Hizentra

Developed for: immunodeficiency disease · acquired immunodeficiency · common variable immunodeficiency · dysgammaglobulinemia · myasthenia gravis
Investigated by: CSL Behring · Mazen Dimachkie, MD · Rochester General Hospital · University Health Network, Toronto · University of Alabama at Birmingham

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Hizentra	—	2011-04-14	europa.eu ↗

Trials 5

today

EU approved 2011

NCT05193552 · Ph 4 NCT03730129 · Ph 2/3 NCT03401268 · not/applicable NCT02711228 · Ph 4 NCT02100969 · Ph 2

20112012201320142015201620172018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 21 trial · 1 met primary
Phase 2	NCT02100969	May 2015 → Nov 2017	myasthenia gravis	Mazen Dimachkie, MD	Completed	Met primary
Phase 2/31 trial
Phase 2/3	NCT03730129	Nov 2018 → Jul 2020	immunodeficiency disease	Rochester General Hospital	Completed	No outcome recorded
Phase 42 trials
Phase 4	NCT05193552	Jan 2024 → Dec 2026 expected	common variable immunodeficiency	University of Alabama at Birmingham	Recruiting	No outcome recorded
Phase 4	NCT02711228	Mar 2016 → Jan 2018	acquired immunodeficiency, immunodeficiency disease	CSL Behring	Completed	No outcome recorded
Phase not applicable1 trial
—	NCT03401268	Feb 2018 → May 2019	dysgammaglobulinemia	University Health Network, Toronto	Completed	No outcome recorded
Comparator or background therapy1 trial
—	NCT01354587 Comparator	Oct 2010 → Aug 2012	immunodeficiency disease	University of South Florida	Unknown	No outcome recorded

Press releases naming this drug 28 releases

Date	Issuer	Release
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 ↗
2014-12-04	CSL Behring	EMA Approves Amended Product Label for CSL Behring’s Hizentra® csl.com ↗
2014-10-30	CSL Behring	Evidence presented at the 16th Biennial Meeting of the European Society for Immunodeficiencies (ESID) Supports Individualized Dosing with Hizentra® csl.com ↗
2014-05-20	CSL Behring	CSL Behring Launches Hizentra® Co-Pay Relief Program csl.com ↗
2013-09-27	CSL Behring	FDA Approves New Dosing Option for CSL Behring’s Hizentra® csl.com ↗
2013-09-27	CSL Behring	CSL Behring Gains Approval to License Hizentra® in Japan for the Treatment of Primary Immunodeficiency and Secondary Immunodeficiency csl.com ↗
2013-09-03	CSL Behring	CSL Behring Announces FDA Approval of a 10 g (50 mL) Vial Size for Hizentra® csl.com ↗
2012-10-04	CSL Behring	Study Supports Efficacy, Safety of Hizentra® in Japanese Patients with Primary Immunodeficiency Disease csl.com ↗
2012-07-06	CSL Behring	CSL Behring Launches New Hizentra® Dosing Calculator App for Healthcare Professionals on the Move csl.com ↗
2012-03-26	CSL Behring	First patient enrolled in CSL Behring PATH trial to evaluate Immune Globulin Subcutaneous (Human) 20% Liquid, Hizentra®, in the treatment of CIDP csl.com ↗
2011-04-21	CSL Behring	CSL Behring Receives European Commission Marketing Authorization for Hizentra, the first 20 Percent Subcutaneous Human Immunoglobulin for Treatment of Primary and Secondary Immunodeficiencies csl.com ↗
2011-04-19	CSL Behring	FDA Approves Expansion of Innovative CSL Behring Hizentra® Production Facility in Bern, Switzerland csl.com ↗
2011-03-21	CSL Behring	Study demonstrates relationship between subcutaneous IgG (SCIg) dosage and clinical outcomes with Hizentra treatment in patients with primary immunodeficiencies csl.com ↗
2011-02-24	CSL Behring	CSL Behring Receives FDA Approval to Extend Shelf Life of Hizentra to 30 Months csl.com ↗
2010-10-07	CSL Behring	Data Support Hizentra Efficacy, Safety After Dose-Equivalent Switch in Adult and Pediatric Patients with Primary Immunodeficiency csl.com ↗
2010-09-18	CSL Behring	CSL Behring Receives FDA Approval to Extend Shelf Life of Hizentra from 18 Months to 24 Months csl.com ↗
2010-03-04	CSL Behring	CSL Behring Receives FDA Approval of Hizentra™, First 20 Percent Subcutaneous Immunoglobulin Therapy csl.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

Field	Value	Cited text
Known as	Hizentra	“A Pilot Study to Assess Tolerability of Subcutaneous Immunoglobulin Treatment (Hizentra) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation” NCT03401268 ↗ 5 NCT02711228 ↗ NCT05193552 ↗ NCT01354587 ↗ NCT02100969 ↗ NCT03730129 ↗
Action	Restore	“subcutaneous immunoglobulin replacement” NCT03730129 ↗
Modality	Protein / enzyme biologic	“Hizentra® (20% SCIG Product)” NCT01354587 ↗
Route	Subcutaneous	“using weekly subcutaneous infusions” NCT01354587 ↗