Last reviewed 2026-04-20 · How we verify

Xenleta (LEFAMULIN)

At a glance

Approved indications

• Bacterial pneumonia
• Bronchopneumonia due to Haemophilus influenzae
• Haemophilus influenzae pneumonia
• Legionella pneumonia
• Pneumonia caused by Chlamydia pneumoniae
• Pneumonia due to Mycoplasma pneumoniae
• Pneumonia due to Staphylococcus aureus
• Pneumonia due to Streptococcus

Common side effects

• Nausea
• Hepatic enzyme elevation
• Administration site reactions
• Hypokalemia
• Insomnia
• Headache

Serious adverse events

• Serious adverse reactions (overall)
• Death within 28 days
• Clostridioides difficile colitis
• QT prolongation
• Atrial fibrillation

Key clinical trials

• Lefamulin for M. Genitalium Treatment Failures (PHASE1,PHASE2)
• Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis (PHASE1)
• Study Comparing the Safety and Efficacy of Two Doses of BC-3781 vs Vancomycin in Patients With Acute Bacterial Skin and Skin Structure Infection (ABSSSI) (PHASE2)
• Study to Compare Lefamulin to Moxifloxacin (With or Without Linezolid) for the Treatment of Adults With Pneumonia (PHASE3)
• Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia (PHASE3)
• A Study to Assess Mass Balance Recovery, Metabolite Profile and Identification of IV and Oral 14C-BC-3781 (PHASE1)
• Bioavailability and Pharmacokinetics of Lefamulin When Administered to Fed and Fasted Healthy Subjects (PHASE1)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Xenleta CI brief — competitive landscape report
• Xenleta updates RSS · CI watch RSS
• Hong Kong portfolio CI