DelveInsight’s “Acute Myeloid Leukemia Pipeline Insights 2026” 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 Acute Myeloid Leukemia clinical trials and nonclinical stage products. It also covers the Acute Myeloid Leukemia pipeline 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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Key Takeaways from the Acute Myeloid Leukemia Pipeline Report
- On May 20, 2026- Syndax Pharmaceuticals initiated a phase 3 study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.
- On May 20, 2026- M.D. Anderson Cancer Center conducted a phase I-II clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine/cedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL).
- On May 12, 2026- AbbVie initiated a phase 4 study will assess the change in disease activity and adverse events in adult participants with acute myeloid leukemia (AML) being treated with of the combination of azacitidine and venetoclax, in India.
- On May 08, 2026- Janssen Research & Development LLC conducted a study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
- DelveInsight’s Acute Myeloid Leukemia Pipeline analysis depicts a robust space with 100+ active players working to develop 110+ pipeline treatment therapies.
- The leading Acute Myeloid Leukemia Companies such as Johnson & Johnson, Orca Biosystems, Inc., Ryvu Therapeutics, Advanced BioDesign, CERo Therapeutics Holdings, Inc., Promicell INC., Sunshine Lake Pharma, Sichuan Baili Pharmaceutical, Stemline Therapeutics, OncoVerity, Changzhou Qianhong Bio-pharma Co., Ltd., Delta-Fly Pharma, Menarini, Debiopharm International SA, Akeso Biopharma, AstraZeneca, Miltenyi Biomedicine GmbH, AB Science, Chordia Therapeutics, Molecular Partners AG, Takeda, ARCE Therapeutics, Galecto Biotech AB, Shenzhen TargetRx Co., Ltd., CRISPR Therapeutics, Lomond Therapeutics, BioLite, Mind Medicine, Tris Pharma, RespireRx Pharmaceuticals and others.
- Promising Acute Myeloid Leukemia Therapies such as OCV-501, SEL24/MEN1703, Venetoclax, Alvocidib, TL-895, KRT-232, XY0206, Azacitidine, Venetoclax, and others.
Gain in-depth knowledge of key clinical trials, emerging drugs, and market opportunities @ Acute Myeloid Leukemia Clinical Trials Assessment
The Acute Myeloid Leukemia Pipeline Report provides disease overview, pipeline scenario and therapeutic assessment of the key pipeline therapies in this domain. The Acute Myeloid Leukemia Pipeline Report also highlights the unmet needs with respect to the Acute Myeloid Leukemia.
Acute Myeloid Leukemia Overview
Acute myeloid leukemia (AML) is a rapidly progressing myeloid neoplasm characterized by the clonal expansion of immature myeloid-derived cells, known as blasts, in the peripheral blood and bone marrow. This expansion results in ineffective erythropoiesis and megakaryopoiesis, clinically manifesting as relatively rapid bone marrow failure compared to chronic and indolent leukemias. This leads to inadequate production of red blood cells and platelets.
Acute Myeloid Leukaemia Emerging Drugs Profile
- Orca-T: Orca Biosystems, Inc.
Orca-T is an investigational allogeneic T-cell immunotherapy under evaluation for the treatment of multiple hematologic malignancies including acute leukemias and myelodysplastic syndromes. Orca-T is composed of highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from either related or unrelated matched donors. Currently, the drug is being evaluated in the Preregistration stage of its development for the treatment of Acute Myeloid Leukemia.
- Bleximenib: Johnson & Johnson
Bleximenib (JNJ-75276617) is an investigational, oral, small-molecule menin-KMT2A inhibitor showing promising activity against acute myeloid leukemia (AML) with KMT2A rearrangements or NPM1 mutations. It targets a key oncogenic interaction between menin and KMT2A fusion proteins, disrupting a pathway that drives leukemic cell growth in patients with KMT2Ar or NPM1m mutations. Currently, the drug is being evaluated in the Phase III stage of its development for the treatment of Acute Myeloid Leukemia.
- Romaciclib: Ryvu Therapeutics
Romaciclib is a highly selective inhibitor of CDK8 and CDK19, minimizing off-target effects and enhancing therapeutic efficacy. This targeted approach disrupts key transcriptional programs essential for cancer cell survival while sparing healthy cells. Romaciclib has demonstrated a low potential for drug-drug interactions, making it a safer choice for patients undergoing multiple concurrent treatments. This reduces the likelihood of adverse interactions and supports better overall treatment outcomes. Currently, the drug is being evaluated in the Phase II stage of its development for the treatment of Acute Myeloid Leukemia.
- ABD-3001: Advanced BioDesign
ABD-3001, is a small-molecules inhibitor of the ALDH family of enzymes that is at the initial stage of clinical development for a wide range of cancers, including acute myeloid leukemia. Currently, the drug is being evaluated in the Phase I/II stage of its development for the treatment of Acute Myeloid Leukemia. This drug irreversibly binds to and inhibits ALDH1 and ALDH3, leading to metabolic stress and destruction of cancer stem cells. Currently, the drug is being evaluated in the Phase I/II stage of its development for the treatment of Acute Myeloid Leukemia.
