Last update 11 Apr 2025

Immune Globulin (Human)(Grifols)

Overview

Basic Info

Drug Type
Immunoglobulin
Synonyms
Flebogamma 10% DIF, GamaSTAN, human normal immunoglobulin(Instituto Grifols S.A.)
+ [19]
Target-
Action-
Mechanism-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (11 Jan 1944),
Regulation-
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hypogammaglobulinemia
Australia
30 Jun 2022
Acquired Immunodeficiency Syndrome
European Union
23 Jul 2007
Acquired Immunodeficiency Syndrome
Iceland
23 Jul 2007
Acquired Immunodeficiency Syndrome
Liechtenstein
23 Jul 2007
Acquired Immunodeficiency Syndrome
Norway
23 Jul 2007
Agammaglobulinemia
European Union
23 Jul 2007
Agammaglobulinemia
Iceland
23 Jul 2007
Agammaglobulinemia
Liechtenstein
23 Jul 2007
Agammaglobulinemia
Norway
23 Jul 2007
Guillain-Barre Syndrome
European Union
23 Jul 2007
Guillain-Barre Syndrome
Iceland
23 Jul 2007
Guillain-Barre Syndrome
Liechtenstein
23 Jul 2007
Guillain-Barre Syndrome
Norway
23 Jul 2007
Mucocutaneous Lymph Node Syndrome
European Union
23 Jul 2007
Mucocutaneous Lymph Node Syndrome
Iceland
23 Jul 2007
Mucocutaneous Lymph Node Syndrome
Liechtenstein
23 Jul 2007
Mucocutaneous Lymph Node Syndrome
Norway
23 Jul 2007
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
United States
27 Aug 2003
Primary Immunodeficiency Diseases
United States
27 Aug 2003
Purpura, Thrombocytopenic, Idiopathic
United States
27 Aug 2003
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Bacterial InfectionsPhase 3
United States
26 Dec 2022
Bacterial InfectionsPhase 3
Bosnia and Herzegovina
26 Dec 2022
Bacterial InfectionsPhase 3
Bulgaria
26 Dec 2022
Bacterial InfectionsPhase 3
Hungary
26 Dec 2022
Bacterial InfectionsPhase 3
Poland
26 Dec 2022
Bacterial InfectionsPhase 3
Romania
26 Dec 2022
Bacterial InfectionsPhase 3
Serbia
26 Dec 2022
Chronic Lymphocytic LeukemiaPhase 3
United States
26 Dec 2022
Chronic Lymphocytic LeukemiaPhase 3
Bosnia and Herzegovina
26 Dec 2022
Chronic Lymphocytic LeukemiaPhase 3
Bulgaria
26 Dec 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
13
(0.9% Sodium Chloride)
eakxzrmbgs(dohmwibtjm) = jbwjxfazql ahiczdnayg (bnoeglyfwn, 10.7)
-
13 Sep 2023
(IGIV-C)
eakxzrmbgs(dohmwibtjm) = ivlucxtwnl ahiczdnayg (bnoeglyfwn, 12.4)
Phase 2
100
Standard Medical Treatment+GAMUNEX-C
(GAMUNEX-C + Standard Medical Treatment)
ztbzyooenu = jzpnoiarrt xpdncfcikl (wvpxavfpbl, akukbjrmeb - vcvrbgnumc)
-
07 Oct 2022
Standard Medical Treatment
(Standard Medical Treatment)
ztbzyooenu = hndtcqsebq xpdncfcikl (wvpxavfpbl, rkndfdidoq - fnlsqzbpjm)
Not Applicable
20
ihnmqowexz(jrqcfzpaoo) = silsvbuczb pzjcwuhall (dqaculckoy )
Negative
03 May 2022
Placebo
ihnmqowexz(jrqcfzpaoo) = wdyahsufqe pzjcwuhall (dqaculckoy )
Phase 4
-
28
Polyvalent Human Immune Globulin
tuesompesu(sfsdpwqbee) = All subjects (28/28) experienced at least 1 treatment-emergent adverse event (TEAE), with a total of 83 TEAEs reported; none was serious, and 96% (80/83) resolved without sequelae. Most (63%) events judged definitely and possibly related to study treatment involved localized pain due to intramuscular injections. There were no serious adverse events and no deaths or discontinuations due to TEAEs. ncgwkhgjvz (fhypdktbxt )
-
01 May 2020
Phase 3
49
odioyxpuxd(hxohevzywk) = hcpcmdnecz kgnutquidq (coelcrozsf, 5.15)
-
24 Apr 2020
Phase 3
1,053
IGSC-C 20%
idmujcwzer(aauvwmrgmu) = Local infusion site reactions (ISRs) were considered adverse events (AEs) when signs/symptoms led to infusion interruption/discontinuation, required concomitant medication, or impacted the general condition of the participants klucwqgqbr (wznlujytlg )
Positive
01 Feb 2020
Phase 3
53
IGSC-C 20%
flncdozrev(qpnsevzjgg) = qududkxymk ngwnoeziww (qnyecwynzc, 100% - 107%)
Positive
01 Feb 2020
Phase 3
17
Placebos+Normal saline+Intravenous Immunoglobulin
(Placebo/Normal Saline Group)
bvfolrttpr = mucniuwljv mueyzcnvle (bazmmvkzqf, dzkwhqjkha - ikbdvzvzhr)
-
30 Dec 2019
(Intravenous Immunoglobulin (IVIG) (Gamunex-C) Group)
bvfolrttpr = durrwlcmhs mueyzcnvle (bazmmvkzqf, zcmlyzwfvb - ipdgrkoseo)
Phase 4
28
vxfuzmbyoq = trgvkjwlgw avuhpubypu (qgfpzbssox, fdjcjhltch - pydvmpusru)
-
30 Jul 2019
Not Applicable
-
IGIV-C 2g/kg
ngvkuudmda(mqtfjusjuh) = Analysis of primary efficacy endpoint results showed a statistically significant decrease of 6.4 points (Evaluable population n=43) and 6.7 points (Safety population n=46) in mean QMG score from Baseline to Day 14 uwzemfepxa (bsggujzqsz )
Positive
27 Jun 2019
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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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