With relapsed/refractory acute myeloid leukemia (AML) becoming increasingly prevalent worldwide and contributing to comorbidities such as diabetes, cardiovascular disease, and other cancers, there is a rising need for safer and more effective therapies. According to DelveInsight, the AML pipeline includes 50+ pharmaceutical and biotech companies actively developing over 75 therapeutic candidates targeting relapsed/refractory AML. These candidates span multiple stages of clinical and preclinical development, highlighting the strong innovation and commitment to tackling this critical healthcare challenge.
DelveInsight’s “Relapsed/refractory Acute Myeloid Leukemia (AML) Pipeline Insight 2025” report provides a comprehensive and strategic assessment of the R&D landscape. It covers clinical trial progress, emerging therapies, mechanisms of action, competitive positioning, and key company initiatives, serving as an essential resource for researchers, healthcare investors, and decision-makers seeking insights into the evolving AML therapeutics market and the innovations shaping its future.
Explore the Cutting-Edge Landscape of Relapsed/refractory acute myeloid leukemia (AML) Drug Development @ https://www.delveinsight.com/report-store/relapsed-refractory-acute-myeloid-leukemia-r-r-aml-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Key Takeaways from the Relapsed/refractory acute myeloid leukemia (AML) Pipeline Report
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DelveInsight’s Relapsed/refractory acute myeloid leukemia (AML) pipeline report highlights a dynamic landscape with 50+ active companies developing over 75 therapeutic candidates for the treatment of relapsed/refractory AML.
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In May 2025, ARCE Therapeutics Inc. initiated a study evaluating ARD103, a CAR-T therapy targeting C-type lectin-like molecule-1 (CLL-1). CLL-1 is highly expressed on myeloid blasts and leukemia stem cells (LSCs) but not on healthy hematopoietic stem cells, making it a promising therapeutic target for AML and other myeloid malignancies.
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In the same month, Vor Biopharma launched a Phase 1/2 trial of VCAR33, a donor-derived anti-CD33 CAR-T therapy, in patients with relapsed or refractory AML after HLA-matched allogeneic stem cell transplantation.
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Also in May 2025, Apollo Therapeutics Ltd began a Phase 1/2 trial assessing the safety and efficacy of APL-4098, administered alone or in combination with azacitidine, in patients with relapsed/refractory AML, MDS/AML, and MDS with excess blasts (EB). The Phase 1 portion is limited to patients with the MDS-EB subtype.
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Key companies developing treatments for relapsed/refractory AML include Ascentage Pharma, Cullinan Oncology, Kronos Bio, Maxinovel Pharmaceuticals, AB Science, CicloMed, Karyopharm Therapeutics, Antengene Corporation, GlycoMimetics, Servier, Novartis, ImmunoGen, and others.
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Promising pipeline therapies under development include APG-2575, CLN 049, Lanraplenib, and additional candidates in various clinical stages.
Relapsed/refractory acute myeloid leukemia (AML) Overview:
Relapsed/refractory acute myeloid leukemia (AML) is an aggressive blood cancer with a poor prognosis and limited therapeutic options. Its symptoms—such as fatigue, weakness, shortness of breath, and weight loss—are often vague and can mimic less serious conditions, resulting from anemia and decreased production of healthy blood cells. Allogeneic hematopoietic cell transplantation (allo-HCT) remains the most effective treatment for eligible patients, but it carries significant risks and is not suitable for everyone. Despite these challenges, recent advances, including targeted therapies, are providing additional options that may offer fewer side effects and longer periods of remission. Treatment decisions are highly individualized, taking into account factors such as patient age, overall health, genetic profiles, prior therapies, and timing of relapse.
Download the Relapsed/refractory acute myeloid leukemia (AML) sample report to know in detail about the Relapsed/refractory acute myeloid leukemia (AML) treatment market @ https://www.delveinsight.com/sample-request/relapsed-refractory-acute-myeloid-leukemia-r-r-aml-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Relapsed/refractory acute myeloid leukemia (AML) Pipeline Analysis
The Relapsed/refractory acute myeloid leukemia (AML) pipeline insights report 2025, provides insights into:
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Provides comprehensive insights into key companies developing therapies in the Relapsed/refractory acute myeloid leukemia (AML) Market.
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Categorizes Relapsed/refractory acute myeloid leukemia (AML) therapeutic companies by development stage: early, mid, and late-stage.
