AG-120

Phase 3Small molecule

Institut de Recherches Internationales Servier

AG-120 is one of 132 small molecule programs targeting Acute Myeloid Leukemia (AML). It is currently in Phase 3.

Indications

Total Trials

Active Trials

131

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute Myeloid Leukemia (AML)Active, not recruiting

Myelodysplastic SyndromesActive, not recruiting

Refractory Acute Myeloid LeukemiaRecruiting

Advanced Hematologic MalignanciesRecruiting

ChondrosarcomaActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Acute Myeloid Leukemia (AML)Phase 3

Active, not recruiting

Myelodysplastic SyndromesPhase 2

Active, not recruiting

Refractory Acute Myeloid LeukemiaPreclinical

Recruiting

Advanced Hematologic MalignanciesPhase 1

Recruiting

ChondrosarcomaPhase 2

Active, not recruiting

Acute Myeloid LeukemiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Novantrone

Pfizer

Phase 3

34 2

Xospata

Astellas

Phase 3

24 3

Vepesid

AAvyxa

Phase 3

52 4

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 5

Vanflyta

Daiichi Sankyo

Phase 3

14 6

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 7

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

30 8

Nexavar

Bayer

Phase 3

12 9

Cellcept

Roche

Phase 3

10 10

Cytoxan

BBaxter Healthcare Corporation

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1/2Active, not recruiting

Acute Myeloid Leukemia

NCT02677922

Q2 2027

Phase 2Active, not recruiting

Myelodysplastic Syndromes

NCT03503409

Q4 2032

PreclinicalRecruiting

Refractory Acute Myeloid Leukemia

NCT03013998

Q3 2034

Phase 3Active, not recruiting

Acute Myeloid Leukemia

NCT03839771

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia3 trials

A Study to Assess the Safety and Efficacy of Two Combinations of Isocitrate Dehydrogenase (IDH) Mutant Targeted Therapies Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) Harboring IDH Mutations Who Are Not Candidates to Receive Intensive Induction Chemotherapy

Active, not recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT02677922·130 enrolled

Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation

Active, not recruiting· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 1·NCT02632708·153 enrolled

A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy

Active, not recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 3·NCT03839771·968 enrolled

Glioma1 trial

Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation

Completed· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 1·NCT02073994·174 enrolled

Relapsed/Refractory AML1 trial

A Study of the IDH1 Inhibitor AG-120 in Combination With the Checkpoint Blockade Inhibitor, Nivolumab, for Patients With IDH1 Mutated Relapsed/Refractory AML and High Risk MDS

Withdrawn·YYale University·Phase 2·NCT04044209

Chondrosarcoma1 trial

AG-120 in People With IDH1 Mutant Chondrosarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04278781·6 enrolled

Low Grade Glioma1 trial

Study of AG-120 and AG-881 in Subjects With Low Grade Glioma

Completed· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 1·NCT03343197·49 enrolled

6 more indications

Moderate Hepatic Impairment1 trial

A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function

Completed·AAgios Pharmaceuticals, Inc.·Phase 1·NCT03282513·33 enrolled

Cholangiocarcinoma1 trial

Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)

Completed· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 3·NCT02989857·187 enrolled

Advanced Hematologic Malignancies1 trial

Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

Recruiting· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 1·NCT02074839·291 enrolled

Refractory Acute Myeloid Leukemia1 trial

A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)

Recruiting·BBeat AML, LLC·Preclinical·NCT03013998·3,000 enrolled

Myelodysplastic Syndromes1 trial

A Single-arm Phase II Multicenter Study of IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome

Active, not recruiting·GGroupe Francophone des Myelodysplasies·Phase 2·NCT03503409·68 enrolled

Acute Myeloid Leukemia (AML)1 trial

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

Active, not recruiting· Institut de Recherches Internationales Servier logo

Institut de Recherches Internationales Servier·Phase 3·NCT03173248·146 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for AG-120. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AG-120 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AG-120. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Institut de Recherches Internationales Servier company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Institut de Recherches Internationales Servier

AG-120

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q2 2027

Q4 2032

Q3 2034

Trials by Indication[1]

Acute Myeloid Leukemia3 trials

Glioma1 trial

Relapsed/Refractory AML1 trial

Chondrosarcoma1 trial

Low Grade Glioma1 trial

Moderate Hepatic Impairment1 trial

Cholangiocarcinoma1 trial

Advanced Hematologic Malignancies1 trial

Refractory Acute Myeloid Leukemia1 trial

Myelodysplastic Syndromes1 trial

Acute Myeloid Leukemia (AML)1 trial

References

Drug Info

Quick Facts

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