Abstract
Objective: The goals of this article are reviewing the clinical aspects of ensifentrine, results from the clinical trials that led to its approval and examining its potential impact on patient care to aid therapeutic decision-making. Data Sources: A literature search of studies took place between October 2024 and December 2024 on PubMed using the terms ensifentrine, roflumilast, Ohtuvayre™ and ensifentrine chronic obstructive pulmonary disease (COPD). Study selection/data extraction: Phase II and III randomized controlled trials were eligible for inclusion. Pertinent clinical trials included those focusing on the use of ensifentrine in the treatment of COPD. Meeting abstracts, systematic reviews and meta-analyses were excluded from this article. Data synthesis: Food and Drug Administration approval for ensifentrine is based off the phase III ENHANCE clinical trials in patients with COPD. Ensifentrine demonstrated improvement in lung function and a reduction in symptoms in clinical studies with a tolerable safety profile. Conclusion: The development and approval of ensifentrine for the maintenance of COPD demonstrates an advancement in patient care for a disease with significant morbidity and mortality. Ensifentrine could be a viable option as adjunct therapy for patients still experiencing symptoms despite treatment with currently recommended therapies.