tovorafenib
Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Apr 23, 2024
Clinical trial activity
7 trials · 4 clinical orgs · 1 marketing orgs
Phase 1
3
Phase 2
4
Phase 3
0
Phase 4
0
Earliest trial started May 2, 2022 (NCT07121829)
Timeline
2020s
- Sep 24, 2020
Orphan Drug Designation
- Jan 1, 2022
Day One Biopharmaceuticals, Inc. — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2023
Earliest Phase 2 Sponsor(trial)
- Apr 23, 2024
Day One Biopharmaceuticals, Inc. — Earliest FDA Approval
- Apr 23, 2024
Day One Biopharmaceuticals, Inc. — NDA Organization
Indications
Approved for
Studied for
- Astrocytoma · Phase 1
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Colorectal Neoplasms · Phase 1
- Diffuse Intrinsic Pontine Glioma · Phase 2
- Glioma · Phase 2
- Histiocytosis, Langerhans-Cell · Phase 2
- Leukemia, Hairy Cell · Phase 1/Phase 2
- Melanoma · Phase 1
- Mutation · Phase 1
- Neoplasm Metastasis · Phase 2
- Neoplasms · Phase 1
- Pancreatic Neoplasms · Phase 1
Mechanism of action
Approval history
- approvedPriority reviewAcceleratedBreakthroughApr 23, 2024
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06965114 | Phase 1/Phase 2 (Phase 2) | Jun 27, 2026 | National Cancer Institute (NCI), Ohio State University |
| NCT07206849 | Phase 2 | Mar 1, 2026 | Ohio State University |
| NCT06381570 | Early Phase 1 (Phase 1) | Mar 21, 2024 | University of Toronto |
| NCT05828069 | Phase 2 | Jan 2, 2024 | National Cancer Institute (NCI) |
| NCT05287295 | Phase 2 | Mar 8, 2023 | National Cancer Institute (NCI) |
| NCT07121829 | Phase 1 | May 2, 2022 | Day One Biopharmaceuticals, Inc. |
| NCT05760586 | N/A | — | Day One Biopharmaceuticals, Inc. |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Cancer Institute (NCI) | Government | 3 | 3 | 1 | 2023 |
| Day One Biopharmaceuticals, Inc. | For profit | 2 | 2 | 2 | 2022 |
| Ohio State University | Academic/Hospital | 2 | 1 | 1 | 2026 |
| University of Toronto | Academic/Hospital | 1 | 1 | 1 | 2024 |
4 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Day One Biopharmaceuticals, Inc. | For profit | NDA | Apr 23, 2024 |