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:
Recent & Upcoming Milestones
- The FDA granted priority review to Agios Pharmaceuticals' SNDM for Tibsovo in newly diagnosed AML, with a PDUFA date of June 21, 2019.
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 ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT05030441 |
NCT05030441 | P2 |
Active, not recruiting |
Anemia|Leukopenia|Thrombocytopenia |
2030-01-31 |
12% |
2025-08-15 |
Primary Endpoints|Treatments|Trial Status |
NCT07006688 |
S095031-218 | P1 |
Not yet recruiting |
Oncology Unspecified |
2028-07-01 |
50% |
2025-06-06 |
Primary Endpoints |
NCT06707493 |
NCT06707493 | P2 |
Recruiting |
Hematopoietic Stem Cell Transplant|Acute Myeloid Leukemia |
2028-01-01 |
12% |
2025-10-23 |
Primary Endpoints|Start Date |
NCT05615818 |
SAFIR-ABC10 | P3 |
Recruiting |
Biliary Tract Cancer |
2027-06-01 |
17% |
2024-06-26 |
Primary Endpoints|Treatments |
NCT04278781 |
NCT04278781 | P2 |
Active, not recruiting |
Chondrosarcoma |
2026-03-01 |
12% |
2024-10-16 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
2024-514051-15-00 |
MOLIVO-1/AMLSG33-22 | P2 |
Recruiting |
Myelodysplastic Syndrome|Acute Myeloid Leukemia |
2026-02-01 |
2025-05-02 |
Treatments |
|
NCT05907057 |
DIM-95031-006 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2026-01-01 |
43% |
2023-09-01 |
Primary Endpoints|Treatments |
NCT05876754 |
ProvIDHe | P3 |
Recruiting |
Cholangiocarcinoma |
2025-06-01 |
9% |
2023-09-01 |
Primary Endpoints|Start Date|Treatments |
NCT04056910 |
HCC 19-096 | P2 |
Completed |
Glioma |
2023-11-13 |
29% |
2025-02-07 |
Patient Enrollment|Primary Endpoints|Treatments |
2024-520219-42-00 |
adIVO | P3 |
Not yet recruiting |
Cholangiocarcinoma |
2030-12-31 |
|||
NCT06127407 |
CHONQUER | P3 |
Recruiting |
Chondrosarcoma |
2028-02-01 |
17% |
2024-07-26 |
|
2022-501709-11-00 |
DIM-95031-006 | P3 |
Recruiting |
Acute Myeloid Leukemia |
2026-12-17 |
2025-05-02 |
Treatments |
|
NCT05756777 |
NCT05756777 | P1 |
Recruiting |
Acute Myeloid Leukemia |
2026-02-01 |
12% |
2025-03-06 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2022-501463-40-01 |
DIM-95031-002 | P3 |
Active, not recruiting |
Cholangiocarcinoma |
2025-12-31 |
2025-05-02 |
Treatments |
|
2017-003681-27 |
2017-003681-27 | P2 |
Active, not recruiting |
Myelodysplastic Syndrome |
2024-12-07 |
2022-03-13 |
Treatments |
|
NCT05921760 |
CL1-95031-006 | P2 |
Completed |
Cholangiocarcinoma |
2024-11-21 |
40% |
2024-12-19 |
|
NCT06081829 |
CL2-95031-008 | P2 |
Active, not recruiting |
Cholangiocarcinoma |
2024-10-01 |
12% |
2025-01-11 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT03498521 |
CUPISCO | P2 |
Completed |
Oncology Unspecified |
2023-02-14 |
12% |
2025-02-05 |
Primary Endpoints |
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 |
|
2016-004907-30 |
2016-004907-30 | P3 |
Active, not recruiting |
Acute Myeloid Leukemia |
2022-09-21 |
2025-05-06 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
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 |
|
02/19/2025 |
News Article |
In vitro diagnostics Market Poised for Significant Growth to Reach value of USD 133.24 Billion from 2025 to 2034 |