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NRx Pharmaceuticals (NRXP) FDA Events

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FDA Events for NRx Pharmaceuticals (NRXP)

This section highlights FDA-related milestones and regulatory updates for drugs developed by NRx Pharmaceuticals (NRXP). Over the past two years, NRx Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as HTX-100, NRX-100, and NRX-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

NRx Pharmaceuticals' Drugs in FDA Review

HTX-100 - FDA Regulatory Timeline and Events

HTX-100 is a drug developed by NRx Pharmaceuticals for the following indication: IV Ketamine. 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.

NRX-100 - FDA Regulatory Timeline and Events

NRX-100 is a drug developed by NRx Pharmaceuticals for the following indication: To treat acute depression and suicidality. 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.

NRX-101 - FDA Regulatory Timeline and Events

NRX-101 is a drug developed by NRx Pharmaceuticals for the following indication: Bipolar Depression with Sub-Acute Suicidality. 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.

NRx Pharmaceuticals FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, NRx Pharmaceuticals (NRXP) has reported FDA regulatory activity for the following drugs: NRX-101, NRX-100 and HTX-100.

The most recent FDA-related event for NRx Pharmaceuticals occurred on June 5, 2025, involving NRX-100. The update was categorized as "Provided Update," with the company reporting: "NRx Pharmaceuticals, Inc. announced the transmission of its Abbreviated New Drug Application (ANDA) for electronic filing to the U.S. Food and Drug Administration (FDA) for NRX-100, its preservative-free IV ketamine formulation, for use in all existing approved indications such as anesthesia and pain management."

Current therapies from NRx Pharmaceuticals in review with the FDA target conditions such as:

  • Bipolar Depression with Sub-Acute Suicidality - NRX-101
  • To treat acute depression and suicidality - NRX-100
  • IV Ketamine - HTX-100

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:NRXP) was last updated on 7/10/2025 by MarketBeat.com Staff
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