Acute Myeloid Leukemia Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies
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Key Takeaways from the Acute Myeloid Leukemia Pipeline Report
In March 2025, Janssen Research & Development, LLC conducted a study to determine the recommended Phase 2 dose(s) (RP2D[s]) of bleximenib in Phase 1 (Part 1 - Dose Escalation) and assess its safety and tolerability at RP2D in Phase 1 (Part 2 - Dose Expansion). The Phase 2 part of the study aims to evaluate the efficacy of bleximenib at the RP2D.
In March 2025, Akeso initiated an open-label, Phase Ib/II study involving patients diagnosed with acute myeloid leukemia (AML) with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. The study's objective is to evaluate the safety and efficacy of AK117 + azacitidine in AML patients.
DelveInsight's Acute Myeloid Leukemia Pipeline analysis depicts a robust space with 110+ active players working to develop 120+ pipeline treatment therapies.
The leading Acute Myeloid Leukemia Companies such as 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.
Promising Acute Myeloid Leukemia Therapies such as OCV-501, SEL24/MEN1703, Venetoclax, Alvocidib, TL-895, KRT-232, XY0206, Azacitidine, Venetoclax, and others.
Discover groundbreaking developments in Acute Myeloid Leukemia therapies! Gain in-depth knowledge of key Acute Myeloid Leukemia clinical trials, emerging drugs, and market opportunities @ Acute Myeloid Leukemia Clinical Trials Assessment
Acute Myeloid Leukaemia Emerging Drugs Profile
Uproleselan: GlycoMimetics
GlycoMimetics is developing uproleselan, a specific E-selectin antagonist, to be used in combination with chemotherapy to treat patients with Acute Myeloid Leukemia (AML) (AML) and potentially other hematologic cancers. Uproleselan is designed to bind to E-selectin and block the normal processes controlled by E-selectin. E-selectin is expressed on the surface of blood vessels, and its binding to myeloid cells confers a pro-survival effect via NF-kB signaling. Uproleselan is designed to provide a novel approach to disrupting established mechanisms of leukemic cell resistance. It is believed that by binding to E-selectin, uproleselan pushes AML cells out of their protective niche, blocks cellular communication signals that promote survival, and sensitizes cancer cells to the toxic effects of chemotherapy. Currently, the drug is in Phase III stage of its development for the treatment of Acute Myeloid Leukemia (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).
MK-0482: Merck Sharp & Dohme LLC
MK-0482, a novel humanized IgG4 mAb targeting ILT3, is undergoing phase I evaluation ±pembrolizumab (pembro) in advanced solid tumors. MK-0482 ± pembro was generally well tolerated, and combination therapy provided modest antitumor activity in patients with heavily pretreated advanced solid tumors. The RP2D of MK-0482 + pembro is under further evaluation in tumor-specific cohorts. Currently, the drug is in Phase I stage of its development for the treatment of AML.
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 I/II stage of its development for the treatment of 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 Preclinical 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
Stay informed about the Acute Myeloid Leukemia pipeline trends! Uncover critical updates on therapeutic innovations and their potential impact on patients and the healthcare industry @ Acute Myeloid Leukemia Unmet Needs
Acute Myeloid Leukemia Companies
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.
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
Transform your understanding of the Acute Myeloid Leukemia Pipeline! 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- 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 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
Stay Ahead in Oncology Research–Access the Full Acute Myeloid Leukemia Pipeline Analysis Today! @ Acute Myeloid Leukemia Drugs and Companies
Table of Content
Introduction
Executive Summary
Acute myeloid leukaemia: Overview
Pipeline Therapeutics
Therapeutic Assessment
Acute myeloid leukaemia – DelveInsight's Analytical Perspective
Late Stage Products (Phase III)
Uproleselan: GlycoMimetics
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
BST-236: BioSight
Drug profiles in the detailed report…..
Early Stage Products (Phase I)
MK-0482: Merck Sharp & Dohme LLC
Drug profiles in the detailed report…..
Preclinical and Discovery Stage Products
SENTI 202: Senti Biosciences
Drug profiles in the detailed report…..
Inactive Products
Acute myeloid leukaemia Key Companies
Acute myeloid leukaemia Key Products
Acute myeloid leukaemia- Unmet Needs
Acute myeloid leukaemia- Market Drivers and Barriers
Acute myeloid leukaemia- Future Perspectives and Conclusion
Acute myeloid leukaemia Analyst Views
Acute myeloid leukaemia Key Companies
Appendix
About Us
DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.
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