New York, USA, Jan. 30, 2023 (GLOBE NEWSWIRE) -- Thrombocytopenia Pipeline Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 27+ Companies Working in the Domain
The prevalence of thrombocytopenia has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of Thrombocytopenia and the growing research and development activities to develop novel therapies to treat Thrombocytopenia to drive the market. The companies developing the potential therapies in the last stage of development include argenx, HUTCHMED, Takeda, and several others.
DelveInsight’s 'Thrombocytopenia Pipeline Insight – 2023' report provides comprehensive global coverage of available, marketed, and pipeline thrombocytopenia therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the thrombocytopenia pipeline domain.
Key Takeaways from the Thrombocytopenia Pipeline Report
- DelveInsight’s thrombocytopenia pipeline report depicts a robust space with 27+ active players working to develop 30+ pipeline therapies for thrombocytopenia treatment.
- Key thrombocytopenia companies such as Takeda, argenx, Keros Therapeutics, Sanofi, Veralox Therapeutics, Novartis Pharmaceuticals, Pfizer, HUTCHMED, Principia Biopharma, Genosco, UCB, Qilu Pharmaceutical, Jiangsu HengRui Medicine Co., Ltd., InnoCare Pharma, eXIthera Pharmaceuticals, Harbour BioMed (Guangzhou) Co. Ltd., CTI BioPharma, AO GENERIUM, Chugai Pharmaceutical, Takeda, PhytoHealth Corporation, Inmunova S.A., Biotest Pharmaceuticals, COUR Pharmaceuticals, HanAll Biopharma, and others are evaluating new drugs for thrombocytopenia to improve the treatment landscape.
- Promising thrombocytopenia pipeline therapies in various stages of development include Mezagitamab, Efgartigimod alfa, KER 050, Rilzabrutinib, VLX 1005, Iptacopan, PF 06755347, Sovleplenib, PF 06835375, Cevidoplenib, Rozanolixizumab, QL0911, Hetrombopag, Ianalumab, Orelabrutinib, EP-7041, HBM9161, PACIFICA, GNR-069, Crovalimab, TAK 755, PHN013, INM004, BT-595, CNP-105, HL161, and others.
- In January 2023, Takeda announced that the totality of evidence from a pre-planned interim analysis of a pivotal Phase III study supports the efficacy and safety of TAK-755 as enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP).The interim results showed that TAK-755 reduced the incidence of thrombocytopenia events by 60% (95% Confidence Interval, 30%-70%), an important marker of disease activity in cTTP, as compared to SoC. The proportion of subjects experiencing adverse events determined to be related to the treatment was substantially lower among subjects during treatment with TAK-755 (8.9%) compared to that while receiving SoC therapy (47.7%).
- In January 2023, HUTCHMED (China) Limited (“HUTCHMED”) announced that it had completed patient enrollment of ESLIM-01, a pivotal Phase III clinical trial of sovleplenib for the treatment of adult patients with primary immune thrombocytopenia (“ITP”) in China. The last patient was enrolled on December 31, 2022.The ESLIM-01 study, initiated in October 2021, is a randomized, double-blinded, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of sovleplenib in treating adult patients with ITP. The primary endpoint of the study is the durable response rate. Secondary and exploratory endpoints include overall response rate (ORR), the incidence of treatment-emergent adverse events, and patient quality of life improvement. A total of 188 patients were enrolled.
- In April 2022, Biotest AG announced that the marketing authorisation application for the Biotest development product IgG Next Generation in the so-called decentralized procedure (DCP) was submitted in Germany and Austria by 31 March 2022. IgG Next Generation is the first product to be produced in Biotest's new manufacturing facility Biotest Next Level (BNL).The marketing authorization application covers the biochemical-pharmaceutical-technical part, as well as the preclinical and clinical studies in the indications Primary Immunodeficiency Diseases (PID) and chronic Primary Immune Thrombocytopenia (ITP).
- In April 2022, Positive results from the Phase I/II dose-finding study evaluating the safety, pharmacokinetics, and clinical activity of rilzabrutinib, an investigational oral Bruton’s tyrosine kinase (BTK) inhibitor, in adults with heavily pre-treated immune thrombocytopenia (ITP) were published in the New England Journal of Medicine. Results demonstrated treatment with rilzabrutinib led to a rapid and durable increase in platelet count and supported an acceptable safety profile. Sanofi is investigating the safety and efficacy of twice daily rilzabrutinib (400 mg) for adults and adolescents with chronic ITP in the ongoing Phase 3 clinical study LUNA 3, initiated in April 2021.
- In May 2022, argenx SE announced positive data from the Phase III ADVANCE trial of VYVGART® (efgartigimod alfa-fcab) in adults with primary ITP. ADVANCE met its primary endpoint, demonstrating that a higher proportion of chronic ITP patients receiving VYVGART achieved a sustained platelet count response compared to placebo. ADVANCE is the first Phase 3 clinical trial of a neonatal Fc receptor (FcRn) blocker in ITP.
- In January 2022, HUTCHMED (China) Limited announced that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to HMPL-523, a novel, investigational spleen tyrosine kinase (“Syk”) inhibitor, for the treatment of chronic adult primary immune thrombocytopenia (“ITP”) patients who have received at least one prior therapy.
Request a sample and discover the recent advances in thrombocytopenia treatment drugs @ Thrombocytopenia Pipeline Report
The thrombocytopenia pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage thrombocytopenia drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the thrombocytopenia clinical trial landscape.
