AG-221

Phase 3Small molecule

Bristol-Myers Squibb

AG-221 is one of 103 small molecule programs targeting Myelodysplastic Syndromes. It is currently in Phase 3.

Indications

Total Trials

Active Trials

102

Competitors

Pipeline

Status by Indication[3][1]

Indication

Myelodysplastic SyndromesActive, not recruiting

Refractory Acute Myeloid LeukemiaRecruiting

Acute Myeloid LeukemiaActive, not recruiting

Myelodysplastic SyndromesPhase 2

Active, not recruiting

Refractory Acute Myeloid LeukemiaPreclinical

Recruiting

Acute Myeloid LeukemiaPhase 3

Active, not recruiting

Competition

Competitive Landscape

255 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Idamycin

Pfizer

Phase 3

59 2

Fludara

Sanofi

Phase 3

17 3

Vepesid

AAvyxa

Phase 3

52 4

Vanflyta

Daiichi Sankyo

Phase 3

14 5

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 6

Nexavar

Bayer

Phase 3

12 7

Cellcept

Roche

Phase 3

10 8

Trexall

Jazz Pharmaceuticals

Phase 3

9 9

Cytoxan

BBaxter Healthcare Corporation

Busulfex

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

Q4 2026

Phase 2Active, not recruiting

Myelodysplastic Syndromes

NCT03744390

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 Leukemia4 trials

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

An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT02577406·319 enrolled

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

Show 1 more trial

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

ESS1 trial

Expanded Access for AG-221

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT03723057

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 IDH2 (AG-221) Inhibitor in Patients With IDH2 Mutated Myelodysplastic Syndrome

Active, not recruiting·GGroupe Francophone des Myelodysplasies·Phase 2·NCT03744390·68 enrolled

Unspecified2 trials

PK and Safety Study of AG-221 in Healthy Male Japanese Subjects and Healthy Male Caucasian Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02387866·62 enrolled

Radiolabeled Study of AG-221 in Healthy Male Subjects.

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02443168·8 enrolled

Sources

References

[1]
ClinicalTrials.gov — 9 trial records for AG-221. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — AG-221 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for AG-221. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Bristol-Myers Squibb

AG-221

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q4 2032

Q3 2034

Trials by Indication[1]

Acute Myeloid Leukemia4 trials

ESS1 trial

Refractory Acute Myeloid Leukemia1 trial

Myelodysplastic Syndromes1 trial

Unspecified2 trials

References

Drug Info

Quick Facts

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