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, 2026“ 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:
Companies across the globe are diligently working toward developing novel Acute Myeloid Leukemia treatment therapies with a considerable amount of success over the years.
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
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.
In OCtober 2026, Cullinan Therapeutics advances CLN-049 into a Phase II study: Cullinan Therapeutics announced that the first patient had been dosed in its potentially registrational Phase II trial evaluating CLN-049, an investigational FLT3×CD3 T-cell engager, in patients with relapsed/refractory AML. The study will assess safety and efficacy, with an exploratory cohort for newly diagnosed TP53-mutated AML. The company also plans to evaluate CLN-049 in combination with azacitidine and venetoclax in newly diagnosed AML.
In September 2026, FDA clears ORM-1153 for clinical testing: Orum Therapeutics received FDA clearance to initiate a first-in-human Phase I trial of ORM-1153, an investigational infusion therapy for relapsed or treatment-resistant AML and other blood cancers. The study (NCT07809906) is expected to enroll approximately 42 participants and assess safety, tolerability, pharmacological properties, and preliminary antitumor activity. This is a clinical trial authorization, not an FDA marketing approval.
In September 2026, Aptevo reports encouraging results for mipletamig combination therapy: Aptevo Therapeutics reported a 93% clinical benefit rate among evaluable patients with newly diagnosed, TP53-mutated AML receiving a mipletamig-based triplet regimen. The findings represent an early clinical development update in a difficult-to-treat patient population; further evaluation is needed to establish the regimen’s efficacy and safety.
In August 2026, FDA grants orphan drug designation to BAL0891: The FDA granted orphan drug designation to BAL0891, an investigational small-molecule therapy that simultaneously targets TTK and PLK1, for AML treatment. BAL0891 is being evaluated in a Phase I clinical trial (NCT05768932) involving patients with relapsed/refractory AML and individuals with advanced solid tumors. The designation may support its development for this rare disease but does not constitute marketing approval.
In July 2026, CLN-049 receives positive FDA feedback for Phase II development: Cullinan Therapeutics announced positive feedback from the FDA following an End-of-Phase I meeting for CLN-049. The company planned to advance the investigational FLT3×CD3 T-cell engager into a potentially registrational Phase II study in relapsed/refractory AML, with an additional combination study planned for newly diagnosed AML.
In May 2026, FDA approves an all-oral combination for newly diagnosed AML: The FDA approved decitabine and cedazuridine tablets (Inqovi) in combination with venetoclax for adults with newly diagnosed AML who are 75 years or older, or who have comorbidities that prevent intensive induction chemotherapy. In the supporting ASTX727-07 study, 41.6% of patients achieved complete remission. The approval expands treatment options for older or medically unfit patients who cannot undergo intensive chemotherapy.
In October 2025, CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based clinical stage biopharmaceutical company focused on harnessing its proprietary technologies to develop novel affordable donor-derived cell-based immunotherapies for the treatment of a broad range of cancers, including both blood and solid tumours, is pleased to announce the publication of a preclinical study, in a research article entitled “Donor-Derived Vγ9Vδ2 T Cells for Acute Myeloid Leukemia: A Promising “off-the-shelf” Immunotherapy Approach”. The study results from this collaborative research with The University of Texas, MD Anderson Cancer Center (MDACC), are suggesting the promising potential of CytoMed’s allogeneic γδ T cell therapy (CTM-GDT) for treating acute myeloid leukemia (AML).
In September 2025, Akeso Inc. (9926.HK) announced that its proprietary next-generation humanized IgG4 monoclonal antibody targeting CD47, ligufalimab (AK117), has received Orphan Drug Designation (ODD) from the U.S. FDA for treating acute myeloid leukemia (AML). The Orphan Drug Designation is an FDA program designed to encourage the development of therapies for rare diseases. Products granted this status receive comprehensive FDA guidance during development, tax incentives, and up to seven years of market exclusivity upon approval.
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.
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.
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:
GNC 035: SystImmune
JSP 191: Jasper Therapeutics
ONC201: Chimerix
AK117: Akeso Biopharma Co., Ltd.
Tamibarotene: Syros Pharmaceuticals
TCB008: TC Biopharm
Elzonris: Stemline Therapeutics
Orca T: Orca Bio
Magrolimab+ azacitidine: Gilead Sciences
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
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 Pipeline Therapeutics Assessment
Acute Myeloid Leukemia Assessment by Product Type
Acute Myeloid Leukemia By Stage and Product Type
Acute Myeloid Leukemia Assessment by Route of Administration
Acute Myeloid Leukemia By Stage and Route of Administration
Acute Myeloid Leukemia Assessment by Molecule Type
Acute Myeloid Leukemia by Stage and Molecule Type
DelveInsight’s Acute Myeloid Leukemia 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)
Pre-clinical and Discovery stage candidates
Discontinued & Inactive candidates
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
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.
It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Acute Myeloid Leukemia Treatment.
Acute Myeloid Leukemia key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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.
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
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
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
Coverage: Global
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
Key Acute Myeloid Leukemia Therapies: GNC 035, JSP 191, ONC201, AK117, Tamibarotene, TCB008, Elzonris, Orca T, Magrolimab+ azacitidine, Uproleselan, and others
Acute Myeloid Leukemia Therapeutic Assessment: Acute Myeloid Leukemia current marketed and Acute Myeloid Leukemia emerging therapies
Acute Myeloid Leukemia Market Dynamics: Acute Myeloid Leukemia market drivers and Acute Myeloid Leukemia market barriers
Request for Sample PDF Report for Acute Myeloid Leukemia Pipeline Assessment and clinical trials
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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