ziftomenib
Small moleculeapprovedOrphan Drug FDA
Approved
Nov 13, 2025
Clinical trial activity
13 trials · 9 clinical orgs · 1 marketing orgs
Phase 1
10
Phase 2
3
Phase 3
1
Phase 4
0
Earliest trial started Aug 26, 2019 (NCT04067336)
Timeline
2010s
- Jan 1, 2019
Kura Oncology, Inc. — Earliest Phase 1 Sponsor(trial)
- Jul 22, 2019
Orphan Drug Designation
2020s
- Jan 1, 2025
Kura Oncology, Inc. — Earliest Phase 3 Sponsor(trial)
- Nov 13, 2025
Earliest FDA Approval
- Nov 13, 2025
Kura Oncology, Inc. — Marketing Organization
- Jan 1, 2026
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Studied for
- Gastrointestinal Stromal Tumors · Phase 1
- Gene Rearrangement · Phase 1
- Hematologic Neoplasms · Phase 1
- Intestinal Neoplasms · Phase 1
- Leukemia · Phase 1
- Leukemia, Biphenotypic, Acute · Phase 1
- Leukemia, Myeloid · Phase 1
- Leukemia, Promyelocytic, Acute · Phase 1
- Mutation · Phase 1
- Neoplasms · Phase 1
- Neoplasms by Histologic Type · Phase 1
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 1/Phase 2
- Recurrence · Phase 1
- Sarcoma, Myeloid · Phase 1
Mechanism of action
- MeninINHIBITOR
MEN1 inhibitor
Approval history
- approvedPriority reviewNov 13, 2025
Chemistry & pharmacology
Loading structure…
SMILES
CNc1nc(NC2CCN(Cc3ccc4c(cc(C#N)n4C[C@H](C)N4CCN(S(C)(=O)=O)CC4)c3C)CC2)c2cc(CC(F)(F)F)sc2n1- Mol. weight
- 717.89 g/mol
- Lipinski Ro5
- 3 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL5095038 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06930352 | Phase 2 | Jan 10, 2026 | Kura Oncology, Inc., Ohio State University |
| NCT07007312 | Phase 3 | Sep 26, 2025 | Kura Oncology, Inc. |
| NCT06769490 | Phase 1 | Jun 30, 2025 | University of Texas at Houston |
| NCT06655246 | Phase 1 | Jan 31, 2025 | Kura Oncology, Inc. |
| NCT06376162 | Phase 1 | Nov 30, 2024 | Kura Oncology, Inc., LLS PedAL Initiative, LLC |
| NCT06448013 | Phase 1 | Nov 29, 2024 | Kura Oncology, Inc., University of Texas at Houston |
| NCT06397027 | Phase 1 | Oct 31, 2024 | Kura Oncology, Inc., University of Texas at Houston |
| NCT06440135 | Phase 1 | Jun 6, 2024 | Harvard University |
| NCT06001788 | Phase 1 | Dec 31, 2023 | Kura Oncology, Inc. |
| NCT05848687 | Phase 1/Phase 2 (Phase 2) | Nov 1, 2023 | Amgen, Department of Defense, Kura Oncology, Inc., Pediatric Oncology Experimental Therapeutics Investigation Consortium, Stanford University |
| NCT05735184 | Phase 1 | Jul 18, 2023 | Kura Oncology, Inc. |
| NCT04067336 | Phase 1 | Aug 26, 2019 | Kura Oncology, Inc. |
| NCT05738538 | N/A | — | Kura Oncology, Inc. |
Showing 13 of 13 trials
Page 1 / 1
Organizations
Research & Development (9)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Kura Oncology, Inc. | For profit | 11 | 6 | 4 | 2019 |
| University of Texas at Houston | Academic/Hospital | 3 | 3 | 1 | 2024 |
| Amgen | For profit | 1 | 0 | 1 | 2023 |
| Department of Defense | Government | 1 | 0 | 1 | 2023 |
| Harvard University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| LLS PedAL Initiative, LLC | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Ohio State University | Academic/Hospital | 1 | 1 | 1 | 2026 |
| Pediatric Oncology Experimental Therapeutics Investigation Consortium | Academic/Hospital | 1 | 0 | 1 | 2023 |
| Stanford University | Academic/Hospital | 1 | 1 | 1 | 2023 |
9 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Kura Oncology, Inc. | For profit | MKTG | Nov 13, 2025 |