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: Eastern America
Company Founding Year: 2008
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Armenia, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Romania, South Korea, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 22
Recent & Upcoming Milestones
- June 21, 2019 PDUFA action date set for Tibsovo® for newly diagnosed AML patients with IDH1 mutation by Agios Pharmaceuticals.
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
Phase 1: Other
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04278781 |
NCT04278781 | P2 |
Active, not recruiting |
Chondrosarcoma |
2026-03-01 |
12% |
2024-10-16 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
NCT05615818 |
SAFIR-ABC10 | P3 |
Recruiting |
Biliary Tract Cancer |
2027-06-01 |
24% |
2024-06-26 |
Primary Endpoints|Treatments |
2022-501463-40-01 |
DIM-95031-002 | P3 |
Active, not recruiting |
Cholangiocarcinoma |
2025-12-31 |
2025-05-02 |
Treatments |
|
2024-514051-15-00 |
MOLIVO-1/AMLSG33-22 | P2 |
Recruiting |
Acute Myeloid Leukemia|Myelodysplastic Syndrome |
2026-02-01 |
2025-05-02 |
Treatments |
|
NCT04056910 |
HCC 19-096 | P2 |
Completed |
Glioma |
2023-11-13 |
29% |
2025-02-07 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT03498521 |
CUPISCO | P2 |
Completed |
Oncology Unspecified |
2023-02-14 |
12% |
2025-11-20 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT05756777 |
NCT05756777 | P1 |
Recruiting |
Acute Myeloid Leukemia |
2026-02-01 |
50% |
2025-03-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05030441 |
NCT05030441 | P2 |
Active, not recruiting |
Leukopenia|Anemia|Thrombocytopenia |
2030-01-31 |
12% |
2025-08-15 |
Primary Endpoints|Treatments|Trial Status |
NCT06707493 |
NCT06707493 | P2 |
Recruiting |
Acute Myeloid Leukemia|Hematopoietic Stem Cell Transplant |
2028-01-01 |
12% |
2025-10-23 |
Primary Endpoints|Start Date |
NCT07006688 |
S095031-218 | P1 |
Recruiting |
Other |
2028-07-31 |
50% |
2026-02-14 |
Primary Endpoints|Start Date|Treatments|Trial Status |
2022-501709-11-00 |
DIM-95031-006 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2026-12-17 |
2025-05-02 |
Treatments |
|
NCT05907057 |
DIM-95031-006 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2026-01-01 |
43% |
2023-09-01 |
Primary Endpoints|Treatments |
2016-004907-30 |
2016-004907-30 | P3 |
Active, not recruiting |
Acute Myeloid Leukemia |
2022-09-21 |
2025-05-06 |
Treatments |
|
CTR20192088 |
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 |
|
NCT07260175 |
adIVO | P2 |
Recruiting |
Cholangiocarcinoma |
2030-12-01 |
12% |
2025-12-04 |
Primary Endpoints|Treatments |
2025-523238-17-00 |
DECISIVO | P2 |
Not yet recruiting |
Acute Myeloid Leukemia |
2030-03-25 |
|||
2017-003681-27 |
2017-003681-27 | P2 |
Active, not recruiting |
Myelodysplastic Syndrome |
2024-12-07 |
2022-03-13 |
Treatments |
|
NCT06081829 |
CL2-95031-008 | P2 |
Active, not recruiting |
Cholangiocarcinoma |
2024-10-01 |
12% |
2025-01-11 |
Primary Completion Date|Primary Endpoints|Treatments |
2024-520219-42-00 |
adIVO | P3 |
Not yet recruiting |
Cholangiocarcinoma |
2030-12-31 |
12% |
||
jRCT2011250047 |
jRCT2011250047 | P3 |
Not yet recruiting |
Cholangiocarcinoma |
2028-06-30 |
|||
NCT06127407 |
CHONQUER | P3 |
Recruiting |
Chondrosarcoma |
2028-02-01 |
15% |
2024-07-26 |
|
NCT05876754 |
ProvIDHe | P3 |
Recruiting |
Cholangiocarcinoma |
2027-12-01 |
17% |
2026-02-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/21/2025 |
News Article |
Hackensack Meridian John Theurer Cancer Center Unveils Research at the 67th American Society of Hematology Annual Meeting |
|
11/13/2025 |
News Article |
Taiho Oncology Announces 14 Presentations, Including Six Oral Presentations, at the 67th American Society of Hematology Annual Meeting and Exposition |
|
11/06/2025 |
News Article |
Servier's New and Updated Data at 2025 ASH Annual Meeting Highlight Commitment to Hematology Research |
|
05/22/2025 |
News Article |
Rigel Announces Poster Presentations at the 2025 ASCO Annual Meeting and EHA2025 Congress |