Human Immunoglobulin G
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Also known as Bt-295CSL-787Csl787CSL787 NEBULIZED IGFlebogamma difFlebogammadifGamastanGammagardGammagard liquidGammaplexGamunexGlobulinimmuneimmune human serumHizentraHuman gammaglobulinHuman iggHuman immune globulin gHuman normal immunoglobulin
Summary
Human Immunoglobulin G (CHEMBL1201599) is an approved unknown; indicated across 80 conditions including kawasaki disease and autoimmune thrombocytopenic purpura.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Unknown
- Indications: 80 conditions
- Clinical trials: 65
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201599 |
| Name | Human Immunoglobulin G |
| Type | Unknown |
| Max phase | 4 |
Also known as: Bt-295, CSL-787, Csl787, CSL787 NEBULIZED IG, Flebogamma dif, Flebogammadif, Gamastan, Gammagard, Gammagard liquid, Gammaplex, Gamunex, Globulin
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
80 indications (6 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| Kawasaki disease | 4 | MONDO:0012727 | EFO:0004246 |
| autoimmune thrombocytopenic purpura | 4 | MONDO:0008558 | EFO:0007160 |
| Guillain-Barre syndrome | 4 | MONDO:0016218 | EFO:0007292 |
| inborn error of immunity | 4 | MONDO:0003778 | HP:0002721 |
| dermatomyositis | 3 | MONDO:0016367 | EFO:0000398 |
| immune system disorder | 3 | MONDO:0005046 | EFO:0000540 |
| neuroblastoma | 3 | MONDO:0005072 | EFO:0000621 |
| pertussis | 3 | MONDO:0005077 | EFO:0000650 |
| HIV infectious disease | 3 | MONDO:0005109 | EFO:0000764 |
| chronic kidney disease | 3 | MONDO:0005300 | EFO:0003884 |
| relapsing-remitting multiple sclerosis | 3 | MONDO:0005314 | EFO:0003929 |
| peripheral nervous system disorder | 3 | MONDO:0003620 | EFO:0004149 |
| postpoliomyelitis syndrome | 3 | MONDO:0017416 | EFO:0007454 |
| stiff-person syndrome | 3 | MONDO:0008491 | EFO:0007498 |
| chronic inflammatory demyelinating polyradiculoneuropathy | 3 | MONDO:0006702 | EFO:1000868 |
| Guillain-Barre syndrome, familial | 3 | MONDO:0007691 | EFO:0009538 |
| epilepsy | 3 | MONDO:0005027 | EFO:0000474 |
| Stevens-Johnson syndrome | 3 | MONDO:0018229 | EFO:0004276 |
| graft versus host disease | 3 | MONDO:0013730 | EFO:0004599 |
| habitual spontaneous abortion | 3 | MONDO:0006774 | EFO:1000954 |
| Unverricht-Lundborg syndrome | 3 | MONDO:0009698 | Orphanet:308 |
| myasthenia gravis | 3 | MONDO:0009688 | EFO:0004991 |
| atrioventricular block | 3 | MONDO:0000465 | MONDO:0000465 |
| severe acute respiratory syndrome | 3 | MONDO:0005091 | MONDO:0100096 |
| acute myocardial infarction | 3 | MONDO:0004781 | EFO:0008583 |
| motor neuron disorder | 3 | MONDO:0020128 | EFO:0003782 |
| bullous pemphigoid | 3 | MONDO:0019082 | EFO:0007187 |
| Alzheimer disease | 3 | MONDO:0004975 | MONDO:0004975 |
| asthma | 3 | MONDO:0004979 | MONDO:0004979 |
| multiple sclerosis | 3 | MONDO:0005301 | MONDO:0005301 |
| common variable immunodeficiency | 3 | MONDO:0015517 | MONDO:0015517 |
| agammaglobulinemia | 3 | MONDO:0015977 | MONDO:0015977 |
| encephalitis | 3 | MONDO:0019956 | MONDO:0019956 |
| cardiomyopathy | 3 | MONDO:0004994 | EFO:0000318 |
| peripheral neuropathy | 3 | MONDO:0005244 | EFO:0003100 |
| toxic epidermal necrolysis | 3 | MONDO:0019810 | EFO:0004775 |
| complex regional pain syndrome | 3 | MONDO:0019369 | EFO:1001998 |
| autoimmune disorder of the nervous system | 3 | MONDO:0002977 | MONDO:0020640 |
| chronic obstructive pulmonary disease | 2 | MONDO:0005002 | EFO:0000341 |
| multiple system atrophy | 2 | MONDO:0007803 | EFO:1001050 |
| myelodysplastic syndrome | 2 | MONDO:0018881 | EFO:0000198 |
