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
NRX-101, NRX-100, and KETAFREE™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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.
- Drug:
- NRX-101
- Announced Date:
- May 7, 2026
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals announces receipt of clearance from the US Food and Drug Administration to initiate a clinical trial of NRX-101 (D-cycloserine/lurasidone fixed dose combination) vs. placebo in patients with depression and suicidality who are being treated with either Robotic-assisted Transcranial Magnetic Stimulation (TMS) or sham TMS.
AI Summary
NRx Pharmaceuticals says it has received U.S. Food and Drug Administration clearance to begin a clinical trial testing NRX-101 (D-cycloserine/lurasidone fixed dose combination) versus placebo in patients with depression and suicidality who are being treated with Robotic-assisted Transcranial Magnetic Stimulation (TMS) or sham TMS. The study will compare the drug combination to placebo alongside active or sham TMS.
The trial will be run by NRx Defense Systems, a subsidiary of NRx Pharmaceuticals. The randomized portion will enroll 240 participants at a leading U.S. academic teaching hospital and three planned HOPE Therapeutics sites, with an additional group at two U.S. Military Treatment Facilities. Study sites will be announced after Institutional Review Board approvals.
NRx leadership said they appreciate the FDA’s support and believe a short-term treatment that can safely return personnel to duty could be a major advance for military and first-responder communities.Read Announcement
- Drug:
- NRX-101
- Announced Date:
- December 3, 2025
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals, announced that it has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to include the use of NRX-101 in association with Transcranial Magnetic Stimulation (TMS) for the treatment of depression, including suicidal depression.
AI Summary
NRx Pharmaceuticals has amended its Investigational New Drug filing for NRX-101 (D-cycloserine/lurasidone) to allow use of the drug alongside Transcranial Magnetic Stimulation (TMS) to treat depression, including suicidal depression. The protocol will be offered through a clinical trial and under the company’s Expanded Access program, and NRx reports it has over 25,000 investigational doses available. Published clinical data and real‑world reports suggest low‑dose D‑cycloserine given with TMS can markedly boost outcomes: one randomized trial showed about 75% clinical response and 40% remission, while a real‑world single‑day protocol reported roughly 87% response and 72% remission at six weeks.
Preclinical work indicates D‑cycloserine enhances neuroplasticity, which may explain the benefit with TMS. NRX-101 combines D‑cycloserine with low‑dose lurasidone to reduce hallucination risk. NRx is discussing joint registration trials with TMS device makers to confirm these findings and broaden patient access.Read Announcement
- Drug:
- NRX-101
- Announced Date:
- November 25, 2024
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals, Inc. announced the publication of a paper by Sapko, et. al. in the peer-reviewed American Journal of Clinical Psychopharmacology.
AI Summary
NRx Pharmaceuticals announced the publication of a study by Sapko, et. al. in the peer‐reviewed American Journal of Clinical Psychopharmacology. The paper, titled “Quality Assurance of Depression Ratings in Psychiatric Clinical Trials,” discusses a new training and monitoring approach developed by NRx. This method was used during their phase 2b/3 clinical trial of NRX-101 and demonstrated higher interrater reliability on the MADRS depression scale compared to traditional industry standards. The study showed that by reducing the typical variability between raters, statistical significance could be achieved with far fewer participants. This breakthrough approach in psychometric rating reliability could lower the number of patients needed in future clinical trials, potentially reducing costs and increasing the likelihood of successful trial outcomes for new antidepressant medications.
Read Announcement- Drug:
- NRX-101
- Announced Date:
- June 28, 2024
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals, Inc. announced that advice from regulatory counsel, which includes former senior officials from the Food and Drug Administration, supports filing two New Drug Applications (NDAs) in 2024: an application for Accelerated Approval for NRX-101 to treat bipolar depression in patients with akathisia and an application for approval of NRX-100 (IV ketamine) for treatment of suicidal depression.
AI Summary
NRx Pharmaceuticals, Inc. announced that advice from its regulatory counsel, which includes former senior FDA officials, supports filing two New Drug Applications (NDAs) in 2024. The first NDA is for Accelerated Approval of NRX-101, an oral treatment targeting bipolar depression in patients with akathisia. This application is driven by positive trial data and a strategic plan that enables the company to act independently without a large commercial partner.
