Acute Myeloid Leukemia - Pipeline Insight, 2025

DelveInsight’s, “Acute Myeloid Leukemia - Pipeline Insight, 2025” report provides comprehensive insights about 110+ companies and 120+ pipeline drugs in Acute 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

Acute Myeloid Leukemia: Understanding

Acute Myeloid Leukemia: Overview

Acute Myeloid Leukemia (AML) is a type of cancer that affects the bone marrow and blood. In AML, the bone marrow produces abnormal myeloid cells, which are immature white blood cells that normally develop into various types of mature blood cells, including red blood cells, white blood cells, and platelets. These abnormal cells multiply rapidly, crowding out healthy blood cells and impairing the normal functioning of the bone marrow. This leads to a deficiency of normal blood cells, causing symptoms and complications throughout the body. Signs and symptoms of AML can vary but often include fatigue, weakness, shortness of breath, easy bruising or bleeding, frequent infections, fever, and weight loss. These symptoms occur due to a lack of healthy blood cells and the buildup of abnormal cells in the bone marrow and bloodstream. AML can progress rapidly, requiring prompt medical attention for diagnosis and treatment.

Acute Myeloid Leukemia (AML) originates from genetic mutations in hematopoietic stem cells, leading to the proliferation of immature myeloid precursor cells in the bone marrow. These abnormal cells fail to differentiate into mature blood cells and accumulate rapidly, crowding out normal hematopoietic cells. This results in bone marrow failure and a decrease in the production of healthy blood cells, including red blood cells, white blood cells, and platelets. The infiltration of leukemic cells into the bloodstream leads to systemic manifestations such as anemia, susceptibility to infections due to neutropenia, and bleeding tendencies due to thrombocytopenia. Additionally, leukemic cells may infiltrate extramedullary sites such as the spleen, liver, and lymph nodes, contributing to organomegaly and other complications.

The exact cause of AML is not always clear, but certain risk factors have been identified, including exposure to high levels of radiation or certain chemicals, such as benzene, prior chemotherapy or radiation therapy for other cancers, certain genetic disorders, such as Down syndrome, and smoking. However, in many cases, the cause of AML remains unknown.

Diagnosis of AML typically involves a thorough physical examination, blood tests to evaluate the levels of different types of blood cells and other markers, and a bone marrow biopsy to examine the cells in the bone marrow for abnormalities. Once diagnosed, treatment for AML usually involves chemotherapy to destroy the abnormal cells and allow healthy blood cells to regenerate. In some cases, a bone marrow transplant may be recommended to replace the diseased bone marrow with healthy donor cells. Other treatments, such as targeted therapy and immunotherapy, may also be used depending on the specific characteristics of the cancer and the individual's overall health. Early detection and treatment of AML are crucial for improving outcomes and increasing the chances of long-term remission.

""Acute Myeloid Leukemia - Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Acute Myeloid Leukemia pipeline landscape is provided which includes the disease overview and Acute Myeloid Leukemia treatment guidelines. The assessment part of the report embraces, in depth Acute 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, Acute 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 Acute Myeloid Leukemia R&D. The therapies under development are focused on novel approaches to treat/improve Acute Myeloid Leukemia.

Acute Myeloid Leukemia Emerging Drugs Chapters

This segment of the Acute 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.

Acute Myeloid Leukemia Emerging Drugs

• Uproleselan: GlycoMimetics

GlycoMimetics is developing uproleselan, a specific E-selectin antagonist, to be used in combination with chemotherapy to treat patients with Acute Myeloid Leukemia (AML) (AML) and potentially other hematologic cancers. Uproleselan is designed to bind to E-selectin and block the normal processes controlled by E-selectin. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect via NF-kB signaling. Uproleselan is designed to provide a novel approach to disrupting established mechanisms of leukemic cell resistance. It is believed that by binding to E-selectin, uproleselan pushes AML cells out of their protective niche, blocks cellular communication signals that promote survival, and sensitizes cancer cells to the toxic effects of chemotherapy. Currently, the drug is in Phase III stage of its development for the treatment of Acute Myeloid Leukemia (AML).

