Acute Myeloid Leukemia (AML) - Pipeline Insight, 2026

DelveInsight's, "Acute Myeloid Leukemia (AML) - Pipeline Insight, 2026" report provides comprehensive insights about 100+ companies and 110+ pipeline drugs in Acute Myeloid Leukemia (AML) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also 2026 the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Acute Myeloid Leukemia (AML): Understanding

Acute Myeloid Leukemia (AML): 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.

The symptoms of acute myeloid leukemia usually develop over a few weeks, becoming more severe as the number of immature white blood cells increases. Symptoms of AML can include: skin looking pale or "washed out", tiredness, breathlessness, losing weight without trying, frequent infections, easily bruised skin, flat red or purple spots on the skin, bone and joint paint.Patients with myeloproliferative neoplasms such as myelofibrosis, essential thrombocythemia, polycythemia vera, and chronic myeloid leukemia can evolve into more aggressive myeloid malignancies like acute myeloid leukemia. The features of disease progression differ according to the underlying clinical presentation, but are often characterized by declining blood counts and rising levels of circulating blasts. Along with myelodysplastic syndromes and other conditions such as aplastic anemia, these disorders are grouped under the category of secondary acute myeloid leukemia.

AML should be suspected in patients presenting with rapidly developing unexplained cytopenias, circulating blast cells in peripheral blood, easy bruising or bleeding, or recurrent infections. Laboratory findings reflecting a high tumor burden and rapid cell turnover may include elevated levels of LDH, uric acid, potassium, and phosphorus. Once the diagnosis is confirmed, baseline assessments such as electrocardiography (ECG) and 2D echocardiography are recommended to evaluate cardiac function and anticipate potential cardiotoxic effects of therapies.Management of Acute Myeloid Leukemia is based on risk-adapted, multi-modal therapy integrating intensive cytotoxic chemotherapy, molecularly targeted approaches, and hematopoietic stem cell transplantation. Induction therapy aims to achieve complete remission through eradication of leukemic blasts, typically using combination regimens that disrupt DNA synthesis and induce apoptosis. This is followed by consolidation therapy to eliminate minimal residual disease and reduce relapse risk, guided by cytogenetic and molecular risk stratification.

"Acute Myeloid Leukemia (AML) - Pipeline Insight, 2026" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Acute Myeloid Leukemia (AML) pipeline landscape is provided which includes the disease overview and Acute Myeloid Leukemia (AML) treatment guidelines. The assessment part of the report embraces, in depth Acute Myeloid Leukemia (AML) 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 (AML) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Acute Myeloid Leukemia (AML) R&D. The therapies under development are focused on novel approaches to treat/improve Acute Myeloid Leukemia (AML).

Acute Myeloid Leukemia (AML) Emerging Drugs Chapters

This segment of the Acute Myeloid Leukemia (AML) report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Acute Myeloid Leukemia (AML) Emerging Drugs

• 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.

Acute Myeloid Leukemia (AML): Therapeutic Assessment

This segment of the report provides insights about the different Acute Myeloid Leukemia (AML) drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Acute Myeloid Leukemia (AML)
• There are approx. 100+ key companies which are developing the therapies for Acute Myeloid Leukemia (AML). The companies which have their Acute Myeloid Leukemia (AML) drug candidates in the most advanced stage, i.e. Preregistration include, Orca Biosystems, Inc., and others.
• Phases

DelveInsight's 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) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Acute Myeloid Leukemia (AML) 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
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Acute Myeloid Leukemia (AML): Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Acute Myeloid Leukemia (AML) therapeutic drugs key players involved in developing key drugs.

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 (AML) drugs.

Acute Myeloid Leukemia (AML) Report Insights

• Acute Myeloid Leukemia (AML) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Acute Myeloid Leukemia (AML) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Acute Myeloid Leukemia (AML) drugs?
• How many Acute Myeloid Leukemia (AML) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Acute Myeloid Leukemia (AML)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Acute Myeloid Leukemia (AML) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Acute Myeloid Leukemia (AML) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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

Key Products

• Bleximenib
• Orca-T
• ABD-3001
• Romaciclib
• CER-1236
• PRO CAR-301
• Clifutinib
• BL-M11D1
• Tagraxofusp
• Cusatuzumab
• QHRD-107
• DFP-10917
• MEN1703
• Debio-1562M
• AK-117
• AZD-3632
• MB-dNPM1-TCR.1
• AB-8939
• CTX-712
• MP-0533
• GDX-012
• ARD-103
• GB3226