Relapsed/Refractory Acute Myeloid Leukemia Clinical Trial Pipeline Gains Momentum: 50+ Companies Lead the Charge in Pioneering New Treatments | DelveInsight

DelveInsight's, "Relapsed/refractory acute myeloid leukemia Pipeline Insight, 2026" report provides comprehensive insights about 50+ companies and 75+ pipeline drugs in Relapsed/refractory acute myeloid leukemia (AML) pipeline landscape. It covers the pipeline drug profiles, including clinical 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 Relapsed/Refractory Acute Myeloid Leukemia Pipeline Report
• In September 2026 - Cullinan Therapeutics, Inc. received FDA Orphan Drug Designation for CLN-049, an investigational FLT3×CD3 T-cell engager, for patients with relapsed/refractory AML. CLN-049 is being evaluated in a Phase I study in R/R AML and MDS.
• In September 2026 - Aspera Biomedicines, Inc. is recruiting patients in a Phase I study of rebecsinib for relapsed/refractory secondary AML or high-risk myelofibrosis. The study is evaluating dosing, safety, and tolerability of the investigational therapy.
• In September 2026 - BlossomHill Therapeutics is conducting a Phase I/1b study of BH-30236 in patients with R/R AML or higher-risk MDS. The trial is evaluating BH-30236 both as monotherapy and in combination with venetoclax.
• DelveInsight's Relapsed/Refractory Acute Myeloid Leukemia pipeline report depicts a robust space with 50+ active players working to develop 75+ pipeline therapies for Relapsed/Refractory Acute Myeloid Leukemia treatment.
• The leading Relapsed/Refractory Acute Myeloid Leukemia Companies such as Ascentage Pharma, Cullinan Oncology, Kronos Bio, Maxinovel Pharmaceuticals, AB Science, CicloMed, Karyopharm Therapeutics, Antengene Corporation, GlycoMimetics, Servier, Novartis, ImmunoGen, and others.
• Promising Relapsed/Refractory Acute Myeloid Leukemia Therapies such as UCART 123, FHD-286, AB8939, ONC201, Sarclisa, TCB008, Keytruda, Uproleselan, Crenolanib, and others.

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Relapsed/Refractory Acute Myeloid Leukemia Overview
Relapsed/refractory acute myeloid leukemia is a devastating disease with a poor prognosis and represents a major unmet medical need. The prognosis of relapsed acute myeloid leukemia (AML) is poor and treatment is challenging. The signs and symptoms of acute myeloid leukemia (AML) are common to other, less serious illnesses. It is common for people with AML to feel a loss of well-being because of the underproduction of normal bone marrow cells. Symptoms of a low red blood cell count (called "anemia") include: Fatigue, weakness, shortness of breath during normal physical activities, lightheadedness, dizziness or faintness, headaches and pale complexion. Other general symptoms of AML include: Loss of appetite, unexplained weight loss, discomfort in bones or joints, fullness or swelling in the abdomen, due to an enlarged spleen or liver.

Relapsed/Refractory Acute Myeloid Leukemia Emerging Drugs Profile
• APG-2575: Ascentage Pharma
APG-2575 is a novel oral Bcl-2 selective small molecule inhibitor under development by Ascentage Pharma. It restores the programmed cell death mechanism (apoptosis) of tumor cells by selectively inhibiting Bcl-2 protein, thereby inducing tumor cell apoptosis. , to achieve the purpose of tumor treatment. APG-2575 is the first locally developed Bcl-2 selective inhibitor to enter clinical stage in China. APG-2575 has been granted orphan drug designation by the US FDA for five indications (Indications: refractory chronic lymphocytic leukemia CLL, multiple myeloma, Waldenström macroglobulinemia, acute myeloid leukemia, follicular lymphoma).