• BST-236: BioSight

Aspacytarabine (BST-236) is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine, enabling delivery of high cytarabine doses to leukemia patients with lower systemic exposure to the free drug. Currently, the drug is in Phase II stage of its development for the treatment of Acute Myeloid Leukemia (AML).

• MK-0482: Merck Sharp & Dohme LLC

MK-0482, a novel humanized IgG4 mAb targeting ILT3, is undergoing phase I evaluation ±pembrolizumab (pembro) in advanced solid tumors. MK-0482 ± pembro was generally well tolerated, and combination therapy provided modest antitumor activity in patients with heavily pretreated advanced solid tumors. The RP2D of MK-0482 + pembro is under further evaluation in tumor-specific cohorts. Currently, the drug is in Phase I stage of its development for the treatment of AML.

• Ziftomenib - Kura Oncology

Ziftomenib is a novel, once-daily, oral investigational drug candidate targeting the menin-KMT2A/MLL protein-protein interaction for treatment of genetically defined AML patients with high unmet need. In preclinical models, ziftomenib inhibits the KMT2A/MLL protein complex and exhibits downstream effects on HOXA9/MEIS1 expression and potent anti-leukemic activity in genetically defined preclinical models of AML. Ziftomenib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML. Currently, the drug is in Phase I/II stage of its development for the treatment of AML.

• SENTI 202: Senti Biosciences

SENTI-202 is a first in class Logic-gated CAR-NK product engineered with an OR and a NOT Logic Gate gene circuit approach to enhance therapeutic efficacy and safety, with additional arming via expression of calibrated release IL-15 (crIL-15). A dual targeting activating CAR (aCAR) that recognizes both CD33 and FLT3 tumor antigens improves the anti-tumor activity, ensuring the targeting of AML blasts and LSCs. Currently, the drug is in Preclinical stage of its development for the treatment of AML.

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

Acute Myeloid Leukemia: Therapeutic Assessment

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

• Major Players in Acute Myeloid Leukemia
• There are approx. 110+ key companies which are developing the therapies for Acute Myeloid Leukemia. The companies which have their Acute Myeloid Leukemia drug candidates in the most advanced stage, i.e. phase III include, GlycoMimetics.
• Phases

DelveInsight’s report covers around 120+ 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

Acute 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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

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

Acute Myeloid Leukemia: Pipeline Development Activities

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

Acute Myeloid Leukemia Report Insights

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

Acute 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 Acute Myeloid Leukemia drugs?
• How many Acute 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 Acute Myeloid Leukemia?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Acute 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 Acute Myeloid Leukemia and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• GlycoMimetics
• BioSight
• Merck Sharp & Dohme LLC
• Kura Oncology
• Senti Biosciences
• Chimerix
• Takeda
• Apollo Therapeutics
• Immune-Onc Therapeutics
• AbbVie/Genentech
• Altor BioScience Corporation
• Merck & Co
• Astex Pharmaceuticals
• Karyopharm Therapeutics
• Mesoblast
• SELLAS Life Sciences Group
• Molecular Partners
• Kling Biotherapeutics
• HitGen
• Chordia Therapeutics, Inc
• Cullinan Therapeutics Inc.
• Aptose Biosciences Inc.
• Celgene

Key Products

• Uproleselan
• BST-236
• MK-0482
• Ziftomenib
• SENTI 202
• Dordaviprone
• ADCLEC.syn1 CAR-T cell therapy
• APL 4098
• IO 202
• Venetoclax
• Dordaviprone
• IO 202
• Nogapendekin alfa inbakicept
• Pembrolizumab
• Azacitidine/cedazuridine
• Selinexor
• Rexlemestrocel L - Mesoblast/Teva Pharmaceutical Industries
• Galinpepimut S
• cKITxCD16axCD47 fusion protein therapeutic
• KBA 1331
• HGP 2514
• CTX-712
• CLN-049
• CG-806
• CC-96191

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