Data updated: May 26, 2026
LASIX ONYU (furosemide)
Cardiovascular
Approved 2025-10-07
LASIX ONYU is indicated for the treatment of Edema; Heart Failure.
Source: FDA Label • SQ INNOVATION
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2025-10-07
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
LASIX ONYU Approval History
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
What LASIX ONYU Treats
2 indicationsLASIX ONYU is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Edema
- Heart Failure
Source: FDA Label
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Clinical Trial Registry
72 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05915286 DIURESED | Pro00119451 | Ph 4 | terminated | Diuretic Use in Hemodialysis Patients With Residual Renal Function |
| NCT06941415 BUFF | IRB_00186841 | Ph 3 | not yet recruiting | Bumetanide vs. Furosemide in Cirrhosis |
| NCT05470283 | 2022-0356 NCI-2022-06873 | Ph 1 | active not recruiting | Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma |
| NCT06899061 | D9723C00002 2024-513692-41-00 | Ph 1 | active not recruiting | Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib |
| NCT07431866 | 2828-005 | Ph 1 | recruiting | A Clinical Study of the Effect of MK-2828 on Rosuvastatin or Furosemide in Healthy People (MK-2828-005) |
| NCT03892148 ProDUCT-HF | CHU-428 2018-A02971-54 | Ph 4 | completed | Protocol of Diuretics Use in Congestive Therapy in Heart Failure |
| NCT06036914 results posted | 23-005262 | Ph 2 | completed | A Study of Ultra High Dose Diuretics to Treat Heart Failure |
| NCT06504862 results posted | 1479-0015 2024-510628-38-00, U1111-1302-1171 | Ph 1 | completed | A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood |
| NCT04481789 results posted | MT-1186-J02 | Ph 1 | completed | Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study) |
| NCT06979726 GatorScalesWHF | IRB202500547 | Ph 4 | recruiting | Gator SCALES-WHF: SubCutaneous Administration of Lasix to Eliminate Symptoms of Worsening Heart Failure |
| NCT05779943 results posted | STUDY00004720 RAD5689-22-BED-IIT-439, STUDY00004720 | Ph 2 | active not recruiting | Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer |
| NCT03296813 TRANSFORM-HF results posted | Pro00080595 U01HL125511-01A1 | Ph 3 | completed | TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure |
| NCT07173738 | BIA-51058-111 2017-002807-93 | Ph 1 | completed | Pharmacokinetics, Safety and Tolerability of Concurrent Doses of BIA 5-1058 and Furosemide |
| NCT05986773 P-Value-AHF | P-Value-AHF | Ph 4 | terminated | Diuretic Strategies in Acute Heart Failure Patients at High Risk for Diuretic Resistance |
| NCT04180397 GODIF | GODIF | Ph 4 | recruiting | Controlled Fluid Removal in Critical Ill Patients With Fluid Overload in the Intensive Care Unit. |
| NCT05079789 AMILOR results posted | AmiloridNS-01 2019-002607-18 | Ph 3 | terminated | Amiloride in Nephrotic Syndrome |
| NCT04752475 LAPP results posted | AAAT2525 | Ph 3 | completed | Lasix for the Prevention of De Novo Postpartum Hypertension |
| NCT05981365 results posted | GBT440-0122 C5341029 | Ph 1 | completed | Voxelotor CYP and Transporter Cocktail Interaction Study |
| NCT05093621 TFO results posted | 2000029589 | Ph 3 | completed | Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure |
| NCT02163655 DIUPRE | DIUPRE DIUPRE | Ph 4 | completed | Diuretics for Postpartum High Blood Pressure in Preeclampsia |
| NCT04615624 results posted | 2020-003 | Ph 3 | completed | Furosemide vs. Placebo for Severe Antepartum Hypertension |
| NCT06218199 DART-HA | Dart-HA | Ph 4 | recruiting | Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts |
| NCT02574845 results posted | 352.2094 2015-003052-46 | Ph 1 | completed | DDI (Effect of Metformin and Furosemide on Rosuvastatin PK) |
| NCT02854527 results posted | 352.2096 2016-001893-14 | Ph 1 | completed | Transporter Cocktail Mutual Interaction |
| NCT03307252 results posted | 0352-2100 2017-001549-29 | Ph 1 | completed | This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men |
