Corstasis Therapeutics’ Enbumyst Gains FDA Approval

Corstasis Therapeutics, a biopharmaceutical company providing outpatient therapeutic options for patients with cardiovascular and renal disease, announced that the U.S. Food and Drug Administration (FDA) has approved Enbumyst (bumetanide nasal spray).

Enbumyst is indicated to treat edema associated with congestive heart failure (CHF), hepatic and renal disease, including nephrotic syndrome in adults.

Enbumyst demonstrated rapid absorption and predictable diuretic response in clinical studies, with a similar effect on diuresis, natriuresis, and urinary potassium excretion when compared to IV bumetanide injection. This adds a new self-administered outpatient diuretic therapy, which may help bridge the gap between oral and IV diuretics for treating edema in patients with CHF, liver disease, and kidney disease. 

The FDA-approved Prescribing Information for Enbumyst does not include a boxed warning. 

Corstasis expects to launch Enbumyst in the U.S. in the fourth quarter of 2025, targeting cardiologists, nephrologists, hepatologists, outpatient heart failure clinics, and integrated delivery networks (IDNs). 

The company is also preparing a robust market access strategy, including real-world outcomes data and payer partnerships, to support rapid adoption and coverage.