NDANASALSPRAY
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
6/8 — Strong
ENBUMYST (bumetanide) by Aspiro Therapeutics is henle. Approved for autism spectrum disorder, heart failure, cirrhosis and 3 more indications. First approved in 2025.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENBUMYST is a nasal spray formulation of bumetanide, a potent loop diuretic that acts on the ascending limb of the Henle loop to produce robust diuresis independent of carbonic anhydrase or aldosterone inhibition. It is approved for multiple indications including heart failure, cirrhosis, autism spectrum disorder, epilepsy, type 2 diabetes, and Alzheimer disease. The novel nasal delivery route represents a significant formulation advancement for a classical diuretic mechanism.
Growth19.0 years to LOE
As a newly launched product (September 2025) with innovative nasal delivery targeting high-burden indications, commercial teams will focus on market establishment and provider education; modest team expansion expected in the first 24 months post-launch.
Mechanism of Action
Henle. The high degree of diuresis is largely due to the unique site of action. The action on the distal tubule is independent of any inhibitory effect on carbonic anhydrase and aldosterone.
Pharmacologic Class:
Loop Diuretic
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.