Acute Myeloid Leukemia Pipeline Insight report provides comprehensive insights about 260+ companies and 260+ pipeline drugs in the AML Pipeline Landscape

Acute Myeloid Leukemia Pipeline Drugs, Companies Report

DelveInsight&rsquo;s, &ldquo;Acute Myeloid Leukemia - Pipeline Insight, 2025&rdquo; 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.
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<h2>Geography Covered</h2>
<ul>
<li>Global coverage</li>
</ul>
&nbsp;
<h2>Acute Myeloid Leukemia: Understanding</h2>
Acute Myeloid Leukemia: Overview
Acute myeloid leukemia (AML) is a rapidly progressing hematologic malignancy marked by the clonal expansion of immature myeloid-derived cells, or blasts, which accumulate in the peripheral blood and bone marrow. This expansion leads to a significant disruption in hematopoiesis, specifically impairing the production of red blood cells and platelets due to ineffective erythropoiesis and megakaryopoiesis. As a result, AML is associated with rapid bone marrow failure, which distinguishes it from chronic or indolent forms of leukemia. Clinically, this manifests as symptoms such as anemia, bleeding, and increased susceptibility to infections. While multiagent induction chemotherapy can induce complete remission in some cases, allogeneic stem cell transplantation remains the only established curative treatment. However, despite significant advancements in therapeutic strategies, the prognosis for AML remains poor, particularly among older populations, highlighting the need for novel therapies and improved management approaches to enhance survival outcomes.
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The European LeukemiaNet (ELN) 2022 consensus recommendations provide a framework for classifying AML based on mutational profiles, but understanding the disease's origins and progression is key. Patients with high-risk myelodysplastic syndrome (MDS), marked by transfusion-dependent cytopenias and peripheral blasts, are at increased risk of developing AML and require careful monitoring. Similarly, myeloproliferative neoplasms, such as myelofibrosis and essential thrombocythemia, can progress to AML, often indicated by declining blood counts and elevated peripheral blasts. These conditions, along with others like aplastic anemia, can lead to secondary AML. Additionally, patients exposed to chemotherapy, particularly alkylating agents or radiation, are at risk of therapy-related MDS/AML, often associated with specific chromosomal abnormalities. Environmental factors like radiation, tobacco smoke, and benzene also increase the risk of AML, though most cases arise de novo without a clear cause.
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AML is characterized by the clonal proliferation of undifferentiated myeloid precursor cells, or blasts, in the bone marrow, driven by various genomic and cytogenetic abnormalities. This disruption leads to ineffective erythropoiesis, megakaryopoiesis, and bone marrow failure. The disease is classified into favorable, intermediate, or high-risk categories based on genetic mutations. Favorable risk includes chromosomal translocations like t(8;21) or inv(16) and mutations such as FLT3-ITD-negative and NPM1 or CEBPA mutations. Intermediate-risk AML is associated with FLT3-ITD mutations or MLL rearrangements, while high-risk AML includes complex cytogenetic abnormalities and mutations in genes like ASXL1, EZH2, SRSF2, or TP53. RUNX1, a key gene for hematopoiesis, is commonly translocated in AML, leading to resistance to therapy. Additionally, IDH mutations are present in a significant portion of AML cases and are linked to poor prognosis.&nbsp;
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Induction therapy for AML aims to achieve remission but can cause significant toxicity, including bone marrow suppression, renal failure, and electrolyte imbalances from tumor lysis syndrome (TLS). The treatment regimen varies based on the patient's age and risk factors. Younger, fit patients typically receive the ""7+3"" protocol, while older or unfit patients may receive hypomethylating agents with venetoclax. For complex or secondary AML, FLAG therapy is preferred. Early involvement of bone marrow transplant specialists is essential for those with intermediate- or high-risk disease, as allogeneic stem cell transplantation is the only curative option. Consolidation therapy follows induction to address minimal residual disease, and for relapsed AML, targeted therapies based on genetic mutations, such as FLT3 or IDH inhibitors, are used. Transfusional support with irradiated blood products is crucial to prevent graft-versus-host disease.
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"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.
