taletrectinib
Small moleculeapprovedOrphan Drug FDA
Approved
Jun 11, 2025
Clinical trial activity
9 trials · 5 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
6
Phase 3
2
Phase 4
0
Earliest trial started Jun 30, 2020 (NCT04395677)
Timeline
2020s
- Jan 1, 2020
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2021
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2024
Earliest Phase 3 Sponsor(trial)
- Jul 16, 2024
Orphan Drug Designation
- Jun 11, 2025
Earliest FDA Approval
- Jun 11, 2025
Nuvation Bio Inc. — Marketing Organization
Indications
Approved for
Mechanism of action
ROS1 inhibitor
Neurotrophic tyrosine kinase receptor inhibitor
Also inhibits some ROS variants
Approval history
- approvedPriority reviewJun 11, 2025
Chemistry & pharmacology
Loading structure…
SMILES
C[C@@H](N)COc1ccc(-c2cnc3ccc(N[C@H](C)c4cccc(F)c4)nn23)cc1.O=C(O)CCCCC(=O)O- Mol. weight
- 551.62 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4650989 ↗
- ChEMBLCHEMBL4650361 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07154706 | Phase 3 | Aug 21, 2025 | Nuvation Bio Inc. |
| NCT06214793 | Phase 2 | Oct 1, 2024 | AnHeart Therapeutics Inc., Case Western Reserve University, The Cleveland Clinic |
| NCT06564324 | Phase 3 | Sep 30, 2024 | AnHeart Therapeutics Inc., Huazhong University of Science and Technology |
| NCT05357820 | Phase 1 | Jul 19, 2021 | AnHeart Therapeutics Inc. |
| NCT05357911 | Phase 1 | Jul 13, 2021 | AnHeart Therapeutics Inc. |
| NCT04919811 | Phase 2 | Jun 30, 2021 | AnHeart Therapeutics Inc. |
| NCT04617054 | Phase 2 | Dec 31, 2020 | AnHeart Therapeutics Inc. |
| NCT04395677 | Phase 2 | Jun 30, 2020 | AnHeart Therapeutics Inc., Huazhong University of Science and Technology |
| NCT06841874 | N/A | — | Nuvation Bio Inc. |
Showing 9 of 9 trials
Page 1 / 1
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AnHeart Therapeutics Inc. | For profit | 7 | 6 | 3 | 2020 |
| Huazhong University of Science and Technology | Academic/Hospital | 2 | 0 | 2 | 2020 |
| Nuvation Bio Inc. | For profit | 2 | 2 | 2 | 2025 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| The Cleveland Clinic | Academic/Hospital | 1 | 0 | 1 | 2024 |
5 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Nuvation Bio Inc. | For profit | MKTG | Jun 11, 2025 |