NRX-100 FDA Approval Status
Last updated by Judith Stewart, BPharm on Feb 4, 2025.
FDA Approved: No
Brand name: NRX-100
Generic name: ketamine
Company: NRx Pharmaceuticals, Inc.
Treatment for: Major Depressive Disorder with Acute Suicidal Ideation
NRX-100 (ketamine) is an intravenous formulation of ketamine in development for the treatment of suicidal depression.
- Intravenous ketamine is widely accepted as a standard of care for the acute treatment of suicidal depression on an off-label basis in the absence of an FDA-labeled product.
- 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.
- A New Drug Application (NDA) submission has been filed with the U.S. Food & Drug Administration (FDA) for NRX-100 for the treatment of suicidal depression, based on results of well-controlled clinical trials conducted under the auspices of the US National Institutes of Health and newly obtained data from French health authorities, licensed under a data sharing agreement.
- NRX-100 was initially granted Fast Track Designation in 2017 for use in combination with NRX-101 (D-cycloserine/lurasidone) for treatment of suicidal bipolar depression. NRx Pharmaceuticals, Inc. is now seeking to expand the indication to include Suicidal Ideation in Major Depressive Disorder and other forms of depression, based on data from NIH- and European Government-funded trials.
Development timeline for NRX-100
| Date | Article |
|---|---|
| Dec 30, 2024 | NRx Pharmaceuticals, Inc. Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.