To know more information about the epidemiology report-&nbsp;<a href="../../report-store/acute-myeloid-leukemia-aml-epidemiology-forecast">Acute Myeloid Leukaemia Epidemiology Report</a>
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<h2>Report Highlights</h2>
<ul>
<li>The companies and academics are working to assess challenges and seek opportunities that could influence Acute Myeloid Leukemia R&amp;D. The therapies under development are focused on novel approaches to treat/improve Acute Myeloid Leukemia.</li>
</ul>
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<h2>Acute Myeloid Leukemia Emerging Drugs Chapters</h2>
This segment of the Acute Myeloid Leukemia report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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.
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Acute Myeloid Leukemia Emerging Drugs
<ul>
<li>Galinpepimut-S: Sellas Life Sciences Group</li>
</ul>
Galinpepimut-S (GPS), is a WT1-targeting cancer immunotherapeutic which is being developed as a monotherapy and in combination with other therapeutic agents to treat different types of cancers. WT1 is a protein that resides in the cell&rsquo;s nucleus and participates in the process of cancer formation and progression. WT1 plays a key role in the development of the kidneys in fetal life, but then almost disappears from normal organs and tissues. GPS is a multi-peptide product that has been modified to enhance the degree and duration of the immune response against the WT1 protein. Two of the four peptides in the peptide mixture comprising GPS are deliberately mutated in a single amino acid residue. These mutated peptides are recognized by the immune system as non-self-entities and are therefore less likely to induce immune tolerance. These mutated peptides are designed using artificial intelligence (AI) to elicit strong T cell response against both mutated peptides and naturally occurring peptides in cancer cells. The FDA has granted rare pediatric disease designation to galinpepimut-S (GPS) for the treatment of pediatric patients with acute myeloid leukemia (AML). Currently, the drug is in Phase III stage of its development for the treatment of Acute Myeloid Leukemia.
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<ul>
<li>Tagraxofusp: Stemline Therapeutics, Inc.</li>
</ul>
TAGRAXOFUSP is a novel targeted therapy directed to the IL-3 receptor &alpha; (CD123), a target present on a wide range of malignancies. It comprises human IL-3 recombinantly fused to a truncated diphtheria toxin (DT) payload engineered such that IL-3 replaces the native DT receptor-binding domain. The IL-3 domain of TAGRAXOFUSP directs the cytotoxic DT payload to cells expressing CD123. Upon internalization, TAGRAXOFUSP irreversibly inhibits protein synthesis and induces apoptosis of the target cell. Currently, the drug is in Phase II stage of its development for the treatment of Acute Myeloid Leukemia.
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<ul>
<li>WU-NK-101: Wugen, Inc.</li>
</ul>
WU-NK-101 is a novel immunotherapy harnessing the power of memory natural killer (NK) cells to treat liquid and solid tumors. Memory NK cells are hyper-functional, long-lasting immune cells that exhibit enhanced anti-tumor activity and a cytokine-induced memory-like (CIML) phenotype. This rare cell population has a superior phenotype, proliferation capacity, and metabolic fitness, making it better suited for cancer therapy than other NK cell therapies. WU-NK-101 is currently in development for acute myelogenous leukemia (AML). Studies of WU-NK-101 to date have shown promising robust in vivo activity in various tumor indications, retention of anti-cancer activity in TME, resistance to immune suppression, and enhanced activity with checkpoint inhibitors. Additionally, Wugen announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to WU-NK-101 for the treatment of AML. Currently, the drug is in Phase I/II stage of its development for the treatment of Acute Myeloid Leukemia.
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<ul>
<li>SGR-2921: Schrodinger, Inc.</li>
</ul>
SGR-2921 is a cell division cycle 7-related protein kinase (CDC7) inhibitor. CDC7 is a protein kinase that plays a critical role in cell cycle regulation and DNA replication. Elevated replication stress is a common feature of many cancers with high cell proliferation. CDC7 has been shown to activate key components of the replication stress response, helping to mitigate cancer cells&rsquo; DNA damage and promote genomic stability. Inhibiting CDC7 in cancer cells results in an impaired response to replication stress, leading to accumulation of DNA damage and cell death. External clinical studies are showing promise of CDC7 as a therapeutic target in oncology. In addition, preclinical data demonstrate anti-tumor activity of SGR-2921 in tumor models resistant to standard of care agents. Currently, the drug is in Phase I stage of its development for the treatment of Acute Myeloid Leukemia.
