Chronic Myeloid Leukemia Pipeline Summary

DelveInsight’s, “Chronic Myeloid Leukemia - Pipeline Insight, 2026” report provides comprehensive insights about 25+ companies and 26+ pipeline drugs in Chronic Myeloid Leukemia 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.

Geography Covered

• Global coverage

Chronic Myeloid Leukemia: Understanding

Chronic Myeloid Leukemia: Overview

Chronic myeloid leukemia (CML) is also known as chronic myelogenous leukemia. It's a type of cancer that starts in certain blood-forming cells of the bone marrow. In CML, a genetic change takes place in an early (immature) version of myeloid cells -- the cells that make red blood cells, platelets, and most types of white blood cells (except lymphocytes). This change forms an abnormal gene called BCR-ABL, which turns the cell into a CML cell. The leukemia cells grow and divide, building up in the bone marrow and spilling over into the blood. In time, the cells can also settle in other parts of the body, including the spleen. CML is a fairly slow growing leukemia, but it can change into a fast-growing acute leukemia that's hard to treat.

Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm primarily caused by the formation of the Philadelphia chromosome, which results from a reciprocal translocation between chromosomes 9 and 22. This genetic abnormality creates the BCR::ABL1 fusion gene, which encodes a constitutively active tyrosine kinase that drives uncontrolled proliferation of myeloid progenitor cells, inhibits apoptosis, and promotes genomic instability. Although the precise cause of this chromosomal translocation remains unknown, exposure to high-dose ionizing radiation is the only well-established environmental risk factor. Most cases occur sporadically, and inherited genetic predisposition has not been clearly established.

The diagnosis of CML is based on a combination of clinical findings, hematologic evaluation, bone marrow examination, and molecular testing. Patients typically present with leukocytosis detected on complete blood count, often accompanied by basophilia, eosinophilia, thrombocytosis, and splenomegaly. Bone marrow aspiration and biopsy usually demonstrate hypercellularity with marked myeloid hyperplasia. Confirmation of the diagnosis requires detection of the Philadelphia chromosome or the BCR::ABL1 fusion gene using conventional cytogenetics (karyotyping), fluorescence in situ hybridization (FISH), or reverse transcriptase polymerase chain reaction (RT-PCR), the latter also serving as the standard method for monitoring treatment response.

The treatment of CML has been transformed by BCR::ABL1-targeted tyrosine kinase inhibitors (TKIs), which are the standard first-line therapy for patients with chronic-phase disease. First-generation and newer-generation TKIs effectively inhibit the constitutively active BCR::ABL1 kinase, resulting in durable hematologic, cytogenetic, and molecular responses in most patients. Treatment selection is guided by disease phase, patient comorbidities, mutation profile, and treatment response. Regular molecular monitoring using quantitative RT-PCR is essential to assess therapeutic efficacy and detect resistance. Patients with TKI-resistant disease, advanced-phase CML, or specific resistance mutations may require alternative TKIs, combination therapy, or allogeneic hematopoietic stem cell transplantation, which remains the only established curative treatment for selected patients.

"Chronic Myeloid Leukemia- Pipeline Insight, 2026" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Chronic Myeloid Leukemia pipeline landscape is provided which includes the disease overview and Chronic Myeloid Leukemia treatment guidelines. The assessment part of the report embraces, in depth Chronic Myeloid Leukemia commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Chronic Myeloid Leukemia collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Chronic Myeloid Leukemia R&D. The therapies under development are focused on novel approaches to treat/improve Chronic Myeloid Leukemia.

Chronic Myeloid Leukemia Emerging Drugs Chapters

This segment of the Chronic Myeloid Leukemia report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Chronic Myeloid Leukemia Emerging Drugs

• RS 5614: Renascience

RS5614 is an investigational, orally administered plasminogen activator inhibitor-1 (PAI-1) inhibitor for the treatment of chronic myeloid leukemia (CML) in combination with tyrosine kinase inhibitors (TKIs). Unlike TKIs, which primarily eliminate proliferating leukemic cells, RS5614 targets CML stem cells residing in the bone marrow niche. By inhibiting intracellular PAI-1, it activates pathways that promote the mobilization of leukemic stem cells from the bone marrow niche, rendering them susceptible to TKI-mediated elimination. This novel mechanism is intended to enhance deep molecular responses, facilitate treatment-free remission, and potentially achieve a functional cure for CML. Currently, the drug is being evaluated in the Phase III stage of its development for the treatment of Chronic Myeloid Leukemia.

