cu-64 dotatate
Trade name: Detectnet
Small moleculeapprovedImaging agentOrphan Drug FDAFast Track FDA
Approved
Sep 3, 2020
Clinical trial activity
4 trials · 4 clinical orgs · 2 marketing orgs
Phase 1
2
Phase 2
2
Phase 3
1
Phase 4
0
Earliest trial started Aug 23, 2018 (NCT03673943)
Timeline
2010s
- May 18, 2016
Orphan Drug Designation
- Jan 1, 2018
RadioMedix — Earliest Phase 3 Sponsor(trial)
2020s
- Sep 3, 2020
RadioMedix — Earliest FDA Approval
- Sep 3, 2020
RadioMedix — Marketing Organization
- Sep 3, 2020
RadioMedix — NDA Secondary Org
- Sep 3, 2020
RadioMedix — NDA Organization
- Sep 3, 2020
Curium Pharma — Marketing Organization
- Jan 1, 2023
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2023
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- SomatostatinBINDING AGENT
SST binding agent
Approval history
- approvedPriority reviewFast trackSep 3, 2020
Chemistry & pharmacology
- Imaging
- 64-Copper
Oral
No
Parenteral
No
Topical
No
Also known as
- cu-64 dotatate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06122610 | Phase 1 | Feb 29, 2024 | University of Wisconsin |
| NCT05709171 | Phase 2 | Jan 17, 2023 | University of Copenhagen |
| NCT05880394 | Phase 1 | Jan 10, 2023 | Hoag Memorial Hospital Presbyterian |
| NCT03673943 | Phase 3 | Aug 23, 2018 | RadioMedix |
Showing 4 of 4 trials
Page 1 / 1
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Hoag Memorial Hospital Presbyterian | Academic/Hospital | 1 | 1 | 1 | 2023 |
| RadioMedix | For profit | 1 | 1 | 1 | 2018 |
| University of Copenhagen | Academic/Hospital | 1 | 1 | 1 | 2023 |
| University of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2024 |
4 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Curium Pharma | For profit | MKTG | Sep 3, 2020 |
| RadioMedix | For profit | MKTG | Sep 3, 2020 |
| RadioMedix | For profit | NDA2 | Sep 3, 2020 |
| RadioMedix | For profit | NDA | Sep 3, 2020 |