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Asceniv

(Immune globulin)

ApprovedSmall molecule

This medication supplies antibodies from human blood plasma to help your immune system fight infections and manage various immune-related conditions. It is given as an infusion directly into a vein and works by boosting your body's ability to combat diseases and manage disorders where the immune system isn't functioning properly.[2] Asceniv is currently approved and in use across 17 indications[4].[1]

Asceniv is one of 396 small molecule programs targeting Chronic Inflammatory Demyelinating Polyneuropathy. It is currently in Approved.

17

Indications

32

Total Trials

4

Active Trials

395

Competitors

Pipeline

Status by Indication[4][1]

Indication

Chronic Inflammatory Demyelinating PolyneuropathyActive, not recruiting

HepatitisActive, not recruiting

Cerebellar AtaxiaActive, not recruiting

Eye DiseaseActive, not recruiting

Immunodeficiency DiseaseActive, not recruiting

MyopathyActive, not recruiting

MyositisActive, not recruiting

Kidney TransplantActive, not recruiting

Guillain-Barre SyndromeActive, not recruiting

ImmunodeficiencyActive, not recruiting

Chronic Inflammatory Demyelinating PolyneuropathyPreclinical

Active, not recruiting

HepatitisApproved

Active, not recruiting

Cerebellar AtaxiaPhase 1

Active, not recruiting

Eye DiseasePhase 1/Phase 2

Active, not recruiting

Immunodeficiency DiseasePhase 3

Active, not recruiting

MyopathyPhase 1

Active, not recruiting

MyositisPhase 2/Phase 3

Active, not recruiting

Kidney TransplantPhase 3

Active, not recruiting

Guillain-Barre SyndromePreclinical

Active, not recruiting

ImmunodeficiencyPhase 2

Active, not recruiting

Showing 10 of 17 indications

Competition

Competitive Landscape

1932 competitors in COVID-19

#DrugCompanyPhaseTrials

Asceniv

Bnt162b2

Calciferol

Alnylam Pharmaceuticals

Aquasol E

NNational Eye Institute (NEI)

HB-Admscs

HHope Biosciences Research Foundation

Aprotinin

Antithrombin-III

Interferon-Gamma

SSPP Pharmaclon Ltd.

Biological Collection

AAssistance Publique - Hôpitaux de Paris

MRNA COVID-19 Vaccine

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

Timeline

Expected Milestones

Q1 2027

Phase 2/3Recruiting

Antibiotic Therapy

NCT07202078

Phase 2/3Recruiting

Antibiotic Therapy

NCT07202091

Phase 2/3Recruiting

Antibiotic Therapy

NCT07202065

Clinical

Trials by Indication[1]

Kidney Transplant3 trials

Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients

Terminated·LLoma Linda University·N/A·NCT00586716·22 enrolled

An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant Antigens

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00000935·100 enrolled

IVIG/Rituximab vs Rituximab in Kidney Transplant With de Novo Donor-specific Antibodies

Completed·SSeoul National University Hospital·Phase 4·NCT04033276·50 enrolled

Antibiotic Therapy3 trials

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Starting Immunoglobulin (Start Ig)

Recruiting·MMonash University·Phase 2/3·NCT07202078·900 enrolled

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Immunoglobulin Stopping or Extension (Stop Ig)

Recruiting·MMonash University·Phase 2/3·NCT07202091·900 enrolled

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy Dosing Immunoglobulin (Dose Ig)

Recruiting·MMonash University·Phase 2/3·NCT07202065·900 enrolled

Chronic Inflammatory Demyelinating Polyneuropathy2 trials

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004772·90 enrolled

Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Completed·UUniversity of South Florida·N/A·NCT02465359·15 enrolled

Intravenous2 trials

Intravenous Pertussis Immune Globulin in Patients With Severe Childhood Pertussis Infection

Completed·IIWK Health Centre·Phase 3·NCT00004422·174 enrolled

Intravenous Gammaglobulin for Sickle Cell Pain Crises

Completed·—·Phase 1/2·NCT01757418·300 enrolled

Immunodeficiency2 trials

Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

Completed· CSL Behring logo

CSL Behring·Phase 3·NCT01461018·22 enrolled

A Trial of the Pharmacokinetics, Safety, and Tolerability of Subcutaneous Gamunex® in Primary Immunodeficiency