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Highlights major companies involved in targeted therapy development, including both active and inactive (paused/discontinued) projects.
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Reviews emerging Relapsed/refractory acute myeloid leukemia (AML) drugs under development based on:
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Stage of development
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Relapsed/refractory acute myeloid leukemia (AML) Route of administration
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Target receptor
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Monotherapy vs. combination therapy
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Relapsed/refractory acute myeloid leukemia (AML) Mechanism of action
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Molecular type
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Offers detailed analysis of:
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Company-to-company and company-academia collaborations
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Relapsed/refractory acute myeloid leukemia (AML) Licensing agreements
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Funding and investment activities supporting future Relapsed/refractory acute myeloid leukemia (AML) market advancement.
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Unlock key insights into emerging Relapsed/refractory acute myeloid leukemia (AML) therapies and market strategies here: https://www.delveinsight.com/report-store/relapsed-refractory-acute-myeloid-leukemia-r-r-aml-pipeline-insight?utm_source=abnewswire&utm_medium=market&utm_campaign=kpr
Relapsed/refractory acute myeloid leukemia (AML) Emerging Drugs
APG-2575: Ascentage Pharma
APG-2575, developed by Ascentage Pharma, is an oral, selective Bcl-2 inhibitor designed to block the Bcl-2 protein and trigger apoptosis in cancer cells, promoting their destruction. It is the first Bcl-2 selective inhibitor from China to enter clinical trials. The U.S. FDA has granted APG-2575 orphan drug designation for five indications: refractory chronic lymphocytic leukemia (CLL), multiple myeloma, Waldenström macroglobulinemia, acute myeloid leukemia, and follicular lymphoma.
CLN 049: Cullinan Oncology
CLN-049 (Florentine) is a humanized bispecific T cell-engaging antibody being developed for acute myeloid leukemia (AML). It binds to FLT3 on leukemia cells and CD3 on T cells, prompting T cells to kill cancer cells via their natural cytotoxic activity. Unlike other AML targets such as CD33 and CD123, FLT3 is frequently expressed on AML cells but rarely on healthy blood cells, offering a more selective approach. Preclinical studies have demonstrated potent, specific AML cell killing and enhanced survival in mouse models. A Phase I trial is currently ongoing in patients with relapsed or refractory AML or myelodysplastic syndromes (MDS).
Lanraplenib: Kronos Bio
Lanraplenib is a next-generation SYK inhibitor originally investigated for autoimmune disorders. Preclinical research has shown its anti-leukemic activity in AML samples harboring NPM1 and FLT3 mutations. It is currently being developed for patients with relapsed or refractory FLT3-mutated AML, as well as for newly diagnosed patients with NPM1 and/or FLT3 mutations who are aged over 75 or are unsuitable for intensive induction chemotherapy.
Relapsed/refractory acute myeloid leukemia (AML) Pipeline Therapeutic Assessment
Relapsed/refractory acute myeloid leukemia (AML) Assessment by Product Type
• Mono
• Combination
• Mono/Combination
Relapsed/refractory acute myeloid leukemia (AML) By Stage
• 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
Relapsed/refractory acute myeloid leukemia (AML) Assessment by Route of Administration
• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical
Relapsed/refractory acute myeloid leukemia (AML) Assessment by Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
Download sample pages to get an in-depth assessment of the emerging Relapsed/refractory acute myeloid leukemia (AML) therapies and key Relapsed/refractory acute myeloid leukemia (AML) companies
Table of Contents
1. Report Introduction
2. Executive Summary
3. Relapsed/refractory acute myeloid leukemia (AML) Current Treatment Patterns
4. Relapsed/refractory acute myeloid leukemia (AML) – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Relapsed/refractory acute myeloid leukemia (AML) Late-Stage Products (Phase-III)
7. Relapsed/refractory acute myeloid leukemia (AML) Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Relapsed/refractory acute myeloid leukemia (AML) Discontinued Products
13. Relapsed/refractory acute myeloid leukemia (AML) Product Profiles
14. Relapsed/refractory acute myeloid leukemia (AML) Key Companies
15. Relapsed/refractory acute myeloid leukemia (AML) Key Products
16. Dormant and Discontinued Products
17. Relapsed/refractory acute myeloid leukemia (AML) Unmet Needs
18. Relapsed/refractory acute myeloid leukemia (AML) Future Perspectives
19. Relapsed/refractory acute myeloid leukemia (AML) Analyst Review
20. Appendix
21. Report Methodology
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