Merck Initiates Phase 3 Study Evaluating Ohtuvayre® (ensifentrine) for the Prevention of COPD Exacerbations in Adult Patients Receiving Standard of Care With a History of Exacerbations
Business Wire•03/11/2026•06:45 ET
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Key Highlights
- ➤Merck initiates Phase 3 ENHANCE-3 study evaluating OHTUVAYRE for COPD exacerbation prevention
- ➤ENHANCE-3 plans to enroll approximately 2,136 patients across 28 countries
- ➤Trial primary endpoint is annualized moderate or severe COPD exacerbation rate over 52 weeks
- ➤OHTUVAYRE received FDA approval in June 2024 for adult COPD maintenance treatment
Expert Statements
Mahesh Patel, Vice president, global clinical development, Merck Research Laboratories
“Many patients with COPD continue to experience persistent symptoms such as shortness of breath, despite current standard-of-care therapy. For these patients, exacerbations remain a major driver of disease progression and diminished quality of life”
Mahesh Patel, Vice president, global clinical development, Merck Research Laboratories
“The initiation of the Phase 3 ENHANCE-3 study marks an important step in our efforts to further strengthen the body of evidence supporting OHTUVAYRE and its potential to address significant unmet needs in COPD care. We remain committed to advancing innovative research to help the millions of people impacted by this disease worldwide.”
Merck Initiates Phase 3 Study Evaluating Ohtuvayre(®) (ensifentrine) for the Prevention of COPD Exacerbations in Adult Patients Receiving Standard of Care With a History of Exacerbations
ENHANCE-3 study represents Merck’s commitment to addressing the burden of COPD exacerbations
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