delafloxacin

Trade name: BAXDELA

Small moleculeexperimental

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

Phase 1
4
Phase 2
7
Phase 3
5
Phase 4
0

Earliest trial started Jun 1, 2008 (NCT00719810)

Timeline

2000s

  1. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2014

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Chemistry & pharmacology

Loading structure…

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

Black box warning

Sources

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 IDPhaseStart dateSponsor(s)
NCT06612255Phase 1Jun 3, 2024Department of Health and Human Services, Melinta Therapeutics
NCT04042077Phase 3Aug 31, 2019Hospital Agostino Gemelli, Menarini Group
NCT03534622Phase 1Apr 30, 2018Melinta Therapeutics
NCT02679573Phase 3Dec 14, 2016Melinta Therapeutics
NCT02505997Phase 1Jun 1, 2015Melinta Therapeutics
NCT02245243Phase 1Sep 1, 2014Melinta Therapeutics
NCT01984684Phase 3May 1, 2014Melinta Therapeutics
NCT02015637Phase 3Jan 1, 2014Melinta Therapeutics
NCT01811732Phase 3Apr 1, 2013Melinta Therapeutics
NCT01283581Phase 2Jan 1, 2011Melinta Therapeutics
NCT00719810Phase 2Jun 1, 2008Melinta Therapeutics
Showing 11 of 11 trials
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Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Melinta TherapeuticsFor profit101032008
Department of Health and Human ServicesGovernment1012024
Hospital Agostino GemelliAcademic/Hospital1012019
Menarini GroupFor profit1112019
4 organizations
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