Chronic Myelocytic Leukemia (CML) - Pipeline Insight, 2025: Advancing Beyond TKIs with Novel Therapeutic Strategies | DelveInsight

DelveInsight's "Chronic Myelocytic Leukemia (CML) - Pipeline Insight, 2025" offers a deep dive into the current and emerging treatment landscape of this hematologic malignancy, which arises from the BCR-ABL1 fusion gene and predominantly progresses through a chronic, accelerated, and blast phase. While Tyrosine Kinase Inhibitors (TKIs) like imatinib revolutionized CML care and transformed it into a manageable chronic condition, newer therapies are aiming to overcome resistance, minimize long-term toxicity, and achieve treatment-free remission (TFR).

The pipeline for CML is maturing with next-generation TKIs that are more potent, selective, and better tolerated. These include agents targeting specific mutations like T315I, which confer resistance to earlier TKIs. In addition, therapeutic innovation is now branching into combination regimens, immunomodulatory agents, allosteric inhibitors, and BCR-ABL1 degraders to deepen molecular responses and suppress leukemic stem cells.

There's a growing emphasis on personalized medicine, supported by minimal residual disease (MRD) monitoring and mutation profiling, enabling dynamic treatment adaptation. Furthermore, investigational therapies are being assessed in earlier lines of therapy and in patients aiming for TFR - a paradigm shift that moves beyond disease control toward potential operational cure.

Clinical trials in CML are increasingly exploring novel endpoints such as sustained MR4.5 responses, time to TFR, and quality-of-life improvements, reflecting evolving treatment goals. The continued pipeline expansion, regulatory support, and real-world evidence integration are paving the way for a new era of precision CML therapy, where durability, safety, and remission sustainability will redefine treatment success.

Interested in learning more about the current treatment landscape and the key drivers shaping the chronic myelocytic leukemia pipeline? Click here: https://www.delveinsight.com/report-store/chronic-myelocytic-leukemia-cml-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Chronic Myelocytic Leukemia Pipeline Report
• DelveInsight's chronic myelocytic leukemia pipeline analysis depicts a strong space with 25+ active players working to develop 25+ pipeline drugs for chronic myelocytic leukemia treatment.
• The leading chronic myelocytic leukemia companies include Novartis Oncology, Servier, Eltrombopag, Immune-Onc Therapeutics, H3 Biomedicine, Chroma Therapeutics, Nerviano Medical Sciences, Astex Pharmaceuticals, Takeda Oncology, Argenx, Kura Oncology, Incyte Corporation, Genentech, Inc., Sensei Biotherapeutics, Pfizer, BioLite, Inc., Newave Pharmaceutical Inc, Ellipses Pharma, Eli Lilly and Company, Aprea Therapeutics, Treadwell Therapeutics, Prelude Therapeutics, Onconova Therapeutics, Immune Pharmaceuticals, Teva Pharmaceutical Industries, and others are evaluating their lead assets to improve the chronic myelocytic leukemia treatment landscape.
• Key chronic myelocytic leukemia pipeline therapies in various stages of development include Sabatolimab, Enasidenib, IO 202, H3B 8800, Tefinostat, NMS 03592088, Guadecitabine, Pevonedistat, Cusatuzumab, Tipifarnib, Ruxolitinib, Venetoclax, SNS-301, Cobimetinib, Glasdegib, BLEX 404, LP-108, Canakinumab, EP0042, LY3410738, APR-246, CFI-400945, PRT543, Rigosertib, Histamine dihydrochloride injection, Arsenic trioxide, and others.
• In March 2025, Zydus Lifesciences' stock rose by 3.33% to Rs 917.10 after receiving final approval from the US FDA to manufacture generic Dasatinib Tablets in multiple strengths. The generic version of Sprycel Tablets is used to treat Philadelphia chromosome-positive chronic myeloid leukemia (CML) in newly diagnosed adults and those with resistance or intolerance to prior therapies, including imatinib.
• In February 2025, Cipla received final US FDA approval for its Nilotinib Capsules (50 mg, 150 mg, 200 mg) to treat Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML). The product is expected to launch in FY2025-26 in the US.
• In November 2024, Marks Shorla Oncology announced that the FDA approved imatinib (Imkeldi), making it the first oral, liquid tyrosine kinase inhibitor (TKI) approved for treating various cancers, including gastrointestinal tumors (GIST), myelodysplastic syndromes (MDS), myeloproliferative disease (MPD), chronic myeloid leukemia (CML), and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

