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Ivosidenib

Alternative Names: ivosidenib, tibsovo, ag-120, ag120, ag 120
Latest Update: 2024-02-13
Latest Update Note: Clinical Trial Update

Product Description

an inhibitor of mutant isocitrate dehydrogenase 1 (IDH1) (Sourced from: https://www.nejm.org/doi/full/10.1056/NEJMoa2117344)

Mechanisms of Action: IDH Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Priority Review - Myelodysplastic Syndrome *

Approval Status: Approved

Approved Countries: Australia | Belgium | Croatia | Czech | European Medicines Agency | Finland | Germany | Hungary | Iceland | Ireland | Lithuania | Poland | Portugal | Slovakia | Slovenia | Sweden | United Arab Emirates | United States

Approved Indications: Acute Leukemia | Acute Myeloid Leukemia | Leukemia | Myeloid Leukemia | Cholangiocarcinoma | Oncology Unspecified

Known Adverse Events: Abdominal Pain | Labor Pain | Pain Unspecified | Mucositis | Anemia | Leukocytosis | Arthralgia | Myalgia | Acute Myeloid Leukemia | Cholangiocarcinoma | Oncology Unspecified | Dyspnea | Diarrhea | Edema

Company: Agios
Company Location: CAMBRIDGE MA 02139
Company CEO: Jacqualyn A. Fouse
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Ivosidenib

Countries in Clinic: Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Latvia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, United States

Active Clinical Trial Count: 19

Highest Development Phases

Phase 3: Acute Myeloid Leukemia|Biliary Tract Cancer|Cholangiocarcinoma|Chondrosarcoma|Myelodysplastic Syndrome

Phase 2: Anemia|Glioma|Leukopenia|Oncology Unspecified|Thrombocytopenia

Phase 1: Allogeneic Stem Cell Transplant|Hematopoietic Stem Cell Transplant

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

HOVON 150 / AMLSG 29-18

P3

Active, not recruiting

Myelodysplastic Syndrome|Acute Myeloid Leukemia

2033-03-01

SAFIR-ABC10

P3

Not yet recruiting

Biliary Tract Cancer

2027-06-01

CL2-95031-008

P2

Recruiting

Cholangiocarcinoma

2027-05-01

57%

CHONQUER

P3

Not yet recruiting

Chondrosarcoma

2026-12-01

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