Myelofibrosis Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies by DelveInsight

DelveInsight's, "Myelofibrosis Pipeline Insight" report provides comprehensive insights about 35+ companies and 40+ pipeline drugs in Myelofibrosis pipeline landscape. It covers the Myelofibrosis pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Myelofibrosis therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

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Key Takeaways from the Myelofibrosis Pipeline Report

* In January 2025:- Sumitomo Pharma America Inc.:- This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.
* In January 2025:- Keros Therapeutics Inc.:- KER-050 is an investigational therapeutic protein designed to increase red blood cell and platelet production by inhibiting the signaling of a subset of the transforming growth factor beta (TGF-Ss) family of proteins to promote hematopoiesis. It is being developed for the treatment of low blood cell counts, or cytopenias including anemia and thrombocytopenia in patients with Myelodysplastic Syndrome (MDS) and Myelofibrosis (MF)
* In January 2025:- Geron Corporation :- The purpose of the study is to evaluate the overall survival of participants treated with imetelstat compared to best available therapy with intermediate-2 or high-risk Myelofibrosis (MF) who are relapsed/refractory (R/R) to Janus Kinase (JAK)-Inhibitor treatment.
* In January 2025:- Karyopharm Therapeutics Inc.:- This is a global, multicenter, 2-part study to evaluate the efficacy and safety of selinexor plus ruxolitinib in JAK inhibitor (JAKi) treatment-naive myelofibrosis (MF) participants. The study will be conducted in two phases: Phase 1 (open-label) and Phase 3 (double-blind). Phase 1 (enrollment completed) was an open-label evaluation of the safety and recommended Phase 2 dose (RP2D) of selinexor in combination with ruxolitinib and included a dose escalation using a standard 3+3 design (Phase 1a) and a dose expansion part (Phase 1b).
* In January 2025:- Ryvu Therapeutics SA:- The objective of this clinical trial is to evaluate the efficacy (how well the drug works), safety, pharmacokinetics (PK), and pharmacodynamics (PD) of the study drug, RVU120, in treating adult patients with intermediate or high-risk, primary or secondary myelofibrosis. RVU120 will be given as a single agent or in combination with ruxolitinib.
* DelveInsight's Myelofibrosis pipeline report depicts a robust space with 35+ active players working to develop 40+ pipeline therapies for Myelofibrosis treatment.
* The leading Myelofibrosis Companies such as Geron Corporation, Merck, Telios Pharma Inc., Ryvu Therapeutics SA, Taiga Biotechnologies, Inc., Morphic Therapeutic, iOnctura, Pharmaxis, Nippon Shinyaku, Active Biotech, Incyte Corporation, Sumitomo Pharma America, Inc., and others.
* Promising Myelofibrosis Therapies such as Momelotinib, Luspatercept, Bomedemstat, Pacritinib, RVU120, Ruxolitinib , and others.

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Myelofibrosis Emerging Drugs Profile

* Imetelstat: Geron Corporation

Imetelstat sodium (imetelstat) is a small oligonucleotide composed of a nucleic acid and a lipid moiety. The proprietary nucleic acid backbone provides resistance to degradation, thus conferring improved stability in plasma and tissues, as well as significantly improved binding affinity to its target. The lipid group enhances cell permeability, which results in increased potency and improved pharmacokinetic and pharmacodynamic properties.

* Bomedemstat: Merck

Bomedemstat is an irreversible inhibitor of lysine-specific demethylase 1 (LSD1), an enzyme critical for regulating the proliferation of hematopoietic stem cells and the maturation of progenitors. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Myelofibrosis.

* TL-895: Telios Pharma, Inc.

It is an orally bioavailable inhibitor of tyrosine kinase, with potential anti-inflammatory and antineoplastic activities. Upon oral administration, tyrosine kinase inhibitor TL-895 targets, binds to, and inhibits tyrosine kinase. This may result in the inhibition of tumor angiogenesis and cell proliferation, and the inhibition of immune-mediated inflammatory processes. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Myelofibrosis.

* RVU120: Ryvu Therapeutics SA

RVU120 is a selective, first-in-class dual CDK8/19 kinase inhibitor developed by Ryvu Therapeutics. RVU120's mechanism of action (MoA) involves targeting CDK8/19 kinases. Specifically, translational data confirm the proposed MoA in a molecularly-defined subset of patients with DNMT3A and NPM1 mutations. Currently, the drug is in the Phase II stage of development to treat Myelofibrosis.

* TBX-2400: Taiga Biotechnologies, Inc.

TBX-2400 is an allogeneic stem cell therapy developed by Taiga Biotechnologies that aims to improve the rate of engraftment and reconstitution of the immune system for patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Currently, the drug is in the Phase I stage of development to treat Myelofibrosis.

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Myelofibrosis Companies

Geron Corporation, Merck, Telios Pharma Inc., Ryvu Therapeutics SA, Taiga Biotechnologies, Inc., Morphic Therapeutic, iOnctura, Pharmaxis, Nippon Shinyaku, Active Biotech, Incyte Corporation, Sumitomo Pharma America, Inc., and others.

Myelofibrosis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

Myelofibrosis Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

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Scope of the Myelofibrosis Pipeline Report

* Coverage- Global
* Myelofibrosis Companies- Geron Corporation, Merck, Telios Pharma Inc., Ryvu Therapeutics SA, Taiga Biotechnologies, Inc., Morphic Therapeutic, iOnctura, Pharmaxis, Nippon Shinyaku, Active Biotech, Incyte Corporation, Sumitomo Pharma America, Inc., and others.
* Myelofibrosis Therapies- Momelotinib, Luspatercept, Bomedemstat, Pacritinib, RVU120, Ruxolitinib, and others.
* Myelofibrosis Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Myelofibrosis Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* Myelofibrosis: Overview
* Myelofibrosis Pipeline Therapeutics
* Myelofibrosis Therapeutic Assessment
* Myelofibrosis - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Imetelstat: Geron Corporation
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* RVU120: Ryvu Therapeutics SA
* Drug profiles in the detailed report.....
* TBX-2400: Taiga Biotechnologies, Inc.
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Myelofibrosis Key Companies
* Myelofibrosis Key Products
* Myelofibrosis- Unmet Needs
* Myelofibrosis- Market Drivers and Barriers
* Myelofibrosis- Future Perspectives and Conclusion
* Myelofibrosis Analyst Views
* Appendix

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