The second NDA submission will seek approval for NRX-100 (IV ketamine) to treat suicidal depression. Backed by positive clinical trials and special regulatory designations like Fast Track, this application also awaits the required 12‑month stability data. Filing both NDAs in 2024 positions NRx Pharmaceuticals to address important market needs and potentially generate significant revenue in the near term.
Read Announcement- Drug:
- NRX-101
- Announced Date:
- June 28, 2024
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals, Inc. announced that Fast Track Designation. Potential revenue in 2025
AI Summary
NRx Pharmaceuticals recently announced two major drug development plans that could impact its near-term revenue. The company is preparing to file a New Drug Application (NDA) in 2024 for NRX-101, a treatment aimed at bipolar depression with akathisia. Additionally, NRx is advancing NRX-100, an intravenous ketamine formulation for suicidal depression. Notably, NRX-100 has received Fast Track Designation from the FDA, which could speed up its review and approval process. This fast track status highlights the urgent need for effective treatment options in acute suicidal depression, potentially offering patients a life-changing therapy. The company projects the potential revenue from both drugs could be realized as early as 2025, offering promising financial returns while addressing significant mental health challenges.
Read Announcement- Drug:
- NRX-101
- Announced Date:
- May 28, 2024
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals, Inc. announced presentation of its Phase 2b/3 trial of NRX-101, entitled "A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior" at the American Society of Clinical Psychopharmacology (ASCP) in Miami Beach, FL.
AI Summary
NRx Pharmaceuticals announced that data from its Phase 2b/3 trial of NRX-101 will be presented at the American Society of Clinical Psychopharmacology meeting in Miami Beach, FL. The trial, titled “A Randomized, Double-Blind Controlled Comparison of NRX-101 (D-cycloserine/lurasidone) to Lurasidone for Adults with Bipolar Depression and Subacute Suicidal Ideation or Behavior,” compared NRX-101 with standard lurasidone treatment. While both treatments produced a greater than 50% reduction in depressive symptoms, NRX-101 showed additional benefits. It achieved a 58% reduction in the time required for sustained remission from suicidality and a 76% reduction in akathisia, a side effect linked to an increased risk of suicide. The study, led by Professor Andrew Nierenberg of Massachusetts General Hospital and Harvard Medical School, underlines NRX-101’s potential as a safer and more effective treatment option for patients with bipolar depression.
Read Announcement
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.
- Drug:
- NRX-100
- Announced Date:
- March 16, 2026
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, announced that it has received confirmatory minutes from an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration.
AI Summary
NRx Pharmaceuticals said it received confirmatory minutes from an in‑person Type C guidance meeting at the U.S. Food and Drug Administration headquarters. The minutes show the FDA is willing to review NRx’s New Drug Application for NRX‑100 (preservative‑free ketamine) based on substantial evidence from existing adequate and well‑controlled trials, and the agency did not request additional clinical trials. NRx agreed to submit existing patient‑level data. In the discussed trials, ketamine showed clear superiority to placebo and to an active placebo, non‑inferiority versus electroconvulsive therapy (ECT), and a statistically significant reduction in suicidal ideation. The minutes note ECT has a ~30% incidence of memory loss while ketamine did not.
The FDA also confirmed it would consider Real World Evidence as confirmatory; preliminary RWE supports IV ketamine’s effectiveness for depression and suicidal ideation. The agency said no extra nonclinical data or bridging studies are needed for NRx’s preservative‑free formulation. NRx will seek a primary indication to treat severe depression, including patients with suicidal ideation.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- February 17, 2026
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, announced that it has completed an in-person Type C guidance meeting at the headquarters of the US Food and Drug Administration.
AI Summary
NRx Pharmaceuticals announced it completed an in-person Type C guidance meeting at the U.S. Food and Drug Administration headquarters. The company and the FDA will work together in the coming weeks to finalize the statistical analysis protocol for a full 65,000-person Real World Evidence dataset under the FDA’s newly published guidance. The discussion focused on how that large real-world dataset will be analyzed and used to support NRx’s regulatory review.
