Ensifentrine in chronic obstructive pulmonary disease: a profile of its use

<b>Declarations</b><b>Funding</b> The preparation of this review was not supported by any external funding.<b>Authorship and conflict of interest</b> A. Zhuang-Yan and Y. Y. Syed are salaried employees of Adis International Ltd/Springer Nature and declare no relevant conflicts of interest. All authors contributed to this article and are responsible for its content.<b>Ethics approval, Consent to participate, Consent for publication, Availability of data and material, Code availability</b> Not applicable.Additional information about this Adis Drug Review can be found <b>here</b>.<b>©</b> Springer Nature Switzerland AG 2025<b>Abstract</b>Ensifentrine (OHTUVAYRE^™), a first-in-class, dual inhibitor of phosphodiesterase (PDE) enzymes PDE3 and PDE4, is a novel, steroid-free therapeutic option approved in the USA for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. The dual mechanism of ensifentrine provides both bronchodilator and anti-inflammatory effects in the lungs. In two phase 3 clinical trials in adults with moderate to severe COPD, twice-daily nebulized ensifentrine significantly improved lung function at week 12 compared with placebo. Over 24 weeks, ensifentrine improved patient-reported COPD symptoms and health-related quality of life, with statistically significant differences versus placebo in one of the two trials. In a pooled analysis of both trials, ensifentrine significantly reduced the rate of moderate or severe COPD exacerbations over 24 weeks compared with placebo. Ensifentrine was generally well tolerated over up to 48 weeks.