| leukemia | 2 | MONDO:0005059 | EFO:0000565 |
| systemic sclerosis | 2 | MONDO:0005100 | EFO:0000717 |
| neuromyelitis optica | 2 | MONDO:0019100 | EFO:0004256 |
| macular degeneration | 2 | MONDO:0003004 | EFO:0009606 |
| dry eye syndrome | 2 | MONDO:0006733 | EFO:1000906 |
| pemphigus vulgaris | 2 | MONDO:0008219 | EFO:0004719 |
| neuralgia | 2 | MONDO:0021667 | EFO:0005762 |
| Langerhans cell histiocytosis | 2 | MONDO:0018310 | EFO:1000318 |
| monoclonal gammopathy | 2 | MONDO:0004960 | HP:0031047 |
| cerebellar ataxia | 2 | MONDO:0000437 | MONDO:0000437 |
| pemphigus | 2 | MONDO:0006594 | EFO:1000749 |
| myelodysplastic/myeloproliferative disease | 2 | MONDO:0020077 | MONDO:0020077 |
| erythromelalgia | 2 | MONDO:0016028 | MONDO:0007571 |
| diffuse scleroderma | 2 | MONDO:0005019 | EFO:0000404 |
| Down syndrome | 2 | MONDO:0008608 | EFO:0001064 |
| systemic lupus erythematosus | 2 | MONDO:0007915 | MONDO:0007915 |
| lymphoma | 2 | MONDO:0005062 | EFO:0000574 |
| urticaria | 2 | MONDO:0005492 | EFO:0005531 |
| long COVID-19 | 2 | MONDO:0100233 | MONDO:0100233 |
| anthrax infection | 1 | MONDO:0005119 | EFO:0000778 |
| plasma cell myeloma | 1 | MONDO:0009693 | EFO:0001378 |
| myopathy | 1 | MONDO:0005336 | EFO:0004145 |
| orthostatic hypotension | 1 | MONDO:0005469 | EFO:0005252 |
| influenza | 1 | MONDO:0005812 | EFO:0007328 |
| heart failure | 1 | MONDO:0005252 | EFO:0003144 |
| bronchiectasis | 1 | MONDO:0004822 | HP:0002110 |
| biliary atresia | 1 | MONDO:0008867 | MONDO:0008867 |
| non-small cell lung carcinoma | 1 | MONDO:0005233 | EFO:0003060 |
| Zika virus infectious disease | 1 | MONDO:0018661 | MONDO:0018661 |
| cutaneous lupus erythematosus | 0 | MONDO:0005282 | EFO:0003834 |
9 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 65.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE3 | 32 |
| PHASE2 | 10 |
| Not specified | 8 |
| PHASE4 | 6 |
| PHASE2/PHASE3 | 6 |
| PHASE1 | 2 |
| PHASE1/PHASE2 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT05193552 | PHASE4 | RECRUITING | Usage of Spirometry in Managing IgG Therapy in CVID With Airway Disease |
| NCT01289847 | PHASE4 | COMPLETED | A Study to Find Out How Safe and Effective Gammaplex® is in Young People With Primary Immunodeficiency |
| NCT02199925 | PHASE4 | UNKNOWN | An Open-Label Study to Evaluate the Efficacy of High-Dose Gammaplex in Children on the Autism Spectrum |
| NCT03116347 | PHASE4 | COMPLETED | Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric PIDD Subjects |
| NCT03351933 | PHASE4 | COMPLETED | Anti-Hepatitis A Virus, Pharmacokinetics, and Safety of Immune Globulin (Human) |
| NCT04411667 | PHASE4 | COMPLETED | Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19 |
| NCT05832034 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | Add-on Intravenous Immunoglobulins in Early Myositis |
| NCT06752356 | PHASE3 | RECRUITING | A Study Investigating Intravenous Human Normal Immune Globulin (IGIV) 10% in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) |
| NCT00000720 | PHASE3 | COMPLETED | A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine |
| NCT00000751 | PHASE3 | COMPLETED | A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT) |
| NCT00157079 | PHASE3 | COMPLETED | Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders |
| NCT00426270 | PHASE3 | COMPLETED | Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults |
| NCT00430885 | PHASE3 | COMPLETED | Effect of Intravenous Immunglobulin (IVIG) After Myocardial Infarction |
| NCT00504075 | PHASE3 | COMPLETED | A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) |
