Acute Myeloid Leukemia Pipeline

DelveInsight’s “Acute Myeloid Leukemia Pipeline Insight, 2025” report provides comprehensive insights about 100+ companies and 110+ pipeline drugs in Acute Myeloid Leukemia pipeline landscape. It covers the Acute Myeloid Leukemia 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 Acute Myeloid Leukemia pipeline products in this space.

Geography Covered

• Global coverage

Acute Myeloid Leukemia Disease: 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.

Acute Myeloid Leukemia Diagnosis 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 Acute Myeloid Leukemia Treatment 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 Acute Myeloid Leukemia Pipeline Report, detailed description of the drug is given which includes mechanism of action of the drug, Acute Myeloid Leukemia Clinical Trials, 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.

Explore the latest market trends and forecasts @ Acute Myeloid Leukemia Treatment Market Size

Acute Myeloid Leukemia Pipeline Report Highlights

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

 

Acute Myeloid Leukemia Drugs Analysis

This segment of the Acute Myeloid Leukemia Pipeline 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 Acute Myeloid Leukemia Clinical Trials details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

Acute Myeloid Leukemia Emerging Drugs

• 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 III stage of its development for AML treatment.

 

• Annamycin: Moleculin Biotech, Inc.

Annamycin is a next-generation anthracycline being evaluated in the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial, a pivotal, adaptive design Phase III trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia (AML). If successful, Annamycin has the potential to transform the standard of care for 2nd line AML. Annamycin is also in development for the treatment of soft tissue sarcoma. Annamycin has demonstrated in multiple clinical trials a lack of cardiotoxicity, allowing us to exceed the currently set maximum lifetime dosing for an anthracycline and potentially realizing the full therapeutic potential of anthracyclines to treat serious, hard-to-treat cancers. Currently the drug is in Phase III stage of its clinical trial for AML treatment.

 

• SNDX-5613: Syndax Pharmaceuticals

SNDX-5613 (revumenib) is an oral, selective inhibitor of the menin-KMT2A (MLL) interaction, being developed by Syndax Pharmaceuticals for the treatment of acute leukemias, particularly acute myeloid leukemia (AML) with KMT2A rearrangements or NPM1 mutations. By disrupting the menin-KMT2A complex, SNDX-5613 restores normal gene expression and promotes differentiation of leukemic cells. The therapy has shown promising efficacy in relapsed or refractory AML patients in early-phase clinical trials. Revumenib has received multiple regulatory designations, including Breakthrough Therapy and Orphan Drug status from the FDA. Currently the drug is in Phase II/III stage of its development for the treatment of 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 the Phase II stage of its development for Acute Myeloid Leukemia.

 

• 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 the Phase I stage of its development for AML treatment.

Discover disease prevalence and patient insights @ Acute Myeloid Leukemia Prevalence

Acute Myeloid Leukemia Pipeline 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 Acute Myeloid Leukemia Companies
• There are approx. 100+ key Acute Myeloid Leukemia Companies that are developing therapies for Acute Myeloid Leukemia. The companies that have their Acute Myeloid Leukemia drug candidates in the most advanced stage, i.e. phase III include, Kura Oncology.

 

Acute Myeloid Leukemia Phases

DelveInsight’s Acute Myeloid Leukemia Pipeline Report covers around 110+ 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

 

Acute Myeloid Leukemia 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

 

Acute Myeloid Leukemia Molecule Type

Acute Myeloid Leukemia Products have been categorized under various Molecule types such as

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

 

Acute Myeloid Leukemia Product Type

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

 

Acute Myeloid Leukemia Pipeline Development Activities

The Acute Myeloid Leukemia Pipeline 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. 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 Pipeline Report Insights

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

 

Acute Myeloid Leukemia Pipeline Report Assessment

• Acute Myeloid Leukemia Pipeline Drugs Profiles
• Acute Myeloid Leukemia Therapeutic Assessment
• Acute Myeloid Leukemia Pipeline Assessment
• Inactive drugs assessment
• Acute Myeloid Leukemia Unmet Needs

 

Key Questions Answered in the Acute Myeloid Leukemia Pipeline Report

Current Acute Myeloid Leukemia 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 Acute Myeloid Leukemia Treatment?
• 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 Acute Myeloid Leukemia Clinical Studies going on and their status?
• What are the key designations that have been granted to the emerging drugs?