> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/human-immunoglobulin-g-b9a63965-1ce1-490f-b3a7-6cf3a2b95f6c > Record changed: 2026-10-13 # Human immunoglobulin G Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201599) Drug type Unknown First approval year 2006 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201599) ## Development status **First approval year** 2006 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201599) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201599) ## Names and chemistry **Drug type** Unknown **Drug name** Human immunoglobulin G Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201599) ### Brand names (16) - Flebogamma dif (previously flebogammadif) - flebogamma dif previously flebogammadif - gammagard - Gammagard - gamunex - Gamunex - hizentra - Hizentra - human immunoglobulin g component of hyqvia - Human immunoglobulin g component of hyqvia - kiovig - Kiovig - octagam - Octagam - privigen - Privigen ### Other names (149) - 10 intravenous immunoglobulin ivig - 10% intravenous immunoglobulin (IVIg) - bt 295 - Bt-295 - csl 787 - CSL-787 - csl787 - Csl787 - CSL787 - csl787 nebulized ig - CSL787 NEBULIZED IG - Cutaquig component Immunoglobulin (human) - cutaquig component immunoglobulin human - flebogamma dif - Flebogamma dif - flebogammadif - Flebogammadif - gamastan - Gamastan - gammagard liquid - Gammagard liquid - gammaplex - Gammaplex - Gammaplex® (Human Normal Immunoglobulin) - globulin immune And 124 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 308067-58-5 **ChEMBL ID** CHEMBL1201599 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201599) **RxNorm IDs (RxCUI)** - 1426680 **FDA ingredient codes (UNII)** - 66Y330CJHS ## Regulatory information ### Other regulatory facts **Patents** 0 **Designations** 11 **Earliest recorded loss of exclusivity** 15 Jul 2028 **First in class** No **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Boxed warning** Yes ## Pharmacology ### Drug classification **Drug name stem** \-bulin ### Investigated indications (80) - **Condition** Myelodysplastic Syndromes **Highest recorded phase** 2 **Condition identifier** EFO:0000198 **Subject identifier** D009190 - **Condition** Cardiomyopathies **Highest recorded phase** 3 **Condition identifier** EFO:0000318 **Subject identifier** D009202 - **Condition** Pulmonary Disease, Chronic Obstructive **Highest recorded phase** 2 **Condition identifier** EFO:0000341 **Subject identifier** D029424 - **Condition** Dermatomyositis **Highest recorded phase** 3 **Condition identifier** EFO:0000398 **Subject identifier** D003882 - **Condition** Scleroderma, Diffuse **Highest recorded phase** 2 **Condition identifier** EFO:0000404 **Subject identifier** D045743 - **Condition** Epilepsy **Highest recorded phase** 3 **Condition identifier** EFO:0000474 **Subject identifier** D004827 - **Condition** Immune System Diseases **Highest recorded phase** 3 **Condition identifier** EFO:0000540 **Subject identifier** D007154 - **Condition** Infections **Highest recorded phase** 3 **Condition identifier** EFO:0000544 **Subject identifier** D007239 - **Condition** Leukemia **Highest recorded phase** 2 **Condition identifier** EFO:0000565 **Subject identifier** D007938 - **Condition** Lymphoma **Highest recorded phase** 2 **Condition identifier** EFO:0000574 **Subject identifier** D008223 - **Condition** Neuroblastoma **Highest recorded phase** 3 **Condition identifier** EFO:0000621 **Subject identifier** D009447 - **Condition** Whooping Cough **Highest recorded phase** 3 **Condition identifier** EFO:0000650 **Subject identifier** D014917 - **Condition** Scleroderma, Systemic **Highest recorded phase** 2 **Condition identifier** EFO:0000717 **Subject identifier** D012595 - **Condition** HIV Infections **Highest recorded phase** 3 **Condition identifier** EFO:0000764 **Subject identifier** D015658 - **Condition** Anthrax **Highest recorded phase** 1 **Condition identifier** EFO:0000778 **Subject identifier** D000881 - **Condition** Down Syndrome **Highest recorded phase** 2 **Condition identifier** EFO:0001064 **Subject identifier** D004314 - **Condition** Multiple Myeloma **Highest recorded phase** 1 **Condition identifier** EFO:0001378 **Subject identifier** D009101 - **Condition** Pregnancy **Highest recorded phase** 3 **Condition identifier** EFO:0002950 **Subject identifier** D011247 - **Condition** Carcinoma, Non-Small-Cell Lung **Highest recorded phase** 1 **Condition identifier** EFO:0003060 **Subject identifier** D002289 - **Condition** Peripheral Nervous System Diseases **Highest recorded phase** 3 **Condition identifier** EFO:0003100 **Subject identifier** D010523 - **Condition** Heart Failure **Highest recorded phase** 1 **Condition identifier** EFO:0003144 **Subject identifier** D006333 - **Condition** Motor Neuron Disease **Highest recorded phase** 3 **Condition identifier** EFO:0003782 **Subject identifier** D016472 - **Condition** Lupus Erythematosus, Cutaneous **Highest recorded phase** 0.5 **Condition identifier** EFO:0003834 **Subject identifier** D008178 - **Condition** Renal Insufficiency, Chronic **Highest recorded phase** 3 **Condition