Lefamulin

Generic Name
Lefamulin
Brand Names
Xenleta
Drug Type
Small Molecule
Chemical Formula
C28H45NO5S
CAS Number
1061337-51-6
Unique Ingredient Identifier
21904A5386
Background

Lefamulin is a pleuromutilin antibiotic used for the treatment of bacterial community-acquired pneumonia. A pleuromotilin is a more recently developed type of antibiotic that is derived from the fungus, Pleurotus mutilus. Lefamulin is available in intravenous and oral preparations and was granted FDA approval in August 2019. This drug is the first semi-synth...

Indication

Lefamulin is indicated to treat adults diagnosed with community-acquired bacterial pneumonia (CABP) that is caused by susceptible bacteria. Its use should be reserved for confirmed susceptible organisms or a high probability of infection with susceptible organisms. The list of susceptible bacteria includes Streptococcus pneumoniae, Staphylococcus aureus (met...

Associated Conditions
Community acquired pneumonia caused by Streptococcus Pneumoniae, Haemophilus Influenzae, Methicillin-Sensitive Staphylococcus Aureus Infection, Legionella Pneumophila Infections, Mycoplasma pneumoniae infection, Chlamydophila Pneumoniae Infections
Associated Therapies
-

Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis

Phase 1
Completed
Conditions
Interventions
First Posted Date
2022-02-07
Last Posted Date
2024-06-17
Lead Sponsor
Nabriva Therapeutics AG
Target Recruit Count
13
Registration Number
NCT05225805
Locations
🇺🇸

Boston Children's Hospital, Boston, Massachusetts, United States

🇺🇸

New York Medical College, Valhalla, New York, United States

🇺🇸

University of Kansas School of Medicine, Kansas City, Kansas, United States

and more 3 locations

Lefamulin for M. Genitalium Treatment Failures

First Posted Date
2021-11-08
Last Posted Date
2024-10-26
Lead Sponsor
University of Washington
Target Recruit Count
12
Registration Number
NCT05111002
Locations
🇺🇸

University of Washington, Seattle, Washington, United States

Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia

First Posted Date
2016-06-27
Last Posted Date
2019-10-23
Lead Sponsor
Nabriva Therapeutics AG
Target Recruit Count
738
Registration Number
NCT02813694
Locations
🇺🇸

Site 1060, Houston, Texas, United States

🇺🇸

Site 1065, Fresno, California, United States

🇺🇸

Site 1069, Houston, Texas, United States

and more 152 locations

Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia

First Posted Date
2015-09-24
Last Posted Date
2019-10-23
Lead Sponsor
Nabriva Therapeutics AG
Target Recruit Count
551
Registration Number
NCT02559310
Locations
🇦🇷

Site 3005, La Plata, Buenos Aires, Argentina

🇦🇷

Site 3007, Córdoba, Argentina

🇦🇷

Site 3001, Córdoba, Argentina

and more 96 locations

Bioavailability and Pharmacokinetics of Lefamulin When Administered to Fed and Fasted Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2015-09-23
Last Posted Date
2015-09-23
Lead Sponsor
Nabriva Therapeutics AG
Target Recruit Count
20
Registration Number
NCT02557789
Locations
🇬🇧

Quotient Clinical, Nottingham, United Kingdom

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