Primary Immune Deficiency Disorder

5
Pipeline Programs
3
Companies
7
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
5
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Octapharma
OctapharmaAustria - Vienna
5 programs
3
CUTAQUIGPhase 31 trial
OctanormPhase 31 trial
octanorm 16.5%Phase 31 trial
Cutaquig®N/A1 trial
Octagam 5%N/A1 trial
Active Trials
NCT04354129Active Not Recruiting36Est. Sep 2025
NCT01859754Completed623Est. May 2019
NCT03939533Completed64Est. Jan 2022
+2 more trials
CSL Behring
CSL BehringIL - Bradley
1 program
1
Immune globulin subcutaneousPhase 31 trial
Active Trials
NCT01458171Completed23Est. Apr 2012
GC Biopharma
GC BiopharmaKorea - Yongin
1 program
1
ImmunoglobulinPhase 31 trial
Active Trials
NCT03492710WithdrawnEst. Apr 2019

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
OctapharmaCUTAQUIG
GC BiopharmaImmunoglobulin
OctapharmaOctanorm
Octapharmaoctanorm 16.5%
CSL BehringImmune globulin subcutaneous
OctapharmaCutaquig®
OctapharmaOctagam 5%

Clinical Trials (7)

Total enrollment: 846 patients across 7 trials

NCT03939533OctapharmaCUTAQUIG

Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases

Start: Oct 2019Est. completion: Jan 202264 patients
Phase 3Completed
NCT03492710GC BiopharmaImmunoglobulin

Study of Immune Globulin Intravenous (Human) GC5101F in Subjects With Primary Humoral Immunodeficiency

Start: Apr 2019Est. completion: Apr 2019
Phase 3Withdrawn
NCT03988426OctapharmaOctanorm

Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases

Start: Mar 2017Est. completion: Jan 201825 patients
Phase 3Completed
NCT01888484Octapharmaoctanorm 16.5%

Study of Octanorm Subcutaneous IG in Patients With PID

Start: Mar 2014Est. completion: Jun 202075 patients
Phase 3Completed
NCT01458171CSL BehringImmune globulin subcutaneous

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

Start: Apr 2011Est. completion: Apr 201223 patients
Phase 3Completed
NCT04354129OctapharmaCutaquig®

Observational Study of Subcutaneous Immunoglobulin (Cutaquig) in Patients With Primary and Secondary Immunodeficiency.

Start: Apr 2023Est. completion: Sep 202536 patients
N/AActive Not Recruiting
NCT01859754OctapharmaOctagam 5%

Octagam 5% Versus Comparator Post Marketing Trial

Start: May 2013Est. completion: May 2019623 patients
N/ACompleted

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
3 companies competing in this space