Overview
Epetraborole has been used in trials studying the treatment of Infections, Bacterial, Infections, Intestinal, Infections, Urinary Tract, and Community-acquired Infection.
Indication
No indication information available.
Associated Conditions
No associated conditions information available.
Research Report
Epetraborole (DB11744): A Comprehensive Monograph on a Novel Boron-Based Antibiotic
Executive Summary of Epetraborole
Epetraborole is a first-in-class, orally bioavailable, investigational small molecule antibiotic distinguished by its boron-containing benzoxaborole chemical structure.[1] It represents a significant innovation in the field of antimicrobial therapy, primarily due to its novel mechanism of action. The compound is a potent and selective inhibitor of bacterial leucyl-tRNA synthetase (LeuRS), an essential enzyme in protein synthesis.[1] Epetraborole functions via a unique Oxaborole tRNA-Trapping (OBORT) mechanism, forming a stable adduct with transfer RNA for leucine (tRNALeu) within the enzyme's editing site, which effectively halts bacterial protein production—a mode of action distinct from all currently approved antibiotic classes.[3]
The drug exhibits a broad spectrum of activity, with notable potency against several difficult-to-treat pathogens. Its development has primarily focused on nontuberculous mycobacteria (NTM), including Mycobacterium avium complex (MAC) and the highly drug-resistant Mycobacterium abscessus, as well as the Gram-negative pathogen Burkholderia pseudomallei, the causative agent of the severe tropical disease melioidosis.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/08/16 | Phase 1 | Completed | |||
2022/04/14 | Phase 2 | Terminated | |||
2022/03/17 | Phase 1 | Completed | |||
2021/05/19 | Phase 1 | Completed | |||
2012/10/08 | Phase 1 | Terminated | |||
2011/06/27 | Phase 2 | Terminated | |||
2010/12/29 | Phase 1 | Completed | |||
2010/12/17 | Phase 1 | Completed | |||
2009/11/17 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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