- CER-1236: CERo Therapeutics Holdings, Inc.
CER-1236 is an autologous chimeric engulfment receptor T cell (CER-T) which fuses external domain of TIM-4 with intracellular domains from T cells and innate immune cells including Toll-like receptor 2 (TLR2), CD28 and CD3ζ. This receptor binds TIM-4-ligand (phosphatidylserine) on tumor cells leading to phagocytosis and lysis of target cells followed by tumor antigen processing and cross-presentation to induce an adaptive immune response. CER-1236 was shown to eliminate AML cell in vitro, and in vivo in a xenograft model. Currently, the drug is being evaluated in the Phase I stage of its development for the treatment of Acute Myeloid Leukemia.
- PRO CAR-301: Promicell INC.
PRO CAR-301 is an autologous CD33-directed CAR T cell that integrates a next-generation armor known as “SAVVY/IL-18”. It is an armored CD33-specific CAR T therapy for acute myeloid leukemia. It targets CD33, a cell surface protein expressed by mature myeloid cells and hematopoietic stems cells. This protein is expressed on over 80% of AML cells and hematopoietic stem cells which makes it an effective treatment target. Currently, the drug is being evaluated in the preclinical stage of its development for the treatment of Acute Myeloid Leukemia.
Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Acute Myeloid Leukemia Unmet Needs
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 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
Acute Myeloid Leukemia Companies
Johnson & Johnson, Orca Biosystems, Inc., Ryvu Therapeutics, Advanced BioDesign, CERo Therapeutics Holdings, Inc., Promicell INC., Sunshine Lake Pharma, Sichuan Baili Pharmaceutical, Stemline Therapeutics, OncoVerity, Changzhou Qianhong Bio-pharma Co., Ltd., Delta-Fly Pharma, Menarini, Debiopharm International SA, Akeso Biopharma, AstraZeneca, Miltenyi Biomedicine GmbH, AB Science, Chordia Therapeutics, Molecular Partners AG, Takeda, ARCE Therapeutics, Galecto Biotech AB, Shenzhen TargetRx Co., Ltd., CRISPR Therapeutics, Lomond Therapeutics, BioLite, Mind Medicine, Tris Pharma, RespireRx Pharmaceuticals and others.
The 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 Leukaemia Products have been categorized under various Molecule types such as
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
See the latest progress in drug development and clinical research @ Acute Myeloid Leukemia Market Drivers and Barriers, and Future Perspectives
Scope of the Acute Myeloid Leukemia Pipeline Report
- Coverage- Global
- Acute Myeloid Leukemia Companies- Johnson & Johnson, Orca Biosystems, Inc., Ryvu Therapeutics, Advanced BioDesign, CERo Therapeutics Holdings, Inc., Promicell INC., Sunshine Lake Pharma, Sichuan Baili Pharmaceutical, Stemline Therapeutics, OncoVerity, Changzhou Qianhong Bio-pharma Co., Ltd., Delta-Fly Pharma, Menarini, Debiopharm International SA, Akeso Biopharma, AstraZeneca, Miltenyi Biomedicine GmbH, AB Science, Chordia Therapeutics, Molecular Partners AG, Takeda, ARCE Therapeutics, Galecto Biotech AB, Shenzhen TargetRx Co., Ltd., CRISPR Therapeutics, Lomond Therapeutics, BioLite, Mind Medicine, Tris Pharma, RespireRx Pharmaceuticals and others.
- Acute Myeloid Leukemia Therapies- OCV-501, SEL24/MEN1703, Venetoclax, Alvocidib, TL-895, KRT-232, XY0206, Azacitidine, Venetoclax, and others.
- Acute Myeloid Leukemia Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Acute Myeloid Leukemia Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
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Table of Content
- Introduction
- Executive Summary
- Acute Myeloid Leukemia (AML): Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Acute Myeloid Leukemia (AML) – DelveInsight’s Analytical Perspective
- Late Stage Products (Preregistration)
- Orca-T: Orca Biosystems, Inc.
- Mid Stage Products (Phase II)
- Romaciclib: Ryvu Therapeutics
- Early Stage Products (Phase I)
- CER-1236: CERo Therapeutics Holdings, Inc.
- Preclinical and Discovery Stage Products
- PRO CAR-301: Promicell Inc.
- Inactive Products
- Acute Myeloid Leukemia (AML) Key Companies
- Acute Myeloid Leukemia (AML) Key Products
- Acute Myeloid Leukemia (AML) – Unmet Needs
- Acute Myeloid Leukemia (AML) – Market Drivers and Barriers
- Acute Myeloid Leukemia (AML) – Future Perspectives and Conclusion
- Acute Myeloid Leukemia (AML) Analyst Views
- Acute Myeloid Leukemia (AML) Key Companies
- Appendix
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