repotrectinib
Trade name: Augtyro
Small moleculeapprovedOrphan Drug FDA
Approved
Nov 15, 2023
Clinical trial activity
3 trials · 2 clinical orgs · 2 marketing orgs
Phase 1
3
Phase 2
2
Phase 3
0
Phase 4
0
Earliest trial started Feb 27, 2017 (NCT03093116)
Timeline
2010s
- Jan 1, 2017
Earliest Phase 1 Sponsor(trial)
- Jun 22, 2017
Orphan Drug Designation
2020s
- Nov 15, 2023
Bristol-Myers Squibb — Earliest FDA Approval
- Nov 15, 2023
Bristol-Myers Squibb — NDA Organization
- Nov 15, 2023
Bristol-Myers — Marketing Organization
Indications
Approved for
Mechanism of action
DDR1 inhibitor
ROS1 inhibitor
- ALK tyrosine kinase receptorINHIBITOR
ALK inhibitor
Approval history
- approvedPriority reviewNov 15, 2023
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Also known as
- tpx-0005
- tpx-0005
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05828303 | Phase 1 | Jul 28, 2022 | Bristol-Myers Squibb, Turning Point Therapeutics |
| NCT05071183 | Phase 1/Phase 2 (Phase 2) | Oct 31, 2021 | Turning Point Therapeutics |
| NCT03093116 | Phase 1/Phase 2 (Phase 2) | Feb 27, 2017 | Turning Point Therapeutics |
Showing 3 of 3 trials
Page 1 / 1
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Turning Point Therapeutics | For profit | 3 | 3 | 2 | 2017 |
| Bristol-Myers Squibb | For profit | 1 | 0 | 1 | 2022 |
2 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bristol-Myers | For profit | MKTG | Nov 15, 2023 |
| Bristol-Myers Squibb | For profit | NDA | Nov 15, 2023 |