DelveInsight’s “Chronic Lymphocytic Leukemia Pipeline Insight 2025” report offers an in-depth analysis of the Chronic Lymphocytic Leukemia pipeline, featuring insights into 55+ companies and 60+ investigational therapies currently under development. The Chronic Lymphocytic Leukemia clinical trial report provides detailed profiles of both clinical and preclinical candidates and includes a comprehensive evaluation of therapies by product type, development stage, route of administration, and molecule type. Additionally, it outlines the inactive or discontinued drug candidates within the Chronic Lymphocytic Leukemia pipeline landscape.
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Key Takeaways from the Chronic Lymphocytic Leukemia Pipeline Report
- In December 2025, Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent Bruton tyrosine kinase (BTK) inhibitor. This FDA action expands the Jaypirca label to include patients earlier in their treatment course and also converts the December 2023 accelerated approval for later-line CLL/SLL to a traditional approval.
- In December 2025, AbbVie (NYSE: ABBV) today announced it will unveil new data at the 2025 American Society of Hematology (ASH) Congress, showcasing continued advances in research across multiple blood cancers including — multiple myeloma (MM), follicular lymphoma (FL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and amyloidosis (AL). Data across AbbVie's blood cancer portfolio will be featured in multiple oral and poster presentations including investigational compounds etentamig (ABBV-383) and PVEK (pivekimab sunirine), as well as approved therapies EPKINLY® (epcoritamab-bysp) and VENCLEXTA® (venetoclax).
- On Sept. 30, Umoja Biopharma announced that the FDA granted fast track designation to UB-VV111, an investigational off-the-shelf CAR T-cell therapy, for the treatment of relapsed/refractory large B-cell lymphoma and chronic lymphocytic leukemia after at least two or more prior lines of therapy.
- In August 2025, Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its Birelentinib (DZD8586) for the treatment of adult patients with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.
- In June 2025, BeiGene announced a study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated CLL. This study is designed to assess the contribution of sonrotoclax to the efficacy outcome of the combination of zanubrutinib and sonrotoclax.
- In June 2025, German CLL Study Group conducted a phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation or complex karyotype).
- In June 2025, Acerta Pharma BV organized a Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia.
- The leading Chronic Lymphocytic Leukemia Companies such as AstraZeneca, Lava Therapeutics, Nurix Therapeutics, MorphoSys, Novartis, Genor Biopharma, Celgene Corporation, TG Therapeutics, Loxo Oncology, Oncternal Therapeutics, Aprea Therapeutics, MingSight Pharmaceuticals, Bristol Myers Squibb, Incyte Corporation, Astex Therapeutics, Starton Therapeutics, and others.
- Promising Chronic Lymphocytic Leukemia Therapies such as Obinutuzumab, Rituximab, Chlorambucil, Acalabrutinib, and others.
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Chronic Lymphocytic Leukemia Emerging Drugs Profile
- Pirtobrutinib: Loxo Oncology
Pirtobrutinib is an investigational, oral, highly-selective, non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor, signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. Pirtobrutinib was designed to reversibly bind BTK, deliver consistently high target coverage regardless of BTK turnover rate, preserve activity in the presence of the C481 acquired resistance mutations, and avoid off-target kinases that have complicated the development of both covalent and investigational non-covalent BTK inhibitors. The drug is currently being evaluated in Phase III stage of development for the treatment of chronic lymphocytic leukemia.
- Cirmtuzumab: Oncternal Therapeutics
Cirmtuzumab is a first-in-class humanized monoclonal antibody that binds with high affinity to a biologically important epitope on ROR1 (Receptor-tyrosine kinase-like Orphan Receptor 1). ROR1 is a type 1 transmembrane protein, essential for fetal development that is expressed on the plasma membrane with an extracellular domain that is essential for ligand binding and signal transduction. Cirmtuzumab binds to many different types of cancer cells but does not recognize most normal adult tissues. Cirmtuzumab was developed at the University of California in San Diego based on the pioneering scientific research of Thomas Kipps, MD, Ph.D., and his colleagues at the Moores Cancer Center. Oncternal holds an exclusive worldwide license to develop and commercialize antibodies recognizing ROR1. The development of cirmtuzumab has been supported by the California Institute for Regenerative Medicine (CIRM), in recognition of the role of ROR1 in conferring stem cell-like properties to the cancer cells that express it. A Phase II clinical trial is evaluating Cirmtuzumab to treat CLL.
- MS-553: MingSight Pharmaceuticals
MS-553 is a potent, highly selective, oral, non-covalent inhibitor of PKCβ, a signaling molecule immediately downstream of BTK and PLCγ2 in the B-cell receptor (BCR) pathway. As PKCβ is downstream of both BTK and PLCγ2, it has the potential to treat acquired BTK resistance mutations in either protein, a feature absent from many second-generation BTK inhibitors. In the preliminary results, MS-553 was generally well tolerated, with initial anti-tumor activity seen in the heavily pretreated population. Potent to full inhibition of PKCβ signaling over 24 hours of exposure has been demonstrated. Additional dosing of patients will be completed to further assess MS-553 efficacy in patients with acquired resistance mutations in BTK and PLCG2. Currently, the drug is being evaluated in the Phase I/II stage of its development for the treatment of CLL.