Completed· Grifols Therapeutics LLC logo

Grifols Therapeutics LLC·Phase 2·NCT00389324·35 enrolled

19 more indications

Immune2 trials

Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

Completed· CSL Behring logo

CSL Behring·Phase 3·NCT01458171·23 enrolled

Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

Completed· CSL Behring logo

CSL Behring·Phase 3·NCT01199705·25 enrolled

Immune Deficiency1 trial

Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules

Completed· CSL Behring logo

CSL Behring·Phase 4·NCT02711228·26 enrolled

Medication1 trial

Study to Evaluate the Amount of Medications That May be Removed From the Body During Plasmapheresis

Withdrawn·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University··NCT00203281

Cerebellar Ataxia1 trial

An Open-label Trial of Intravenous Immune Globulin (IVIG)in Treating Spinocerebellar Ataxias

Unknown status·UUniversity of South Florida·Phase 1·NCT02287064·10 enrolled

Immunodeficiency Disease1 trial

A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID)

Completed·BBaxalta now part of Shire·Phase 3·NCT04346108·17 enrolled

Myositis1 trial

Add-on Intravenous Immunoglobulins in Early Myositis

Active, not recruiting·—·Phase 2/3·NCT05832034·44 enrolled

Hepatitis1 trial

Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human)

Completed· Grifols Therapeutics LLC logo

Grifols Therapeutics LLC·Phase 4·NCT03351933·28 enrolled

Heart1 trial

Preventive IVIG Therapy for Congenital Heart Block

Completed·NNYU Langone Health·Phase 1·NCT00460928·20 enrolled

Eye Disease1 trial

IVIG-eye Drops Treatment for Dry Eye Disease

Completed·SSandeep Jain, MD·Phase 1/2·NCT03992482·27 enrolled

Therapeutics1 trial

Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%

Completed·PPrometic Biotherapeutics, Inc.·Phase 3·NCT02269163·82 enrolled

COVID-191 trial

Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19)

Completed·IInstituto Grifols, S.A.·Phase 2·NCT04432324·100 enrolled

Pompe Disease1 trial

Immune Modulation Therapy for Pompe Disease

Unknown status·NNational Taiwan University Hospital·Phase 4·NCT02525172·8 enrolled

Myopathy1 trial

Intravenous Immune Globulin to Treat Hereditary Inclusion Body Myopathy

Completed·NNational Human Genome Research Institute (NHGRI)·Phase 1·NCT00195637·4 enrolled

Neuropathy1 trial

Phase III Multicenter Double Blind Controlled Trial of Human Immune Globulin Therapy in Previously Untreated Patients With Chronic Inflammatory Demyelinating Neuropathy

Completed·NNational Center for Research Resources (NCRR)·Phase 3·NCT00004286·120 enrolled

Asthma1 trial

IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency

Unknown status·—·Phase 3·NCT01992328·30 enrolled

Diabetic Neuropathy1 trial

Randomized Study of Intravenous Immunoglobulin (IVIg) in Patients With Subacute Proximal Diabetic Neuropathy

Terminated·MMayo Clinic·N/A·NCT00004407·75 enrolled

Guillain-Barre syndrome1 trial

Randomized Study of Plasmapheresis or Human Immunoglobulin Infusion in Childhood Guillain-Barre Syndrome

Terminated·EEmory University·N/A·NCT00004833·170 enrolled

Myasthenia Gravis1 trial

Randomized Study of Intravenous Immunoglobulin in Patients With Mild or Moderate Myasthenia Gravis

Terminated·UUniversity of Texas·N/A·NCT00004682·100 enrolled

Multiple Sclerosis1 trial

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 3·NCT00004744·76 enrolled

Sources

References

[1]
ClinicalTrials.gov — 32 trial records for Immune globulin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Asceniv drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Immune globulin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Immune globulin. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — CSL Behring company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: CSL Behring

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