Drugs / IgPro20

Trials 13

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT06976476 May 2025 → May 2029 expected B cell deficiency, acquired immunodeficiency, plasma cell myeloma Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 2 NCT04137224 Sep 2019 → May 2022 diffuse cutaneous systemic sclerosis CSL Behring Completed No outcome recorded
Phase 39 trials · 2 met primary
Phase 3 NCT07648264 Jul 2026 → Feb 2029 expected acquired immunodeficiency CSL Behring Not yet recruiting No outcome recorded
Phase 3 NCT06524739 Aug 2024 → Jun 2025 postural orthostatic tachycardia syndrome CSL Behring Terminated No outcome recorded Stop: Business
Phase 3 NCT02027701 Jul 2014 → Jul 2017 chronic inflammatory demyelinating polyradiculoneuropathy, polyneuropathy, inflammatory demyelinating, chronic CSL Behring Completed No outcome recorded
Phase 3 NCT01545076 Mar 2012 → Sep 2016 polyneuropathy, inflammatory demyelinating, chronic, polyradiculoneuropathy CSL Behring Completed Met primary
Phase 3 NCT01199705 Sep 2010 → Aug 2011 immunodeficiency disease CSL Behring Completed No outcome recorded
Phase 3 NCT00751621 Aug 2008 → Dec 2011 immunodeficiency disease CSL Behring Completed No outcome recorded
Phase 3 NCT00719680 Jun 2008 → Jun 2010 immunodeficiency disease CSL Behring Completed No outcome recorded
Phase 3 NCT00542997 Sep 2007 → Aug 2009 Bruton-type agammaglobulinemia, autosomal agammaglobulinemia, common variable immunodeficiency CSL Behring Completed No outcome recorded
Phase 3 NCT00419341 Nov 2006 → Oct 2008 immunodeficiency disease CSL Behring Completed Met primary
Phase 42 trials
Phase 4 NCT07076446 Jul 2025 → Jun 2026 immunodeficiency disease CSL Behring Completed No outcome recorded
Phase 4 NCT03033745 Feb 2017 → Dec 2018 immunodeficiency disease CSL Behring Completed No outcome recorded

Press releases naming this drug 31 releases

DateIssuerRelease
2024-01-03 CSL Behring CSL Behring Announces Availability of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 10g Prefilled Syringe csl.com ↗
2023-04-18 CSL Behring CSL Behring Receives FDA Approval for Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) 50mL Prefilled Syringe csl.com ↗
2021-06-08 CSL Behring Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) To Be Covered Under Medicare Part B Effective July 18, Improving Access and Reducing Out-of-Pocket Costs for CIDP Patients csl.com ↗
2021-04-29 CSL Behring Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) Label Update Provides New Dosing Guidelines for Physicians, Allowing for Greater Flexibility in Treating CIDP Patients csl.com ↗
2020-12-09 CSL Behring HIZENTRA® (Immune Globulin Subcutaneous [Human] 20% Liquid) Receives Orphan-Drug Exclusivity for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2020-04-21 CSL Behring CSL Behring Announces Results from Three Analyses of Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) in Primary Immunodeficiency (PI) csl.com ↗
2019-06-20 CSL Behring CSL Behring to showcase clinical advances and insights in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) with Hizentra ® [human normal immunoglobulin, 20%, subcutaneous], at the 2019 Peripheral Nerve Society Annual Meeting csl.com ↗
2018-03-16 CSL Behring FDA Approves Hizentra® (Immune Globulin Subcutaneous [Human] 20% Liquid) for the Treatment of Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2018-03-15 CSL Behring European Commission Approves Hizentra® [Human normal immunoglobulin (SCIg)] to Treat Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2017-11-09 CSL Behring Lancet Neurology Publishes Results from CSL Behring Phase III Study of Hizentra® (Immune Globulin Subcutaneous [Human] 20% liquid) as Maintenance Therapy in Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) csl.com ↗
2017-07-19 CSL Behring FDA Accepts CSL Behring’s Supplemental Biologics License Application for Hizentra® Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Indication csl.com ↗
2015-02-02 CSL Behring FDA Approves New Dosing Option for CSL Behring’s Hizentra® csl.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as IgPro20 “Human Normal Immunoglobulin for Subcutaneous Administration (IgPro20) is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at...” NCT00419341 ↗
12

“evaluated the efficacy, tolerability, and safety of IgPro20 (Hizentra®; L-proline-stabilized 20 % human SCIG) in adult and pediatric Japanese patients with PID.” PMID 24504846 ↗ Feb 2014

“IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.” NCT00542997 ↗

“IgPro20 is a solution for infusion for subcutaneous administration.” NCT07076446 ↗

NCT02027701 ↗

NCT04137224 ↗

NCT00751621 ↗

NCT06976476 ↗

NCT03033745 ↗

NCT06524739 ↗

NCT07648264 ↗

Show 2 more sources

Known as Hizentra “IgPro20 (Subcutaneous Immunoglobulin, Hizentra®)” NCT04137224 ↗
Modality Protein / enzyme biologic “Human Normal Immunoglobulin for Subcutaneous Administration (IgPro20) is a liquid formulation of normal human IgG” NCT00419341 ↗
Route Subcutaneous “IgPro20 was administered subcutaneously once weekly” PMID 21553933 ↗ Jun 2011