• CLN 049: Cullinan Oncology
CLN-049 (Florentine) is a humanized bispecific T cell engaging antibody being developed for the treatment of acute myeloid leukemia (AML). CLN-049 is designed to simultaneously bind to FLT3 on targeted leukemic cells and to CD3 on T cells, triggering the T cells to kill the selected cancer cells via their intrinsic cytolytic mechanisms. FLT3 is expressed frequently on AML cells and leukemic blasts but minimally on healthy blood cells, unlike other tumor surface antigens identified in AML, such as CD33 and CD123. CLN-049 can mediate potent and specific lysis of AML cells in vitro and promotes enhanced survival of mice bearing AML tumors. A phase I clinical trial with CLN-049 is currently ongoing for the treatment of patients with relapsed/refractory AML or MDS.

• Lanraplenib: Kronos Bio
Lanraplenib, is a next-generation SYK inhibitor that has previously been studied as a potential treatment for autoimmune diseases. In preclinical studies, Lanraplenib was shown to have anti-leukemic activity against NPM1-mutated and FLT3-mutated AML samples. Lanraplenib, is being developed for the treatment of patients with relapsed/refractory FLT3-mutated AML and patients newly diagnosed with NPM1-mutated and/orFLT3-mutated AML who are older than 75 years old or are not eligible for intensive induction chemotherapy.

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Relapsed/refractory acute myeloid leukemia (AML) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.
• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Relapsed/Refractory Acute Myeloid Leukemia Products have been categorized under various Molecule types such as
• Oligonucleotide
• Peptide
• Small molecule

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Relapsed/Refractory Acute Myeloid Leukemia Market Drivers
• Rising incidence of Acute Myeloid Leukemia, advancements in pharmacology and molecular biology to promote drug development, rising geriatric population are some of the important factors that are fueling the Relapsed/Refractory Acute Myeloid Leukemia Market.

Relapsed/Refractory Acute Myeloid Leukemia Market Barriers
• However, high cost associated with the management of AML, side effects associated with the AML treatment and other factors are creating obstacles in the Relapsed/Refractory Acute Myeloid Leukemia Market growth.

Scope of the Relapsed/Refractory Acute Myeloid Leukemia Pipeline Report
• Coverage- Global
• Relapsed/Refractory Acute Myeloid Leukemia Companies- Ascentage Pharma, Cullinan Oncology, Kronos Bio, Maxinovel Pharmaceuticals, AB Science, CicloMed, Karyopharm Therapeutics, Antengene Corporation, GlycoMimetics, Servier, Novartis, ImmunoGen, and others.
• Relapsed/Refractory Acute Myeloid Leukemia Therapies- UCART 123, FHD-286, AB8939, ONC201, Sarclisa, TCB008, Keytruda, Uproleselan, Crenolanib, and others.
• Relapsed/Refractory Acute Myeloid Leukemia Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
• Relapsed/Refractory Acute Myeloid Leukemia Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content
1. Introduction
2. Executive Summary
3. Relapsed/refractory acute myeloid leukemia (AML): Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Relapsed/refractory acute myeloid leukemia (AML)- DelveInsight's Analytical Perspective
7. Late Stage Products (Phase III)
8. Drug name : Company name
9. Drug profiles in the detailed report.....
10. Mid Stage Products (Phase I/II)
11. APG-2575: Ascentage Pharma
12. Drug profiles in the detailed report.....
13. Early Stage Products (Phase I)
14. CLN 049: Cullinan Oncology
15. Drug profiles in the detailed report.....
16. Preclinical and Discovery Stage Products
17. Drug name : Company name
18. Drug profiles in the detailed report.....
19. Inactive Products
20. Relapsed/refractory acute myeloid leukemia Key Companies
21. Relapsed/refractory acute myeloid leukemia Key Products
22. Relapsed/refractory acute myeloid leukemia Unmet Needs
23. Relapsed/refractory acute myeloid leukemia Market Drivers and Barriers
24. Relapsed/refractory acute myeloid leukemia Future Perspectives and Conclusion
25. Relapsed/refractory acute myeloid leukemia Analyst Views
26. Relapsed/refractory acute myeloid leukemia Key Companies
27. Appendix

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