diazoxide choline
Small moleculeapprovedOrphan Drug FDA
Approved
Mar 26, 2025
Clinical trial activity
12 trials · 14 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
9
Phase 3
5
Phase 4
0
Earliest trial started May 1, 2008 (NCT00688857)
Timeline
2010s
- Jan 1, 2011
Earliest Phase 3 Sponsor(trial)
- May 13, 2014
Orphan Drug Designation
2020s
- Mar 26, 2025
Earliest FDA Approval
- Mar 26, 2025
Soleno Therapeutics, Inc. — Marketing Organization
Indications
Approved for
Mechanism of action
KCNJ11 activator
Approval history
- approvedPriority reviewMar 26, 2025
Chemistry & pharmacology
Loading structure…
SMILES
CC1=Nc2ccc(Cl)cc2S(=O)(=O)[N-]1.C[N+](C)(C)CCO- Mol. weight
- 333.84 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4297276 ↗
Also known as
- diazoxide choline
- diazoxide choline
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05701774 | Phase 3 | Jan 31, 2023 | Soleno Therapeutics, Inc. |
| NCT04086810 | Phase 3 | Oct 15, 2019 | Soleno Therapeutics, Inc. |
| NCT03714373 | Phase 3 | Oct 1, 2018 | Soleno Therapeutics, Inc. |
| NCT03440814 | Phase 3 | May 9, 2018 | Soleno Therapeutics, Inc. |
| NCT02893618 | Phase 2 | Jul 1, 2017 | Essentialis, Inc. |
| NCT02034071 | Phase 1/Phase 2 (Phase 2) | Apr 1, 2014 | Essentialis, Inc., University of California, Irvine |
| NCT00973271 | Phase 3 | Mar 1, 2011 | Essentialis, Inc. |
| NCT00901823 | Phase 1 | Mar 1, 2011 | Essentialis, Inc. |
| NCT01211860 | Phase 1 | Oct 1, 2010 | Essentialis, Inc., PRACS |
| NCT01211847 | Phase 2 | Oct 1, 2010 | Essentialis, Inc., Medpace, Inc. |
| NCT00696475 | Phase 2 | Jun 1, 2008 | Allied Research International, Essentialis, Inc., Frederick C. Smith Clinic, Jacksonville Center for Clinical Research, L-Marc Research Center, Medpace, Inc., Meridien Research, Midwest Institute for Clinical Research, PMG Research, Sterling Research Group, Ltd, TriCities Medical Research |
| NCT00688857 | Phase 1 | May 1, 2008 | Essentialis, Inc., PRACS |
Showing 12 of 12 trials
Page 1 / 1
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Essentialis, Inc. | For profit | 8 | 8 | 3 | 2008 |
| Soleno Therapeutics, Inc. | For profit | 4 | 4 | 1 | 2018 |
| Medpace, Inc. | For profit | 2 | 0 | 1 | 2008 |
| PRACS | For profit | 2 | 0 | 1 | 2008 |
| Allied Research International | For profit | 1 | 0 | 1 | 2008 |
| Frederick C. Smith Clinic | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Jacksonville Center for Clinical Research | For profit | 1 | 0 | 1 | 2008 |
| L-Marc Research Center | Academic/Hospital | 1 | 0 | 1 | 2008 |
| Meridien Research | For profit | 1 | 0 | 1 | 2008 |
| Midwest Institute for Clinical Research | For profit | 1 | 0 | 1 | 2008 |
| PMG Research | For profit | 1 | 0 | 1 | 2008 |
| Sterling Research Group, Ltd | For profit | 1 | 0 | 1 | 2008 |
| TriCities Medical Research | Academic/Hospital | 1 | 0 | 1 | 2008 |
| University of California, Irvine | Academic/Hospital | 1 | 0 | 1 | 2014 |
14 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Soleno Therapeutics, Inc. | For profit | MKTG | Mar 26, 2025 |