Enmetazobactam
Small moleculeapprovedFast Track FDA
Approved
Feb 22, 2024
Clinical trial activity
7 trials · 3 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
3
Phase 3
1
Phase 4
0
Earliest trial started Oct 10, 2013 (NCT03685084)
Timeline
2010s
2020s
- Feb 22, 2024
Earliest FDA Approval
- Feb 22, 2024
Orchid Pharma — NDA Secondary Org
Indications
Approved for
Mechanism of action
- Penicillin-binding protein 1INHIBITOR
pbp1 inhibitor
Combination products
exblifep
with cefepime
Also known as cefepime and enmetazobactam, cefepime, enmetazobactam
Approval history
- approvedPriority reviewFast trackFeb 22, 2024
Chemistry & pharmacology
Oral
No
Parenteral
No
Topical
No
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT05826990 | Phase 2 | Apr 15, 2023 | Allecra, Linical Co., Ltd. |
| NCT03775668 | Phase 1 | Nov 27, 2018 | Allecra |
| NCT03687255 | Phase 3 | Sep 24, 2018 | Allecra, Medpace, Inc. |
| NCT03680612 | Phase 2 | Sep 5, 2017 | Allecra, Medpace, Inc. |
| NCT03680352 | Phase 1 | Sep 1, 2017 | Allecra |
| NCT03680378 | Phase 1 | Jul 1, 2017 | Allecra |
| NCT03685084 | Phase 1 | Oct 10, 2013 | Allecra |
Showing 7 of 7 trials
Page 1 / 1
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Allecra | For profit | 7 | 7 | 3 | 2013 |
| Medpace, Inc. | For profit | 2 | 0 | 2 | 2017 |
| Linical Co., Ltd. | For profit | 1 | 0 | 1 | 2023 |
3 organizations
Page 1 / 1
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Orchid Pharma | For profit | NDA2 | Feb 22, 2024 |