The Acute Myeloid Leukemia Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.
“Acute Myeloid Leukemia Pipeline Insight, 2025" report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Acute Myeloid Leukemia Market.
Some of the key takeaways from the Acute Myeloid Leukemia Pipeline Report:
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Companies across the globe are diligently working toward developing novel Acute Myeloid Leukemia treatment therapies with a considerable amount of success over the years.
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Acute Myeloid Leukemia companies working in the treatment market are SystImmune, Jasper Therapeutics, Chimerix, Akeso Biopharma Co., Ltd., Syros Pharmaceuticals, TC Biopharm, Stemline Therapeutics, Orca Bio, Gilead Sciences, GlycoMimetics, and others, are developing therapies for the Acute Myeloid Leukemia treatment
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Emerging Acute Myeloid Leukemia therapies in the different phases of clinical trials are- GNC 035, JSP 191, ONC201, AK117, Tamibarotene, TCB008, Elzonris, Orca T, Magrolimab+ azacitidine, Uproleselan, and others are expected to have a significant impact on the Acute Myeloid Leukemia market in the coming years.
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In April 2025, CERo Therapeutics has announced that the Colorado Blood Cancer Institute (CBCI) at the Sarah Cannon Research Institute (SCRI), US, will serve as the lead site for its Phase I clinical trial of CER-1236 for the treatment of acute myeloid leukemia (AML). Patient enrollment is currently underway for this first-in-human study, with initial cohort dosing expected to begin by June. This open-label, multi-centre Phase I/Ib trial is designed to evaluate the early safety and efficacy of CER-1236 in patients with relapsed or refractory AML, measurable residual disease, or those carrying a tumor protein p53 (TP53) gene mutation.
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In February 2025, U.S.-based Moleculin Biotech received approval from Ukraine’s Ministry of Health to initiate patient enrollment for its Phase III MIRACLE trial, evaluating annamycin with cytarabine for the treatment of acute myeloid leukemia (AML). The study will be conducted across multiple sites in Europe, the Middle East, and the U.S., enrolling AML patients who are refractory to or have relapsed after induction therapy.
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In January 2025, The FDA granted Fast Track designation to LYT-200, a first-in-class anti-galectin-9 monoclonal antibody, for its potential in treating patients with acute myeloid leukemia (AML). Luba Greenwood, JD, entrepreneur-in-residence at PureTech and leader of the Gallop Oncology program, stated in a press release that this designation supports their confidence in LYT-200’s potential to meet the urgent needs of AML patients. This achievement adds to previous FDA recognitions, including orphan drug status for AML and another Fast Track designation awarded last year for head and neck cancers.
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In October 2024, Qurient Co. Ltd. (KRX: 115180) has initiated a clinical trial for adrixetinib (formerly Q702) following the U.S. FDA's approval of its investigational new drug (IND) application. This Phase 1 dose-escalation and expansion study aims to evaluate the safety and preliminary efficacy of adrixetinib as a monotherapy and in a triplet combination with venetoclax and azacitidine for patients with relapsed or refractory acute myeloid leukemia (AML) (ClinicalTrials.gov Identifier: NCT06445907). Adrixetinib, an oral selective inhibitor targeting AXL/MER/CSF1R kinases, has shown strong anti-tumor activity, enhancing chemo-sensitivity and immune response in various tumor models. The novel combination therapy holds promise for synergistically improving outcomes in AML treatment.
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In September 2024, Rigel Pharmaceuticals announced the enrollment of the first participant in a Phase Ib/II clinical trial evaluating REZLIDHIA (olutasidenib) in combination with decitabine and venetoclax for patients with acute myeloid leukemia (AML) harboring mutated isocitrate dehydrogenase-1 (mIDH1). This multicenter, open-label, non-randomized study is sponsored and conducted by The University of Texas MD Anderson Cancer Center in the US.
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In May 2024, GlycoMimetics, a biotechnology company based in the United States, has unveiled the key findings from its Phase III clinical trial of uproleselan, an E-selectin antagonist developed for the treatment of relapsed/refractory acute myeloid leukemia (r/r AML). The randomized, double-blind, placebo-controlled trial evaluated uproleselan in combination with either mitoxantrone, etoposide, and cytarabine (MEC) or fludarabine, cytarabine, and idarubicin (FAI) chemotherapy regimens. Patients were administered either uproleselan or a placebo during one cycle of induction and up to three cycles of consolidation, if applicable.
Acute Myeloid Leukemia Overview
Acute Myeloid Leukemia (AML) is a type of cancer that affects the bone marrow and blood. It is characterized by the rapid growth of abnormal white blood cells, known as myeloblasts or leukemic blasts, which are immature cells that fail to mature into normal white blood cells. These abnormal cells accumulate in the bone marrow and interfere with the production of normal blood cells, including red blood cells, white blood cells, and platelets.
