Relapsed/Refractory Acute Myeloid Leukemia Pipeline Outlook 2025: Emerging Therapies and Key Players

Strategic Insights -

DelveInsight's report provides a comprehensive analysis of the relapsed/refractory acute myeloid leukemia (AML) pipeline landscape, covering the development of 75+ therapies for the treatment of relapsed/refractory AML. The report highlights the presence of 50+ companies, including Ascentage Pharma, Cullinan Oncology, Kronos Bio, and Maxinovel Pharmaceuticals, among others, that are actively working on developing innovative therapies for the treatment of this disease.

The report also emphasizes the growing interest in targeted therapeutics, with companies focusing on developing novel treatments such as APG-2575, Cytarabine, and Venetoclax. Additionally, the report provides insights into the ongoing clinical trials, emerging therapies, and collaborations between companies and academia.

Key Takeaways:

  • **50+ companies** are actively working on developing 75+ therapies for relapsed/refractory AML, including Ascentage Pharma, Cullinan Oncology, Kronos Bio, and Maxinovel Pharmaceuticals, among others.
  • **22%** of the pipeline therapies are in the Phase III stage, making them promising candidates for the treatment of relapsed/refractory AML.
  • **APG-2575**, developed by Ascentage Pharma, is a novel oral Bcl-2 selective small molecule inhibitor showing potential in inducing tumor cell apoptosis.
  • **CLN 049**, developed by Cullinan Oncology, is a humanized bispecific T cell engaging antibody 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.
  • **Lanraplenib**, developed by Kronos Bio, is a next-generation SYK inhibitor with anti-leukemic activity against NPM1-mutated and FLT3-mutated AML samples.
  • **Servier** and **Novartis** are among the key players involved in the development of relapsed/refractory AML therapies.
  • **Venetoclax Oral Tablet**, developed by AbbVie, is expected to be a promising treatment option for patients with relapsed/refractory AML.
  • **APG-2575** has been granted orphan drug designation by the US FDA for five indications.
  • **CLN 049** has a strong potential to be a first-in-class therapy for the treatment of relapsed/refractory AML.

Statistics:

  • **75+** pipeline therapies are under development for relapsed/refractory AML.
  • **50+** companies are involved in the development of relapsed/refractory AML therapies.
  • **22%** of the pipeline therapies are in the Phase III stage.
  • **APG-2575** has been granted orphan drug designation by the US FDA for five indications.

Sources:

  • M2 PressWIRE-August 25, 2025-: Relapsed/Refractory Acute Myeloid Leukemia Pipeline Outlook 2025: Clinical Trial Studies, EMA, PDMA, FDA Approvals, MOA, ROA, NDA, IND, and Companies
  • DelveInsight's "Relapsed/refractory acute myeloid leukemia Pipeline Insight 2025" report
  • Company websites and press releases of Ascentage Pharma, Cullinan Oncology, Kronos Bio, Maxinovel Pharmaceuticals, AB Science, CicloMed, Karyopharm Therapeutics, Antengene Corporation, GlycoMimetics, Servier, Novartis, ImmunoGen and others.