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<ul>
<li>Voruciclib: MEI Pharma, Inc.</li>
</ul>
Voruciclib is an investigational orally administered cyclin-dependent kinase 9 (&ldquo;CDK9&rdquo;) inhibitor with potential to treat both hematological malignancies and solid tumors. It is in clinical development for acute myeloid leukemia and B-cell malignancies. The CDK family of proteins are important cell cycle regulators responsible for the control of cell proliferation, differentiation, apoptosis, and DNA repair. CDK9, one of several members of the CDK family of proteins, functions as a gene transcription controller and is also involved in regulating protein degradation. Specifically, CDK9 is a promising target to treat a range of cancers because of its role in controlling two other proteins often dysregulated in cancerous cells: myeloid leukemia cell differentiation protein (&ldquo;Mcl-1&rdquo;) and the MYC proto-oncogene protein (""MYC""). MYC regulates cell proliferation and growth. Upregulation of MYC is implicated in many human cancers and is frequently associated with poor prognosis and unfavorable patient survival. CDK9, in addition to being a transcription factor for MYC, also decreases phosphorylation of MYC protein that is implicated in stabilizing MYC in KRAS mutant cancers. Targeting MYC directly has historically been difficult, but CDK9 is a promising approach to target this oncogene. Currently, the drug is in Phase I stage of its development for the treatment of Acute Myeloid Leukemia.
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<ul>
<li>VADC45: Vor Bio</li>
</ul>
VADC45 is composed of a human IgG1 antibody attached to the DGN549-C linker-payload, which has been used in two clinical-stage ADCs. VADC45 has been engineered to have a short half-life but highly specific to bind human CD45, which is expressed on normal hematopoietic stem and progenitor cells (HSPCs) and immune cells, including mature myeloid and lymphoid cells. CD45 is an attractive target for conditioning of HSPCs and immune cells prior to hematopoietic cell transplant (HCT), with the potential to prevent allograft rejection and to improve outcomes with an improved safety and tolerability profile. Currently, the drug is in Preclinical stage of its development for the treatment of Acute Myeloid Leukemia.
Further product details are provided in the report&hellip;&hellip;..
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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:
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Major&nbsp; 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, Sellas Life Sciences Group.
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Phases
DelveInsight&rsquo;s report covers around 120+ products under different phases of clinical development like
<ul>
<li>Late stage products (Phase III)</li>
<li>Mid-stage products (Phase II)</li>
<li>Early-stage product (Phase I) along with the details of&nbsp;</li>
<li>Pre-clinical and Discovery stage candidates</li>
<li>Discontinued &amp; Inactive candidates</li>
</ul>
&nbsp;
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&nbsp;
<ul>
<li>Oral</li>
<li>Intravenous</li>
<li>Subcutaneous</li>
<li>Parenteral&nbsp;</li>
<li>Topical</li>
</ul>
&nbsp;
Molecule Type
Products have been categorized under various Molecule types such as
<ul>
<li>Recombinant fusion proteins</li>
<li>Small molecule</li>
<li>Monoclonal antibody</li>
<li>Peptide</li>
<li>Polymer&nbsp;</li>
<li>Gene therapy</li>
</ul>
&nbsp;
Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
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<h2>Acute Myeloid Leukemia: Pipeline Development Activities&nbsp;</h2>
The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Acute Myeloid Leukemia therapeutic drugs key players involved in developing key drugs.&nbsp;
&nbsp;
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.