In preliminary comments before the meeting, the FDA indicated it does not expect additional nonclinical data and does not require bridging studies to compare NRx’s preservative-free ketamine formulation with the currently approved preservative-containing version. NRx said it will share more details once the FDA issues the final meeting minutes. If confirmed, these points could help streamline the company’s path forward.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- January 14, 2026
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, Inc announced that it has licensed Real World Evidence (RWE) drawn from over 70,000 patients in the United States who were treated with either intravenous ketamine or nasal S-ketamine for depression and suicidal ideation.
AI Summary
NRx Pharmaceuticals has licensed real-world evidence from more than 70,000 U.S. patients treated with intravenous ketamine or nasal S‑ketamine for depression and suicidal ideation. The data, provided by Osmind from electronic medical records across the country, will support NRx’s application seeking approval of NRX-100 (preservative-free ketamine) as a treatment for suicidal ideation.
Osmind’s dataset is large and detailed: nearly one million treatment sessions, continuous vital-sign recordings during treatment, and specific measures such as bladder symptoms and sedation tracked over time. The data covers a diverse patient population and includes both effectiveness and safety measures, making it suitable for regulatory review.
A preliminary analysis of a 20,000-patient subset showed rapid improvement in depression and suicidal thoughts after ketamine treatment and compared favorably with existing therapies. NRx plans to present the full 70,000-patient analysis to regulators to support approval and help broaden safe access to this treatment under medical supervision.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- August 27, 2025
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, announced its expanded access policy for NRX-100 (preservative-free ketamine) based on grant of Fast Track designation for NRX-100 in the treatment of suicidal ideation in patients with depression, including bipolar depression.
AI Summary
The FDA has granted Fast Track designation to NRX-100, a preservative-free ketamine treatment for suicidal ideation in patients with depression, including bipolar depression. In response, NRx Pharmaceuticals has opened an expanded access program to make NRX-100 available to patients facing serious or life-threatening suicidal depression who have not responded to or cannot tolerate existing treatments.
Under this policy, physicians may request NRX-100 for qualified patients if the drug is in active development, sufficient data exist to guide dosing, a benefit-risk assessment supports its use, providing it won’t delay clinical trials or regulatory review, and there is adequate supply. Doctors can apply by contacting NRx via email or through the company website. NRx CEO Dr. Jonathan Javitt emphasized the company’s commitment “to Bring Hope to Life” by serving patients in critical need.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- August 11, 2025
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, Inc. announced US Food and Drug Administration (FDA) has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression, including bipolar depression.
AI Summary
NRx Pharmaceuticals announced that the FDA granted Fast Track designation to NRX-100 for treating suicidal ideation in patients with depression, including bipolar depression.
It expands to the 13 million Americans who seriously consider suicide each year. The designation can speed development, support accelerated approval, and access via the Commissioner’s National Priority Voucher program.
Early clinical data to the FDA showed intravenous ketamine cut suicidal thoughts significantly. In a Columbia University trial, ketamine achieved a 55% response versus 30% with an active comparator. In another study, 63% of patients reached remission within three days versus 31% on placebo.
With Fast Track status, NRx will post an expanded access policy, pursue priority and rolling reviews, and meet with FDA leadership to finalize data for accelerated approval. The company aims to make NRX-100 broadly available to help address the national suicide crisis.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- June 5, 2025
- Indication:
- To treat acute depression and suicidality
Announcement
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.
AI Summary
NRx Pharmaceuticals, Inc. has electronically filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for NRX-100. This new product is a preservative-free intravenous ketamine formulation. It is designed for all approved uses of ketamine including anesthesia and pain management. The formulation avoids the inclusion of benzethonium chloride, a preservative known to be neurotoxic and cytotoxic. NRx believes that removing such preservatives will offer a safer option for patients, especially as hospitals now typically use single vials of medication. With ketamine currently in short supply and increasing demand in the market, NRX-100 is expected to provide a reliable alternative. By filing the ANDA for NRX-100, NRx aims to better meet patient needs, support healthcare providers, and align with current health priorities to eliminate toxic ingredients in medications.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- May 5, 2025
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, Inc. announced the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression.
