XENLETA—a flexible and
effective CABP treatment1

XENLETA was evaluated in
2 phase III CABP trials:
Trial 1 (IV to oral switch) and
Trial 2 (oral treatment only)1

XENLETA is a systemic, empiric pleuromutilin antibiotic with activity against CABP-specific Gram-positive, Gram-negative, and atypical respiratory bacteria1

Trial 1:
IV with optional oral switch Trial 2:
Oral treatment only Proven microbiologic activity
and response

XENLETA monotherapy achieved early and effective clinical response1

Primary endpoint:
early clinical response (ECR) rates1

XENLETA - Trial 1 primary endpoint

Secondary endpoint: investigator-assessed
clinical response (IACR) rates at test of cure (TOC)1

XENLETA - Trial 1 secondary endpoint

Results above from Trial 1 (IV with optional oral switch), which evaluated XENLETA monotherapy (n=276) for 5-10 days vs moxifloxacin ± linezolid (n=275) for 7-10 days. ECR (72-120 hours after the first dose) was defined as survival with improvement of ≥2 symptoms consistent with CABP, no worsening of any symptom, and no receipt of non-study antibacterial treatment for CABP. IACR at TOC (5-10 days after last dose) was defined as survival with improvement of signs and symptoms based on the investigator’s assessment and no receipt of non-study antibacterial treatment for CABP.1

  1. aIf MRSA was suspected at screening, patients randomized to moxifloxacin received adjunctive linezolid, and patients randomized to XENLETA received linezolid placebo.

Phase III, multicenter, randomized, double-blind, double-dummy, noninferiority study1,2

Selected inclusion/exclusion criteria:
  • Adults with acute onset of:
    • ≥3 of the following (new or worsening) symptoms: dyspnea, new or
      increased cough, purulent sputum production,
      chest pain due to pneumonia
    • ≥2 of the following symptoms: fever or hypothermia,
      hypotension, tachycardia, tachypnea
  • At least 1 other clinical sign or laboratory finding of CABP
  • PORT Risk Class III, IV, or V (≥25% subjects with
    PORT Risk Class IV or V)
  • Required IV antibiotic therapy as initial treatment
  • Expected (but not required) to be hospitalized
  • ≤25% of randomized subjects were to have received
    a single dose of a short-acting antibacterial medication
    for CABP within 72 hours before randomization
  • Lobar or multilobar infiltrates or diffuse opacities
    on chest X-ray or chest CT scan consistent with acute
    bacterial pneumonia within 48 hours before enrollment
XENLETA - Trial 1 design XENLETA - Trial 1 design

CT=computed tomography; PORT=Pneumonia Patient Outcomes Research Team.

5 days with XENLETA achieved comparable efficacy to 7 days with moxifloxacin—nearly 30% less time on treatment1,a

Primary endpoint:
early clinical response (ECR) rates1

XENLETA - Trial 2 primary endpoint

Secondary endpoint: investigator-assessed
clinical response (IACR) rates at test of cure (TOC)1

XENLETA - Trial 2 secondary endpoint

Results from Trial 2 (oral treatment only), which evaluated 5 days of treatment with XENLETA (n=370) vs 7 days of treatment with moxifloxacin (n=368). ECR (72-120 hours after the first dose) was defined as survival with improvement of ≥2 symptoms consistent with CABP, no worsening of any symptom, and no receipt of non-study antibacterial treatment for CABP. IACR at TOC (5-10 days after last dose) was defined as survival with improvement of signs and symptoms based on the investigator’s assessment and no receipt of non-study antibacterial treatment for CABP.1

  1. aThese results established noninferiority.1

Phase III, multicenter, randomized, double-blind, noninferiority study1,2

Selected inclusion/exclusion criteria:
  • Adults with acute onset of:
    • ≥3 of the following (new or worsening) symptoms: dyspnea,
      new or increased cough, purulent sputum production,
      chest pain due to pneumonia
    • ≥2 of the following symptoms: fever or hypothermia,
      hypotension, tachycardia, tachypnea
  • At least 1 other clinical sign or laboratory finding of CABP
  • PORT Risk Class II, III, or IV (≥50% subjects with
    PORT Risk Class III or IV)
  • Appropriate candidates for oral antibiotic therapy
  • Not required to be hospitalized
  • ≤25% of randomized subjects were to have received
    a single dose of a short-acting antibacterial
    medication for CABP within 72 hours before randomization
  • Lobar or multilobar infiltrates or diffuse opacities on
    chest X-ray or chest CT scan consistent with acute
    bacterial pneumonia within 48 hours before enrollment
XENLETA - Trial 2 design XENLETA - Trial 2 design

CT=computed tomography; PORT=Pneumonia Patient Outcomes Research Team.

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Proven microbiologic activity and response in CABP1

XENLETA targets and acts against the pathogens that commonly cause CABP, including S. pneumoniae and others.1

Clinical response rates at TOC by baseline pathogen (Trial 1 and Trial 2)1,a

Gram-positive

Proven microbiologic activity - Gram-positive

XENLETA has shown in vitro activity against
methicillin-resistant Staphylococcus aureus
(MRSA) isolates. However, the clinical
significance of this is unknown.1

Gram-negative

Proven microbiologic activity - Gram-negative

Atypical bacteria

Proven microbiologic activity - Other bacteria
  1. aMicrobiologic ITT analysis set, which included all patients with at least one identified baseline pathogen.

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