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<h2>Acute Myeloid Leukemia Report Insights</h2>
<ul>
<li>Acute Myeloid Leukemia Pipeline Analysis</li>
<li>Therapeutic Assessment</li>
<li>Unmet Needs</li>
<li>Impact of Drugs</li>
</ul>
&nbsp;
<h2>Acute Myeloid Leukemia Report Assessment</h2>
<ul>
<li>Pipeline Product Profiles</li>
<li>Therapeutic Assessment</li>
<li>Pipeline Assessment</li>
<li>Inactive drugs assessment</li>
<li>Unmet Needs</li>
</ul>
<h2>Key Questions</h2>
Current Treatment Scenario and Emerging Therapies:
<ul>
<li>How many companies are developing Acute Myeloid Leukemia drugs?</li>
<li>How many Acute Myeloid Leukemia drugs are developed by each company?</li>
<li>How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Acute Myeloid Leukemia?</li>
<li>What are the key collaborations (Industry&ndash;Industry, Industry&ndash;Academia), Mergers and acquisitions, licensing activities related to the Acute Myeloid Leukemia therapeutics?&nbsp;</li>
<li>What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?&nbsp;</li>
<li>What are the clinical studies going on for Acute Myeloid Leukemia and their status?</li>
<li>What are the key designations that have been granted to the emerging drugs?</li>
</ul>
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To read more about the latest highlights related to the Acute Myeloid Leukemia market, get a snapshot of the key highlights entailed @ <a href="../../report-store/acute-myeloid-leukemia-aml-market">Acute Myeloid Leukemia Market Report</a>
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Introduction
Executive Summary
Acute Myeloid Leukemia: Overview
<ul>
<li>Introduction</li>
<li>Causes</li>
<li>Pathophysiology&nbsp;</li>
<li>Signs and Symptoms</li>
<li>Diagnosis</li>
<li>Treatment</li>
</ul>
Pipeline Therapeutics
<ul>
<li>Comparative Analysis</li>
</ul>
Therapeutic Assessment
<ul>
<li>Assessment by Product Type</li>
<li>Assessment by Stage and Product Type</li>
<li>Assessment by Route of Administration</li>
<li>Assessment by Stage and Route of Administration</li>
<li>Assessment by Molecule Type</li>
<li>Assessment by Stage and Molecule Type&nbsp;</li>
</ul>
Acute Myeloid Leukemia&ndash; DelveInsight&rsquo;s Analytical Perspective
Late Stage Products (Phase III)
<ul>
<li>Comparative Analysis</li>
</ul>
Galinpepimut-S: Sellas Life Sciences Group
<ul>
<li>Product Description</li>
<li>Research and Development&nbsp;</li>
<li>Product Development Activities&nbsp;</li>
</ul>
Drug profiles in the detailed report&hellip;..
&nbsp;
Mid Stage Products (Phase II)
<ul>
<li>Comparative Analysis</li>
</ul>
Tagraxofusp: Stemline Therapeutics, Inc.
<ul>
<li>Product Description</li>
<li>Research and Development&nbsp;</li>
<li>Product Development Activities&nbsp;</li>
</ul>
Drug profiles in the detailed report&hellip;..
&nbsp;
Early Stage Products (Phase I)&nbsp;
<ul>
<li>Comparative Analysis</li>
</ul>
SGR-2921: Schrodinger, Inc.
<ul>
<li>Product Description</li>
<li>Research and Development&nbsp;</li>
<li>Product Development Activities&nbsp;</li>
</ul>
Drug profiles in the detailed report&hellip;..
&nbsp;
Preclinical and Discovery Stage Products&nbsp;
<ul>
<li>Comparative Analysis</li>
</ul>
VADC45: Vor Bio
<ul>
<li>Product Description</li>
<li>Research and Development&nbsp;</li>
<li>Product Development Activities&nbsp;</li>
</ul>
Drug profiles in the detailed report&hellip;..
&nbsp;
Inactive Products
<ul>
<li>Comparative Analysis</li>
</ul>
Acute Myeloid Leukemia Key Companies
Acute Myeloid Leukemia Key Products
Acute Myeloid Leukemia- Unmet Needs
Acute Myeloid Leukemia- Market Drivers and Barriers
Acute Myeloid Leukemia- Future Perspectives and Conclusion
Acute Myeloid Leukemia Analyst Views
Acute Myeloid Leukemia Key Companies
Appendix

DelveInsight’s, “Acute Myeloid Leukemia Pipeline Insight, 2024,” report provides comprehensive insights about 110+ companies and 120+ pipeline drugs in Acute Myeloid Leukemia pipeline landscape. It covers the pipeline drug profiles, including Acute Myeloid Leukemia clinical trials 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. 

Acute Myeloid Leukemia Pipeline

Acute Myeloid Leukemia Pipeline Insight, 2025

Acute Myeloid Leukemia (AML) Pipeline Insights, 2025 report  by DelveInsight outlays comprehensive insights of present clinical development scenario and growth prospects across the Acute My..