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: None
Known Adverse Events: None
Company: Agios
Company Location: CAMBRIDGE MA 02139
Company CEO: Jacqualyn A. Fouse
Additional Commercial Interests: None
Clinical Description
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
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Acute Myeloid Leukemia|Biliary Tract Cancer|Cholangiocarcinoma|Chondrosarcoma
Phase 2: Anemia|Glioma|Hematopoietic Stem Cell Transplant|Leukopenia|Myelodysplastic Syndrome|Oncology Unspecified|Thrombocytopenia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| S095031-218 | P1 |
Not yet recruiting |
Oncology Unspecified |
2028-07-01 |
23% |
2025-06-06 |
Primary Endpoints |
| NCT05756777 | P1 |
Recruiting |
Acute Myeloid Leukemia |
2026-02-01 |
23% |
2025-03-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| CTR20192088 | P1 |
Completed |
Acute Myeloid Leukemia |
2023-01-18 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
| NCT05030441 | P2 |
Recruiting |
Thrombocytopenia|Anemia|Leukopenia |
2030-01-31 |
12% |
2024-11-01 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| NCT06707493 | P2 |
Not yet recruiting |
Acute Myeloid Leukemia|Hematopoietic Stem Cell Transplant |
2028-01-01 |
68% |
2024-11-28 |
Primary Endpoints|Treatments |
| NCT04278781 | P2 |
Active, not recruiting |
Chondrosarcoma |
2026-03-01 |
12% |
2024-10-16 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
| MOLIVO-1/AMLSG33-22 | P2 |
Recruiting |
Myelodysplastic Syndrome|Acute Myeloid Leukemia |
2026-02-01 |
2025-05-02 |
Treatments |
|
| 2017-003681-27 | P2 |
Active, not recruiting |
Myelodysplastic Syndrome |
2024-12-07 |
2022-03-13 |
Treatments |
|
| CL1-95031-006 | P2 |
Completed |
Cholangiocarcinoma |
2024-11-21 |
40% |
2024-12-19 |
|
| CL2-95031-008 | P2 |
Active, not recruiting |
Cholangiocarcinoma |
2024-10-01 |
12% |
2025-01-11 |
Primary Completion Date|Primary Endpoints|Treatments |
| HCC 19-096 | P2 |
Completed |
Glioma |
2023-11-13 |
29% |
2025-02-07 |
Patient Enrollment|Primary Endpoints|Treatments |
| CUPISCO | P2 |
Completed |
Oncology Unspecified |
2023-02-14 |
12% |
2025-02-05 |
Primary Endpoints |
| CHONQUER | P3 |
Recruiting |
Chondrosarcoma |
2028-02-01 |
12% |
2024-07-26 |
|
| SAFIR-ABC10 | P3 |
Recruiting |
Biliary Tract Cancer |
2027-06-01 |
17% |
2024-06-26 |
Primary Endpoints|Treatments |
| DIM-95031-006 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2026-12-17 |
2025-05-02 |
Treatments |
|
| DIM-95031-006 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2026-01-01 |
43% |
2023-09-01 |
Primary Endpoints|Treatments |
| DIM-95031-002 | P3 |
Active, not recruiting |
Cholangiocarcinoma |
2025-12-31 |
2025-05-02 |
Treatments |
|
| ProvIDHe | P3 |
Recruiting |
Cholangiocarcinoma |
2025-06-01 |
9% |
2023-09-01 |
Primary Endpoints|Start Date|Treatments |
| 2016-004907-30 | P3 |
Active, not recruiting |
Acute Myeloid Leukemia |
2022-09-21 |
2025-05-06 |
Treatments |