Primary Immune Thrombocytopenia

Hematology
15
Pipeline Programs
6
Companies
15
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
4
0
10
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
686%
Small Molecule
114%
+ 8 programs with unclassified modality

On Market (1)

Approved therapies currently available

UP
RYSTIGGOApproved
rozanolixizumab
UCB Pharma
Neonatal Fc Receptor Blocker [EPC]subcutaneous2023

Competitive Landscape

6 companies ranked by most advanced pipeline stage

UP
UCB PharmaBelgium - Brussels
3 programs
3
1
RozanolixizumabPhase 3Monoclonal Antibody1 trial
RozanolixizumabPhase 3Monoclonal Antibody1 trial
RozanolixizumabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT04224688Terminated30Est. May 2022
NCT04200456Terminated33Est. Apr 2022
NCT04596995Terminated43Est. Dec 2022
argenx
argenxBelgium - Zwijnaarde
5 programs
1
4
Efgartigimod PH20 SCPhase 31 trial
efgartigimodPhase 31 trial
efgartigimodPhase 31 trial
efgartigimod PH20 SCPhase 31 trial
ARGX-113Phase 21 trial
Active Trials
NCT03102593Completed38Est. Apr 2019
NCT04687072Completed207Est. Oct 2023
NCT04188379Completed131Est. Feb 2022
+2 more trials
Novartis
NovartisBASEL, Switzerland
3 programs
1
1
IanalumabPhase 3Monoclonal Antibody1 trial
IanalumabPhase 2Monoclonal Antibody1 trial
ianalumabN/AMonoclonal Antibody1 trial
Active Trials
NCT07244289Available
NCT07039422Recruiting60Est. Aug 2030
NCT05653219Active Not Recruiting152Est. Apr 2028
CT
2 programs
1
1
TQB3473 TabletsPhase 31 trial
TQB3473 TabletsPhase 21 trial
Active Trials
NCT07083739Not Yet RecruitingEst. Mar 2028
NCT06900920RecruitingEst. Dec 2027
Qilu Pharmaceutical
Qilu PharmaceuticalChina - Jinan
1 program
1
QL0911Phase 31 trial
Active Trials
NCT05621330CompletedEst. Dec 2021
InnoCare
InnoCareChina - Beijing
1 program
1
OrelabrutinibPhase 2Small Molecule1 trial
Active Trials
NCT05232149Unknown30Est. Dec 2024

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
Chia Tai TianQing Pharmaceutical GroupTQB3473 Tablets
NovartisIanalumab
argenxefgartigimod PH20 SC
UCB PharmaRozanolixizumab
argenxEfgartigimod PH20 SC
UCB PharmaRozanolixizumab
argenxefgartigimod
UCB PharmaRozanolixizumab
argenxefgartigimod
Qilu PharmaceuticalQL0911
NovartisIanalumab
Chia Tai TianQing Pharmaceutical GroupTQB3473 Tablets
InnoCareOrelabrutinib
argenxARGX-113

Clinical Trials (15)

Total enrollment: 998 patients across 15 trials

NCT06900920Chia Tai TianQing Pharmaceutical GroupTQB3473 Tablets

A Study of TQB3473 Tablets Compared to Placebo in the Treatment of Adult Primary Immune Thrombocytopenia

Start: Apr 2025Est. completion: Dec 2027
Phase 3Recruiting
NCT05653219NovartisIanalumab

A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids

Start: Feb 2023Est. completion: Apr 2028152 patients
Phase 3Active Not Recruiting
NCT04812925argenxefgartigimod PH20 SC

A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Start: Nov 2021Est. completion: Oct 2026173 patients
Phase 3Active Not Recruiting
NCT04596995UCB PharmaRozanolixizumab

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Start: Jan 2021Est. completion: Dec 202243 patients
Phase 3Terminated
NCT04687072argenxEfgartigimod PH20 SC

A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

Start: Dec 2020Est. completion: Oct 2023207 patients
Phase 3Completed
NCT04224688UCB PharmaRozanolixizumab

A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Start: Jun 2020Est. completion: May 202230 patients
Phase 3Terminated
NCT04225156argenxefgartigimod

A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

Start: Jun 2020Est. completion: Mar 2026101 patients
Phase 3Completed
NCT04200456UCB PharmaRozanolixizumab

A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Start: Jan 2020Est. completion: Apr 202233 patients
Phase 3Terminated
NCT04188379argenxefgartigimod

A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

Start: Dec 2019Est. completion: Feb 2022131 patients
Phase 3Completed
NCT05621330Qilu PharmaceuticalQL0911

Efficacy and Safety of QL0911 in Adult Patients With Chronic Primary Immune Thrombocytopenia

Start: Oct 2019Est. completion: Dec 2021
Phase 3Completed
NCT07039422NovartisIanalumab

Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab

Start: Apr 2026Est. completion: Aug 203060 patients
Phase 2Recruiting
NCT07083739Chia Tai TianQing Pharmaceutical GroupTQB3473 Tablets

A Study on the Safety and Efficacy of TQB3473 Tablets in the Treatment of Persistent or Chronic Primary Immune Thrombocytopenia (ITP) in Adults

Start: Aug 2025Est. completion: Mar 2028
Phase 2Not Yet Recruiting
NCT05232149InnoCareOrelabrutinib

A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia

Start: Feb 2022Est. completion: Dec 202430 patients
Phase 2Unknown
NCT03102593argenxARGX-113

A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP

Start: Mar 2017Est. completion: Apr 201938 patients
Phase 2Completed
NCT07244289Novartisianalumab

Managed Access Programs for VAY736, Ianalumab

N/AAvailable

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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

10 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 998 patients
6 companies competing in this space

Related Indications

Anemia(92)Myelofibrosis(21)Polycythemia Vera(16)Primary Myelofibrosis(14)Immune Thrombocytopenia(12)Thrombocytopenia(11)Beta-Thalassemia(10)Aplastic Anemia(7)Anemia of Chronic Kidney Disease(7)Iron Deficiency Anemia(6)