delafloxacin
Trade name: BAXDELA
Delafloxacin (CAS registry number 189279-58-1) was described as WQ-3034 by Wakunaga Pharmaceutical Co., Ltd., Osaka & Hiroshima, Japan. It was first licensed in 1999 to Abbott Park, IL, and further developed as ABT-492. Delafloxacin (Baxdela), a fluoroquinolone antibiotic, is currently being developed by Melinta Therapeutics. It is a novel investigational fluoroquinolone in development for the treatment of uncomplicated gonorrhea, and acute bacterial skin and skin structure infections. Delafloxacin shows MICs remarkably low against Gram-positive organisms and anaerobes and similar to those of ciprofloxacin against Gram-negative bacteria. It remains active against most fluoroquinolone-resistant strains, except enterococci. Its potency is further increased in acidic environments (found in many infection sites). Delafloxacin is active on staphylococci growing intracellularly or in biofilms. Delafloxacin is a dual-targeting fluoroquinolone, capable of forming cleavable complexes with DNA and topoisomerase IV or DNA gyrase and of inhibiting the activity of these enzymes in both Gram-positive and Gram-negative bacteria. On Oct 24, 2016, Melinta Therapeutics Submitted Baxdela New Drug Application for hospital-treated skin infections. — NCATS
Clinical trial activity
11 trials · 4 clinical orgs · 0 marketing orgs
Earliest trial started Jun 1, 2008 (NCT00719810)
Timeline
Indications
Approved for
Studied for
- Bacterial Infections · Phase 3
- Community-Acquired Infections · Phase 3
- Dermatology · Phase 2
- Drug Interactions · Phase 1
- Gonorrhea · Phase 3
- Healthy Volunteers · Phase 1
- Liver Diseases · Phase 1
- Pneumonia · Phase 1
- Pneumonia, Bacterial · Phase 3
- Skin Diseases, Bacterial · Phase 2
- Soft Tissue Infections · Phase 3
- Staphylococcal Skin Infections · Phase 2
- Surgical Wound Infection · Phase 3
Mechanism of action
- Gyrase BINHIBITOR
Q6S6F1 inhibitor
Chemistry & pharmacology
SMILES
NC1=NC(N2C=C(C(O)=O)C(=O)C3=C2C(Cl)=C(N4CC(O)C4)C(F)=C3)=C(F)C=C1F- Mol. weight
- 440.76 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- WikipediaDelafloxacin ↗
- NCATS6315412YVF ↗
- ChEMBLCHEMBL2105637 ↗
Also known as
- abt492
- abt 492
- abt-492
- abt-492
- abt-492
- baxdela
- baxdela
- delafloxacin
- delafloxacin
- delafloxacin
- delafloxacin
- delafloxacin
- delafloxacin
- delafloxacin
- rx-3341
- rx-3341
- rx-3341
- wq 3034
- wq-3034
- wq-3034
- wq-3034
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06612255 | Phase 1 | Jun 3, 2024 | Department of Health and Human Services, Melinta Therapeutics |
| NCT04042077 | Phase 3 | Aug 31, 2019 | Hospital Agostino Gemelli, Menarini Group |
| NCT03534622 | Phase 1 | Apr 30, 2018 | Melinta Therapeutics |
| NCT02679573 | Phase 3 | Dec 14, 2016 | Melinta Therapeutics |
| NCT02505997 | Phase 1 | Jun 1, 2015 | Melinta Therapeutics |
| NCT02245243 | Phase 1 | Sep 1, 2014 | Melinta Therapeutics |
| NCT01984684 | Phase 3 | May 1, 2014 | Melinta Therapeutics |
| NCT02015637 | Phase 3 | Jan 1, 2014 | Melinta Therapeutics |
| NCT01811732 | Phase 3 | Apr 1, 2013 | Melinta Therapeutics |
| NCT01283581 | Phase 2 | Jan 1, 2011 | Melinta Therapeutics |
| NCT00719810 | Phase 2 | Jun 1, 2008 | Melinta Therapeutics |
Organizations
Research & Development (4)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Melinta Therapeutics | For profit | 10 | 10 | 3 | 2008 |
| Department of Health and Human Services | Government | 1 | 0 | 1 | 2024 |
| Hospital Agostino Gemelli | Academic/Hospital | 1 | 0 | 1 | 2019 |
| Menarini Group | For profit | 1 | 1 | 1 | 2019 |