Myelofibrosis Clinical Trials Outlook 2025: Competitive Landscape, Regulatory Milestones, Therapies in Development, Mechanisms of Action, and Routes of Administration - By DelveInsight

(Albany, USA) DelveInsight's, "Myelofibrosis Pipeline Insight 2025" report provides comprehensive insights about 35+ companies and 40+ pipeline drugs in Myelofibrosis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

The Myelofibrosis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The myelofibrosis disease pipeline drugs assessment report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

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Key Takeaways from the Myelofibrosis Pipeline Report
• In September 2025, Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that it has completed enrollment in the Phase 3 SENTRY trial, which is evaluating selinexor in combination with ruxolitinib in JAKi-naïve myelofibrosis patients.
• In July 2025, Incyte announced that the Phase I data in patients with myelofibrosis as monotherapy and in combination with ruxolitinib are anticipated in the second half of 2025.
• In June 2025, QIAGEN and Incyte announced a new global collaboration to develop a novel diagnostic panel to support Incyte's extensive portfolio of investigational therapies for patients with myeloproliferative neoplasms (MPNs), including Incyte's monoclonal antibody INCA033989.
• 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-naïve 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.
• In January 2025:- AbbVie:- A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Navitoclax in Combination With Ruxolitinib Versus Best Available Therapy in Subjects With Relapsed/Refractory Myelofibrosis (TRANSFORM-2)
• In January 2025:- Celgene:- The purpose of this Phase 3 study is to evaluate the efficacy and safety of Luspatercept compared with placebo in subjects with myeloproliferative neoplasm (MPN)-associated Myelofibrosis (MF) and anemia on concomitant Janus kinase 2 (JAK2) inhibitor therapy and who require red blood cell count (RBC) transfusions.
• In January 2025:- Stemline Therapeutics Inc.:- This multicenter, multi-arm trial evaluated the safety and efficacy of tagraxofusp, a cell division cycle protein 123 homolog-targeted therapy, in participants with either CMML or MF. There were 2 CMML cohorts, 1 enrolled participant with CMML (CMML-1 or CMML-2) who were refractory/resistant or intolerant to hypomethylating agents (HMA), hydroxyurea (HU), or intensive chemotherapy and 1 enrolled treatment-naive participants with CMML (CMML-1 or CMML-2) with molecular features associated with poor prognosis.
• 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 Incyte Corporation, Keros Therapeutics, Karyopharm Therapeutics, Celgene Corporation, PharmaEssentia, Novartis, SecuraBio, Pharmaxis, Novartis Oncology, AstraZeneca, Cellenkos, Jacobio Pharmaceuticals, Ohmoncology, Geron Corporation, AbbVie, Sierra Oncology, Galecto Biotech, Actuate Therapeutics, Kartos Therapeutics, Menarini Group, Telios Pharma, Novartis Pharmaceuticals, NS Pharma, Celgene/Bristol-Myers Squibb, MorphoSys, Imago BioSciences, Roche, and others.
• Myelofibrosis pipeline includes drugs such as BESREMi (PharmaEssentia and AOP Orphan Pharmaceuticals), INCB057643 (Incyte), XPOVIO (Karyopharm Therapeutics), RYTELO (Geron), REBLOZYL (Bristol Myers Squibb and Merck), Navtemadlin (Kartos Therapeutics), Pelabresib (Novartis), Bomedemstat (Merck), TL-895 (Telios Pharma), RVU120 (Ryvu Therapeutics), TP-3654 (Sumitomo Pharma), SNT-5505 (Syntara), DISC-0974 (Disc Medicine), and ELZONRIS (Menarini Group), among others

Stay informed about the cutting-edge advancements in Myelofibrosis treatments. Download for updates and be a part of the revolution in care @ Myelofibrosis Clinical Trials Assessment- https://www.delveinsight.com/sample-request/myelofibrosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Myelofibrosis disease pipeline drugs assessment
• 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. The compound has a long residence time in bone marrow, spleen, and liver. Imetelstat binds with high affinity to the template region of the RNA component of telomerase, resulting in direct, competitive inhibition of telomerase enzymatic activity rather than eliciting its effect through an antisense inhibition of protein translation. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Myelofibrosis.

• 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.

Learn more about Myelofibrosis Drugs opportunities in our groundbreaking Myelofibrosis Research and development projects @ Myelofibrosis Unmet Needs- https://www.delveinsight.com/sample-request/myelofibrosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Myelofibrosis Companies
Incyte Corporation, Keros Therapeutics, Karyopharm Therapeutics, Celgene Corporation, PharmaEssentia, Novartis, SecuraBio, Pharmaxis, Novartis Oncology, AstraZeneca, Cellenkos, Jacobio Pharmaceuticals, Ohmoncology, Geron Corporation, AbbVie, Sierra Oncology, Galecto Biotech, Actuate Therapeutics, Kartos Therapeutics, Menarini Group, Telios Pharma, Novartis Pharmaceuticals, NS Pharma, Celgene/Bristol-Myers Squibb, MorphoSys, Imago BioSciences, Roche, 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

Discover the latest advancements in Myelofibrosis treatment by visiting our website. Stay informed about how we're transforming the future of disease @ Myelofibrosis Disease Pipeline Drugs Assessment - https://www.delveinsight.com/sample-request/myelofibrosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

Scope of the Myelofibrosis Pipeline Report
• Coverage- Global
• Myelofibrosis Companies- Incyte Corporation, Keros Therapeutics, Karyopharm Therapeutics, Celgene Corporation, PharmaEssentia, Novartis, SecuraBio, Pharmaxis, Novartis Oncology, AstraZeneca, Cellenkos, Jacobio Pharmaceuticals, Ohmoncology, Geron Corporation, AbbVie, Sierra Oncology, Galecto Biotech, Actuate Therapeutics, Kartos Therapeutics, Menarini Group, Telios Pharma, Novartis Pharmaceuticals, NS Pharma, Celgene/Bristol-Myers Squibb, MorphoSys, Imago BioSciences, Roche, and others.
• Myelofibrosis Therapies- BESREMi (PharmaEssentia and AOP Orphan Pharmaceuticals), INCB057643 (Incyte), XPOVIO (Karyopharm Therapeutics), RYTELO (Geron), REBLOZYL (Bristol Myers Squibb and Merck), Navtemadlin (Kartos Therapeutics), Pelabresib (Novartis), Bomedemstat (Merck), TL-895 (Telios Pharma), RVU120 (Ryvu Therapeutics), TP-3654 (Sumitomo Pharma), SNT-5505 (Syntara), DISC-0974 (Disc Medicine), and ELZONRIS (Menarini Group), among 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

For a detailed overview of our latest research findings and future plans, read the full details of Myelofibrosis Pipeline on our website @ Myelofibrosis Emerging Drugs and Companies- https://www.delveinsight.com/sample-request/myelofibrosis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

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Ankit Nigam
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About DelveInsight
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