Primary Immune Deficiency

7
Pipeline Programs
3
Companies
8
Clinical Trials
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
0
0
6
1
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

3 companies ranked by most advanced pipeline stage

CSL Behring
CSL BehringIL - Bradley
6 programs
4
1
Subcutaneous Immune GlobulinPhase 41 trial
Human Normal Immunoglobulin for Subcutaneous AdministrationPhase 31 trial
IgPro20Phase 31 trial
Immune Globulin SubcutaneousPhase 31 trial
Immune globulin subcutaneousPhase 31 trial
+1 more programs
Active Trials
NCT01166074Completed27Est. Dec 2010
NCT00419341Completed49Est. Oct 2008
NCT00719680Completed21Est. Jun 2010
+3 more trials
GC Biopharma
GC BiopharmaKorea - Yongin
1 program
1
GC5107Phase 31 trial
Active Trials
NCT04565015Active Not RecruitingEst. Nov 2026
Octapharma
OctapharmaAustria - Vienna
1 program
1
NewnormPhase 31 trial
Active Trials
NCT04640142Active Not Recruiting50Est. Sep 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
CSL BehringSubcutaneous Immune Globulin
OctapharmaNewnorm
GC BiopharmaGC5107
CSL BehringImmune globulin subcutaneous
CSL BehringImmune Globulin Subcutaneous
CSL BehringIgPro20
CSL BehringHuman Normal Immunoglobulin for Subcutaneous Administration
CSL BehringSubcutaneous IgG

Clinical Trials (8)

Total enrollment: 220 patients across 8 trials

NCT02711228CSL BehringSubcutaneous Immune Globulin

Study of Immune Deficiency Patients Treated With Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules

Start: Mar 2016Est. completion: Jan 201826 patients
Phase 4Completed

Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability, and Safety of Subcutaneous Human Immunoglobulin (Newnorm) in Patients With Primary Immunodeficiency Diseases

Start: Aug 2021Est. completion: Sep 202650 patients
Phase 3Active Not Recruiting

Study of Immune Globulin Intravenous (Human) GC5107 in Pediatric Subjects With Primary Humoral Immunodeficiency

Start: Dec 2020Est. completion: Nov 2026
Phase 3Active Not Recruiting
NCT01461018CSL BehringImmune globulin subcutaneous

Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

Start: Oct 2011Est. completion: Jul 201422 patients
Phase 3Completed
NCT01199705CSL BehringImmune Globulin Subcutaneous

Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

Start: Sep 2010Est. completion: Nov 201125 patients
Phase 3Completed

Extension Study of Subcutaneous Immunoglobulin Human in Patients With Primary Immunodeficiency (PID)

Start: Jun 2008Est. completion: Jun 201021 patients
Phase 3Completed
NCT00419341CSL BehringHuman Normal Immunoglobulin for Subcutaneous Administration

Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

Start: Nov 2006Est. completion: Oct 200849 patients
Phase 3Completed
NCT01166074CSL BehringSubcutaneous IgG

Retrospective Chart Review of Subcutaneous IgG Use in Infants

Start: May 2010Est. completion: Dec 201027 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

6 late-stage (Phase 3) programs — potential near-term approvals
3 companies competing in this space