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Emerging Acute Myeloid Leukemia Drugs Under Different Phases of Clinical Development Include:
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GNC 035: SystImmune
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JSP 191: Jasper Therapeutics
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ONC201: Chimerix
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AK117: Akeso Biopharma Co., Ltd.
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Tamibarotene: Syros Pharmaceuticals
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TCB008: TC Biopharm
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Elzonris: Stemline Therapeutics
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Orca T: Orca Bio
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Magrolimab+ azacitidine: Gilead Sciences
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Uproleselan: GlycoMimetics
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
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Oral
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Intravenous
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Subcutaneous
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Parenteral
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Topical
Acute Myeloid Leukemia Molecule Type
Acute Myeloid Leukemia Products have been categorized under various Molecule types, such as
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Recombinant fusion proteins
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Small molecule
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Monoclonal antibody
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Peptide
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Polymer
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Gene therapy
Acute Myeloid Leukemia Pipeline Therapeutics Assessment
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Acute Myeloid Leukemia Assessment by Product Type
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Acute Myeloid Leukemia By Stage and Product Type
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Acute Myeloid Leukemia Assessment by Route of Administration
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Acute Myeloid Leukemia By Stage and Route of Administration
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Acute Myeloid Leukemia Assessment by Molecule Type
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Acute Myeloid Leukemia by Stage and Molecule Type
DelveInsight's Acute Myeloid Leukemia Report covers around 120+ products under different phases of clinical development like
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Late-stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I)
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
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Route of Administration
Further Acute Myeloid Leukemia product details are provided in the report. Download the Acute Myeloid Leukemia pipeline report to learn more about the emerging Acute Myeloid Leukemia therapies
Some of the key companies in the Acute Myeloid Leukemia Therapeutics Market include:
Key companies developing therapies for Acute Myeloid Leukemia are - 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, and others.
Acute Myeloid Leukemia Pipeline Analysis:
The Acute Myeloid Leukemia pipeline report provides insights into
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The report provides detailed insights about companies that are developing therapies for the treatment of Acute Myeloid Leukemia with aggregate therapies developed by each company for the same.
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It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Acute Myeloid Leukemia Treatment.
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Acute Myeloid Leukemia key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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Acute Myeloid 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.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Acute Myeloid Leukemia market.
The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.
Download Sample PDF Report to know more about Acute Myeloid Leukemia drugs and therapies
Acute Myeloid Leukemia Pipeline Market Drivers
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Rising incidence of Acute Myeloid Leukemia, advancements in pharmacology and molecular biology to promote drug development, rising geriatric population are some of the important factors that are fueling the Acute Myeloid Leukemia Market.
Acute Myeloid Leukemia Pipeline Market Barriers
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However, high cost associated with the management of AML, side effects associated with the AML treatment and other factors are creating obstacles in the Acute Myeloid Leukemia Market growth.
Scope of Acute Myeloid Leukemia Pipeline Drug Insight
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Coverage: Global
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Key Acute Myeloid Leukemia Companies: SystImmune, Jasper Therapeutics, Chimerix, Akeso Biopharma Co., Ltd., Syros Pharmaceuticals, TC Biopharm, Stemline Therapeutics, Orca Bio, Gilead Sciences, GlycoMimetics, and others
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Key Acute Myeloid Leukemia Therapies: GNC 035, JSP 191, ONC201, AK117, Tamibarotene, TCB008, Elzonris, Orca T, Magrolimab+ azacitidine, Uproleselan, and others
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Acute Myeloid Leukemia Therapeutic Assessment: Acute Myeloid Leukemia current marketed and Acute Myeloid Leukemia emerging therapies
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Acute Myeloid Leukemia Market Dynamics: Acute Myeloid Leukemia market drivers and Acute Myeloid Leukemia market barriers
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Table of Contents
1. Acute Myeloid Leukemia Report Introduction
2. Acute Myeloid Leukemia Executive Summary
3. Acute Myeloid Leukemia Overview
4. Acute Myeloid Leukemia- Analytical Perspective In-depth Commercial Assessment
5. Acute Myeloid Leukemia Pipeline Therapeutics
6. Acute Myeloid Leukemia Late Stage Products (Phase II/III)
7. Acute Myeloid Leukemia Mid Stage Products (Phase II)
8. Acute Myeloid Leukemia Early Stage Products (Phase I)
9. Acute Myeloid Leukemia Preclinical Stage Products
10. Acute Myeloid Leukemia Therapeutics Assessment
11. Acute Myeloid Leukemia Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Acute Myeloid Leukemia Key Companies
14. Acute Myeloid Leukemia Key Products
15. Acute Myeloid Leukemia Unmet Needs
16 . Acute Myeloid Leukemia Market Drivers and Barriers
17. Acute Myeloid Leukemia Future Perspectives and Conclusion
18. Acute Myeloid Leukemia Analyst Views
19. Appendix
20. About DelveInsight
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. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
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