Demadex

(Torsemide)

ApprovedSmall molecule

Torsemide is used to remove excess water and salt from the body to reduce swelling and improve breathing in patients with heart failure, liver disease, or kidney disease. It also helps lower high blood pressure.[2] Demadex is currently approved and in use across 7 indications[4].[1]

Demadex is one of 198 small molecule programs targeting Cardiovascular Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

197

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Cardiovascular DiseaseActive, not recruiting

Mitral RegurgitationActive, not recruiting

StrokeActive, not recruiting

Myocardial InfarctionActive, not recruiting

PreeclampsiaApproved

Heart FailureCompleted

Cardiovascular DiseaseApproved

Active, not recruiting

Mitral RegurgitationPreclinical

Active, not recruiting

StrokeApproved

Active, not recruiting

Myocardial InfarctionApproved

Active, not recruiting

PreeclampsiaApproved

Approved

Heart FailureApproved

Completed

Competition

Competitive Landscape

198 competitors in Heart Failure

#DrugCompanyPhaseTrials

Demadex

SSarfez Pharmaceuticals, Inc.

Approved

5 2

Bayer Aspirin

Bayer

Preclinical

2 3

Amidate

Pfizer

Preclinical

1 4

Activase

Adriamycin

Savaysa

Xifaxan

2 8

Oraverse

LLife Extension Foundation Inc.

Preclinical

1 9

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 10

Tamiflu

CConrado Roberto Hoffmann Filho

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Treatment

NCT06218199

Clinical

Trials by Indication[1]

Heart Failure5 trials

TRANSFORM-HF: ToRsemide compArisoN With furoSemide FORManagement of Heart Failure

Completed·—·Phase 3·NCT03296813·2,973 enrolled

Weight-Based Torsemide Dosing in Subjects With Heart Failure

Completed·NNew York City Health and Hospitals Corporation·Phase 4·NCT03187509·52 enrolled

Torsemide Comparison With Furosemide for Management of Patients With Stable Heart Failure

Completed·YYale University·Phase 3·NCT05093621·47 enrolled

Show 2 more trials

Study of Drug Therapy for Pediatric Heart Failure

Unknown status·CChina National Center for Cardiovascular Diseases··NCT06039540·200 enrolled

A Randomized, Two-Period, Two-Arm, Double-Dummy, Crossover Study to Compare Natriuretic Effects of Extended Release Torsemide to Immediate Release Torsemide in Patients With Heart Failure (NEXT-HF)

Withdrawn·SSarfez Pharmaceuticals, Inc.·Approved·NCT06995144

Fasting Conditions2 trials

Bioavailability Study of Torsemide Tablets Under Fasting Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00653549·26 enrolled

Bioequivalency Study of Torsemide Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00602303·28 enrolled

Fed2 trials

Bioavailability Study of Torsemide Tablets Under Fed Conditions

Completed·PPar Pharmaceutical, Inc.·Phase 1·NCT00654043·24 enrolled

Bioequivalency Study of Torsemide Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00602615·28 enrolled

Tics2 trials

A Study to Investigate the Effect of Urine Acid-base Disequilibrium on the Pharmacokinetics of Captopril

Completed·SSeoul National University Hospital·Phase 1·NCT06292091·12 enrolled

Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics

Completed·IInstitut fuer anwendungsorientierte Forschung und klinische Studien GmbH·Phase 1·NCT01845194·117 enrolled

Drug Metabolism1 trial

Open Label Study for the Functional Characterization of Drug Metabolism and Transport

Completed·MMatthias Schwab·Phase 1·NCT01788254·144 enrolled

9 more indications

MPA1 trial

A Crossover Study of Patients with HF to Compare Natriuretic Effects of IR Torsemide Vs. ER Torsemide Over 12 Hrs

Terminated·SSarfez Pharmaceuticals, Inc.·Phase 4·NCT06708611·5 enrolled

Renal insufficiency1 trial

A Study of MK-7145 in Participants With Renal Insufficiency (Part I) and Heart Failure With Renal Insufficiency (Part II) (MK-7145-011)

Terminated· Merck & Co. logo

Merck & Co.·Phase 1·NCT01558674·11 enrolled

Congestive Heart Failure1 trial

Effect of Extended Release Torsemide in Patients With Congestive Heart Failure and Overactive Bladder

Completed·SSarfez Pharmaceuticals, Inc.·Phase 2·NCT06206512·24 enrolled

Completed·SSarfez Pharmaceuticals, Inc.·Phase 3·NCT07015671·24 enrolled

Treatment1 trial

Diuretics vs. Afterload Reduction for Treatment of HeartLogic Alerts

Recruiting·HHeart Center Research, LLC·Phase 4·NCT06218199·80 enrolled

Hypertension1 trial

ToRsemide for pOstpartum HYpertension

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02813551·118 enrolled

Unspecified1 trial

Immediate Release Torsemide Versus Extended Release Torsemide After Salty Meal

Terminated·SSarfez Pharmaceuticals, Inc.·Phase 2·NCT06176794·1 enrolled

Regulatory

FDA Approval Timeline[5]

Aug 23, 1993

DEMADEX

NDA NDA020137

Aug 23, 1993

DEMADEX

NDA NDA020136

Jun 14, 2021

SOAANZ

NDA NDA213218

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Torsemide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Demadex drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Torsemide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Torsemide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA213218). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Demadex. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Sarfez Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium-(potassium)-Chloride Cotransporter 2 Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSarfez Pharmaceuticals, Inc.

Patent Landscape[6]

Patent Cliff

Oct 6, 2033

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10154963Oct 6, 2033

Demadex

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Heart Failure5 trials

Fasting Conditions2 trials

Fed2 trials

Tics2 trials

Drug Metabolism1 trial

MPA1 trial

Renal insufficiency1 trial

Congestive Heart Failure1 trial

Ventricular Function1 trial

Mitral regurgitation1 trial

Spironolactone1 trial

Treatment1 trial

Hypertension1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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