dabigatran etexilate + BI 1323495

Dabigatran etexilate + BI 1323495 is a drug combination investigated by Boehringer Ingelheim, consisting of the anticoagulant dabigatran etexilate and the novel neutrophil elastase inhibitor BI 1323495. Dabigatran etexilate is a prodrug that is converted to dabigatran, a direct thrombin inhibitor used to prevent thromboembolism. BI 1323495 is a highly selective, small molecule oral inhibitor of neutrophil elastase (NE), a protease that plays a key role in the inflammatory response and tissue destruction associated with chronic respiratory diseases. The combination was evaluated in Phase 1 clinical trials to determine the relative bioavailability and potential pharmacokinetic interactions between the two drugs. BI 1323495 was being developed for indications including non-cystic fibrosis bronchiectasis (NCFB), chronic obstructive pulmonary disease (COPD), and cystic fibrosis, although a Phase 1c trial in NCFB was terminated in early 2022.