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Primary Immune Deficiency

9
Pipeline Programs
8
Companies
11
Clinical Trials
1 recruiting
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
5
4
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

7 companies ranked by most advanced pipeline stage

CSL Seqirus
CSL SeqirusUK - Maidenhead
6 programs
4
1
Subcutaneous Immune GlobulinPhase 4
Human Normal Immunoglobulin for Subcutaneous AdministrationPhase 3
IgPro20Phase 3
Immune Globulin SubcutaneousPhase 3
Immune globulin subcutaneousPhase 3
+1 more programs
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
2 programs
1
PneumovaxPhase 41 trial
Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell DeathN/A1 trial
Active Trials
NCT00246857Recruiting5,000
NCT00023504Terminated21Est. Oct 2021
ADMA Biologics
ADMA BiologicsNJ - Ramsey
2 programs
2
Asceniv™Phase 41 trial
Immune Globulin Intravenous (Human)Phase 4
Active Trials
NCT05070455Unknown12Est. Jun 2023
Biopharma Group
Biopharma GroupUK - Winchester
1 program
1
GC5107Phase 31 trial
Active Trials
NCT04565015Active Not Recruiting24Est. Nov 2026
CSL Behring
CSL BehringIL - Bradley
6 programs
Subcutaneous IgGN/A1 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
GC5107PHASE_3
Octapharma
OctapharmaAustria - Vienna
1 program
NewnormPHASE_31 trial
Active Trials
NCT04640142Active Not Recruiting50Est. Sep 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
ADMA BiologicsAsceniv™
CSL BehringSubcutaneous Immune Globulin
Allergy TherapeuticsPneumovax
OctapharmaNewnorm
Biopharma GroupGC5107
CSL BehringImmune globulin subcutaneous
CSL BehringImmune Globulin Subcutaneous
CSL BehringIgPro20
CSL BehringHuman Normal Immunoglobulin for Subcutaneous Administration
CSL BehringSubcutaneous IgG
Allergy TherapeuticsScreening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death

Clinical Trials (11)

Total enrollment: 5,277 patients across 11 trials

NCT05070455ADMA BiologicsAsceniv™

An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)

Start: Sep 2022Est. completion: Jun 202312 patients
Phase 4Unknown
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
NCT00023504Allergy TherapeuticsPneumovax

Antibody Production in Immune Disorders

Start: Jun 2002Est. completion: Oct 202121 patients
Phase 4Terminated
NCT04640142OctapharmaNewnorm

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
NCT04565015Biopharma GroupGC5107

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

Start: Dec 2020Est. completion: Nov 202624 patients
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
NCT00719680CSL BehringIgPro20

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
NCT00246857Allergy TherapeuticsScreening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death

Screening Protocol for Genetic Diseases of Lymphocyte Homeostasis and Programmed Cell Death

Start: Feb 20075,000 patients
N/ARecruiting

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 5,277 patients
8 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.