• TERN-701: Merck & Co., Inc.

TERN-701 is an investigational, once-daily oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI) being developed by MSD for the treatment of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML). Unlike ATP-competitive TKIs, TERN-701 selectively binds to the myristoyl pocket of the ABL1 kinase, locking the BCR::ABL1 protein in its inactive conformation and thereby inhibiting its kinase activity. This allosteric mechanism suppresses BCR::ABL1-driven leukemic cell proliferation while offering the potential to overcome resistance associated with certain ATP-binding site mutations and improve tolerability. Currently, the drug is being evaluated in the Phase I/II stage of its development for the treatment of Chronic Myeloid Leukemia.

• ELVN-001: Enliven Therapeutics

ELVN-001, is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the BCR-ABL fusion gene product, the oncogenic driver for patients with chronic myeloid leukemia (CML). ELVN-001 targets the ATP-binding site of the ABL1 kinase domain and binds to a unique P-loop “folded-in” active conformation of ABL1, creating a narrow selectivity tunnel against the broader kinome. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR-ABL mutation, which confers resistance to nearly all approved tyrosine kinase inhibitors (TKIs), as well as activity against mutations known to confer resistance to allosteric BCR-ABL inhibitors. As per the company pipeline, the drug is in Phase I stage of its clinical trial for the treatment of Chronic Myeloid Leukemia.

• MGD024: MacroGenics/ Gilead Sciences

MGD024 is an investigational CD123 × CD3 bispecific DART® (Dual-Affinity Re-Targeting) antibody being developed by MacroGenics in collaboration with Gilead Sciences for the treatment of CD123-positive hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). The drug is designed to simultaneously bind CD123 expressed on leukemic cells and CD3 on T cells, thereby redirecting and activating cytotoxic T cells to selectively recognize and eliminate CD123-expressing malignant cells. Its next-generation DART® design incorporates a modified CD3-binding domain to reduce cytokine release syndrome (CRS) while preserving potent antitumor activity, and an Fc domain that extends half-life to enable intermittent dosing. MGD024 is currently being evaluated in a Phase I clinical study in patients with relapsed or refractory CD123-positive hematologic malignancies.

Further product details are provided in the report……..

Chronic Myeloid Leukemia: Therapeutic Assessment

This segment of the report provides insights about the different Chronic Myeloid Leukemia drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Chronic Myeloid Leukemia

There are approx. 25+ key companies which are developing the therapies Chronic Myeloid Leukemia. The companies which have their Chronic Myeloid Leukemia drug candidates in the most advanced stage, i.e. Phase III include, Renascience and others.

• Phases

DelveInsight’s report covers around 26+ products under different phases of clinical development like

• 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
• Route of Administration

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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Chronic Myeloid Leukemia: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Chronic Myeloid Leukemia therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Chronic Myeloid Leukemia drugs.

Chronic Myeloid Leukemia Report Insights

• Chronic Myeloid Leukemia Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Chronic Myeloid Leukemia Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Chronic Myeloid Leukemia drugs?
• How many Chronic Myeloid Leukemia drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Chronic Myeloid Leukemia?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Chronic Myeloid Leukemia therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Chronic Myeloid Leukemia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Merck & Co., Inc.
• Enliven Therapeutics
• Shenzhen Zhenxing Medical Technology
• ImmunoForge
• Renascience
• MacroGenics
• Gilead Sciences
• Mendus AB
• Shenzhen TargetRx Co., Ltd.
• Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
• Crossbow Therapeutics, Inc.

Key Products

• TERN-701
• ELVN-001
• CUDC-201
• KF 1601
• RS 5614
• MGD024
• Vididencel
• TGRX-678
• TQB3911
• CBX-250