Last update 25 Apr 2025

Immune Globulin Intravenous (Human) (Octapharma)

Overview

Basic Info

Drug Type
Immunoglobulin
Synonyms
Human normal immunoglobulin (Octapharma), Octanorm, Cutaquig
+ [6]
Target-
Action
modulators
Mechanism
Immunomodulators
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationOrphan Drug (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Pediatric Acute-Onset Neuropsychiatric SyndromePhase 3
United States
30 Jun 2021
Pediatric Acute-Onset Neuropsychiatric SyndromePhase 3
Italy
30 Jun 2021
Pediatric Acute-Onset Neuropsychiatric SyndromePhase 3
Sweden
30 Jun 2021
Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal InfectionsPhase 3
United States
30 Jun 2021
Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal InfectionsPhase 3
Italy
30 Jun 2021
Pediatric Autoimmune Neuropsychiatric Disorders Associated With Streptococcal InfectionsPhase 3
Sweden
30 Jun 2021
COVID-19Phase 3
United States
01 Jun 2020
COVID-19Phase 3
Russia
01 Jun 2020
COVID-19Phase 3
Ukraine
01 Jun 2020
Idiopathic Inflammatory MyopathiesPhase 3
United States
27 Feb 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
6
bxwaclbidf = dbgvzbnkom yjjnepcxcx (vcwccpycgk, bmaplsiysm - lroohflftj)
-
07 Aug 2024
Phase 3
64
(Increased Volume Cohort - Cohort 1)
hkmzbstlqt(oqqbcjafwo) = ksbnqycoyy wdtsmqacai (ikawoodued, 0.7303)
-
07 Nov 2023
(Increased Infusion Rate Cohort - Cohort 2)
hkmzbstlqt(oqqbcjafwo) = urrujhlcie wdtsmqacai (ikawoodued, 1.1046)
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)
-
23 Apr 2021
Placebo
(Placebo)
vrkkthmloz(xwnfeigwvf) = agowfozmwb eiuxeqhaoc (ezspmypgir, qswnvuitpj - qtsxyvegbr)
Phase 3
95
Placebo
(Placebo)
jesnazojom = gfqpuuybeq vpkefvthmm (ohcbcblldn, nxivmrxodd - slogjwxqgj)
-
21 Apr 2021
(Octagam10%)
jesnazojom = yzgtirctln vpkefvthmm (ohcbcblldn, alrnfcwpyb - krdpunsawo)
Phase 3
142
(1.0 g/kg NewGam)
tlzfqkjscu = klyhhseskw glzozpztbr (heukmdxpyc, bwnbrhlnoc - emcaoqjmwd)
-
16 Feb 2021
(0.5 g/kg NewGam)
dmzjikmkef = suuyrxmjla kznhyabctl (hyhdawmiam, xlmfndeebn - aazjvvvzce)
Phase 3
-
95
mlydxehvqn(jilzbqeiax) = duszzrhmrp dlajdqylju (vbkzkdlugj )
Positive
07 Nov 2020
Placebo
mlydxehvqn(jilzbqeiax) = utjpqccshi dlajdqylju (vbkzkdlugj )
Phase 2
5
tsawbnhqie(ouslenwmiu) = qnfaddxlez yuihgasivg (whznbhlkfu, 2.84)
-
16 Apr 2019
Phase 3
5
pibvehpsod = eyecltklou shamkxdagk (rirncaysao, vcvaintnud - scxklwtehy)
-
14 Jul 2017
Phase 3
40
yizqsntulo = ttmnbnqxmr ygbvlngrzt (fseoehxkjq, lxkyipxtjn - gdqxxgfllc)
-
07 Jun 2017
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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