Thrombocytopenia Overview
Thrombocytopenia is the medical term for a platelet count that is less than 150000/microliter (for adults), the lower limit of normal. The hazards of thrombocytopenia range from no danger at all to bleeding risks and thrombosis. Platelets are blood cells that aid in blood clotting and wound healing. Uncertainty exists regarding the relationship between bleeding risk and thrombocytopenia severity. Platelet counts below 10,000/microliter can cause spontaneous bleeding, and numbers below 50,000/microL can cause surgical bleeding. Heparin-induced thrombocytopenia (HIT), antiphospholipid antibody syndrome (APS), disseminated intravascular coagulation (DIC), thrombotic microangiopathy (TMA), and paroxysmal nocturnal hemoglobinuria are a few situations where thrombocytopenia is linked to a risk of thrombosis (PNH). According to a prospective study, patients with mild thrombocytopenia (100000 to 150000/microliter) have a 10-year likelihood of acquiring autoimmune diseases, according to a prospective study.
Find out more about thrombocytopenia treatment drugs @ Drugs for Thrombocytopenia Treatment
A snapshot of the Thrombocytopenia Pipeline Drugs mentioned in the report:
| Drugs | Company | Phase | MoA | RoA |
| Efgartigimod alfa | argenx | Phase III | Neonatal Fc receptor antagonists | Intravenous |
| Sovleplenib | HUTCHMED | Phase III | Syk kinase inhibitors | Oral |
| Cevidoplenib | Genosco | Phase II | Syk kinase inhibitors | Oral |
| Mezagitamab | Takeda | Phase II | Antibody-dependent cell cytotoxicity; T lymphocyte stimulants | Subcutaneous |
| KER 050 | Keros Therapeutics | Phase II | Erythropoiesis stimulants; Transforming growth factor beta inhibitors | Subcutaneous |
| VLX 1005 | Veralox Therapeutics | Phase I | 12-lipoxygenase inhibitors; Platelet aggregation inhibitors | Intravenous |
| PF 06755347 | Pfizer | Phase I | Immunomodulators | Intravenous |
Learn more about the emerging thrombocytopenia pipeline therapies @ Thrombocytopenia Clinical Trials
Thrombocytopenia Therapeutics Assessment
The thrombocytopenia pipeline report proffers an integral view of thrombocytopenia emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration.
Scope of the Thrombocytopenia Pipeline Report
- Coverage: Global
- Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
- Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
- Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous
- Therapeutics Assessment By Molecule Type: Small molecule, Cell Therapy, Peptides, Polymer, Small molecule, Gene therapy
- Therapeutics Assessment By Mechanism of Action: Neonatal Fc receptor antagonists, Syk kinase inhibitors, Antibody-dependent cell cytotoxicity, T lymphocyte stimulants, Erythropoiesis stimulants, Transforming growth factor beta inhibitors, 12-lipoxygenase inhibitors, Platelet aggregation inhibitors, Immunomodulators
- Key Thrombocytopenia Companies: Takeda, argenx, Keros Therapeutics, Sanofi, Veralox Therapeutics, Novartis Pharmaceuticals, Pfizer, HUTCHMED, Principia Biopharma, Genosco, UCB, Qilu Pharmaceutical, Jiangsu HengRui Medicine Co., Ltd., InnoCare Pharma, eXIthera Pharmaceuticals, Harbour BioMed (Guangzhou) Co. Ltd., CTI BioPharma, AO GENERIUM, Chugai Pharmaceutical, Takeda, PhytoHealth Corporation, Inmunova S.A., Biotest Pharmaceuticals, COUR Pharmaceuticals, HanAll Biopharma and others.
- Key Thrombocytopenia Pipeline Therapies: Mezagitamab, Efgartigimod alfa, KER 050, Rilzabrutinib, VLX 1005, Iptacopan, PF 06755347, Sovleplenib, PF 06835375, Cevidoplenib, Rozanolixizumab, QL0911, Hetrombopag, Ianalumab, Orelabrutinib, EP-7041, HBM9161, PACIFICA, GNR-069, Crovalimab, TAK 755, PHN013, INM004, BT-595, CNP-105, HL161, and others.
Dive deep into rich insights for new drugs for thrombocytopenia treatment; visit @ Thrombocytopenia Drugs
Table of Contents
| 1. | Thrombocytopenia Pipeline Report Introduction |
| 2. | Thrombocytopenia Pipeline Report Executive Summary |
| 3. | Thrombocytopenia Pipeline: Overview |
| 4. | Analytical Perspective In-depth Commercial Assessment |
| 5. | Thrombocytopenia Clinical Trial Therapeutics |
| 6. | Thrombocytopenia Pipeline: Late Stage Products (Pre-registration) |
| 7. | Thrombocytopenia Pipeline: Late Stage Products (Phase III) |
| 7.1. | Efgartigimod alfa: argenx |
| 8. | Thrombocytopenia Pipeline: Mid Stage Products (Phase II) |
| 8.1. | Cevidoplenib: Genosco |
| 9. | Thrombocytopenia Pipeline: Early Stage Products (Phase I) |
| 9.1. | VLX 1005: Veralox Therapeutics |
| 10. | Thrombocytopenia Pipeline Therapeutics Assessment |
| 11. | Inactive Products in the Thrombocytopenia Pipeline |
| 12. | Company-University Collaborations (Licensing/Partnering) Analysis |
| 13. | Key Companies |
| 14. | Key Products in the Thrombocytopenia Pipeline |
| 15. | Unmet Needs |
| 16. | Market Drivers and Barriers |
| 17. | Future Perspectives and Conclusion |
| 18. | Analyst Views |
| 19. | Appendix |
For further information on the thrombocytopenia pipeline therapeutics, reach out @ Thrombocytopenia Medications
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