durlobactam
Trade name: Xacduro
Small moleculeapprovedFast Track FDA
Approved
May 23, 2023
Clinical trial activity
0 trials · 0 clinical orgs · 2 marketing orgs
Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
0
Timeline
2020s
- May 23, 2023
Innoviva — Earliest FDA Approval
- May 23, 2023
Entasis Therapeutics — NDA Secondary Org
- May 23, 2023
Innoviva — NDA Secondary Org
- May 23, 2023
Innoviva — NDA Organization
Indications
Approved for
Mechanism of action
- Beta-lactamaseINHIBITOR
Beta-lactamase inhibitor
- Beta-lactamaseINHIBITOR
Beta-lactamase inhibitor
- Beta-lactamaseINHIBITOR
Beta-lactamase inhibitor
- Beta-lactamaseINHIBITOR
Beta-lactamase inhibitor
- ADC-11INHIBITOR
ampC inhibitor
Combination products
xacduro (copackaged)
with sulbactam
Also known as sulbactam, durlobactam, sulbactam-durlobactam (sul-dur)
Approval history
- approvedPriority reviewFast trackMay 23, 2023
Chemistry & pharmacology
Loading structure…
SMILES
CC1=C[C@@H]2CN(C(=O)N2OS(=O)(=O)[O-])[C@@H]1C(N)=O.[Na+]- Mol. weight
- 299.24 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- ChEMBLCHEMBL4298137 ↗
- ChEMBLCHEMBL4297378 ↗
Organizations
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Entasis Therapeutics | For profit | NDA2 | May 23, 2023 |
| Innoviva | For profit | NDA2 | May 23, 2023 |
| Innoviva | For profit | NDA | May 23, 2023 |