Trial intelligence / Profile preview

PyramIDH study of ivosidenib versus azacitidine monotherapy in HMA-naive IDH1-mutated myelodysplastic syndrome

NL-OMON58725Phase 3Recruiting

Sponsor
Servier
Start
Aug 2025
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Covalent Small Molecules → Small Molecules
Countries
1
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Overview

Phase 3, randomised, open-label trial in myelodysplastic syndrome (MDS) comparing Ivosidenib monotherapy with Azacitidine monotherapy (2 arms). Primary endpoint: Complete remission plus partial remission by 4 months. Started Aug 2025; status: recruiting.

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Drugs

ivosidenibazacitidine
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Conditions

myelodysplastic syndrome (MDS)

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