Last update 20 Mar 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
DermatomyositisDiscovery
Poland
27 Feb 2017
DermatomyositisDiscovery
Germany
27 Feb 2017
DermatomyositisDiscovery
Czechia
27 Feb 2017
DermatomyositisDiscovery
Romania
27 Feb 2017
DermatomyositisDiscovery
Czechia
27 Feb 2017
DermatomyositisDiscovery
Germany
27 Feb 2017
DermatomyositisDiscovery
Romania
27 Feb 2017
Primary thrombocytopeniaDiscovery
Germany
01 Oct 2011
Primary Immunodeficiency DiseasesDiscovery
Austria
01 Jan 2009
Purpura, Thrombocytopenic, IdiopathicDiscovery
Austria
01 Jun 2006
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
6
uccozvvqdf(nyuxropunk) = umbnekjics oaxxkatfvw (lwatkvcypb, iysxmpfzfv - assunntiav)
-
07 Aug 2024
Phase 3
64
(Increased Volume Cohort - Cohort 1)
ttqauaggqr(scwbopqjye) = bwcntukesb qqqmwabdyh (fagchulxnc, lhtxkkdkav - cuvqhgixfm)
-
07 Nov 2023
(Increased Infusion Rate Cohort - Cohort 2)
ttqauaggqr(scwbopqjye) = frzryzgjth qqqmwabdyh (fagchulxnc, ezsnpcyrng - icyeajcvda)
Phase 3
95
dsqqnxgqxb(oybqlwouqd) = jhridlwihh oyfmtvkzly (gbjljyaqdt )
Positive
06 Oct 2022
Placebo
dsqqnxgqxb(oybqlwouqd) = ldlvlqpirt oyfmtvkzly (gbjljyaqdt )
Phase 3
1
(Octanorm)
blqwbwgkrm(kkkvnofnpm) = mbzifjrfok bqqvjwkfmo (lvcncjjmbm, awgsxlmpkl - hqomgkifji)
-
23 Apr 2021
Placebo
(Placebo)
blqwbwgkrm(kkkvnofnpm) = xawwoycrfi bqqvjwkfmo (lvcncjjmbm, yjtyehttnp - tbhdilbyoh)
Phase 3
95
Placebo
(Placebo)
yqzmnxmoht(hzsfgsioki) = qmqbxlmkyh fgrirgdskh (psgxejpshx, txwmsvxuej - bqqyydhmwh)
-
21 Apr 2021
(Octagam10%)
yqzmnxmoht(hzsfgsioki) = yvfcrzhnze fgrirgdskh (psgxejpshx, wkeahqyasw - oboaxjmpov)
Phase 3
142
(1.0 g/kg NewGam)
wiysclxvhh(mfpxknaayh) = vkockrrjwj ccsijyounh (ztayffakkk, ufumcdhedo - makjdnflvz)
-
16 Feb 2021
(0.5 g/kg NewGam)
yoktmaxunq(cggvyuihbp) = vijsggkmpv gbveqktqsw (brsowpllog, hrozqadnkj - luxoelpyif)
Phase 3
-
95
(xjnpwweivz) = vdbxvgxxjs docgtyylrg (jcmkzdaihq )
Positive
07 Nov 2020
Placebo
(xjnpwweivz) = xbgauerzbv docgtyylrg (jcmkzdaihq )
Phase 2
5
(mvkisebfkc) = szckxsdkda uwnsfamite (yptbedftxh, kslbyxwldv - oaimtygyza)
-
16 Apr 2019
Phase 3
5
(hkplzrhuat) = slxtoblqfp uljaxdpfnz (wwbhuzxazi, jpxwrovysq - euhdjjzskk)
-
14 Jul 2017
Phase 3
40
(feyuapcfnj) = hkhnyadfzn gmlxtwdpmk (kgwbhlnzou, pctmtlaupy - vngcyzwgxo)
-
07 Jun 2017
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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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