Trial intelligence / Profile preview

PyramIDH: Ivosidenib vs Azacitidine in IDH1-mutant HMA-naive MDS

2023-510155-37-00Phase 3Authorised

Sponsor
Servier
Start
Dec 2024
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
9
01

Overview

Phase 3, randomised, open-label trial in myelodysplastic syndrome (MDS) comparing Ivosidenib monotherapy with Azacitidine (Vidaza) monotherapy (2 arms). Primary endpoint: Complete remission (CR) + Partial remission (PR) by 4 months (IWG 2006). Planned start Dec 2024; status: authorised.

02

Drugs

ivosidenibazacitidine
03

Conditions

myelodysplastic syndrome (MDS)

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