FDA Meeting Indicates Path to New Drug Application for NRX-100 (Ketamine) in Suicidal Depression

NRx Pharmaceuticals Seeks Broader Indication for Treatment-Resistant Depression with Suicidality

Published on Feb. 19, 2026

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NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) announced that it has completed an in-person Type C guidance meeting with the FDA, which indicated a path to filing a New Drug Application for NRX-100 (preservative-free ketamine) based on existing clinical trial data and real-world evidence from over 65,000 patients. The company will seek a broader indication to serve patients with treatment-resistant depression who may have suicidality, rather than only those with suicidality.

Why it matters

The potential approval of NRX-100 could provide a new treatment option for the over 13 million Americans who seriously consider suicide each year, as there is currently no FDA-approved medication to treat suicidal ideation. The use of real-world data to support the application is also notable, as it could set a precedent for the use of such evidence in the drug approval process.

The details

NRx Pharmaceuticals plans to submit data on the real-world use of ketamine in over 70,000 patients to support the Accelerated Approval of NRX-100 under the FDA's Fast Track Designation. Preliminary analyses suggest the clinical response to intravenous ketamine is consistent with prior randomized trial data and compares favorably to currently-approved products. The company is also exploring the use of NRX-101, which contains D-cycloserine and lurasidone, as an augmentation therapy for Transcranial Magnetic Stimulation (TMS) in the treatment of depression, including suicidal depression.

  • On February 17th, NRx Pharmaceuticals completed an in-person Type C guidance meeting with the FDA.
  • On January 14th, NRx Pharmaceuticals announced it has licensed real-world evidence data on the use of ketamine in over 70,000 patients to support the Accelerated Approval of NRX-100.
  • On January 5th, NRx Pharmaceuticals announced a partnership with neurocare Group AG to create a nationwide network of clinics offering integrated neuroplastic care for the treatment of depression, PTSD, and other mental health disorders.
  • On December 18th, NRx Pharmaceuticals announced the elimination of all balance sheet debt through strategic equity conversion.
  • On December 3rd, NRx Pharmaceuticals announced an amendment to its Investigational New Drug filing for NRX-101 to include its use in association with Transcranial Magnetic Stimulation (TMS) for the treatment of depression, including suicidal depression.

The players

NRx Pharmaceuticals, Inc.

A clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal bipolar depression, chronic pain and PTSD.

FDA Division of Psychiatry Products

The division within the FDA that oversees the review and approval of drugs for the treatment of psychiatric disorders.

FDA Center for Drug Evaluation and Research (CDER)

The center within the FDA responsible for the evaluation and monitoring of prescription drugs, including the review and approval of new drug applications.

neurocare Group AG

A company that partners with NRx Pharmaceuticals to create a nationwide network of clinics offering integrated neuroplastic care for the treatment of depression, PTSD, and other mental health disorders.

D. Boral

An analyst who has issued a Buy rating and $34 price target on NRx Pharmaceuticals.

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What they’re saying

“We must not let individuals continue to damage private property in San Francisco.”

— Robert Jenkins, San Francisco resident (San Francisco Chronicle)

“Fifty years is such an accomplishment in San Francisco, especially with the way the city has changed over the years.”

— Gordon Edgar, grocery employee (Instagram)

What’s next

The FDA and NRx Pharmaceuticals will work collaboratively in the coming weeks to finalize the statistical analysis protocol for the full 65,000-person real-world evidence dataset.

The takeaway

The potential approval of NRX-100 (ketamine) for the treatment of suicidal depression, based on a combination of clinical trial data and real-world evidence, could provide a much-needed new treatment option for the millions of Americans who struggle with suicidal thoughts. The use of real-world data in the drug approval process is a significant development that could pave the way for more innovative and patient-centric approaches to drug development and approval.