- NX-2127: Nurix Therapeutics
NX-2127 is an oral small molecule that combines the activity of a targeted BTK degrader with the cereblon immunomodulatory activity of an IKZF degrader. Cereblon immunomodulatory drugs that induce degradation are IKZF1 and IKZF3. Preclinical data support the activity of NX-2127 in tumor models harboring either wild-type BTK or BTK with mutations conferring clinical resistance to FDA-approved agents. Studies in non-human primates confirm potent BTK degradation with once-daily oral dosing. NX-2127 is being tested in an ongoing Phase I trial for patients with chronic lymphocytic leukemia who have failed prior treatments.
- NX-5948: Nurix Therapeutics
NX-5948 is an oral small molecule degrader of BTK. Preclinical data support the activity of NX-5948 in tumor models harboring either wild-type BTK or BTK with mutations conferring clinical resistance to leading FDA approved agents. NX-5948 lacks cereblon immunomodulatory activity and has demonstrated the ability to cross the blood-brain barrier in animal models. NX-5948 has also demonstrated activity in animal models of autoimmune disease. The drug is currently being evaluated in the Phase I stage of development for the treatment of chronic lymphocytic leukemia.
The Chronic Lymphocytic Leukemia Pipeline Report Provides Insights into
- The report provides detailed insights about companies that are developing therapies for the treatment of Chronic Lymphocytic Leukemia with aggregate therapies developed by each company for the same.
- It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Chronic Lymphocytic Leukemia Treatment.
- Chronic Lymphocytic Leukemia Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- Chronic Lymphocytic Leukemia Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
- Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Chronic Lymphocytic Leukemia market
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Chronic Lymphocytic Leukemia Companies
Loxo Oncology, Oncternal Therapeutics, MingSight Pharmaceuticals, Nurix Therapeutics, Starton Therapeutics, TG Therapeutics, Bristol Myers Squibb, Novartis, Aprea Therapeutics, AstraZeneca, Genor Biopharma, Incyte Corporation, MorphoSys, Astex Therapeutics, Lava Therapeutics, Celgene Corporation, and others.
Chronic lymphocytic 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
- Intravenous
- Subcutaneous
- Oral
- Intramuscular
Chronic Lymphocytic Leukemia Products have been categorized under various Molecule types such as
- Monoclonal antibody
- Small molecule
- Peptide
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Scope of the Chronic Lymphocytic Leukemia Pipeline Report
- Coverage – Global
- Chronic Lymphocytic Leukemia Companies – Key players include Loxo Oncology, Oncternal Therapeutics, MingSight Pharmaceuticals, Nurix Therapeutics, Starton Therapeutics, TG Therapeutics, Bristol Myers Squibb, Novartis, Aprea Therapeutics, AstraZeneca, Genor Biopharma, Incyte Corporation, MorphoSys, Astex Therapeutics, Lava Therapeutics, Celgene Corporation, among others.
- Chronic Lymphocytic Leukemia Therapies – Major therapeutic options highlighted include Obinutuzumab, Rituximab, Chlorambucil, Acalabrutinib, and additional candidates.
- Therapeutic Assessment by Product Type – Treatments are categorized as monotherapy, combination therapy, or those offering both mono and combination approaches.
- Therapeutic Assessment by Clinical Stage – Therapies are evaluated across various development phases, including Discovery, Preclinical, Phase I, Phase II, and Phase III.
Which companies are leading the race in Chronic Lymphocytic Leukemia drug development? Find out in DelveInsight’s exclusive Chronic Lymphocytic Leukemia Pipeline Report—access it now! @ Chronic Lymphocytic Leukemia Emerging Drugs and Major Companies
Table of Content
- Introduction
- Executive Summary
- Chronic lymphocytic leukemia: Overview
- Chronic lymphocytic leukemia Pipeline Therapeutics
- Chronic lymphocytic leukemia Therapeutic Assessment
- Chronic lymphocytic leukemia - DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Pirtobrutinib: Loxo Oncology
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- Cirmtuzumab: Oncternal Therapeutics
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- NX-2127: Nurix Therapeutics
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug name: Company name
- Drug profiles in the detailed report…..
- Inactive Chronic lymphocytic leukemia Products
- Chronic lymphocytic leukemia Key Companies
- Chronic lymphocytic leukemia Key Products
- Chronic lymphocytic leukemia- Unmet Needs
- Chronic lymphocytic leukemia- Market Drivers and Barriers
- Chronic lymphocytic leukemia- Future Perspectives and Conclusion
- Chronic lymphocytic leukemia Analyst Views
- Chronic lymphocytic leukemia Key Companies
- Appendix
About DelveInsight
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