NDANASALSPRAY
Approved
Sep 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
5
Data completeness
5/8 — Partial
ENBUMYST (bumetanide) by Aspiro Therapeutics is henle. First approved in 2025.
Drug data last refreshed 1h ago · AI intelligence enriched 6d 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 loop of Henle to produce significant diuresis independent of carbonic anhydrase or aldosterone inhibition. This novel delivery route represents a differentiated approach to diuretic therapy for patients requiring rapid fluid management. The nasal formulation enables non-invasive administration compared to traditional IV/oral routes.
Launch18.9 years to LOE
Early-stage launch product with no established market share; commercial team will focus on market education and formulary access expansion.
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
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (5)
Bumetanide vs. Furosemide in Cirrhosis
Started May 2026
500 enrolled
Cirrhosis
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder.
Started Oct 2018
211 enrolled
Autism Spectrum Disorder (ASD)
Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder
Started Sep 2018
211 enrolled
Autism Spectrum Disorder (ASD)
Pilot Study of Bumetanide for Newborn Seizures
Started Jan 2010
43 enrolled
Seizures
Study to Evaluate the Potential Pharmacokinetic Interaction and Pharmacodynamic Effects on Renal Parameters of Bumetanide (1mg) and Dapagliflozin (10 mg) When Co-administered in Healthy Subjects
Started Jul 2009
42 enrolled
Type 2 Diabetes Mellitus
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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.