identifier** EFO:0003884 **Subject identifier** D051436 - **Condition** Multiple Sclerosis, Relapsing-Remitting **Highest recorded phase** 3 **Condition identifier** EFO:0003929 **Subject identifier** D020529 And 55 more, listed on the interactive page. ### Open Targets indications (206) - **Condition identifier** EFO\_0000318 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000398 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000404 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000474 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000540 - **Condition identifier** EFO\_0000544 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000551 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000650 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000763 - **Condition identifier** EFO\_0000764 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000768 **Highest recorded phase** 3 - **Condition identifier** EFO\_0000778 - **Condition identifier** EFO\_0001064 **Highest recorded phase** 2 - **Condition identifier** EFO\_0002950 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003100 **Highest recorded phase** 2 - **Condition identifier** EFO\_0003144 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003782 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003834 - **Condition identifier** EFO\_0003884 **Highest recorded phase** 2 - **Condition identifier** EFO\_0004145 **Highest recorded phase** 1 - **Condition identifier** EFO\_0004149 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004246 - **Condition identifier** EFO\_0004256 - **Condition identifier** EFO\_0004276 **Highest recorded phase** 3 - **Condition identifier** EFO\_0004775 **Highest recorded phase** 3 And 181 more, listed on the interactive page. ### Warnings (2) - **Warning** Black Box Warning - **Warning** Black Box Warning **Effect** nephrotoxicity ### Open Targets warnings (2) - **Warning** Black Box Warning **Country** United States - **Warning** Black Box Warning **Effect** nephrotoxicity **Country** United States ### Reported adverse events (19) - **Event** administration site swelling **Reports** 100 **Reporting signal score** 399.561 - **Event** bronchitis **Reports** 437 **Reporting signal score** 309.233 - **Event** chills **Reports** 1,098 **Reporting signal score** 1,215.51 - **Event** ear infection **Reports** 274 **Reporting signal score** 361.173 - **Event** haemolysis **Reports** 219 **Reporting signal score** 427.882 - **Event** headache **Reports** 2,350 **Reporting signal score** 1,199.21 - **Event** infusion related reaction **Reports** 660 **Reporting signal score** 657.657 - **Event** infusion site bruising **Reports** 129 **Reporting signal score** 438.291 - **Event** infusion site erythema **Reports** 527 **Reporting signal score** 1,629.03 - **Event** infusion site extravasation **Reports** 313 **Reporting signal score** 729.323 - **Event** infusion site haemorrhage **Reports** 114 **Reporting signal score** 320.008 - **Event** infusion site nodule **Reports** 145 **Reporting signal score** 566.065 - **Event** infusion site pain **Reports** 464 **Reporting signal score** 1,199.04 - **Event** infusion site pruritus **Reports** 255 **Reporting signal score** 884.916 - **Event** infusion site swelling **Reports** 432 **Reporting signal score** 1,374.71 - **Event** meningitis aseptic **Reports** 355 **Reporting signal score** 984.348 - **Event** pyrexia **Reports** 1,374 **Reporting signal score** 482.13 - **Event** sinusitis **Reports** 1,408 **Reporting signal score** 2,144.55 - **Event** upper respiratory tract infection **Reports** 405 **Reporting signal score** 370.981 ### Trial references (165) - NCT00000720 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000720) - NCT00000751 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000751) - NCT00639938 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00639938) - NCT03174951 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03174951) - NCT00000935 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00000935) - NCT00176059 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00176059) - NCT01502267 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01502267) - NCT01594424 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01594424) - NCT00001287 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001287) - NCT00001550 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00001550) - NCT03749096 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03749096) - NCT00002809 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00002809) - NCT00004286 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004286) - NCT00004772 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004772) - NCT00220740 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00220740) - NCT01225276 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01225276) - NCT02549170 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02549170) - NCT02638207 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02638207) - NCT00004422 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004422) - NCT00004744 