Acute Myeloid Leukemia Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies

DelveInsight's, "Acute Myeloid Leukemia Pipeline Insight" 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 22 August 2025, Debiopharm International SA announced a Phase 1 is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development (Dose optimization). The primary objective of Phase 2 is to evaluate the antileukemic activity of Debio 1562M.
* On 22 August 2025, Ascentage Pharma Group Inc . conducted a phase III pivotal registration study, to evaluate the efficacy of APG-2575 (Lisaftoclax) combined with azacitidine (AZA) versus placebo combined with azacitidine in newly diagnosed acute myeloid leukemia who are not eligible for standard induction chemotherapy.
* On 20 August 2025, OncoVerity, Inc . organized a study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.
* 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 BioSight, 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, Syndax Pharmaceuticals, Moleculin Biotech Inc. and others.
* Promising Acute Myeloid Leukemia Therapies such as OCV-501, SEL24/MEN1703, Venetoclax, Alvocidib, TL-895, KRT-232, XY0206, Azacitidine, Venetoclax, and others.

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Acute Myeloid Leukaemia Emerging Drugs Profile

* Ziftomenib - Kura Oncology

Ziftomenib is a novel, once-daily, oral investigational drug candidate targeting the menin-KMT2A/MLL protein-protein interaction for treatment of genetically defined AML patients with high unmet need. In preclinical models, ziftomenib inhibits the KMT2A/MLL protein complex and exhibits downstream effects on HOXA9/MEIS1 expression and potent anti-leukemic activity in genetically defined preclinical models of AML. Ziftomenib has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of AML. Currently, the drug is in Phase III stage of its development for the treatment of AML.

* Annamycin: Moleculin Biotech, Inc.

Annamycin is a next-generation anthracycline being evaluated in the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) Trial, a pivotal, adaptive design Phase III trial evaluating Annamycin in combination with cytarabine, together referred to as AnnAraC, for the treatment of relapsed or refractory acute myeloid leukemia (AML). If successful, Annamycin has the potential to transform the standard of care for 2nd line AML. Annamycin is also in development for the treatment of soft tissue sarcoma (STS). Annamycin has demonstrated in multiple clinical trials a lack of cardiotoxicity, allowing us to exceed the currently set maximum lifetime dosing for an anthracycline and potentially realizing the full therapeutic potential of anthracyclines to treat serious, hard-to-treat cancers. Currently the drug is in Phase III stage of its clinical trial for the treatment of AML.

* SNDX-5613: Syndax Pharmaceuticals

SNDX-5613 (revumenib) is an oral, selective inhibitor of the menin-KMT2A (MLL) interaction, being developed by Syndax Pharmaceuticals for the treatment of acute leukemias, particularly acute myeloid leukemia (AML) with KMT2A rearrangements or NPM1 mutations. By disrupting the menin-KMT2A complex, SNDX-5613 restores normal gene expression and promotes differentiation of leukemic cells. The therapy has shown promising efficacy in relapsed or refractory AML patients in early-phase clinical trials. Revumenib has received multiple regulatory designations, including Breakthrough Therapy and Orphan Drug status from the FDA. Currently the drug is in Phase II/III stage of its development for the treatment of AML.

* BST-236: BioSight

Aspacytarabine (BST-236) is a novel proprietary anti-metabolite. It is composed of cytarabine covalently bound to asparagine, acting as a pro-drug of cytarabine, enabling delivery of high cytarabine doses to leukemia patients with lower systemic exposure to the free drug. Currently, the drug is in Phase II stage of its development for the treatment of Acute Myeloid Leukemia (AML).

* SENTI 202: Senti Biosciences

SENTI-202 is a first in class Logic-gated CAR-NK product engineered with an OR and a NOT Logic Gate gene circuit approach to enhance therapeutic efficacy and safety, with additional arming via expression of calibrated release IL-15 (crIL-15). A dual targeting activating CAR (aCAR) that recognizes both CD33 and FLT3 tumor antigens improves the anti-tumor activity, ensuring the targeting of AML blasts and LSCs. Currently, the drug is in Phase I stage of its development for the treatment of AML.

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

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Acute Myeloid Leukemia Companies

BioSight, 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, Syndax Pharmaceuticals, Moleculin Biotech Inc. and others.

The Acute Myeloid Leukaemia 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

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Scope of the Acute Myeloid Leukemia Pipeline Report

* Coverage- Global
* Acute Myeloid Leukemia Companies- BioSight, 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, Syndax Pharmaceuticals, Moleculin Biotech Inc. 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: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Acute Myeloid Leukemia - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Ziftomenib: Kura Oncology
* Mid Stage Products (Phase II)
* BST-236: BioSight
* Early Stage Products (Phase I)
* SENTI 202: Senti Biosciences
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Inactive Products
* Acute Myeloid Leukemia Key Companies
* Acute Myeloid Leukemia Key Products
* Acute Myeloid Leukemia - Unmet Needs
* Acute Myeloid Leukemia - Market Drivers and Barriers
* Acute Myeloid Leukemia - Future Perspectives and Conclusion
* Acute Myeloid Leukemia Analyst Views
* Acute Myeloid Leukemia Key Companies
* Appendix

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