Immune thrombocytopenia (ITP) is a serious immune-mediated disorder characterized by a low platelet count, leading to increased bleeding risk. According to Sophia Lee et al., 2024, the incidence of ITP is 6.1 per 100,000 people, highlighting its growing prevalence. According to the immune thrombocytopenia (ITP) pipeline analysis by Expert Market Research, the therapeutic landscape includes corticosteroids, thrombopoietin receptor agonists, immunoglobulins, and emerging targeted therapies. There is a growing focus on novel biologics and small-molecule agents aimed at improving patient outcomes. With continued research and development, the ITP drug pipeline is expected to experience significant growth in the coming years.
Major companies involved in the immune thrombocytopenia (ITP) pipeline analysis include Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Geropharm, and others.
Leading drugs currently in the pipeline include HMPL-523, NVG-2089, CID-103, and others.
The pipeline shows robust growth driven by novel thrombopoietin receptor agonists and targeted immunomodulatory therapies. Emerging oral and biologic candidates are expected to expand treatment options and improve patient outcomes.
The Immune Thrombocytopenia (ITP) Pipeline Analysis Report by Expert Market Research gives comprehensive insights into immune thrombocytopenia (ITP) therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for immune thrombocytopenia (ITP). The immune thrombocytopenia (ITP) report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The immune thrombocytopenia (ITP) pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with immune thrombocytopenia (ITP) treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to immune thrombocytopenia (ITP).
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Immune thrombocytopenia (ITP) is an autoimmune disorder characterized by low platelet counts due to the immune system mistakenly attacking platelets. This disruption leads to increased bleeding, bruising, and a higher risk of serious hemorrhages, significantly impacting patient quality of life. ITP occurs through complex immune dysregulation, involving both B cells and other immune pathways that destroy platelets prematurely.
Immune thrombocytopenia (ITP) treatment aims to increase platelet counts and regulate immune responses. Common approaches include corticosteroids, immunoglobulins, and thrombopoietin receptor agonists, alongside novel therapies targeting specific immune pathways to restore balance and reduce bleeding risk. In August 2025, Sanofi’s Wayrilz was approved in the US as the first oral Bruton’s tyrosine kinase inhibitor, offering multi-immune modulation with rapid, durable platelet responses and improved symptom management for adults with persistent or chronic ITP.
According to Sophia Lee et al., 2024, immune thrombocytopenia shows an increasing incidence of 6.1 per 100,000 people, which nearly doubles in adults aged 65 years and above, with higher mortality risk due to severe bleeding. As per Mohamed Amine Bekadja et al., 2024, the annual incidence of immune thrombocytopenia ranges from 1.9–6.4 per 100,000 children and 3.3 per 100,000 adults, with women exhibiting higher rates than men. Studies from Europe and Asia indicate the highest incidence occurs between 60-84 years, emphasizing the need for focused therapeutic development.
This section of the report covers the analysis of immune thrombocytopenia (ITP) drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The immune thrombocytopenia (ITP) pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration.
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total immune thrombocytopenia (ITP) clinical trials, representing 50% of ongoing developments. It is followed by phase III at 21% and phase I at 20%. This robust pipeline across multiple phases indicates strong potential for innovative therapies, enhancing treatment options and positively impacting the ITP market.
The drug molecule categories covered under the immune thrombocytopenia (ITP) pipeline analysis include small molecules, monoclonal antibodies, gene therapies, peptides and polymers. The immune thrombocytopenia (ITP) report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for immune thrombocytopenia (ITP). B cell-targeted therapies are emerging as promising options for patients with primary immune thrombocytopenia (ITP). For instance, ianalumab, a fully human monoclonal antibody, is under Phase III investigation, with top-line results announced in August 2025. It works by depleting B cells via antibody-dependent cellular cytotoxicity and disrupting BAFF-R signaling, thereby improving platelet counts and offering potential long-term disease control with limited dosing.
The EMR report for the immune thrombocytopenia (ITP) pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed immune thrombocytopenia (ITP) therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in immune thrombocytopenia (ITP) clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for immune thrombocytopenia (ITP). It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of immune thrombocytopenia (ITP) drug candidates.
HMPL-523 (sovleplenib) is an investigational, selective oral small-molecule inhibitor targeting spleen tyrosine kinase (Syk), a key component in B-cell receptor signaling. Sponsored by Hutchison Medipharma Limited, this Phase III study is actively evaluating the safety and efficacy of HMPL-523 in adults with chronic immune thrombocytopenic purpura (ITP). The study is examining whether HMPL-523 can effectively increase platelet counts and reduce bleeding risk while maintaining a favorable safety profile.
NVG-2089, sponsored by Nuvig Therapeutics, Inc., is currently recruiting for a Phase 2 study to evaluate its safety, tolerability, and efficacy in participants with immune thrombocytopenia (ITP). NVG-2089 is a recombinant human IgG1-Fc fusion protein designed to mimic the key immunomodulatory effects of intravenous immunoglobulin (IVIg) while overcoming its limitations. The drug selectively activates anti-inflammatory pathways, modulates immune responses, and helps increase platelet counts. The study is examining how NVG-2089 reduces inflammation, supports immune regulation, and provides a scalable, consistent, and patient-friendly alternative to plasma-derived therapies.
CID-103 is a fully human IgG1 anti-CD38 monoclonal antibody being developed by CASI Pharmaceuticals. This Phase 1/2 study is recruiting adults with chronic immune thrombocytopenia (ITP) and is aiming to evaluate the safety, tolerability, and efficacy of CID-103. The study is examining escalating doses in Part A to determine safe and tolerable ranges, followed by Part B, which is identifying the optimal dose and regimen through multi-dose comparison. Administered via intravenous infusion, CID-103 is demonstrating promising preclinical safety and efficacy, potentially offering a novel treatment option for patients not responding to existing therapies.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Immune Thrombocytopenia (ITP) Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for immune thrombocytopenia (ITP). It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into immune thrombocytopenia (ITP) collaborations, regulatory environments, and potential growth opportunities.
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