Vorasidenib
Small moleculeapprovedOrphan Drug FDAFast Track FDABreakthrough Therapy FDA
Approved
Aug 6, 2024
Clinical trial activity
21 trials · 9 clinical orgs · 1 marketing orgs
Phase 1
16
Phase 2
5
Phase 3
3
Phase 4
0
Earliest trial started Jun 1, 2015 (NCT02481154)
Timeline
Indications
Approved for
Mechanism of action
IDH1 inhibitor
IDH2 inhibitor
- IDH1/IDH2INHIBITOR
IDH1/IDH2 inhibitor
Approval history
- approvedPriority reviewFast trackBreakthroughAug 6, 2024
Chemistry & pharmacology
Loading structure…
SMILES
C[C@@H](Nc1nc(N[C@H](C)C(F)(F)F)nc(-c2cccc(Cl)n2)n1)C(F)(F)F- Mol. weight
- 414.74 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4279047 ↗
Also known as
- ag881
- ag881
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07250633 | Phase 1 | Mar 31, 2026 | Servier |
| NCT07286292 | Phase 2 | Mar 15, 2026 | Servier |
| NCT06809322 | Phase 3 | Dec 5, 2025 | Canadian Cancer Trials Group, European Organisation for Research and Treatment of Cancer |
| NCT07235774 | Phase 1 | Nov 5, 2025 | Servier |
| NCT07215910 | Phase 3 | Oct 20, 2025 | National Cancer Institute (NCI) |
| NCT07235748 | Phase 1 | Oct 7, 2025 | Servier |
| NCT06478212 | Phase 1/Phase 2 (Phase 2) | Dec 2, 2024 | Servier |
| NCT06780930 | Phase 3 | Oct 18, 2024 | Servier |
| NCT05843708 | Phase 1 | Apr 14, 2023 | Servier |
| NCT05674474 | Phase 1 | Mar 14, 2023 | Servier |
| NCT05609994 | Phase 1 | Jan 31, 2023 | Duke University, Servier |
| NCT05484622 | Phase 1 | Dec 30, 2022 | Merck, Servier |
| NCT04654078 | Phase 1 | Jan 18, 2021 | Chonbuk National University, Inno.N |
| NCT04654065 | Phase 1 | Jan 4, 2021 | Chonbuk National University, Inno.N |
| NCT04145128 | Phase 1 | Oct 2, 2019 | Agios Pharmaceuticals, Inc. |
| NCT04128787 | Phase 1 | Aug 26, 2019 | Agios Pharmaceuticals, Inc. |
| NCT03960502 | Phase 1 | May 16, 2019 | Agios Pharmaceuticals, Inc. |
| NCT03343197 | Phase 1 | Mar 30, 2018 | Agios Pharmaceuticals, Inc. |
| NCT02492737 | Phase 1 | Jul 1, 2015 | Agios Pharmaceuticals, Inc. |
| NCT02481154 | Phase 1 | Jun 1, 2015 | Agios Pharmaceuticals, Inc. |
Showing 20 of 21 trials
Page 1 / 2
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Servier | For profit | 11 | 10 | 4 | 2022 |
| Agios Pharmaceuticals, Inc. | For profit | 6 | 6 | 1 | 2015 |
| Chonbuk National University | Academic/Hospital | 2 | 0 | 1 | 2021 |
| Inno.N | For profit | 2 | 2 | 1 | 2021 |
| Canadian Cancer Trials Group | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2023 |
| European Organisation for Research and Treatment of Cancer | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Merck | For profit | 1 | 0 | 1 | 2022 |
| National Cancer Institute (NCI) | Government | 1 | 1 | 1 | 2025 |
9 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Servier | For profit | NDA | Aug 6, 2024 |