Duaklir®* is a fixed dose combination product in late-stage development in the United States as a maintenance bronchodilator treatment for adult patients with COPD. It contains the long-acting muscarinic antagonist aclidinium bromide and the long-acting beta agonist formoterol fumarate. Duaklir® is presented as a dry powder for inhalation and is delivered via the breath-actuated multi-dose inhaler Pressair®.
Duaklir® was initially approved in the European Union in 2014 and is approved in approximately 50 countries around the world under a number of brand names. It is currently in a phase III clinical study in the United States, with AstraZeneca responsible for completing the study and pursuing regulatory approval. The study is anticipated to conclude in H2 2017, with AstraZeneca planning a US regulatory filing in H1 2018.
*The Duaklir® trademark is registered in the United States; the mark is not currently approved for use by the FDA.
Pipeline status: Duaklir® US