Corstasis Therapeutics, an innovative biopharmaceutical company focused on providing enhanced 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 for the treatment of edema associated with congestive heart failure (CHF), hepatic disease, and renal disease, including nephrotic syndrome, in adults. It is the first and only intranasal loop diuretic approved in the United States, offering patients a convenient, self-administered alternative between oral and intravenous diuretics.

Edema and fluid overload remain leading causes of hospitalization and readmission among patients with CHF, cirrhosis, and chronic kidney disease. Approximately 6.7 million Americans are living with heart failure, and fluid overload drives more than one million hospitalizations annually, accounting for billions of dollars in healthcare expenditures. Current oral loop diuretics can be limited by poor gastrointestinal absorption and delayed onset, while intravenous therapy requires hospital or infusion settings, often resulting in increased resource utilization and higher costs.

In clinical studies, Enbumyst demonstrated rapid absorption and a predictable diuretic response, with effects on diuresis, natriuresis, and urinary potassium excretion comparable to intravenous bumetanide injection. By providing a new, self-administered outpatient option, Enbumyst bridges the gap between oral and IV diuretics, potentially improving management of fluid overload outside the hospital setting. The FDA-approved Prescribing Information for Enbumyst does not include a boxed warning.

“The FDA approval of Enbumyst represents a meaningful advancement in the treatment of edema for both patients and providers,” said Ben Esque, Chief Executive Officer of Corstasis Therapeutics. “Enbumyst was designed in direct collaboration with cardiologists to address practical challenges in outpatient care,” added Dr. Brian Kolski, Chief Medical Director of Corstasis and Director of the Non-Invasive Vascular Lab at the Orange County Heart Institute, as well as Director of Structural Heart Disease at Providence St. Joseph Hospital in Orange, California.

Corstasis plans to launch Enbumyst in the U.S. in the fourth quarter of 2025, with a focus on cardiologists, nephrologists, hepatologists, outpatient heart failure clinics, and integrated delivery networks (IDNs). The company is preparing a comprehensive market access strategy, supported by real-world outcomes data and payer partnerships, to drive rapid adoption and broad coverage.

The U.S. outpatient diuretic market for edema associated with CHF, liver disease, and kidney disease represents a multi-billion-dollar annual opportunity. This is driven by the high prevalence of these conditions and the urgent need for therapies that can reduce costly hospitalizations and readmissions.

“Enbumyst offers the potential to change the standard of care by enabling earlier outpatient intervention,” said Dr. Anuradha Lala-Trindade, Director of Heart Failure Research at the Mount Sinai Fuster Heart Hospital in New York. “This innovation may meaningfully improve patient outcomes while easing the economic burden on the healthcare system.”