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Primary Immune Deficiency Disorder

4
Pipeline Programs
6
Companies
12
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
3
1
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

6 companies ranked by most advanced pipeline stage

ADMA Biologics
ADMA BiologicsNJ - Ramsey
4 programs
2
1
Immune Globulin Intravenous (Human)Phase 4
Immune Globulin Intravenous (Human)Phase 32 trials
RI-002Phase 31 trial
BivigamN/A1 trial
Active Trials
NCT03037359Unknown200Est. Jun 2023
NCT00538915Completed63Est. Jul 2009
NCT00473824Terminated7Est. Feb 2009
+1 more trials
CSL Seqirus
CSL SeqirusUK - Maidenhead
1 program
1
Immune globulin subcutaneousPhase 3
Octapharma
OctapharmaAustria - Vienna
5 programs
Cutaquig®N/A1 trial
Octagam 5%N/A1 trial
CUTAQUIGPHASE_31 trial
OctanormPHASE_31 trial
octanorm 16.5%PHASE_31 trial
Active Trials
NCT04354129Active Not Recruiting36Est. Sep 2025
NCT01859754Completed623Est. May 2019
NCT03939533Completed64Est. Jan 2022
+2 more trials
Allergy Therapeutics
Allergy TherapeuticsUK - West Sussex
1 program
Primary Immunodeficiency in KuwaitN/A1 trial
Active Trials
NCT03618147Completed314Est. May 2019
CSL Behring
CSL BehringIL - Bradley
1 program
Immune globulin subcutaneousPHASE_31 trial
Active Trials
NCT01458171Completed23Est. Apr 2012
GC Biopharma
GC BiopharmaKorea - Yongin
1 program
ImmunoglobulinPHASE_31 trial
Active Trials
NCT03492710Withdrawn0Est. Apr 2019

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
OctapharmaCUTAQUIG
GC BiopharmaImmunoglobulin
OctapharmaOctanorm
Octapharmaoctanorm 16.5%
ADMA BiologicsRI-002
CSL BehringImmune globulin subcutaneous
ADMA BiologicsImmune Globulin Intravenous (Human)
ADMA BiologicsImmune Globulin Intravenous (Human)
OctapharmaCutaquig®
Allergy TherapeuticsPrimary Immunodeficiency in Kuwait
ADMA BiologicsBivigam
OctapharmaOctagam 5%

Clinical Trials (12)

Total enrollment: 1,489 patients across 12 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 20190
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
NCT01814800ADMA BiologicsRI-002

Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)

Start: Feb 2014Est. completion: Jan 201559 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
NCT00538915ADMA BiologicsImmune Globulin Intravenous (Human)

Open Label, Phase III Study of NABI-IGIV 10% [Immune Globulin Intravenous(Human), 10%] In Subjects With Primary Immune Deficiency Disorders (PIDD)

Start: Sep 2007Est. completion: Jul 200963 patients
Phase 3Completed
NCT00473824ADMA BiologicsImmune Globulin Intravenous (Human)

Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation

Start: May 2007Est. completion: Feb 20097 patients
Phase 2Terminated
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
NCT03618147Allergy TherapeuticsPrimary Immunodeficiency in Kuwait

Primary Immunodeficiency in Kuwait

Start: Jul 2018Est. completion: May 2019314 patients
N/ACompleted
NCT03037359ADMA BiologicsBivigam

A Study About Low Blood Pressure in Patients With Primary Immunodeficiency Disease Treated With Immune Globulin Products

Start: Dec 2016Est. completion: Jun 2023200 patients
N/AUnknown
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

3 late-stage (Phase 3) programs, potential near-term approvals
6 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.