Berdazimer
Trade name: ZELSUVMI
Small moleculeapproved
Approved
Jan 5, 2024
Clinical trial activity
10 trials · 7 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
6
Phase 3
4
Phase 4
0
Earliest trial started Jun 1, 2014 (NCT02164084)
Timeline
2010s
2020s
- Jan 5, 2024
Ligand Pharmaceuticals — Earliest FDA Approval
- Jan 5, 2024
Ligand Pharmaceuticals — NDA Organization
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Releases NO, antimicrobial
- UnclearUnclear
Unclear unclear
Approval history
- approvedJan 5, 2024
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- Yes
- Delivery
- Topical
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
Yes
First in classProdrug
Sources
- ChEMBLCHEMBL4298064 ↗
Also known as
- sb204
- sb208
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04535531 | Phase 3 | Sep 1, 2020 | Novan, Inc., Synteract, Inc., Therapeutics, Inc. |
| NCT02860052 | Phase 2 | Jul 1, 2016 | Novan, Inc. |
| NCT02801903 | Phase 1 | Jun 1, 2016 | Novan, Inc., WCCT Global |
| NCT02798120 | Phase 3 | May 1, 2016 | Chiltern International, Novan, Inc. |
| NCT02672332 | Phase 3 | Feb 1, 2016 | Chiltern International, Novan, Inc. |
| NCT02667444 | Phase 3 | Feb 1, 2016 | Chiltern International, Novan, Inc. |
| NCT02581072 | Phase 1 | Oct 1, 2015 | Novan, Inc., Spaulding Clinical Research Inc. |
| NCT02242760 | Phase 2 | Nov 1, 2014 | Novan, Inc. |
| NCT02250430 | Phase 1 | Sep 1, 2014 | KGL, Inc., Novan, Inc. |
| NCT02164084 | Phase 1 | Jun 1, 2014 | Novan, Inc., Spaulding Clinical Research Inc. |
Showing 10 of 10 trials
Page 1 / 1
Organizations
Research & Development (7)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novan, Inc. | For profit | 10 | 10 | 3 | 2014 |
| Chiltern International | For profit | 3 | 0 | 1 | 2016 |
| Spaulding Clinical Research Inc. | For profit | 2 | 0 | 1 | 2014 |
| KGL, Inc. | For profit | 1 | 0 | 1 | 2014 |
| Synteract, Inc. | For profit | 1 | 0 | 1 | 2020 |
| Therapeutics, Inc. | For profit | 1 | 0 | 1 | 2020 |
| WCCT Global | For profit | 1 | 0 | 1 | 2016 |
7 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ligand Pharmaceuticals | For profit | NDA | Jan 5, 2024 |