Primary Immunodeficiency

10
Pipeline Programs
4
Companies
11
Clinical Trials
2 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
5
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Grifols
GrifolsNEW YORK, NY
6 programs
4
2
GAMUNEX-CPhase 41 trial
IGSC 20%Phase 41 trial
Gamunex-CPhase 31 trial
IGIV-C 10%Phase 31 trial
IGSC 20%Phase 31 trial
+1 more programs
Active Trials
NCT04561115CompletedEst. Mar 2022
NCT02604810CompletedEst. Dec 2017
NCT02806986CompletedEst. May 2019
+3 more trials
Octapharma
OctapharmaAustria - Vienna
2 programs
1
1
Chrono Super PID then Generic Syringe-GammanormPhase 41 trial
Octanorm 16.5%Phase 31 trial
Active Trials
NCT03907241Completed27Est. Sep 2019
NCT02503293Completed30Est. Dec 2017
CSL Behring
CSL BehringIL - Bradley
2 programs
2
IgProPhase 41 trial
IgPro20Phase 41 trial
Active Trials
NCT07076446Recruiting8Est. May 2026
NCT03033745Completed49Est. Dec 2018
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
Metabolic Profiling of Immune Responses in Immune-mediated DiseasesN/A1 trial
Active Trials
NCT04864886RecruitingEst. Jun 2027

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
CSL BehringIgPro
GrifolsIGSC 20%
CSL BehringIgPro20
OctapharmaChrono Super PID then Generic Syringe-Gammanorm
GrifolsGAMUNEX-C
GrifolsGamunex-C
GrifolsIGSC 20% daily push versus every 2 weeks pump
GrifolsIGSC 20%
OctapharmaOctanorm 16.5%
GrifolsIGIV-C 10%
Allergy TherapeuticsMetabolic Profiling of Immune Responses in Immune-mediated Diseases

Clinical Trials (11)

Total enrollment: 114 patients across 11 trials

An Open-label, Multicenter Study to Assess the Pharmacokinetics (PK), Safety, and Tolerability of Subcutaneous IgPro20 in Immunoglobulin (IG) Treatment-naïve Participants With Primary Immunodeficiency (PID)

Start: Jul 2025Est. completion: May 20268 patients
Phase 4Recruiting

A Study to Evaluate IGSC 20% Biweekly Dosing in Treatment-Experienced Participants and Loading/Maintenance Dosing in Treatment-Naïve Participants With Primary Immunodeficiency

Start: Nov 2020Est. completion: Jul 2022
Phase 4Completed

Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra) in Subjects With Primary Immunodeficiency (PID)

Start: Feb 2017Est. completion: Dec 201849 patients
Phase 4Completed
NCT02503293OctapharmaChrono Super PID then Generic Syringe-Gammanorm

A Study to Compare Quality of Life and Satisfaction in Primary Immunodeficient Patients Treated With Subcutaneous Injections of Gammanorm® 165 mg/mL Administered With Two Different Delivery Devices: Injections Using Pump or Rapid Push

Start: Jul 2015Est. completion: Dec 201730 patients
Phase 4Completed

Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency

Start: Nov 2011Est. completion: Oct 2013
Phase 4Completed

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Immune Globulin (Human) 10% (Gamunex-C) PEG Process (IVIG-PEG) Compared to Gamunex-C in Participants With Primary Humoral Immunodeficiency

Start: Sep 2020Est. completion: Mar 2022
Phase 3Completed
NCT03814798GrifolsIGSC 20% daily push versus every 2 weeks pump

Study Evaluating IGSC 20% Flexible Dosing in Treatment-Experienced and Treatment-Naive Subjects With Primary Immunodeficiency

Start: Dec 2019Est. completion: Sep 2020
Phase 3Withdrawn

Efficacy, Pharmacokinetics, Safety, and Tolerability of IGSC 20% in Subjects With Primary Immunodeficiency

Start: Jun 2016Est. completion: May 2019
Phase 3Completed
NCT03907241OctapharmaOctanorm 16.5%

CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL

Start: Mar 2016Est. completion: Sep 201927 patients
Phase 3Completed

Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency

Start: Jan 2016Est. completion: Dec 2017
Phase 3Completed
NCT04864886Allergy TherapeuticsMetabolic Profiling of Immune Responses in Immune-mediated Diseases

Metabolic Profiling of Immune Responses in Immune-mediated Diseases

Start: Aug 2021Est. completion: Jun 2027
N/ARecruiting

Phase Legend

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

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 114 patients
4 companies competing in this space