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 recently completed a phase III clinical study designed to support a regulatory filing in the United States, and our partner AstraZeneca is planning to submit a New Drug Application for the product 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