ENBUMYST (bumetanide)
Enbumyst is a loop diuretic used to manage fluid retention in adults. It helps patients with swelling caused by congestive heart failure, liver disease, or kidney conditions such as nephrotic syndrome. This medication is prescribed to reduce the edema that often accompanies these serious health issues.
How ENBUMYST Works
This medication works by inhibiting the reabsorption of sodium and chloride within the loop of Henle and the proximal and distal tubules of the kidneys. By blocking these minerals from being reabsorbed, the drug promotes significant fluid removal. This action on the distal tubule occurs without relying on the inhibition of carbonic anhydrase or aldosterone.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-09-12
- Patent Cliff
- 2045
- Routes
- NASAL
- Dosage Forms
- SPRAY
ENBUMYST Approval History
What ENBUMYST Treats
5 indicationsENBUMYST is approved for 5 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Edema
- Congestive Heart Failure
- Hepatic Disease
- Renal Disease
- Nephrotic Syndrome
ENBUMYST Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ENBUMYST
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03107416 | 17-141 | Ph 1, Ph 2 | active not recruiting | Delivering a Diuretic Into the Liver Artery Followed by Plugging up the Artery to Starve Out Liver Cancer Cells |
| NCT06941415 BUFF | IRB_00186841 | Ph 3 | not yet recruiting | Bumetanide vs. Furosemide in Cirrhosis |
| NCT07005414 | XHEC-C-2025-089 | Ph 2 | completed | Efficacy of Bumetanide in Children With Autism Spectrum Disorder Guided by Peripheral Blood Biomarkers and Machine Learning Models |
| NCT06052163 BumxAD | IRB-69153 | Ph 2 | recruiting | Bumetanide in Patients With Alzheimer's Disease |
| NCT06036914 results posted | 23-005262 | Ph 2 | completed | A Study of Ultra High Dose Diuretics to Treat Heart Failure |
| NCT06465823 | 1042_OPBG_2016 | Ph 2 | recruiting | Efficacy of Bumetanide to Improve Cognitive Functions in Down Syndrome |
| NCT06218199 DART-HA | Dart-HA | Ph 4 | recruiting | Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts |
| NCT02947880 BUMAUTEP | I14039 | Ph 2 | withdrawn | Evaluation of the Efficiency of Treatment by BUMETANIDE on Autistic Children With a Known Ethiology |
| NCT03156153 | XH-16-048 | Ph 2 | completed | A Study of Bumetanide for the Treatment of Autism Spectrum Disorders |
| NCT04766177 | autism | Ph 3 | recruiting | Role of Bumetanide in Treatment of Autism |
| NCT00830531 | CURE 07120492 1R01NS066929-01A1 | Ph 1 | completed | Pilot Study of Bumetanide for Newborn Seizures |
| NCT03923933 results posted | DI/19/105-B/03/018 | Ph 2 | completed | Chlortalidone and Bumetanide in Advanced Chronic Kidney Disease: HEBE-CKD Trial |
| NCT02582476 | 120542 | Ph 2 | terminated | Bumetanide in Hypokalaemic Periodic Paralysis |
| NCT00930865 | MB102-057 | Ph 1 | completed | 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 |
| NCT01434225 NEMO1 | 08NR26 | Ph 1, Ph 2 | completed | NEMO1:NEonatal Seizure Using Medication Off-patent |
| NCT00372762 | R-06-415 | Ph 3 | withdrawn | Bumetanide Versus Furosemide in Heart Failure |
| NCT01078714 BUMEA | RB09-017 | Ph 3 | completed | Efficiency of Bumetanide in Autistic Children |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ENBUMYST FDA Label Details
Indications & Usage
ENBUMYST is indicated for the treatment of Edema; Congestive Heart Failure; Hepatic Disease; Renal Disease; Nephrotic Syndrome.
ENBUMYST Patents & Exclusivity
Patents (4 active)
Pro Intelligence Preview
Deep insights for ENBUMYST
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2045
- • 4 active patents
Trial Analysis
- • 18 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment