Drug Type Immunoglobulin |
Synonyms Human normal immunoglobulin (Octapharma), Octanorm, Cutaquig + [6] |
Target- |
Action modulators |
Mechanism Immunomodulators |
Therapeutic Areas |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (21 May 2004), |
RegulationOrphan Drug (United States) |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | United States | 02 Aug 2018 | |
Immunologic Deficiency Syndromes | Canada | 15 Feb 2018 | |
Acquired Immunodeficiency Syndrome | Australia | 11 Nov 2009 | |
Agammaglobulinemia | Australia | 11 Nov 2009 | |
Chronic Lymphocytic Leukemia | Australia | 11 Nov 2009 | |
Common Variable Immunodeficiency | Australia | 11 Nov 2009 | |
Guillain-Barre Syndrome | Australia | 11 Nov 2009 | |
Hypogammaglobulinemia | Australia | 11 Nov 2009 | |
Mucocutaneous Lymph Node Syndrome | Australia | 11 Nov 2009 | |
Primary Immunodeficiency Diseases | Australia | 11 Nov 2009 | |
Severe Combined Immunodeficiency | Australia | 11 Nov 2009 | |
Wiskott-Aldrich Syndrome | Australia | 11 Nov 2009 | |
Dermatomyositis | United States | 21 May 2004 | |
Purpura, Thrombocytopenic, Idiopathic | United States | 21 May 2004 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Pediatric Acute-Onset Neuropsychiatric Syndrome | Phase 3 | United States | 30 Jun 2021 | |
Pediatric Acute-Onset Neuropsychiatric Syndrome | Phase 3 | Italy | 30 Jun 2021 | |
Pediatric Acute-Onset Neuropsychiatric Syndrome | Phase 3 | Sweden | 30 Jun 2021 | |
Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections | Phase 3 | United States | 30 Jun 2021 | |
Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections | Phase 3 | Italy | 30 Jun 2021 | |
Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal Infections | Phase 3 | Sweden | 30 Jun 2021 | |
COVID-19 | Phase 3 | United States | 01 Jun 2020 | |
COVID-19 | Phase 3 | Russia | 01 Jun 2020 | |
COVID-19 | Phase 3 | Ukraine | 01 Jun 2020 | |
Idiopathic Inflammatory Myopathies | Phase 3 | United States | 27 Feb 2017 |
Phase 4 | 6 | bxwaclbidf = dbgvzbnkom yjjnepcxcx (vcwccpycgk, bmaplsiysm - lroohflftj) View more | - | 07 Aug 2024 | |||
Phase 3 | 64 | (Increased Volume Cohort - Cohort 1) | hkmzbstlqt(oqqbcjafwo) = ksbnqycoyy wdtsmqacai (ikawoodued, 0.7303) View more | - | 07 Nov 2023 | ||
(Increased Infusion Rate Cohort - Cohort 2) | hkmzbstlqt(oqqbcjafwo) = urrujhlcie wdtsmqacai (ikawoodued, 1.1046) View more | ||||||
Phase 3 | 95 | eocyxfagci(tkfcubhozw) = vibsykztmy fzxqkvshbp (jiqjxnbqlo ) | Positive | 06 Oct 2022 | |||
Placebo | eocyxfagci(tkfcubhozw) = teswpvlgrt fzxqkvshbp (jiqjxnbqlo ) | ||||||
Phase 3 | 1 | (Octanorm) | vrkkthmloz(xwnfeigwvf) = sykfgqzblv eiuxeqhaoc (ezspmypgir, trnjlrwrkr - opeqoiqjvx) View more | - | 23 Apr 2021 | ||
Placebo (Placebo) | vrkkthmloz(xwnfeigwvf) = agowfozmwb eiuxeqhaoc (ezspmypgir, qswnvuitpj - qtsxyvegbr) View more | ||||||
Phase 3 | 95 | Placebo (Placebo) | jesnazojom = gfqpuuybeq vpkefvthmm (ohcbcblldn, nxivmrxodd - slogjwxqgj) View more | - | 21 Apr 2021 | ||
(Octagam10%) | jesnazojom = yzgtirctln vpkefvthmm (ohcbcblldn, alrnfcwpyb - krdpunsawo) View more | ||||||
Phase 3 | 142 | (1.0 g/kg NewGam) | tlzfqkjscu = klyhhseskw glzozpztbr (heukmdxpyc, bwnbrhlnoc - emcaoqjmwd) View more | - | 16 Feb 2021 | ||
(0.5 g/kg NewGam) | dmzjikmkef = suuyrxmjla kznhyabctl (hyhdawmiam, xlmfndeebn - aazjvvvzce) View more | ||||||
Phase 3 | - | 95 | mlydxehvqn(jilzbqeiax) = duszzrhmrp dlajdqylju (vbkzkdlugj ) View more | Positive | 07 Nov 2020 | ||
Placebo | mlydxehvqn(jilzbqeiax) = utjpqccshi dlajdqylju (vbkzkdlugj ) View more | ||||||
Phase 2 | 5 | tsawbnhqie(ouslenwmiu) = qnfaddxlez yuihgasivg (whznbhlkfu, 2.84) View more | - | 16 Apr 2019 | |||
Phase 3 | 5 | pibvehpsod = eyecltklou shamkxdagk (rirncaysao, vcvaintnud - scxklwtehy) View more | - | 14 Jul 2017 | |||
Phase 3 | 40 | yizqsntulo = ttmnbnqxmr ygbvlngrzt (fseoehxkjq, lxkyipxtjn - gdqxxgfllc) View more | - | 07 Jun 2017 |