ENBUMYST™ is the first and only intranasal loop diuretic approved in the U.S. offering a self-administered alternative between oral and intravenous diuretics.

Corstasis Therapeutics Inc., an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease, today 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), and hepatic and renal disease, including nephrotic syndrome in adults.

Addressing a Critical Unmet Need

Edema and fluid overload remain the leading causes of hospitalization and readmission for patients with CHF, cirrhosis, and chronic kidney disease. An estimated 6.7 million Americans live with heart failure, and fluid overload drives over 1 million hospitalizations annually, accounting for billions of dollars in U.S. health care expenditures. Oral loop diuretics can be limited by poor gastrointestinal absorption and delayed onset, while intravenous (IV) therapy requires a hospital or infusion setting, often associated with higher resource utilization and increased healthcare expenditure.

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. ENBUMYST 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. Please refer to the Important Safety Information below.

“The FDA approval of ENBUMYST represents a meaningful advancement in the treatment of edema for 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 the outpatient care setting,” said Dr. Brian Kolski Chief Medical Director of Corstasis and Director, Non-Invasive Vascular Lab at the Orange County Heart Institute and Director of Structural Heart Disease at Providence St Joseph Hospital in Orange, California.

Commercial Strategy and Market Opportunity

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.

The U.S. market for outpatient diuretic therapies addressing edema associated with CHF, and hepatic and renal disease is estimated to represent a multi-billion-dollar opportunity annually, driven by the high prevalence of heart failure and chronic kidney disease, as well as the unmet need for therapies that 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 outcomes while potentially easing the economic burden on the healthcare system.”

About ENBUMYST

ENBUMYST is a nasal spray loop diuretic indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ENBUMYST™ (BUMETANIDE NASAL SPRAY).

INDICATION

ENBUMYST is indicated for the treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults.

IMPORTANT SAFETY INFORMATION

ENBUMYST is contraindicated in patients with anuria, who are in hepatic coma and have a history of hypersensitivity to bumetanide.

ENBUMYST is a diuretic that may cause fluid, electrolyte, and metabolic abnormalities. Excessive fluid loss can lead to dehydration, decreased blood volume, and increased risk of blood clots. Abnormalities may include changes in blood electrolytes, nitrogen, glucose, and uric acid. The chance of getting these abnormalities is higher in people who are elderly, use higher doses or who do not get enough electrolytes by mouth.

If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, discontinue bumetanide.

Although unlikely at the recommended doses, the potential for ototoxicity must be considered a risk of intravenous therapy, at high doses, repeated frequently in the face of renal excretory function impairment.

Avoid use in patients with significant nasal mucosal or structural abnormalities, such as acute episodes of rhinitis or congestion due to any cause.

Advise lactating women treated with ENBUMYST to monitor their infants for excessive urine output, dehydration, and lethargy.

Most common adverse reactions are hypovolemia, headache, muscle cramps, dizziness, hypotension, nausea and encephalopathy (in patients with pre-existing liver disease).

These are not all of the possible side effects of ENBUMYST. To report suspected adverse reactions, contact Corstasis Therapeutics at 1-877-300-5339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see the full Prescribing Information for ENBUMYST.

About Corstasis Therapeutics

Corstasis Therapeutics is an innovative biopharmaceutical company providing enhanced outpatient therapeutic options for patients with cardiovascular and renal disease. The company’s lead product, ENBUMYST™ (bumetanide nasal spray), is the first FDA-approved intranasal loop diuretic, and Corstasis is developing a near term pipeline of subcutaneous diuretic products. Corstasis is committed to advancing care through pragmatic innovations focused on improving patient outcomes, reducing hospitalizations, and lowering the cost of treating edema associated with congestive heart failure, liver disease and kidney disease, including nephrotic syndrome in adults.

Forward-Looking Statements

This press release contains forward-looking statements regarding the future commercialization of ENBUMYST, anticipated market adoption, payer access, and Corstasis’ growth strategy. These statements are subject to risks and uncertainties, including but not limited to, market dynamics, reimbursement decisions, manufacturing scale-up, and clinical outcomes, which could cause actual results to differ materially. Corstasis undertakes no obligation to update these statements except as required by law.

For more information, please visit www.corstasis.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250915243998/en/

Corstasis Therapeutics Announces FDA Approval of ENBUMYST™ (bumetanide nasal spray) for the Treatment of Edema Associated with Congestive Heart Failure, Liver Disease and Kidney Disease