With Acute Myeloid Leukemia (AML) becoming increasingly prevalent worldwide and contributing to comorbidities such as diabetes, cardiovascular disease, and certain cancers, there is an urgent need for safer and more effective therapies. DelveInsight reports that over 110 pharmaceutical and biotech companies are actively developing more than 120 therapeutic candidates targeting AML. These therapies span multiple stages of clinical and preclinical development, highlighting significant innovation and commitment to addressing this major public health challenge.
The “Acute Myeloid Leukemia Pipeline Insight 2025” report by DelveInsight offers a comprehensive strategic analysis of the current R&D landscape. It examines clinical trial progress, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives, making it an essential resource for researchers, healthcare investors, and decision-makers seeking insights into the evolving AML therapeutics market and the breakthroughs shaping its future.
Explore the Cutting-Edge Landscape of Acute Myeloid Leukemia Drug Development
Key Takeaways from the Acute Myeloid Leukemia Pipeline Report
DelveInsight’s report on the Acute Myeloid Leukemia (AML) pipeline highlights a highly active landscape, with over 110 companies developing more than 120 therapeutic candidates targeting AML.
Notable recent developments in 2025 include:
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March 2025: CERo Therapeutics Holdings, Inc. received a favorable FDA review for its IND amendment related to Chemistry, Manufacturing, and Controls (CMC), enabling patient dosing and shortening production timelines by about one week.
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February 2025: Moleculin Biotech, Inc. obtained FDA feedback on its IND amendment, allowing a reduction in Phase 3 trial size for the AnnAraC study, which tests Annamycin + Cytarabine in relapsed or refractory AML (R/R AML) patients.
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February 2025: Kura Oncology and Kyowa Kirin reported positive topline results from KOMET-001, a Phase 2 registration-focused trial of ziftomenib, an oral menin inhibitor for R/R AML patients with NPM1 mutations.
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February 2025: Auron Therapeutics advanced its KAT2A/B program, including the clinical candidate AUTX-703, and completed a $27 million Series B financing round to support further development.
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January 2025: Medexus received FDA approval for GRAFAPEX™, an alkylating agent combined with fludarabine, for use as a preparative regimen in alloHSCT for AML and MDS patients aged one year and older.
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January 2025: PureTech Health was granted Fast Track designation by the FDA for LYT-200, an investigational AML therapy, accelerating development and review due to the urgent need for new treatments.
Leading companies involved in AML drug development include Sellas Life Sciences, Stemline Therapeutics, Wugen, Schrodinger, MEI Pharma, Vor Bio, TC BioPharm, Pacylex Pharmaceuticals, Vor Biopharma, Vincerx Pharma, Aptose Biosciences, Tr1X, Zhejiang ACEA Pharmaceutical, BeiGene, Seagen, Sanofi, Servier Bio-Innovation, Ryvu Therapeutics, Remix Therapeutics, Prelude Therapeutics, Precigen, PharmaEngine, Orca Biosystems, Immune System Key, MacroGenics, Sutro Biopharma, and others.
Promising AML pipeline candidates in various stages of development include Galinpepimut-S, Tagraxofusp, WU-NK-101, SGR-2921, Voruciclib, VADC45, and several more.
Acute Myeloid Leukemia Overview:
Acute Myeloid Leukemia (AML) is a fast-progressing blood cancer marked by the uncontrolled growth of immature myeloid cells (blasts) in the bone marrow and bloodstream. This abnormal proliferation interferes with normal blood cell development, impairing the production of red blood cells and platelets due to defective erythropoiesis and megakaryopoiesis. As a result, AML leads to rapid bone marrow failure, distinguishing it from slower-developing types of leukemia.
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Acute Myeloid Leukemia Pipeline Analysis
The Acute Myeloid Leukemia pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Acute Myeloid Leukemia Market.
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Categorizes Acute Myeloid Leukemia therapeutic companies by development stage: early, mid, and late-stage.
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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.
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Reviews emerging Acute Myeloid Leukemia drugs under development based on:
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Stage of development
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Acute Myeloid Leukemia Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Acute Myeloid Leukemia Mechanism of action
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Molecular type
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Offers detailed analysis of:
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Company-to-company and company-academia collaborations
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Acute Myeloid Leukemia Licensing agreements
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Funding and investment activities supporting future Acute Myeloid Leukemia market advancement.
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Unlock key insights into emerging Acute Myeloid Leukemia therapies and market strategies here: https://www.delveinsight.com/report-store/acute-myeloid-leukemia-aml-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Acute Myeloid Leukemia Emerging Drugs
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Galinpepimut-S: Sellas Life Sciences Group
Galinpepimut-S (GPS) is a novel immunotherapy designed to target the WT1 protein, a nuclear protein implicated in the development and progression of various cancers. While WT1 is essential for fetal kidney development, its expression is largely absent in normal adult tissues, making it an attractive target for cancer therapy.
GPS is being developed both as a monotherapy and in combination with other treatments for multiple cancer types. The therapy comprises four synthetic peptides, two of which carry single amino acid modifications that make them appear “non-self” to the immune system. This strategy helps reduce immune tolerance and enhances the immune system’s ability to identify and eliminate cancer cells.
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Tagraxofusp: Stemline Therapeutics, Inc.
TAGRAXOFUSP is a targeted cancer therapy engineered to act on the interleukin-3 receptor alpha (CD123), which is commonly expressed in several malignancies. The therapy combines recombinant human IL-3 with a modified diphtheria toxin (DT), in which the toxin’s natural receptor-binding domain is replaced by IL-3. This design allows TAGRAXOFUSP to specifically bind to and enter cells expressing CD123.
Acute Myeloid Leukemia Pipeline Therapeutic Assessment
Acute Myeloid Leukemia Assessment by Product Type
• Mono
• Combination
• Mono/Combination
Acute Myeloid Leukemia By Stage
• 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 Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Acute Myeloid Leukemia Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
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Table of Contents
1. Report Introduction
2. Executive Summary
3. Acute Myeloid Leukemia Current Treatment Patterns
4. Acute Myeloid Leukemia - DelveInsight's Analytical Perspective
5. Therapeutic Assessment
6. Acute Myeloid Leukemia Late-Stage Products (Phase-III)
7. Acute Myeloid Leukemia Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Acute Myeloid Leukemia Discontinued Products
13. Acute Myeloid Leukemia Product Profiles
14. Acute Myeloid Leukemia Key Companies
15. Acute Myeloid Leukemia Key Products
16. Dormant and Discontinued Products
17. Acute Myeloid Leukemia Unmet Needs
18. Acute Myeloid Leukemia Future Perspectives
19. Acute Myeloid Leukemia Analyst Review
20. Appendix
21. Report Methodology
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About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
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