This section highlights FDA-related milestones and regulatory updates for drugs developed by scPharmaceuticals (SCPH).
Over the past two years, scPharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FUROSCIX and SCP-111. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
FUROSCIX - FDA Regulatory Timeline and Events
FUROSCIX is a drug developed by scPharmaceuticals for the following indication: Decompensated heart failure.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FUROSCIX
- Announced Date:
- March 6, 2025
- Indication:
- Decompensated heart failure
Announcement
scPharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for FUROSCIX® to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD).
AI Summary
scPharmaceuticals announced that the FDA has approved its supplemental New Drug Application (sNDA) to expand FUROSCIX®’s indication. The approval now includes the treatment of edema in adult patients with chronic kidney disease (CKD), such as those with nephrotic syndrome. This expansion provides clinicians with another treatment option to manage fluid overload in patients with CKD.
According to the company, this milestone represents an important step in addressing unmet needs in cardiorenal care. scPharmaceuticals has taken numerous preparatory measures including engaging key opinion leaders, conducting market research, and planning for a successful product launch. The company is now working to introduce FUROSCIX® to nephrologists and is focused on supporting both heart failure and CKD patients, with availability expected in April 2025.
Read Announcement- Drug:
- FUROSCIX
- Announced Date:
- August 12, 2024
- Indication:
- Decompensated heart failure
Announcement
scPharmaceuticals Inc. announced that the Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) seeking to expand the FUROSCIX indication for heart failure patients.
AI Summary
scPharmaceuticals Inc. announced that the FDA has approved its Supplemental New Drug Application (sNDA) to expand the FUROSCIX indication for treating congestion due to fluid overload in heart failure patients. Originally approved for adults with NYHA Class II and III chronic heart failure, this decision now extends FUROSCIX’s use to include NYHA Class IV patients, who experience the most severe symptoms and limitations in physical activity. The approval is based on established evidence of the medication’s safety and effectiveness in managing fluid overload, potentially reducing the need for heart failure-related hospital admissions or readmissions. This expansion offers cardiologists an additional treatment option for the most critical heart failure patients while reinforcing scPharmaceuticals Inc.’s commitment to improving patient care and managing healthcare costs.
Read Announcement- Drug:
- FUROSCIX
- Announced Date:
- July 25, 2024
- Estimated Event Date Range:
- March 6, 2025 - March 6, 2025
- Target Action Date:
- March 06, 2025
- Indication:
- Decompensated heart failure
Announcement
cPharmaceuticals Inc. announced that The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025.
AI Summary
scPharmaceuticals Inc. announced that the FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025, for its Supplemental New Drug Application (sNDA). This move is part of the company’s effort to expand the use of its product, FUROSCIX, to treat edema caused by fluid overload in patients with chronic kidney disease (CKD). The company is focused on optimizing the delivery of therapies and reducing healthcare costs while advancing patient care.
The March 6, 2025 deadline is a key milestone for scPharmaceuticals, as it supports their strategic growth initiatives and potential market expansion in the CKD patient segment. The upcoming FDA review is keenly awaited as it could provide significant opportunities to improve treatment outcomes for many CKD patients in the United States.
Read Announcement- Drug:
- FUROSCIX
- Announced Date:
- July 25, 2024
- Indication:
- Decompensated heart failure
Announcement
scPharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Supplemental New Drug Application (sNDA) seeking to expand the FUROSCIX indication to include treatment of edema due to fluid overload in patients with chronic kidney disease (CKD).
AI Summary
scPharmaceuticals Inc. announced that the FDA has accepted its Supplemental New Drug Application (sNDA) to expand the use of FUROSCIX. The company seeks to extend the indication to treat edema caused by fluid overload in patients with chronic kidney disease (CKD). This new application represents an important step for scPharmaceuticals as it aims to address the needs of CKD patients who often suffer from fluid imbalance and associated complications.
The FDA has set a target action date of March 6, 2025, for reviewing the application. According to the agency, no additional clinical studies are required if the company can show an adequate pharmacokinetic and pharmacodynamic bridge to the existing furosemide injection. The potential expansion is seen as a significant opportunity to improve patient care and support a key long-term growth initiative for the company.
Read Announcement
SCP-111 - FDA Regulatory Timeline and Events
SCP-111 is a drug developed by scPharmaceuticals for the following indication: pH neutral formulation of furosemide administered via an auto-injector.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SCP-111
- Announced Date:
- August 12, 2024
- Estimated Event Date Range:
- October 1, 2024 - December 31, 2024
- Target Action Date:
- LATE 2024
- Indication:
- pH neutral formulation of furosemide administered via an auto-injector.
Announcement
scPharmaceuticals Inc. announced that Company targeting Supplemental New Drug Application (sNDA) submission to the FDA by year-end 2024
AI Summary
scPharmaceuticals Inc. announced promising results for its SCP-111 autoinjector, designed to deliver a subcutaneous injection of furosemide as an alternative to the currently approved on-body infusor presentation of FUROSCIX. The positive topline data showed that SCP-111 achieved its primary pharmacokinetic and secondary pharmacodynamic endpoints. In light of these encouraging results, the company is targeting the submission of a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024. If approved, the new autoinjector could offer added flexibility for cardiologists and heart failure specialists, potentially improving treatment options and patient care by simplifying the delivery process. The company’s move toward an sNDA submission marks a significant step in its efforts to bring innovative, self-administered treatments to the healthcare market.
Read Announcement- Drug:
- SCP-111
- Announced Date:
- August 12, 2024
- Indication:
- pH neutral formulation of furosemide administered via an auto-injector.
Announcement
scPharmaceuticals Inc announced positive topline results from the pharmacokinetic (PK) study of SCP-111, an investigational, low volume, pH neutral formulation of furosemide administered via an autoinjector as an alternative to the current on-body infusor used with FUROSCIX..
AI Summary
scPharmaceuticals Inc. has announced positive topline results from its pharmacokinetic study of SCP-111, an investigational, low-volume, pH neutral formulation of furosemide delivered via an autoinjector. The study compared SCP-111, given as an autoinjector subcutaneous injection, to the standard method of administering furosemide using two consecutive 40mg IV injections. The results showed that SCP-111 achieved a bioavailability of 107.3% and produced similar urine output and electrolyte excretion as the IV injections, with subjects reporting a median pain score of zero. These findings support the safety, tolerability, and effectiveness of the autoinjector method. scPharmaceuticals plans to target a Supplemental New Drug Application (sNDA) submission to the FDA by the end of 2024, potentially providing cardiologists and heart failure specialists a flexible treatment option for patients.
Read Announcement
Free SCPH Stock Alerts