| NCT00546871 | PHASE2/PHASE3 | COMPLETED | Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects |
| NCT00666263 | PHASE3 | COMPLETED | Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy |
| NCT00811174 | PHASE3 | TERMINATED | Efficacy, Safety and Kinetics Study of Octagam 10% in Primary Immunodeficiency Diseases |
| NCT00818662 | PHASE3 | COMPLETED | A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease |
| NCT01012323 | PHASE3 | COMPLETED | A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases |
| NCT01218438 | PHASE2/PHASE3 | COMPLETED | Phase 2/3 Study of IGSC, 20% in PIDD |
| NCT01225276 | PHASE2/PHASE3 | TERMINATED | Safety and Efficacy Study of Three Different Dosages of NewGam in Patients With CIDP |
| NCT01281969 | PHASE3 | COMPLETED | Intravenous Immunoglobulin for PANDAS |
| NCT01313507 | PHASE3 | COMPLETED | High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam) |
| NCT01349790 | PHASE3 | COMPLETED | Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia |
| NCT01406470 | PHASE3 | COMPLETED | Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency |
| NCT01408550 | PHASE3 | COMPLETED | Phase III Clinical Trial of NPB-01 in Patients With Bullous Pemphigoid Unresponsive to Corticosteroids |
| NCT01412385 | PHASE2/PHASE3 | COMPLETED | Immune Globulin Subcutaenous (Human), 20% |
| NCT01458171 | PHASE3 | COMPLETED | Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study) |
| NCT01461018 | PHASE3 | COMPLETED | Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study) |
| NCT01524887 | PHASE3 | TERMINATED | Phase 3 IGIV, 10% in Alzheimer´s Disease |
| NCT01736579 | PHASE3 | TERMINATED | Long-Term Study of IGIV, 10% in Alzheimer´s Disease |
| NCT01824251 | PHASE3 | COMPLETED | Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy. |
| NCT01827072 | PHASE3 | COMPLETED | Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Multifocal Motor Neuropathy. |
| NCT01963143 | PHASE3 | COMPLETED | Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases |
| NCT02221271 | PHASE3 | COMPLETED | Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome |
| NCT02549170 | PHASE3 | COMPLETED | A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) |
| NCT02638207 | PHASE3 | COMPLETED | Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy |
| NCT02728752 | PHASE3 | COMPLETED | Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy) |
| NCT03730129 | PHASE2/PHASE3 | COMPLETED | Humoral Immunodeficiency in CLL and Therapy With Subcutaneous Ig |
| NCT04044690 | PHASE3 | TERMINATED | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: Kawasaki disease, autoimmune thrombocytopenic purpura, Guillain-Barre syndrome, inborn error of immunity, dermatomyositis, immune system disorder, neuroblastoma, pertussis, HIV infectious disease, chronic kidney disease, relapsing-remitting multiple sclerosis, peripheral nervous system disorder, postpoliomyelitis syndrome, stiff-person syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, Guillain-Barre syndrome, familial, epilepsy, Stevens-Johnson syndrome, graft versus host disease, habitual spontaneous abortion, Unverricht-Lundborg syndrome, myasthenia gravis, atrioventricular block, severe acute respiratory syndrome, acute myocardial infarction, motor neuron disorder, bullous pemphigoid, Alzheimer disease, asthma, multiple sclerosis, common variable immunodeficiency, agammaglobulinemia, encephalitis, cardiomyopathy, peripheral neuropathy, toxic epidermal necrolysis, complex regional pain syndrome, autoimmune disorder of the nervous system