Merck has announced the initiation of the Phase 3 ENHANCE-3 study of Ohtuvarye ensifentrine inhalation suspension, which is expected to enroll 2,136 COPD patients and will evaluate Ohtuvarye for the prevention of exacerbations. Merck acquired Ohtuvarye in 2025 when it acquired Verona Pharma.
Ohtuvarye has been approved for the treatment of COPD in the US since June 2024. The approval was based on data from two Phase 3 trials conducted by Verona, ENHANCE-1 and ENHANCE-2. Both of those trials met their primary endpoints. Verona also initiated a Phase 2 trial of ensifentrine for the treatment of non-CF bronchiectasis in 2024, and that trial is ongoing.
Merck Research Laboratories VP, Global Clinical Development Mahesh Patel commented, “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. The initiation of the Phase 3 ENHANCE-3 study marks an important step in our efforts to further strengthen the body of evidence supporting Ohtuvarye 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.”
Read the Merck press release