| NCT02231931 | 352.2082 2014-001940-40 | Ph 1 | completed | Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin |
| NCT04343235 results posted | 06784 | Ph 4 | terminated | Postpartum Management of Gestational Hypertensive Disorders Using Furosemide |
| NCT05620784 | STU00217795 | Ph 3 | recruiting | Intra-operative Loop Diuretics to Improve Same-day Discharge Rates After HoLEP |
| NCT03362515 results posted | 17D.264 | Ph 2 | terminated | Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide |
| NCT05768360 | D5084C00014 2022-003785-21 | Ph 1 | completed | A Study to Assess the Effects of Savolitinib on the Pharmacokinetics of Digoxin, Rosuvastatin, Metformin, and Furosemide in Healthy Male Subjects |
| NCT05158153 ORKID results posted | 21-33602 | Ph 4 | terminated | Outpatient Recovery From Acute Kidney Injury Requiring Dialysis |
| NCT02450773 | 201501157 | Ph 2 | withdrawn | Prevention of Severe Postpartum Hypertension |
| NCT05840536 COMBIND-HF | OchsnerHS | Ph 4 | withdrawn | Combination Diuretic Therapy for Acute Decompensated Heart Failure |
| NCT01156220 | IPT0901 | Ph 4 | withdrawn | Investigation of Gender Specificity of the Effects of Furosemide in Healthy Female and Male Volunteers |
| NCT04763226 | CV021-004 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986308 in Healthy Participants |
| NCT03901729 AVANTI | 17909 2018-004059-18 | Ph 2 | completed | A Trial to Study BAY1753011 in Patients With Congestive Heart Failure |
| NCT02345681 IRIHS-REA | RC14_0268 | Ph 3 | completed | Impact of Rational Control of Fluid Balance in the Intensive Care Unit |
| NCT03730961 results posted | CV013-034 2018-000970-31 | Ph 2 | completed | An Investigational Study of Continuous 8-Hour Intravenous Administrations of BMS-986231 in Participants With Heart Failure and Reduced Heart Function Given a Standard Dose of Loop Diuretic |
| NCT04691687 OUTLAST | 307139 307139 | Ph 4 | completed | OUTpatient Intravenous LASix Trial in Reducing Hospitalization for Acute Decompensated Heart Failure |
| NCT03731117 FURTHER | P170404J | Ph 4 | terminated | FURosemide Stress Test to Predict Need of Renal Replacement THERapy in Ischemic Acute Tubular Necrosis in ICU |
| NCT04628325 | UPalermo | Ph 3 | completed | Effects of Furosemide Plus Small HSS in Subjects With Heart Failure With Reduced Ejection Fraction (HFrEF) |
| NCT02531581 | 14-AOI-11 | Ph 4 | completed | Diuretic Vascular Filling in the Initial Management of Acute PE With Right Ventricular Dysfunction Normotensive |
| NCT02183792 AQUA-AHF results posted | HS-13-00705 | Ph 4 | completed | Aquaresis Utility for Hyponatremic Acute Heart Failure Study |
| NCT02960412 | Pro00026976 | Ph 4 | completed | Effect of Furosemide on Confirmation of Ureteral Patency During Routine Cystoscopy |
| NCT03801759 | AKB-6548-CI-0031 | Ph 1 | completed | Drug-Drug Interaction Study of Vadadustat With Digoxin, Adefovir and Furosemide |
| NCT02877095 SUBQ-Pilot results posted | Pro00070399 | Ph 1 | completed | Subcutaneous Furosemide in Acute Decompensated Heart Failure Pilot |
| NCT02767024 PRIORITY-ADHF | 2014-3586 | Ph 4 | withdrawn | Intravenous Vasodilator vs. Inotropic Therapy in Patients With Heart Failure |
| NCT01558674 results posted | 7145-011 | Ph 1 | terminated | A Study of MK-7145 in Participants With Renal Insufficiency (Part I) and Heart Failure With Renal Insufficiency (Part II) (MK-7145-011) |
| NCT01901809 ROPA-DOP results posted | NA 00083629 | Ph 4 | completed | Diuretics and Dopamine in Heart Failure With Preserved Ejection Fraction |
| NCT02351934 results posted | 14-008292 UL1TR000135 | Ph 4 | completed | Early Diuresis Following Colorectal Surgery |
Showing 50 of 72 trials
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Trial Timeline
Full development history with FDA approval milestones
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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.
LASIX ONYU FDA Label Details
Indications & Usage
FDA Label (PDF)LASIX ONYU is indicated for the treatment of Edema; Heart Failure.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.