Lasix® ONYU received Tentative FDA Approval in October of 2024. Lasix ONYU has not yet been approved for sale.
Changing the Way Heart Failure Patients Receive Decongestion Treatment
We are engaging with hospitals to improve and increase Decongestion@Home.
If your organization is interested in preparing for change contact using the link below
Lasix (furosemide) was first introduced in the 1960’s. Furosemide has been the leading diuretic for heart failure patients for more than 50 years.
Currently, most patients receive furosemide by IV, resulting in multi-day hospital stays and high medical cost.
We want to change that.
We believe that patients should not have to be admitted into a hospital just to receive effective diuretic treatment.
A New Era
Our team at SQ Innovation has developed a novel drug formulation and a subcutaneous Infusor to deliver hospital-strength diuresis for at-home use. Thanks to its higher concentration, we can administer an 80mg therapeutic dose in a significantly smaller volume.
We designed the Infusor specifically for our new furosemide formulation, aimed at patients with heart failure. In developing this product, we carefully considered the needs of patients, healthcare providers, payors and the environment. We named it Lasix® ONYU.
While subcutaneous drug delivery is not new—first developed in 1853—our goal is to make it more convenient, comfortable, affordable, and widely accessible.
Lasix® ONYU has received Tentative Approval from the U.S. Food and Drug Administration. This means the product meets all necessary safety, efficacy, labeling, and manufacturing requirements, though it has not yet been approved for sale
Does it Work?
Subcutaneous drug delivery is one of the oldest methods to administer medicines. The results are generally excellent, often comparable to IV drug delivery.
The medicine may not act as fast as with an IV but for many drugs therapeutic levels and effects are achieved in 30 minutes, and the patient does not need to be in a medical facility to receive treatment.
Our goal is to bring subcutaneous drug delivery to broad clinical use. It takes the right formulation and device to do this.
Is It Economical?
Healthcare is complex. Payments are increasingly structured to provide incentives to reduce cost and improve quality.
Subcutaneous treatemnt creates a new option – to provide “IV-strength” diuresis outside an acute care setting.
Our next generation Infusor can be recharged and used for 48 treatments. The only thing you throw away is the single-use component. This markedly reduces cost and is better for the environment.
Patient selection is key for patient safety and maximum economic benefit.
Who is a Good Candidate?
Good candidates are hard to define. It is less about the patient, than it is on timing and circumstances. It is easier to define what patients and circumstances are unsuitable.
Timing is critical. A good candidate today may be unsuitable in a couple of days, or even tomorrow.
Clinicians need to evaluate the patient and the environment where the patient may be treated outside the acute care hospital to determine if subcutaneous treatment is a good option.