Delafloxacin

Highest phase reached
Approved
www.ebi.ac.uk
Drug type
Small molecule
www.ebi.ac.uk
First approval year
2017
www.ebi.ac.uk

First approval year
2017
www.ebi.ac.uk
Listing at source
Listed
Highest phase reached
Approved
www.ebi.ac.uk

Drug type
Small molecule
www.ebi.ac.uk
Drug name
Delafloxacin
www.ebi.ac.uk
Molecular weight
440.77
www.ebi.ac.uk
Structure (SMILES)
Nc1nc(-n2cc(C(=O)O)c(=O)c3cc(F)c(N4CC(O)C4)c(Cl)c32)c(F)cc1F
www.ebi.ac.uk

  • 3 quinolinecarboxylic acid 1 6 amino 3 5 difluoro 2 pyridinyl 8 chloro 6 fluoro 1 4 dihydro 7 3 hydroxy 1 azetidinyl 4 oxo
  • 3-QUINOLINECARBOXYLIC ACID, 1-(6-AMINO-3,5-DIFLUORO-2-PYRIDINYL)-8-CHLORO-6-FLUORO-1,4-DIHYDRO-7-(3-HYDROXY-1-AZETIDINYL)-4-OXO-
  • abt 492
  • ABT-492
  • baxdela
  • BAXDELA
  • delafloxacin
  • Delafloxacin
  • delafloxacin [INN]
  • DELAFLOXACIN [MI]
  • DELAFLOXACIN [USAN]
  • Delafloxacin [WHO-DD]
  • delafloxacin inn
  • delafloxacin mi
  • Delafloxacin Powder
  • delafloxacin usan
  • delafloxacin who dd
  • delafloxacine
  • Delafloxacine
  • delafloxacino
  • Delafloxacino
  • rx 3341
  • RX-3341
  • wq 3034
  • WQ-3034

ATC classification codes
  • J01MA23
Sources for recorded values
www.ebi.ac.uk
CAS registry numbers
  • 189279-58-1
ChEMBL ID
CHEMBL2105637
www.ebi.ac.uk
InChIKey
DYDCPNMLZGFQTM-UHFFFAOYSA-N
www.ebi.ac.uk
PubChem compound IDs
  • 487101
RxNorm IDs (RxCUI)
  • 1927663
FDA ingredient codes (UNII)
  • 6315412YVF

Applicant
MELINTA
Approval date
19 Jun 2017
Application number
NDA208610

Status
Authorised
Status date
16 Dec 2019
Authorisation date
16 Dec 2019
Approved indications
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.
Product number
EMEA/H/C/004860
Authorisation holder
A. Menarini Industrie Farmaceutiche Riunite s.r.l.
Priority medicines scheme
No
Generic
No
Biosimilar
No
Generic medicines
0
Biosimilar medicines
0
Advanced therapy
No
Conditional approval
No
Additional monitoring
No
Accelerated assessment
No
Exceptional circumstances
No

Therapeutic areas

  • Community-Acquired Infections
European medicines record
www.ema.europa.eu

Patents
0
Designations
2
First in class
No
Fast track
Yes
Breakthrough designation
No
Orphan designation
No
Priority review
Yes
Orphan exclusivity
No
Accelerated approval
No
Availability
Prescription only
Boxed warning
Yes

Pharmacology name
delafloxacin
Type
Synthetic organic
Drug name stem
-oxacin
Approval recorded by Guide to Pharmacology
Yes

Administration routes

  • Oral
  • Parenteral

  • Mechanism
    Bacterial DNA gyrase inhibitor
    Action type
    Inhibitor
    Target
    Bacterial DNA gyrase
  • Mechanism
    Topoisomerase IV inhibitor
    Action type
    Inhibitor
    Target
    Topoisomerase IV

  • Condition
    Gonorrhea
    Highest recorded phase
    3
    Condition identifier
    DOID:7551
    Subject identifier
    D006069
  • Condition
    Infections
    Highest recorded phase
    3
    Condition identifier
    EFO:0000544
    Subject identifier
    D007239
  • Condition
    Bacterial Infections
    Highest recorded phase
    4
    Condition identifier
    EFO:0000771
    Subject identifier
    D001424
  • Condition
    Liver Diseases
    Highest recorded phase
    1
    Condition identifier
    EFO:0001421
    Subject identifier
    D008107
  • Condition
    Pneumonia
    Highest recorded phase
    1
    Condition identifier
    EFO:0003106
    Subject identifier
    D011014
  • Condition
    Pneumonia, Bacterial
    Highest recorded phase
    3
    Condition identifier
    EFO:1001272
    Subject identifier
    D018410

  • Condition identifier
    DOID_7551
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000544
    Highest recorded phase
    3
  • Condition identifier
    EFO_0000771
  • Condition identifier
    EFO_0001421
    Highest recorded phase
    1
  • Condition identifier
    EFO_0003106
    Highest recorded phase
    1
  • Condition identifier
    MONDO_0004277
    Highest recorded phase
    3
  • Condition identifier
    MONDO_0004492
  • Condition identifier
    MONDO_0005113
    Highest recorded phase
    4

  • Warning
    Black Box Warning
    Effect
    musculoskeletal toxicity
    Country
    United States
  • Warning
    Black Box Warning
    Effect
    neurotoxicity
    Country
    United States

Dose
300 mg
Route
Intravenous
How often
Every 12 hours

Conditions of use

  • Administer over 60 minutes

Hydrogen bond acceptors
7
Hydrogen bond donors
3
Polar surface area
121.68
Calculated partition coefficient (ALogP)
1.92
Calculated partition coefficient (XLogP)
2.7
Prodrug
No
Chirality
Achiral
Inorganic
No
Rule-of-five violations
0
Rotatable bonds
3
Heavy atoms
30
Molecular formula
C18H12ClF3N4O4
Monoisotopic mass
440.0499171
Natural product
No

Recorded assays
175
Active assays
6

Active assay types

  • Screening

Distribution coefficient (LogD)

Median
0.7
Mean
0.7
Minimum
0.7
Maximum
0.7
Unit
unitless
Assays
1
Standard deviation
0
Summary method
median
Censored results excluded
0
Other units excluded
0
Unknown units excluded
0

Measurement types

  • LogD

Solubility

Median
58,100
Mean
58,100
Minimum
58,100
Maximum
58,100
Unit
nM
Assays
1
Standard deviation
0
Summary method
median
Censored results excluded
0
Other units excluded
0
Unknown units excluded
0

Measurement types

  • Solubility

Oral bioavailability

Median
59
Mean
59
Minimum
59
Maximum
59
Unit
%
Assays
1
Standard deviation
0
Summary method
median
Censored results excluded
0
Other units excluded
0
Unknown units excluded
0

Measurement types

  • F

Related records

Trials (257)

Approved for (1)

In development for (4)