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Primary Immunodeficiency

5
Pipeline Programs
8
Companies
14
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
3
2
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

8 companies ranked by most advanced pipeline stage

CSL Seqirus
CSL SeqirusUK - Maidenhead
2 programs
2
IgProPhase 4
IgPro20Phase 4
Biocorp
BiocorpFrance - Issoire
1 program
1
GammaplexPhase 31 trial
Active Trials
NCT00278954Completed50Est. Nov 2007
BioTherapeutics Inc
BioTherapeutics IncVA - Blacksburg
1 program
1
Immune Globulin IntravenousPhase 31 trial
Active Trials
NCT02269163Completed82Est. Jan 2019
Prothya Biosolutions
Prothya BiosolutionsBelgium - Brussels
1 program
1
Intravenous immunoglobulin infusionPhase 31 trial
Active Trials
NCT01985373Completed23Est. Mar 2015
Grifols
GrifolsNEW YORK, NY
6 programs
Gamunex-CPHASE_31 trial
IGIV-C 10%PHASE_31 trial
IGSC 20%PHASE_31 trial
IGSC 20% daily push versus every 2 weeks pumpPHASE_31 trial
GAMUNEX-CPHASE_41 trial
+1 more programs
Active Trials
NCT04561115Completed33Est. Mar 2022
NCT02604810Completed53Est. Dec 2017
NCT02806986Completed61Est. May 2019
+3 more trials
Octapharma
OctapharmaAustria - Vienna
2 programs
Octanorm 16.5%PHASE_31 trial
Chrono Super PID then Generic Syringe-GammanormPHASE_41 trial
Active Trials
NCT03907241Completed27Est. Sep 2019
NCT02503293Completed30Est. Dec 2017
CSL Behring
CSL BehringIL - Bradley
2 programs
IgProPHASE_41 trial
IgPro20PHASE_41 trial
Active Trials
NCT07076446Active Not Recruiting8Est. Jun 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
NCT04864886Recruiting300Est. 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%
BioTherapeutics IncImmune Globulin Intravenous
GrifolsIGIV-C 10%
Prothya BiosolutionsIntravenous immunoglobulin infusion
BiocorpGammaplex
Allergy TherapeuticsMetabolic Profiling of Immune Responses in Immune-mediated Diseases

Clinical Trials (14)

Total enrollment: 761 patients across 14 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: Jun 20268 patients
Phase 4Active Not Recruiting

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 202233 patients
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 201312 patients
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 202233 patients
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 20200
Phase 3Withdrawn

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

Start: Jun 2016Est. completion: May 201961 patients
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
NCT02269163BioTherapeutics IncImmune Globulin Intravenous

Study of ProMetic BioTherapeutics Immune Globulin Intravenous (Human) 10%

Start: Jan 2016Est. completion: Jan 201982 patients
Phase 3Completed

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

Start: Jan 2016Est. completion: Dec 201753 patients
Phase 3Completed
NCT01985373Prothya BiosolutionsIntravenous immunoglobulin infusion

Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Start: Dec 2013Est. completion: Mar 201523 patients
Phase 3Completed

Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.

Start: Jan 2006Est. completion: Nov 200750 patients
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 2027300 patients
N/ARecruiting

Phase Legend

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

Key Insights

3 late-stage (Phase 3) programs, potential near-term approvals
1 actively recruiting trials targeting 761 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.