Duaklir® US

Duaklir® is a fixed dose combination product recently approved in the United States as a treatment for 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®.

Product progress

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. In 2017 it completed a phase III clinical study designed to support a regulatory filing in the United States, which was submitted in Q2 2018. The product was subsequently approved in the US in March 2019 and launch is planned for H2 2019.

Pipeline status: Duaklir® US

Pre-clinicalPhase IPhase IIPhase III / PMA / SubstituteFiledApproved

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