Oral heart failure drug receives FDA’s fast track designation

Michael Walter | November 20, 2025 | Cardiovascular Business | Heart Failure

A majority of medical devices involved in Class I recalls were never required by the U.S. Food and Drug Administration (FDA) to undergo premarket or postmarket clinical testing, according to new research published in Annals of Internal Medicine.[1]

Vasa Therapeutics, a biopharmaceutical company with offices in California and Poland, has received the FDA’s fast track designation for an investigational therapy designed to treat heart failure with preserved ejection fraction (HFpEF).

The therapy in question is VS-041, an oral small molecule inhibitor of matrix metalloproteinases that has demonstrated the potential ability to treat fibroinflammation in patients who present with HFpEF. Researchers have already completed one clinical trial, finding VS-041 to be “safe and well-tolerated” in healthy adult participants. A proof-of-mechanism study has now been cleared that will track the drug’s safety and tolerability when specifically given to HFpEF patients. Vasa Therapeutics expects that trial to be completed by July 2026.

The FDA’s fast track designation is intended to help speed up the approval process for companies developing treatments for life-threatening conditions, especially those that fill an unmet need. Therapies receiving this designation are eligible for more frequent meetings with the FDA, more written communication with the agency and accelerated approvals once certain criteria are met.

“We are extremely pleased that the FDA has granted fast track designation for VS-041,” Noreen R. Henig, MD, chief medical officer of Vasa Therapeutics, said in a statement. “This designation reinforces the potential of VS-041 to address a serious unmet medical need with a novel mechanism of action that targets the underlying pathophysiology of HFpEF. It also supports the opportunity to establish a precision medicine paradigm in diagnosis and treatment of HFpEF by utilizing an emerging biomarker. We look forward to working closely with the FDA as we advance VS-041 through clinical development.”

“The Fast Track Designation for VS-041 treatment of HFpEF marks a significant milestone in our mission to advance a pipeline of drug candidates to address unmet medical needs in large groups of patients, capping off a year of strong execution,” added Artur Plonowski, MD, PhD, chief executive officer and co-founder of Vasa Therapeutics. “We are currently on track to have two assets in clinical development in 2026. I want to thank the entire Vasa team for putting their hearts and science into advancing innovative therapies for cardiovascular and skeletal muscle diseases.”