TNF Pharmaceuticals (TNFA) FDA Events

TNF Pharmaceuticals' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by TNF Pharmaceuticals (TNFA). Over the past two years, TNF Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as TNF-alpha. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

TNF-alpha FDA Regulatory Events

TNF-alpha is a drug developed by TNF Pharmaceuticals for the following indication: TNF-Alpha Inhibitor. 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.

Clinical Trial - February 25,2025

Phase 2b

• Drug: TNF-alpha
• Announced Date: February 25, 2025
• Indication: TNF-Alpha Inhibitor

TNF Pharmaceuticals, Inc. announced the initiation of a fully funded Phase 2b clinical trial evaluating oral TNF-alpha (TNF-α) inhibitor drug candidate isomyosamine as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery.

TNF Pharmaceuticals, Inc. announced that it has initiated a fully funded Phase 2b clinical trial to study its oral TNF-α inhibitor, isomyosamine. The trial will evaluate the drug candidate as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery.

Conducted at the University of Florida, this randomized, placebo-controlled, double-blind study will include 60 patients treated for up to 90 days following surgery. The study is designed to assess isomyosamine’s safety and effectiveness in reducing post-surgical inflammation and improving recovery outcomes. TNF Pharmaceuticals hopes the trial will show that this innovative oral treatment can prevent muscle loss and potentially decrease complications and healthcare costs associated with prolonged recovery.

TNF Pharmaceuticals FDA Events - Frequently Asked Questions

Has TNF Pharmaceuticals received FDA approval?

As of now, TNF Pharmaceuticals (TNFA) has not received any FDA approvals for its therapy in the last two years.

What drugs has TNF Pharmaceuticals submitted to the FDA?

In the past two years, TNF Pharmaceuticals (TNFA) has reported FDA regulatory activity for TNF-alpha.

What is the most recent FDA event for TNF Pharmaceuticals?

The most recent FDA-related event for TNF Pharmaceuticals occurred on February 25, 2025, involving TNF-alpha. The update was categorized as "Clinical Trial," with the company reporting: "TNF Pharmaceuticals, Inc. announced the initiation of a fully funded Phase 2b clinical trial evaluating oral TNF-alpha (TNF-α) inhibitor drug candidate isomyosamine as a treatment for chronic inflammation associated with muscle loss (frailty or sarcopenia) in patients who have undergone hip or femur fracture repair surgery."

What conditions do TNF Pharmaceuticals' current drugs treat?

Currently, TNF Pharmaceuticals has one therapy (TNF-alpha) targeting the following condition: TNF-Alpha Inhibitor.