A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
AG-120 (ivosidenib) is being evaluated in combination with azacitidine for the treatment of previously untreated acute myeloid leukemia (AML) with an IDH1 mutation. This combination therapy targets a specific patient population that is not suitable for intensive chemotherapy, potentially expanding the market for IDH1 inhibitors in AML treatment. The global AML market is projected to grow significantly, driven by advancements in targeted therapies. Competitive landscape includes other IDH inhibitors and hypomethylating agents, necessitating careful monitoring of clinical outcomes and market positioning. Diligence should focus on the trial's efficacy and safety data, as well as regulatory pathways for approval.
Indication: Newly Diagnosed Acute Myeloid Leukemia (AML)
Modality: small molecule
Target: Isocitrate dehydrogenase 1 (IDH1) mutation
Sponsor: Institut de Recherches Internationales Servier
Source URL: ClinicalTrials.gov
Source updated: Nov 10, 2025
Ingested: Jun 12, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Isocitrate dehydrogenase 1 (IDH1) mutation
View original source fields
Condition raw: Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), Leukemia, Myeloid, Acute
Condition normalized: Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), Leukemia, Myeloid, Acute
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Isocitrate dehydrogenase 1 (IDH1) mutation
Target normalized: Isocitrate dehydrogenase 1 (IDH1) mutation