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Chronic Myeloid Leukemia (CML) Pipeline Insights

DelveInsight’s “Chronic Myeloid Leukemia (CML) – Pipeline Insight, 2026” report provides comprehensive insights about 20+ companies developing over 25 pipeline drugs in the Chronic Myeloid Leukemia pipeline landscape. It covers the CML pipeline drug profiles, including clinical and nonclinical stage products, along with therapeutics assessment by product type, stage, route of administration, and molecule type, and further highlights inactive pipeline products in this space.

Explore the latest breakthroughs in the Chronic Myeloid Leukemia treatment landscape. Learn more about the evolving CML pipeline today @ https://www.delveinsight.com/sample-request/chronic-myeloid-leukemia-pipeline-insight?utm_source=abnewswire&utm_medium=pressrelease&utm_campaign=xpr

Key Takeaways from the Chronic Myeloid Leukemia Pipeline Report

• On April 27, 2026, the US FDA granted Breakthrough Therapy Designation to TERN-701, a novel oral allosteric BCR::ABL1 inhibitor, for the treatment of adult patients with Ph+ CML in chronic phase.

• In October 2024, the FDA granted accelerated approval to asciminib (Scemblix) for newly diagnosed Philadelphia chromosome-positive CML in the chronic phase.

• In June 2024, a clinical trial was completed evaluating asciminib monotherapy for chronic phase CML with and without the T315I mutation.

• In September 2023, the FDA approved bosutinib for use in children aged 1 year and older with chronic phase Philadelphia chromosome-positive CML.

• Chronic myeloid leukemia (CML) is a slow-growing cancer of the bone marrow driven by a genetic mutation that creates the abnormal BCR-ABL gene.

• CML prevalence in the United States is expected to triple by 2040, reaching an estimated 150,000 cases in 2025.

• DelveInsight’s report tracks over 20 active players advancing 25+ pipeline therapies across multiple stages, from discovery through Phase III.

• The leading Chronic Myeloid Leukemia companies include Renascience, Novartis Pharmaceuticals, Terns Pharmaceuticals, Enliven Therapeutics, MacroGenics, Kartos Therapeutics, AOP Orphan Pharmaceuticals, and others.

• Promising CML therapies in development include RS-5614, ABL001, TERN-701, ELVN-001, MGD024, and Navtemadlin (KRT-232).

Download for updates and the latest revolution in CML care @ Chronic Myeloid Leukemia Market Insight, Epidemiology And Market Forecast

Chronic Myeloid Leukemia Emerging Drugs Profile

RS-5614: Renascience

RS-5614 is an oral PAI-1 inhibitor currently in Phase III clinical trials for the treatment of Chronic Myeloid Leukemia. It has demonstrated high safety in clinical subjects and represents a late-stage candidate aimed at improving CML management.

ABL001: Novartis Pharmaceuticals

ABL001 (asciminib) is a Phase II allosteric inhibitor designed to overcome treatment resistance by targeting the myristoyl pocket of the BCR-ABL1 protein. This novel mechanism of action differs from traditional active-site tyrosine kinase inhibitors (TKIs) and is currently being evaluated in various clinical settings.

TERN-701: Terns Pharmaceuticals

TERN-701 is a highly selective, oral, allosteric BCR::ABL1 inhibitor designed to deliver improved efficacy, safety, and convenience for CML patients. Early data from the Phase 1 CARDINAL trial showed compelling molecular responses and an encouraging safety profile with no dose-limiting toxicities. Currently, TERN-701 is in Phase I development for the treatment of Chronic Myeloid Leukemia.

For more information on the Chronic Myeloid Leukemia Emerging Drugs Profile, download DelveInsight’s comprehensive Chronic Myeloid Leukemia Pipeline Insight report.

The Chronic Myeloid Leukemia Pipeline Report Provides

• Detailed insights about companies developing therapies for Chronic Myeloid Leukemia, with aggregate therapies developed by each company.

• Different therapeutic candidates, segmented into early-stage, mid-stage, and late-stage of development for CML treatment.

• CML companies that are involved in targeted therapeutics development with respective active and inactive projects.

• CML drugs under development based on stage of development, route of administration, mechanism of action, and molecular type.

• Detailed analysis of collaborations, licensing agreements, and financing details for future advancement of the Chronic Myeloid Leukemia market.

Learn more about Chronic Myeloid Leukemia drug opportunities in our comprehensive CML pipeline report @ Chronic Myeloid Leukemia Unmet Needs

Chronic Myeloid Leukemia Companies and Competitive Landscape

There are 20+ key companies, including Renascience, Novartis Pharmaceuticals, Terns Pharmaceuticals, Enliven Therapeutics, MacroGenics, Kartos Therapeutics, AOP Orphan Pharmaceuticals, and others, developing therapies for Chronic Myeloid Leukemia, with Renascience having its CML drug candidate in the advanced Phase III stage.

DelveInsight’s Chronic Myeloid Leukemia pipeline report provides the therapeutic assessment of the pipeline drugs by Route of Administration. Products have been categorized under various ROAs such as:

• Oral

• Intravenous

• Subcutaneous

• Parenteral

• Topical

Chronic Myeloid Leukemia 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 Chronic Myeloid Leukemia treatment by visiting our website. Stay informed @ Chronic Myeloid Leukemia Market Drivers and Barriers, and Future Perspectives

Scope of the Chronic Myeloid Leukemia Pipeline Report

• Coverage: Global

• Chronic Myeloid Leukemia Companies: Renascience, Novartis Pharmaceuticals, Terns Pharmaceuticals, Enliven Therapeutics, MacroGenics, and others.

• Chronic Myeloid Leukemia Therapies: RS-5614, ABL001, TERN-701, ELVN-001, MGD024, and others.

• Chronic Myeloid Leukemia Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination.

• Chronic Myeloid Leukemia Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III.

Table of Contents

1. Introduction

2. Executive Summary

3. Chronic Myeloid Leukemia: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. Chronic Myeloid Leukemia – DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III)

8. Mid Stage Products (Phase II)

9. Early Stage Products (Phase I)

10. Preclinical and Discovery Stage Products

11. Inactive Products

12. Chronic Myeloid Leukemia Key Companies

13. Chronic Myeloid Leukemia Key Products

14. Chronic Myeloid Leukemia Unmet Needs

15. Chronic Myeloid Leukemia Market Drivers and Barriers

16. Chronic Myeloid Leukemia Future Perspectives and Conclusion

17. Chronic Myeloid Leukemia Analyst Views

18. Appendix

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