Request a sample and discover the recent breakthroughs happening in the chronic myelocytic leukemia pipeline landscape at https://www.delveinsight.com/report-store/chronic-myelocytic-leukemia-cml-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Chronic Myelocytic Leukemia Overview
Chronic Myelocytic Leukemia (CML), also known as Chronic Myeloid Leukemia, is a type of cancer that originates in the bone marrow and leads to the uncontrolled growth of myeloid cells. It is characterized by the presence of the Philadelphia chromosome, a genetic abnormality that results in the formation of the BCR-ABL1 fusion gene. This gene produces an abnormal tyrosine kinase protein that drives the proliferation of leukemic cells.

CML typically progresses through three phases: chronic, accelerated, and blast crisis. Most patients are diagnosed during the chronic phase when symptoms are mild or absent. Common symptoms may include fatigue, night sweats, weight loss, and splenomegaly. Tyrosine kinase inhibitors (TKIs), such as imatinib, dasatinib, and nilotinib, have significantly improved the prognosis for CML patients, often allowing for long-term disease control and a near-normal life expectancy.

Find out more about chronic myelocytic leukemia medication at https://www.delveinsight.com/report-store/chronic-myelocytic-leukemia-cml-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Chronic Myelocytic Leukemia Treatment Analysis: Drug Profile
Sabatolimab: Novartis Oncology
Sabatolimab (MBG453) is an investigational monoclonal antibody targeting TIM-3 (T-cell immunoglobulin and mucin-domain containing-3), under development by Novartis Oncology. It is currently in Phase III clinical trials for the treatment of Chronic Myelocytic Leukemia (CML).

Enasidenib: Servier
Enasidenib (AG-221) is an oral small-molecule inhibitor of the IDH2 enzyme, developed by Servier. It is being evaluated in Phase I clinical trials for the treatment of Chronic Myelocytic Leukemia (CML).

Learn more about the novel and emerging chronic myelocytic leukemia pipeline therapies at https://www.delveinsight.com/report-store/chronic-myelocytic-leukemia-cml-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Chronic Myelocytic Leukemia Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Parenteral
• Intravitreal
• Subretinal
• Topical

By Molecule Type
• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Scope of the Chronic Myelocytic Leukemia Pipeline Report
• Coverage: Global
• Key Chronic Myelocytic Leukemia Companies: Novartis Oncology, Servier, Eltrombopag, Immune-Onc Therapeutics, H3 Biomedicine, Chroma Therapeutics, Nerviano Medical Sciences, Astex Pharmaceuticals, Takeda Oncology, Argenx, Kura Oncology, Incyte Corporation, Genentech, Inc., Sensei Biotherapeutics, Pfizer, BioLite, Inc., Newave Pharmaceutical Inc, Ellipses Pharma, Eli Lilly and Company, Aprea Therapeutics, Treadwell Therapeutics, Prelude Therapeutics, Onconova Therapeutics, Immune Pharmaceuticals, Teva Pharmaceutical Industries, and others.
• Key Chronic Myelocytic Leukemia Pipeline Therapies: Sabatolimab, Enasidenib, IO 202, H3B 8800, Tefinostat, NMS 03592088, Guadecitabine, Pevonedistat, Cusatuzumab, Tipifarnib, Ruxolitinib, Venetoclax, SNS-301, Cobimetinib, Glasdegib, BLEX 404, LP-108, Canakinumab, EP0042, LY3410738, APR-246, CFI-400945, PRT543, Rigosertib, Histamine dihydrochloride injection, Arsenic trioxide, and others.

To dive deep into rich insights for drugs used for chronic myelocytic leukemia treatment, visit: https://www.delveinsight.com/report-store/chronic-myelocytic-leukemia-cml-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Chronic Myelocytic Leukemia Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Chronic Myelocytic Leukemia Pipeline Therapeutics
6. Chronic Myelocytic Leukemia Pipeline: Late-Stage Products (Phase III)
7. Chronic Myelocytic Leukemia Pipeline: Mid-Stage Products (Phase II)
8. Chronic Myelocytic Leukemia Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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This release was published on openPR.