indigotindisulfonate sodium
Trade name: Bludigo
Small moleculeapprovedImaging agent
Approved
Jul 8, 2022
Clinical trial activity
7 trials · 5 clinical orgs · 1 marketing orgs
Phase 1
2
Phase 2
2
Phase 3
1
Phase 4
2
Earliest trial started Mar 1, 2012 (NCT01767415)
Timeline
2010s
- Jan 1, 2012
Earliest Phase 1 Sponsor(trial)
2020s
- Jul 8, 2022
Provepharm Sas — Earliest FDA Approval
- Jul 8, 2022
Provepharm Sas — Marketing Organization
- Jul 8, 2022
Provepharm Sas — NDA Secondary Org
- Jul 8, 2022
Provepharm Sas — NDA Organization
- Jan 1, 2024
Provepharm Sas — Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Diagnostic
Renal dye for visualization of the ureteral orifices
- UnclearUnclear
Unclear unclear
Approval history
- approvedJul 8, 2022
Chemistry & pharmacology
Loading structure…
SMILES
O=C1/C(=C2\Nc3ccc(S(=O)(=O)[O-])cc3C2=O)Nc2ccc(S(=O)(=O)[O-])cc21.[Na+].[Na+]- Mol. weight
- 466.36 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL2105023 ↗
Also known as
- indigo carmine
- indigo carmine
- indigo carmine
- indigo carmine
- indigo carmine
- indigo carmine
- indigotindisulfonate sodium
- sodium indigotindisulfonate
- sodium indigotindisulfonate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06448143 | Phase 3 | Jun 30, 2024 | Provepharm Sas |
| NCT06085183 | Phase 4 | Oct 30, 2023 | Provepharm Sas |
| NCT06054880 | Phase 4 | Oct 12, 2023 | Provepharm Sas |
| NCT01914445 | N/A | Aug 1, 2013 | Hillel Yaffe Medical Center |
| NCT01607255 | N/A | May 16, 2013 | Department of Veteran Affairs |
| NCT01901510 | Phase 1 | May 1, 2013 | Mayo Clinic |
| NCT01767415 | Phase 1/Phase 2 (Phase 2) | Mar 1, 2012 | Cornell University |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (5)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Provepharm Sas | For profit | 3 | 3 | 2 | 2023 |
| Cornell University | Academic/Hospital | 1 | 1 | 1 | 2012 |
| Department of Veteran Affairs | Government | 1 | 1 | 1 | 2013 |
| Hillel Yaffe Medical Center | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Mayo Clinic | Academic/Hospital | 1 | 1 | 1 | 2013 |
5 organizations
Page 1 / 1
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Provepharm Sas | For profit | MKTG | Jul 8, 2022 |
| Provepharm Sas | For profit | NDA2 | Jul 8, 2022 |
| Provepharm Sas | For profit | NDA | Jul 8, 2022 |