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Drug intelligence / Profile preview
mesutoclax + azacitidine
- Development stage
- Phase 1
- Lead developer
- Innocare
- Modality
- Small Molecules
- Administration
- Intravenous, Oral, Subcutaneous
01
Overview
Mesutoclax + azacitidine is an investigational combination regimen being developed for the treatment of myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Mesutoclax (ICP-248) is an orally bioavailable, highly selective small-molecule B-cell lymphoma-2 (BCL-2) inhibitor that restores normal apoptosis in cancer cells. Azacitidine is a nucleoside metabolic inhibitor (hypomethylating agent) that incorporates into DNA and RNA, leading to DNA methyltransferase inhibition, DNA hypomethylation, and direct cytotoxicity. The combination is being evaluated in clinical trials, including a Phase I study (NCT06656494) and a registrational Phase III head-to-head trial comparing it to the standard-of-care venetoclax + azacitidine in treatment-naive elderly or unfit AML patients.
- Other names
- ICP-248 + azacitidinemesutoclax plus azacitidine
02
Targets
BAKBAX (Apoptosis regulator BAX)CYCS (Cytochrome c)DNADNMT1 (DNA (cytosine-5)-methyltransferase 1)BCL-2 (BCL-2 family)
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