Table 1.
State of clinical development in tuberculosis (TB) treatment and general marketing status as at 2019
| Marketing status other than TBA,B | Registered strength (mg) | Clinical development phase for TB (2011–2018)C, D | |
|---|---|---|---|
| WHO recommended fluoroquinolones (2019) | |||
| Gatifloxacin | Discontinued (USA) | – | III |
| Levofloxacin | Approved (USA/EU)E | 250, 500 and 750 | IVF, II, III |
| Moxifloxacin | Approved (USA/EU)E | 400 | IIF, III |
| High-potential fluoroquinolones based on PK/PD | |||
| Sparfloxacin | Discontinued (USA) | – | None |
| Sitafloxacin | None | – | None |
| Trovafloxacin | Discontinued (USA/EUE) | – | None |
| DC-159a | None | – | None |
Searches were conducted in March 2018. A second search in December 2018 revealed no change in marketing or clinical development status
Table format partly adopted from Pranger et al. Current Pharmaceutical Design 2011
Oral formulation unless indicated otherwise
PK/PD pharmacokinetics/pharmacodynamics
AMarketing status is indicated as the state of the fluoroquinolone on the market of the USA and/or the European Union (EU)
BMarketing status ‘none’: registered data was not available on fda.gov or ema.europa.eu
CClinical development status ‘none’: no registered trial (Phase I–IV) on clinicaltrials.gov or available as literature on PubMed
DPulmonary TB unless otherwise indicated
EIntravenous and oral formulation
FFor pulmonary TB as well as TB meningitis