Will KETAFREE Become The First FDA-Approved Preservative-Free Ketamine Formulation?

(RTTNews) - NRx Pharmaceuticals Inc. (NRXP), a clinical-stage biopharmaceutical company, is gearing up for key milestones this year as it advances its lead drug candidate NRX-100.

NRX-100 (ketamine) is an intravenous formulation of ketamine in development for the treatment of patients with severe depression and acute suicidal ideation.

It's worth noting that Ketamine itself is not new - its history dates back more than five decades, when it was developed by Parke-Davis. Intravenous racemic ketamine was approved by the FDA in 1970 for use in diagnostic and surgical procedures. It is also used off label for several psychiatric conditions and other disorders.

The NRX-100 formulation of ketamine differs from the approved form of ketamine used in anesthesia in that it contains no preservatives and utilizes diversion-resistant packaging to enhance the traceability of a medicine known to have abuse potential. The company intends to submit its New Drug Application for NRX-100 to treat depression in patients with severe depression who may have suicidal ideation by June 2026.

According to the CDC, more than 16 million Americans experience depression each year, and 3.6 million Americans contemplate suicide. Yet all antidepressants carry black-box warnings for suicidality and akathisia.

Meanwhile, NRx already has an Abbreviated New Drug Application for KETAFREE, which is also a preservative-free intravenous ketamine formulation, under FDA review for use in anesthesia, with a decision due on July 29, 2026. KETAFREE is a distinct formulation from NRX-100, according to the company.

The current worldwide generic ketamine market is estimated at $750 million per year.

According to the company, KETAFREE is the first preservative-free ketamine formulation that does not include potentially toxic preservatives benzethonium chloride or benzalkonium chloride, which are used in current multidose presentations of ketamine.

Next in the pipeline is NRX-101, a fixed dose combination of D-cycloserine and lurasidone, currently in late-stage clinical studies targeting the NMDA-receptor in the brain, which represents potentially a key new mechanism to treat depression with and without suicidality, as well as chronic pain, PTSD and other indications, as well as potential use in Urinary Tract Infections.

The company's subsidiary, HOPE Therapeutics, Inc., is building a network of interventional psychiatry clinics to offer ketamine and other neuroplastic medications, transcranial magnetic stimulation (TMS), Hyperbaric Oxygen Therapy, and other lifesaving therapies to patients with suicidal depression and related disorders. The clinics also use a digital therapeutic-enabled platform designed to support and extend the clinical benefit of NMDA-targeted drug therapy.

Cash Position

As of September 30, 2025, NRx Pharmaceuticals had approximately $7.1 million in cash and cash equivalents. Including approximately $3.1 million from a subscription receivable, for which the company received the cash in early October, total cash as of September 30, 2025, would have been $10.3 million.

The company also has a shelf registration filed last year, allowing it to offer up to $150 million in securities, including common stock, preferred stock, debt securities, warrants, and units.

NRXP has traded in a range of $1.58 to $3.84 in the last 1 year. As of this writing, the stock is at $2.15, up 15%.