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Furosemide oral tablets
Furosemide oral tablets is a Loop diuretic Small molecule drug developed by Sankyo Pharma Gmbh. It is currently in Phase 3 development for Edema associated with congestive heart failure, Edema associated with hepatic cirrhosis, Edema associated with renal disease.
Furosemide inhibits sodium and chloride reabsorption in the loop of Henle, promoting diuresis and reducing fluid overload.
Furosemide inhibits sodium and chloride reabsorption in the loop of Henle, promoting diuresis and reducing fluid overload. Used for Edema associated with congestive heart failure, Edema associated with hepatic cirrhosis, Edema associated with renal disease.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Furosemide oral tablets |
|---|---|
| Sponsor | Sankyo Pharma Gmbh |
| Drug class | Loop diuretic |
| Target | Na-K-2Cl cotransporter (NKCC2) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Furosemide is a loop diuretic that blocks the Na-K-2Cl cotransporter in the thick ascending limb of the loop of Henle, preventing reabsorption of sodium, potassium, and chloride. This increases urine output and reduces blood volume and interstitial fluid, thereby lowering blood pressure and alleviating edema. It is one of the most potent diuretics available.
Approved indications
- Edema associated with congestive heart failure
- Edema associated with hepatic cirrhosis
- Edema associated with renal disease
- Hypertension
Common side effects
- Hypokalemia
- Hyperuricemia
- Ototoxicity (at high doses)
- Dehydration
- Hypotension
- Hyperglycemia
- Electrolyte imbalances
Key clinical trials
- 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 (PHASE3)
- A Study to Compare How Different Medicines (Rosuvastatin, Digoxin, Metformin, and Furosemide) Are Handled by the Body of Healthy People and People With Liver Cirrhosis (NA)
- A Study in Healthy Men to Test Whether Zongertinib Influences the Amount of 4 Other Medicines (Dabigatran, Rosuvastatin, Metformin, and Furosemide) in the Blood (PHASE1)
- Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study) (PHASE1)
- Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters (EARLY_PHASE1)
- DDI (Effect of Metformin and Furosemide on Rosuvastatin PK) (PHASE1)
- Transporter Cocktail Mutual Interaction (PHASE1)
- This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Furosemide oral tablets CI brief — competitive landscape report
- Furosemide oral tablets updates RSS · CI watch RSS
- Sankyo Pharma Gmbh portfolio CI
Frequently asked questions about Furosemide oral tablets
What is Furosemide oral tablets?
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Related
- Drug class: All Loop diuretic drugs
- Target: All drugs targeting Na-K-2Cl cotransporter (NKCC2)
- Manufacturer: Sankyo Pharma Gmbh — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Edema associated with congestive heart failure
- Indication: Drugs for Edema associated with hepatic cirrhosis
- Indication: Drugs for Edema associated with renal disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing