Acute Myeloid Leukemia Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Acute Myeloid Leukemia Pipeline Insight" report provides comprehensive insights about 110+ companies and 120+ 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 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

* 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.

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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 plus-minus pembrolizumab (pembro) in advanced solid tumors. MK-0482 plus-minus 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

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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

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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

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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

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