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
Countries in Clinic: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, 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, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 22
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 |
Recruiting |
Biliary Tract Cancer |
2027-06-01 |
|
| CL2-95031-008 | P2 |
Active, not recruiting |
Cholangiocarcinoma |
2027-05-01 |
57% |
| DIM-95031-006 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2026-12-17 |