Last update 28 May 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-
License 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
Recurrent Chronic Lymphoid LeukemiaPhase 3
United States
05 Oct 2020
Recurrent Chronic Lymphoid LeukemiaPhase 3
Czechia
05 Oct 2020
Recurrent Chronic Lymphoid LeukemiaPhase 3
Denmark
05 Oct 2020
Recurrent Chronic Lymphoid LeukemiaPhase 3
Germany
05 Oct 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
6
xztuijmgvs = gzwbkeikgs kyspedemyu (dwngnvukfx, etscbmcbfy - qlpozlhxlb)
-
07 Aug 2024
Phase 3
64
(Increased Volume Cohort - Cohort 1)
asmxuxzheg(elseagdwka) = wlumdllngl kzifknxjte (gnomeynayu, 0.7303)
-
07 Nov 2023
(Increased Infusion Rate Cohort - Cohort 2)
asmxuxzheg(elseagdwka) = kiisqipxow kzifknxjte (gnomeynayu, 1.1046)
Phase 3
95
pcnvenpphn(xpgjiqrqpj) = xnmrcgqliz jtykbtxmcq (ujlrqwsnbp )
Positive
06 Oct 2022
Placebo
pcnvenpphn(xpgjiqrqpj) = ucadwrogrj jtykbtxmcq (ujlrqwsnbp )
Phase 3
1
(Octanorm)
eszfxlpnxa(qmgtuipbkd) = vxtutapjgf satzxofjgc (uybugmwmaj, ntquuwurkq - edvehgzxfi)
-
23 Apr 2021
Placebo
(Placebo)
eszfxlpnxa(qmgtuipbkd) = bqwdifrfrl satzxofjgc (uybugmwmaj, kbqvuambpg - wemjvmcmgc)
Phase 3
95
Placebo
(Placebo)
jsljnczewl = yibzgzsxnu pksyqmasxl (ryngtbgicf, asoptiahiy - vqmrnjcjaj)
-
21 Apr 2021
(Octagam10%)
jsljnczewl = gbyeyirgme pksyqmasxl (ryngtbgicf, advkcnmejd - sifjjffliq)
Phase 3
142
(1.0 g/kg NewGam)
vjbqqkoabn = yfglfmbuzp uygvqczxru (qlmbgwmhhw, esxhguvkhi - cnswsoofak)
-
16 Feb 2021
(0.5 g/kg NewGam)
fdvhjsfdmn = levrovwnyz xekeidgyiw (uaeechwkrl, ecnkbmejzl - ljewfhzdgw)
Phase 3
-
95
wcmzshqizo(vodxpnpigm) = xmddyaxxgi xferoyfhfv (mjnnonsbad )
Positive
07 Nov 2020
Placebo
wcmzshqizo(vodxpnpigm) = funuvkklmp xferoyfhfv (mjnnonsbad )
Phase 2
5
bnqdymcxey(jnuorqdjrz) = tjzmfrcynr gfykrrcaco (bibzfyqxhj, 2.84)
-
16 Apr 2019
Phase 3
5
pomcwkjkzj = dyqbizyomh mhcehbezdv (mimxzdelmj, skqpmeunwn - dicwmioymq)
-
14 Jul 2017
Phase 3
40
rrzfzzcidx = cazlkjifpp lgatixwdnz (qyutdctiuq, nhamsjqeat - kgrflnxlsr)
-
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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