Back to discover
Drug

Delafloxacin

Approved · EMA
Emerging researchLate-stage development

Also known as Baxdela.

RxNorm1927663ChEMBLCHEMBL2105637ATCJ01MA23UNII6315412YVF
1
Research papers
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1, Single Part, Partially Randomised, Open-Label Study to Evaluate the Relative Bioavailability of a Taste-Masked Delafloxacin Powder for Oral Suspension With Oral Delafloxacin Tablet Reference in Healthy Subjects

Clinical trial2024-09-11Terminated · ClinicalTrials.gov

New Antibiotics for Multidrug-Resistant Bacterial Strains: Latest Research Developments and Future Perspectives.

Research2021-05-02Molecules (Basel, Switzerland)

A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections

Clinical trial2020-10-28Terminated · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety and Efficacy of Intravenous to Oral Delafloxacin in Adult Subjects With Community-Acquired Bacterial Pneumonia

Clinical trial2020-02-27Results posted · ClinicalTrials.gov

Approval: Quofenix (EMA)

Regulatory2019-12-16EMA

A Phase 2 Exploratory Study of Objective Endpoints in Subjects With Acute Bacterial Skin and Skin Structure Infections Treated With Delafloxacin, Vancomycin, or Linezolid

Clinical trial2019-10-16Results posted · ClinicalTrials.gov

A Phase I, Open-Label, Safety and Pharmacokinetic Study To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults

Clinical trial2018-07-27Completed · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

Clinical trial2017-11-17Results posted · ClinicalTrials.gov

A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections

Clinical trial2017-09-27Results posted · ClinicalTrials.gov

A Phase I Study to Evaluate the Effect of Repeated Oral Doses of Delafloxacin on the Pharmacokinetics of a Single Oral Dose of Midazolam in Healthy Subjects

Clinical trial2015-07-01Completed · ClinicalTrials.gov

An Open Label Evaluation of the Single Dose Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

Clinical trial2015-02-01Completed · ClinicalTrials.gov

A Comparative Evaluation of the Single-dose Efficacy of Oral Delafloxacin Versus the Single-dose Efficacy of an Intramuscular Injection of Ceftriaxone in Subjects With Uncomplicated Urogenital Gonorrhea

Clinical trial2014-12-10Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Delafloxacin
Aliases & brands
Baxdela
RxNorm CUI
1927663
ChEMBL ID
CHEMBL2105637
ATC codes
J01MA23
UNII
6315412YVF
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2019-12-16
Latest approval
2019-12-16
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2019-12-16Approval
Approval: Quofenix (EMA)
Indication: Quofenix is indicated for the treatment of the following infections in adults: acute bacterial skin and skin structure infections (ABSSSI), community-acquired pneumonia (CAP),… Show full indication

Quofenix is indicated for the treatment of the following infections in adults: acute bacterial skin and skin structure infections (ABSSSI), community-acquired pneumonia (CAP), when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

11 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
11
registered trials across all phases
LATEST COMPLETION 2018
5
Late-stage (III+)
8
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 11
Phase 14Phase 22Phase 35

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections

TerminatedPH IIIMenarini Groupn=2682020

A Phase 3, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety and Efficacy of Intravenous to Oral Delafloxacin in Adult Subjects With Community-Acquired Bacterial Pneumonia

CompletedPH IIIMelinta Therapeutics, Inc.n=8602018

A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

CompletedPH IIIMelinta Therapeutics, Inc.n=8502016

A Comparative Evaluation of the Single-dose Efficacy of Oral Delafloxacin Versus the Single-dose Efficacy of an Intramuscular Injection of Ceftriaxone in Subjects With Uncomplicated Urogenital Gonorrhea

TerminatedPH IIIMelinta Therapeutics, Inc.n=4602014

A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections

CompletedPH IIIMelinta Therapeutics, Inc.n=6602014

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Multicenter, Randomized, Double-Blind, Comparator-Controlled Study to Evaluate the Safety and Efficacy of Intravenous to Oral Delafloxacin in Adult Subjects With Community-Acquired Bacterial Pneumonia

CompletedPH IIIMelinta Therapeutics, Inc.n=8602018

A Phase I, Open-Label, Safety and Pharmacokinetic Study To Assess Bronchopulmonary Disposition of Intravenous Delafloxacin in Healthy Adults

CompletedPH IMelinta Therapeutics, Inc.n=302018

A Phase 3, Multicenter, Randomized, Double-blind, Active Controlled Study to Evaluate the Efficacy + Safety of IV + Oral Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections (ABSSSI)

CompletedPH IIIMelinta Therapeutics, Inc.n=8502016

A Phase I Study to Evaluate the Effect of Repeated Oral Doses of Delafloxacin on the Pharmacokinetics of a Single Oral Dose of Midazolam in Healthy Subjects

CompletedPH IMelinta Therapeutics, Inc.n=222015

An Open Label Evaluation of the Single Dose Pharmacokinetics of Delafloxacin in Subjects With and Without Hepatic Impairment

CompletedPH IMelinta Therapeutics, Inc.n=402015

A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Delafloxacin Compared With Vancomycin + Aztreonam in Patients With Acute Bacterial Skin and Skin Structure Infections

CompletedPH IIIMelinta Therapeutics, Inc.n=6602014

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes2
Drug Design1Drug Resistance, Multiple, Bacterial1
Journals, researchers & institutions
Top journals
  • Molecules (Basel, Switzerland)1
Leading researchers
  • Pregnolato M1
  • Taccani M1
  • Terreni M1
Leading institutions
free-text, unnormalised
  • University of Pavia1

Related drugs

7 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Cefiderocol

Studied across 2 of the same disease areas as Delafloxacin in the shared literature.

2 shared diseases1 shared paper
Eravacycline

Studied across 2 of the same disease areas as Delafloxacin in the shared literature.

2 shared diseases1 shared paper
Meropenem

Studied across 2 of the same disease areas as Delafloxacin in the shared literature.

2 shared diseases1 shared paper
Plazomicin

Studied across 2 of the same disease areas as Delafloxacin in the shared literature.

2 shared diseases1 shared paper
Pretomanid

Studied across 2 of the same disease areas as Delafloxacin in the shared literature.

2 shared diseases1 shared paper
Sisomicin

Studied across 2 of the same disease areas as Delafloxacin in the shared literature.

2 shared diseases1 shared paper
Vaborbactam

Studied across 2 of the same disease areas as Delafloxacin in the shared literature.

2 shared diseases1 shared paper
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.