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Report Overview
Chronic myeloid leukemia (CML) is a cancer of the blood-forming cells characterized by uncontrolled white blood cell production driven by the BCR-ABL1 oncogene. It shows an annual incidence of about 1-2 cases per 100,000 people, reflecting its rarity yet growing prevalence due to effective treatments that prolong survival. According to the chronic myeloid leukemia pipeline analysis by Expert Market Research, over 20+ therapies are under development, including novel agents beyond traditional tyrosine kinase inhibitors, targeting resistant disease and improving outcomes. The expanding research focuses on resistance mechanisms, combination strategies, and better tolerability is expected to drive robust growth in the CML drug landscape in the coming years.
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Major companies involved in the chronic myeloid leukemia pipeline analysis include Terns, Inc., Shenzhen TargetRx, Inc., and others.
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Leading drugs currently in the pipeline include TERN-701, TGRX-678, ELVN-001, and others.
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The pipeline growth is driven by next-generation TKIs targeting resistance mutations, combination regimens improving deep molecular responses, and expanded early-line development focused on treatment-free remission and long-term disease control.
Report Coverage
The Chronic Myeloid Leukemia Pipeline Analysis Report by Expert Market Research gives comprehensive insights into chronic myeloid leukemia therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for chronic myeloid leukemia. The chronic myeloid leukemia report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The chronic myeloid leukemia pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with chronic myeloid leukemia treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to chronic myeloid leukemia.
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Chronic Myeloid Leukemia Pipeline Outlook
Chronic myeloid leukemia is a clonal hematologic malignancy characterized by uncontrolled proliferation of myeloid cells in the bone marrow. It occurs due to the Philadelphia chromosome, formed by the BCR-ABL1 gene fusion, which generates a constitutively active tyrosine kinase that drives abnormal cell growth and impairs apoptosis, leading to progressive disease.
Chronic myeloid leukemia is primarily treated with tyrosine kinase inhibitors, including imatinib and newer agents, while stem cell transplantation is reserved for resistant or advanced cases. In October 2024, the United States Food and Drug Administration granted accelerated approval to asciminib by Novartis AG for newly diagnosed Philadelphia chromosome–positive chronic phase disease, strengthening first-line treatment options.
Chronic Myeloid Leukemia Epidemiology
The pipeline is shaped by rising disease prevalence and long-term treatment needs. According to Elias Jabbour et al., 2024, chronic myeloid leukemia has an annual incidence of approximately two cases per 100,000 population and accounts for nearly 15% of adult leukemia diagnoses. In the United States, around 9,280 new cases were reported in 2024. As per published estimates, improved survival with BCR::ABL1 tyrosine kinase inhibitors has reduced mortality to 1–2%, significantly increasing prevalence. Consequently, pipeline development emphasizes next-generation therapies, resistance management, and long-term treatment optimization.
Chronic Myeloid Leukemia – Pipeline Therapeutic Assessment
This section of the report covers the analysis of chronic myeloid leukemia drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
By Drug Class
The chronic myeloid leukemia pipeline analysis report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Peptides
- Oligonucleotides
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration:
- Oral
- Parenteral
- Others
Chronic Myeloid Leukemia Pipeline Assessment Segmentation, By Phases
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II, with 54%, covers a major share of the total chronic myeloid leukemia clinical trials, driven by strong clinical evidence generation and target validation, which can accelerate market adoption. Phase I with 37% reflects a solid safety and tolerability focus, supporting progression to later stages. Phase III, with 32%, indicates pivotal efficacy confirmation, key to regulatory approval.
Chronic Myeloid Leukemia Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the chronic myeloid leukemia pipeline analysis include small molecules, peptides, and oligonucleotides. The chronic myeloid leukemia report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for chronic myeloid leukemia. Targeted drug classes are a key focus in the pipeline, with continued innovation beyond conventional tyrosine kinase inhibitors. For instance, asciminib, a first-in-class inhibitor specifically targeting the ABL Myristoyl Pocket inhibitor, is under advanced clinical evaluation. It demonstrates improved molecular response rates and a favorable safety profile, supporting its potential as an alternative frontline therapy.
Chronic Myeloid Leukemia Clinical Trials – Key Players
The EMR report for the chronic myeloid leukemia pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed chronic myeloid leukemia therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in chronic myeloid leukemia clinical trials:
- Terns, Inc.
- Shenzhen TargetRx, Inc.
- Enliven Therapeutics
- Novartis Pharmaceuticals
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Kartos Therapeutics, Inc.
- Il-Yang Pharm. Co., Ltd.
- Incyte Biosciences
- Ascentage Pharma Group Inc.
- Solu Therapeutics, Inc.
- Taiho Oncology, Inc.
- Orca Biosystems, Inc.
Chronic Myeloid Leukemia – Emerging Drugs Profile
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for chronic myeloid leukemia. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of chronic myeloid leukemia drug candidates.
Drug: TERN-701
TERN-701 is being developed by Terns, Inc. as a highly selective, orally administered allosteric BCR-ABL1 tyrosine kinase inhibitor for chronic phase chronic myeloid leukemia. The ongoing Phase 1/2 CARDINAL study is evaluating safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in previously treated patients. The drug is selectively inhibiting BCR-ABL1 through an allosteric binding mechanism, aiming to overcome resistance mutations while improving tolerability. The trial is conducting dose escalation and dose expansion, with once-daily continuous oral dosing across 28-day treatment cycles.
Drug: TGRX-678
TGRX-678 is a novel allosteric ABL1 inhibitor being developed by Shenzhen TargetRx, Inc. for the treatment of chronic myeloid leukemia (CML). The ongoing Chinese Phase II study is evaluating the safety and efficacy of TGRX-678 in accelerated-phase CML patients who are relapsed or refractory to third-generation TKIs. The study examines TGRX-678’s ability to inhibit BCR-ABL1 signaling by targeting the myristoyl pocket of ABL1, restoring auto-inhibition and overcoming resistance mutations, including T315I. The drug is being administered orally and is demonstrating promising anti-leukemic activity with favorable PK/PD characteristics.
Drug: ELVN-001
ELVN-001 is a novel, highly selective small-molecule tyrosine kinase inhibitor being developed by Enliven Therapeutics for chronic myeloid leukemia with or without the T315I mutation. The ongoing Phase 1 study is recruiting Japanese participants and is evaluating safety, tolerability, pharmacokinetics, and recommended dose for expansion. ELVN-001 is orally administered and directly inhibits the BCR::ABL1 fusion protein, including T315I-mediated resistance. The study is examining dose escalation and early molecular responses to support future clinical development in heavily pretreated CML patients.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
Key Questions Answered in the Chronic Myeloid Leukemia Pipeline Insight Report
- Which companies/institutions are leading the chronic myeloid leukemia drug development?
- Which company is leading the chronic myeloid leukemia pipeline development activities?
- What is the current chronic myeloid leukemia commercial assessment?
- What are the opportunities and challenges present in the chronic myeloid leukemia pipeline landscape?
- What is the efficacy and safety profile of chronic myeloid leukemia pipeline drugs?
- Which company is conducting major trials for chronic myeloid leukemia drugs?
- Which companies/institutions are involved in chronic myeloid leukemia collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in chronic myeloid leukemia?
Reasons To Buy This Report
The Chronic Myeloid Leukemia Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for chronic myeloid leukemia. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into chronic myeloid leukemia collaborations, regulatory environments, and potential growth opportunities.
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Report Summary
Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.
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