV Genotype-specific Neutralizing Antibody Titers at the Day of Transplantation: A Multicenter Study

Completed·UUniversity Hospital, Strasbourg, France·Approved·NCT04222023·359 enrolled

Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy1 trial

The MIGHT Trial - An Exploratory Clinical Trial of Intravenous Immunoglobulin (IVIG) in Anti-3-Hydroxy-3-Methylglutaryl-CoA Reductase (HMGCR) Immune Mediated Necrotizing Myopathy (IMNM)

Recruiting·UUniversity of Alabama at Birmingham·Phase 2·NCT06599697·12 enrolled

Sources

References

[1]
ClinicalTrials.gov — 54 trial records for IVIg. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — IVIg compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for IVIg. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Argenx company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Argenx

IVIg

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q1 2028

Q1 2029

Trials by Indication[1]

Kawasaki Disease6 trials

Intravenous5 trials

Immune Thrombocytopenia3 trials

Pregnancy3 trials

Kidney Transplant2 trials

Chronic Inflammatory Demyelinating Polyneuropathy2 trials

Long COVID2 trials

First-line Treatment1 trial

Randomised Controlled Trial1 trial

Epilepsy1 trial

Multiple Sclerosis1 trial

Neonatal sepsis1 trial

Neuropathy1 trial

Efficacy1 trial

Infants1 trial

Systemic Sclerosis1 trial

Melanoma1 trial

Pneumonia1 trial

NMO Spectrum Disorder1 trial

Single Dose1 trial

Cerebellar Ataxia1 trial

Hypophosphatasia1 trial

Lung Transplantation1 trial

Desensitization1 trial

Pediatric1 trial

COVID-191 trial

Myasthenia Gravis1 trial

Henoch-Schönlein Purpura1 trial

Biomarkers1 trial

Treatment1 trial

Immune Checkpoint Inhibitor1 trial

Cutaneous Lupus Erythematosus1 trial

Neonatal Infection1 trial

CIDP1 trial

Neonatal1 trial

Atrioventricular Block1 trial

Kidney1 trial

Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy1 trial

References

Drug Info

Quick Facts

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