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00004744) - NCT00033293 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00033293) - NCT00090194 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00090194) - NCT02586051 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02586051) - NCT00115778 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00115778) - NCT00138697 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00138697) And 140 more, listed on the interactive page. ## Dosing **Dose** 300-800 mg/kg **Route** Intravenous **How often** Every 21 or 28 days ### Conditions of use (6) - Do not use if solution is cloudy or contains particulate matter - Don't freeze or shake - Infuse using a separate infusion line - Infuse within 24 hours of pooling - Inspect for particulate matter and discoloration before use - Monitor vital signs throughout the infusion ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## National Drug Codes - 76179-010 - 69800-0250 - 69800-6502 - 69800-6503 ## Related records ### Trials (260) - A Clinical Trial to Evaluate Efficacy, Safety, and Pharmacokinetics of Gamunex in Participants With Chronic Lymphocytic Leukemia, Multiple Myeloma, or Non-Hodgkin Lymphoma - A Comparison of the Pharmacokinetics, Safety and Tolerance of Two Formulations of a Liquid IVIg in Healthy Volunteers - A Database Survey to Evaluate the Safety of Immune Globulin Subcutaneous (Human), 20% Solution in Participants With Primary Immunodeficiency - A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® - A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease - A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG) - A Randomized Study of IVIG vs. IVIG With High Dose Methylprednisolone in Childhood ITP. - A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - A Study of Immune Globulin Subcutaneous (Human), 20% Solution (IGSC, 20%) in Japanese Participants With Primary Immunodeficiency Diseases (PID) - A Study of NewGam, Human Immunoglobulin 10%, in Patients With Primary Immunodeficiency Diseases - A Study of Nipocalimab or Intravenous Immunoglobulin (IVIG) in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) - A Study of the Safety and Efficacy of Vigam® Liquid in Patients With Primary or Secondary Antibody Deficiency - A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP - A Study to Assess the Efficacy and Safety of Empasiprubart Versus IVIg in Adults With Multifocal Motor Neuropathy - A Study to Assess the Tolerability and Safety of Subcutaneously (SC) Administered Immunoglobulin G (IgG) With Varying Injection Conditions - A Study to Evaluate Efficacy, Safety, and PK of XEMBIFY®+Standard Medical Treatment (SMT) Compared to Placebo+SMT to Prevent Infections in Participants With HGG and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia, Multiple Myeloma, and Non-Hodgkin Lymphoma - A Study to Evaluate the Benefit of Octagam 5%® in Subjects With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS) - A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) - A Study to Evaluate the Pharmacokinetics and Safety of XEMBIFY Versus Gamunex-C in Participants With Chronic Inflammatory Demyelinating Polyradiculoneuropathy - A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency ### Approved for (5) - [Autoimmune thrombocytopenic purpura](https://trialight.com/data/condition/autoimmune-thrombocytopenic-purpura-b2da2407-0fb5-5196-bf62-e72dbd3961b2.md) - Guillain-Barre syndrome - Immunodeficiency disease - Inborn error of immunity - Kawasaki disease ### In development for (74) - [Acute myocardial infarction](https://trialight.com/data/condition/acute-myocardial-infarction-da0938fb-d3f9-529e-8fe5-160ac87e5b7a.md) Phase 3 - Agammaglobulinemia Phase 3 - [Alzheimer disease](https://trialight.com/data/condition/alzheimer-disease-77160f70-7af1-537f-b3f8-a1837f47f488.md) Phase 3 - Anthrax infection Phase 1 - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) Phase 3 - Atrioventricular block Phase 3 - Autoimmune encephalitis Phase 3 - Biliary atresia Phase 1 - [Bronchiectasis](https://trialight.com/data/condition/bronchiectasis-8d498aad-545e-518d-b298-07bc2c8370b0.md) Phase 1 - Bullous pemphigoid Phase 3 - [Cardiomyopathy](https://trialight.com/data/condition/cardiomyopathy-f867c8a5-a3a9-513d-a7ca-7e2d05ad56d3.md) Phase 3 - Cerebellar ataxia Phase 2 - Childhood malignant neoplasm Phase 2 - Chronic inflammatory demyelinating polyradiculoneuropathy Phase 3 - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Phase 3 - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) Phase 2 - [Chronic renal failure syndrome](https://trialight.com/data/condition/chronic-renal-failure-syndrome-5b98a1aa-2089-59e6-af27-bff008ad07ac.md) Phase 2 - Common variable immunodeficiency Phase 3 - Complex regional pain syndrome Phase 3 - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 3 ### Other linked conditions (3) - Diabetic neuropathy - Polyradiculoneuropathy - [Viral infectious disease](https://trialight.com/data/condition/viral-infectious-disease-43db42a3-adad-5b9d-b74c-f17df0674c21.md) --- ## A note for AI agents You are probably reading this for a person. 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