6 completed, 4 withdrawn, 1 terminated. 4 Phase 3, 3 Phase 1, 2 Phase 2, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 4 | Completed 3, Withdrawn 1 |
| Phase 1 | 3 | Completed 2, Terminated 1 |
| Phase 2 | 2 | Completed 1, Withdrawn 1 |
| Phase 4 | 2 | Withdrawn 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Bioavailability and Bioequivalence Study of ER Torsemide and Spironolactone FDC Tablet in Healthy Subjects 10 mg Torsemide tablet, 25 mg Aldactone (Spironolactone) tablet, FDC (12 mg ER Torsemide + 15mg Spironolactone) tablet - Bioequivalence Study in Healthy Subjects, PK/PD | Phase 3 | Completed | Sarfez Pharmaceuticals, Inc. | 24 | 2025-07-01 | 2026-03-06 |
| A Study to Evaluate the Effect of Food or no Food on the Bioavailability of an Extended Release (ER) Torsemide and Spironolactone Fixed Dose Combination (FDC) Tablet in Healthy Adult Subjects FDC (24 mg ER torsemide and 30 mg Spironolactone) without food, FDC (24 mg ER torsemide and 30 mg Spironolactone) with food - Bioavailability Heathy Volunteers | Phase 3 | Completed | Sarfez Pharmaceuticals, Inc. | 24 | 2025-06-15 | 2026-03-06 |
| Bioavailability and Bioequivalence Study of Extended Release Torsemide and Spironolactone Torsemide and Spironolactone tablet, Torsemide Tablets and Spironolactone Tablets - Bioavailability Heathy Volunteers | Phase 3 | Completed | Sarfez Pharmaceuticals, Inc. | 24 | 2025-06-15 | 2026-03-09 |
| A Study Comparing the Clinical Benefit of Finerenone Versus a Fixed Dose Combination (FDC) of Extended-Release Torsemide and Spironolactone in Patients With Hypertension and Chronic Kidney Disease Combination Product: FDC of spironolactone and ER torsemide, Combination Product: Stabilized doses of loop diuretic and finerenone - Hypertension (HTN) | Phase 3 | Withdrawn | Sarfez Pharmaceuticals, Inc. | 2025-05-01 | 2026-09-22 | |
| Comparing Natriuretic Effects of ER Torsemide to IR Torsemide in Patients With Heart Failure Extended Release Torsemide Tablets, Immedate Release Torsemide Tablets - Heart Failure, Edema | Phase 4 | Withdrawn | Sarfez Pharmaceuticals, Inc. | 2025-05-01 | 2026-09-28 | |
| A Crossover Study of Patients With HF to Compare Natriuretic Effects of IR Torsemide vs. ER Torsemide Over 12 Hrs torsemide - Heart Failure | Phase 4 | Withdrawn | Sarfez Pharmaceuticals, Inc. | 2025-01-15 | 2026-04-27 | |
| Immediate Release Torsemide Versus Extended Release Torsemide After Salty Meal Immediate release torsemide 20mg tablet, Extended release torsemide 24mg tablet - Heart Failure | Phase 2 | Withdrawn | Sarfez Pharmaceuticals, Inc. | 2024-11-15 | 2026-04-27 | |
| Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder Extended release torsemide, Immediate release torsemide, Extended release torsemide placebo - Heart Failure, Overactive Bladder | Phase 2 | Completed | Sarfez Pharmaceuticals, Inc. | 24 | 2024-06-15 | 2026-03-12 |
| Comparison of Once Daily 40 mg Torsemide With Twice-daily 40 mg Furosemide CHF Patients: ER Torsemide 40 mg, CHF Patients: Furosemide 40 mg - Body Weight Changes | Phase 1 | Terminated | Sarfez Pharmaceuticals, Inc. | 20 | 2021-06-30 | 2026-04-24 |
| A Food Effect Study of 60mg ER Torsemide Fed- 60mg ER Torsemide, Fasting- 60mg ER Torsemide - Food-drug Interaction | Phase 1 | Completed | Sarfez Pharmaceuticals, Inc. | 28 | 2017-10-17 | 2018-04-18 |
| Within Subject Variability Study of ER Torsemide 20 mg Tablet in Healthy Subjects Demadex 20mg Tablet, ER Torsemide 20mg Tablet - Congestive Heart Failure, Chronic Kidney Diseases | Phase 1 | Completed | Sarfez Pharmaceuticals, Inc. | 24 | 2017-06-19 | 2018-04-18 |
Heart Failure (5) · Renal Insufficiency, Chronic (2) · Body Weight Changes (1) · Edema (1) · Hypernatremia (1) · Hypertension (1) · Urinary Bladder, Overactive (1)
Torsemide (5) · Spironolactone (3) · Tablets (3) · Furosemide (1) · finerenone (1)
United States (8) · India (3)
Salim Shah, PhD, JD (4) · Christopher Wilcox, MD, PhD (2) · Alvin Chandra, MD (1) · Anil K, MD (1) · Chris Wilcox, MD, PhD (1) · Nayle A Ancares, MD (1) · Parta Hatamizadeh, MD, MPH (1) · Sophia Shah, MD (1)