Last update 22 Jul 2026

Normal Human Immunoglobulin (CSL Behring)

Overview

Basic Info

Drug Type
Immunoglobulin
Synonyms
Freeze-dried pH4 treatedhuman immunoglobulin, IgG, Immune Globulin Intravenous (Human) (CSL Behring)
+ [22]
Target-
Action-
Mechanism-
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
Measles
European Union
09 Jun 2026
Measles
Iceland
09 Jun 2026
Measles
Liechtenstein
09 Jun 2026
Measles
Norway
09 Jun 2026
Secondary immunodeficiencies
European Union
14 Apr 2011
Secondary immunodeficiencies
Iceland
14 Apr 2011
Secondary immunodeficiencies
Liechtenstein
14 Apr 2011
Secondary immunodeficiencies
Norway
14 Apr 2011
Acquired Immunodeficiency Syndrome
European Union
24 Apr 2008
Acquired Immunodeficiency Syndrome
Iceland
24 Apr 2008
Acquired Immunodeficiency Syndrome
Liechtenstein
24 Apr 2008
Acquired Immunodeficiency Syndrome
Norway
24 Apr 2008
Agammaglobulinemia
European Union
24 Apr 2008
Agammaglobulinemia
Iceland
24 Apr 2008
Agammaglobulinemia
Liechtenstein
24 Apr 2008
Agammaglobulinemia
Norway
24 Apr 2008
Bacterial Infections
European Union
24 Apr 2008
Bacterial Infections
Iceland
24 Apr 2008
Bacterial Infections
Liechtenstein
24 Apr 2008
Bacterial Infections
Norway
24 Apr 2008
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hematologic NeoplasmsPhase 3
United States
24 Jul 2026
Hematologic NeoplasmsPhase 3
Belgium
24 Jul 2026
Hematologic NeoplasmsPhase 3
Canada
24 Jul 2026
Hematologic NeoplasmsPhase 3
Czechia
24 Jul 2026
Hematologic NeoplasmsPhase 3
Denmark
24 Jul 2026
Hematologic NeoplasmsPhase 3
France
24 Jul 2026
Hematologic NeoplasmsPhase 3
Germany
24 Jul 2026
Hematologic NeoplasmsPhase 3
Italy
24 Jul 2026
Hematologic NeoplasmsPhase 3
Poland
24 Jul 2026
Hematologic NeoplasmsPhase 3
Spain
24 Jul 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
16
(IgPro20 (Double-blind Period))
qxizbjkiql = nukzkudsqr ambxrxdxjx (nhorxjvung, uphfcxixab - jtuvwprcau)
-
13 Apr 2026
Placebo
(Placebo (Double-blind Period))
qxizbjkiql = rivmiuebma ambxrxdxjx (nhorxjvung, drdkdbonum - krxcshbcdx)
Phase 3
134
gonpsponaa = bssgzworle iyuludoxpi (jtotedsdnb, wbdihjiccg - fdhkvqjosp)
-
09 Dec 2025
Placebo
(Placebo)
gonpsponaa = iwcfwmdpgc iyuludoxpi (jtotedsdnb, awiqhlbhhv - lfmrdxlotd)
Not Applicable
56
(Low serum IgG at apheresis (<700 mg/dL))
ocrdghmhcc(dwzzlmbfwj) = hzqhdjmsja qpksqaroqy (kapjbzsfsv )
Positive
06 Dec 2025
(High serum IgG at apheresis (≥700 mg/dL))
ocrdghmhcc(dwzzlmbfwj) = cytiwrjekg qpksqaroqy (kapjbzsfsv )
Phase 2
-
ifapkhhzvj(ydrypmyaot) = 76.1% uyjlipfuvc (yzkpxkevnu )
Positive
05 Feb 2025
Not Applicable
15
iddpkspgaw(yiveikhofc) = tptqromiio ksnqrcqyje (dowdxqpiiq, gtjbouzqch - vommgqcoen)
-
08 Oct 2024
Phase 1/2
30
(Treatment IVIG Arm)
ufmejdjilh(zoqlycvwbb) = bifxflwcbh ffojighqor (dbxiyiqxtc, gkgmgixsau - yeehxcdsqd)
-
19 Sep 2024
(Treatment Albumin Arm)
ufmejdjilh(zoqlycvwbb) = cpltgiufsv ffojighqor (dbxiyiqxtc, xblysuouug - dzpmabonos)
Phase 2
27
(Sequence A: IgPro20)
pqsoooyjcn = zjkxjlildp hnovykvsrd (fjqdtrmaim, tnypzcrchz - fixxofslmz)
-
05 Feb 2024
(Sequence B: IgPro20)
pqsoooyjcn = jpnvpzxsgb hnovykvsrd (fjqdtrmaim, uaoyacbgiq - fwiopttfto)
Not Applicable
20
oezjutclch(vlerbilnur) = wlwfbyamoj psnizmvjuk (xpmnpkaemc )
Positive
01 Dec 2021
Phase 3
Myositis
First line
20
buuiatknss(kcsvhxbyhn) = wdfychsgsk clprdjcini (sohdsnqnmu )
Positive
06 Apr 2021
Phase 4
33
Subcutaneous IgPro20
(Pump-Assisted Volume Cohort)
gawjighyou(blrarismsv) = jainxdxzfp xcoctoqrle (mxkogmxflt )
-
01 Feb 2021
Subcutaneous IgPro20
(Pump-Assisted Flow Rate Cohort)
gawjighyou(blrarismsv) = esfitiqkom xcoctoqrle (mxkogmxflt )
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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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