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scPharmaceuticals

scPharmaceuticals logo
🇺🇸United States
Ownership
Public
Established
2014-01-01
Employees
136
Market Cap
$257.6M
Website
http://www.scpharmaceuticals.com
Introduction

scPharmaceuticals, Inc. engages in the development of transformative pharmaceutical products for subcutaneous delivery. Its products include FUROSCIX, a furosemide injection which is used as parenteral diuretic in treating heart failure and scCeftriaxone, used as parenteral antibiotic outside the hospital setting. The company was founded by Pieter Muntendam and Bertram Pitt in February 2013 and is headquartered in Burlington, MA.

Clinical Trials

11

Active:1
Completed:10

Trial Phases

3 Phases

Phase 1:3
Phase 2:5
Phase 3:2

Drug Approvals

1

FDA:1

Drug Approvals

FUROSCIX

Approval Date
Nov 30, 2023
FDA

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials

Phase 2
5 (50.0%)
Phase 1
3 (30.0%)
Phase 3
2 (20.0%)

Pharmacokinetics and Pharmacodynamics of Subcutaneous vs Intravenous Furosemide in Healthy Volunteers

Phase 1
Completed
Conditions
Heart Failure
Fluid Overload
Interventions
First Posted Date
2023-12-12
Last Posted Date
2024-06-27
Lead Sponsor
scPharmaceuticals, Inc.
Target Recruit Count
21
Registration Number
NCT06167707
Locations
🇺🇸

Elixia EPCT, LLC, Tampa, Florida, United States

Avoiding Treatment in the Hospital With Furoscix for the Management of Congestion in Heart Failure - A Pilot Study

Phase 2
Completed
Conditions
Heart Failure
First Posted Date
2020-10-20
Last Posted Date
2023-08-01
Lead Sponsor
scPharmaceuticals, Inc.
Target Recruit Count
63
Registration Number
NCT04593823
Locations
🇺🇸

Heart Group of Eastern Shore, Fairhope, Alabama, United States

🇺🇸

The Heart Center Research, LLC, Huntsville, Alabama, United States

🇺🇸

Hartford Hospital, Hartford, Connecticut, United States

and more 15 locations

An Open Label Study to Evaluate the Impact of Duration of Subcutaneous Infusion of a Novel, pH Neutral Formulation of Furosemide (Furoscix®) on Safety and Local Skin Tolerability

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2019-11-13
Last Posted Date
2020-07-10
Lead Sponsor
scPharmaceuticals, Inc.
Target Recruit Count
39
Registration Number
NCT04161482
Locations
🇺🇸

Aventiv Clinical Research, Columbus, Ohio, United States

Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure

Phase 3
Completed
Conditions
Heart Failure
First Posted Date
2018-03-08
Last Posted Date
2023-02-24
Lead Sponsor
scPharmaceuticals, Inc.
Target Recruit Count
27
Registration Number
NCT03458325
Locations
🇺🇸

Olive View - UCLA Medical Center, Sylmar, California, United States

🇺🇸

Bridgeport Hospital, Bridgeport, Connecticut, United States

🇺🇸

Tampa General Hospital, Tampa, Florida, United States

and more 5 locations

Product Design Clinical Performance Study of sc2Wear Furosemide Combination Product

Phase 3
Completed
Conditions
Heart Failure
First Posted Date
2016-06-17
Last Posted Date
2018-06-27
Lead Sponsor
scPharmaceuticals, Inc.
Target Recruit Count
74
Registration Number
NCT02804282
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News

FDA Expands Furoscix Approval to Include Edema Treatment in CKD Patients

• The FDA has approved scPharmaceuticals' supplemental New Drug Application for Furoscix, extending its use to treat edema in chronic kidney disease patients, with availability expected in April 2025. • Furoscix becomes the first subcutaneous loop diuretic approved for both heart failure and CKD patients, offering an at-home alternative to traditional IV diuretic therapy. • The approval was granted without requiring additional clinical studies, based on demonstrating adequate pharmacokinetic and pharmacodynamic equivalence to standard furosemide injection.

FDA Expands Furoscix Indication to Include NYHA Class IV Heart Failure Patients

• The FDA has approved scPharmaceuticals' supplemental New Drug Application (sNDA) for Furoscix, expanding its indication to include NYHA Class IV chronic heart failure patients. • This expansion allows Furoscix to be used in the most symptomatic heart failure patients, who experience the greatest limitations on physical activity, representing approximately 10% of all heart failure patients. • Furoscix offers a potential alternative to hospital admission or readmission for managing congestion due to fluid overload in adult patients with chronic heart failure. • Furoscix is designed for subcutaneous self-administration, offering an outpatient treatment option for heart failure patients.

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