AI Summary
NRx Pharmaceuticals, Inc. has filed a patent application for NRX-100, its innovative preservative-free intravenous ketamine formulation for treating suicidal depression. The application includes twenty claims covering the pharmaceutical composition, treatment methods, and production processes. If approved by the US Patent and Trademark Office, the patent could make NRX-100 eligible for listing in the FDA Orange Book and provide exclusivity until 2045.
NRX-100 is carefully designed without benzethonium chloride, a preservative found in current ketamine formulations that has been linked to potential cytotoxic and neurotoxic effects. By removing such preservatives, the formulation aims to provide a safer alternative for patients with suicidal depression. This patent application not only protects the innovation behind NRX-100 but also reinforces NRx Pharmaceuticals’ commitment to developing effective and safer treatments for this serious condition.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- April 30, 2025
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, Inc., announced the grant of a filing fee waiver by the US Food and Drug Administration ("FDA") to exempt the Company from a $4.3 million fee to file its New Drug Application for NRX-100 (preservative-free ketamine).
AI Summary
NRx Pharmaceuticals, Inc. received an important boost from the US Food and Drug Administration, which granted a fee waiver that eliminates a $4.3 million charge for filing its New Drug Application (NDA) for NRX-100, a preservative-free version of ketamine. This fee waiver, offered at the FDA’s discretion for small business entities and drugs deemed necessary for public health, allows the company to progress with its NDA filing using current corporate resources.
NRx anticipates filing the NDA by the end of the second quarter of 2025. The preservative-free formulation aims to provide a safer alternative to current ketamine products that contain benzethonium chloride, a preservative with potential neurotoxic effects. The approval of NRX-100 could greatly improve treatment options for patients with suicidal depression and related conditions.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- December 30, 2024
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, Inc. announced the transmission of first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the U.S. Food & Drug Administration (FDA).
AI Summary
NRx Pharmaceuticals, Inc. announced that it has transmitted the first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the U.S. Food and Drug Administration (FDA). As part of the submission, the company sent an 1800‐page manufacturing module (Module 3) to the FDA to allow for immediate review. This step is being taken while the remaining clinical data sections are finalized. NRX-100 is developed specifically to treat suicidal depression and includes a ketamine formulation free of potentially toxic preservatives, with packaging designed to prevent abuse. The submission represents a significant move toward expanding the approved indication for NRX-100 and sets the stage for the anticipated completion of the NDA filing in the first quarter of 2025.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- September 30, 2024
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, Inc. announced that twelve-month real-time stability on the first manufactured lot of NRX-100 (Ketamine) at Nephron Pharmaceuticals, utilizing commercial scale processes, was reached on September 24, 2024.
AI Summary
NRx Pharmaceuticals, Inc. announced a significant milestone when the first manufactured lot of NRX-100 (Ketamine) reached twelve-month real-time stability on September 24, 2024, at Nephron Pharmaceuticals. The product maintained its potency without any degradation, proving a robust shelf life projected to exceed three years at room temperature. This milestone is a key step in the preparation of their New Drug Application (NDA) for intravenous ketamine, a treatment aimed at patients with suicidal depression. NRX-100 is unique as the first preservative-free formulation of ketamine, which may help avoid the potential toxic side effects associated with preservatives present in current single-dose anesthetic products. Achieving stability using commercial scale processes reinforces confidence in NRX’s manufacturing and supports the overall timeline for FDA review and potential approval later this year.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- September 30, 2024
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, Inc. announced that Filing of the NDA for NRX-100 is on track for 2024.
AI Summary
NRx Pharmaceuticals announced an important milestone in its development of NRX-100, a new intravenous ketamine formulation for treating suicidal depression. The company confirmed that the filing of the New Drug Application (NDA) for NRX-100 with the US FDA is on track for 2024. In recent stability studies, the first manufactured lot maintained its integrity over twelve months at room temperature, with no degradation observed. This milestone supports the planned NDA submission by showing that NRX-100 remains stable for more than three years, a key requirement for FDA approval. Notably, NRX-100 is the first preservative-free ketamine formulation, which could help avoid potential toxic side effects associated with preservatives. This progress is seen as a significant step towards providing a safer treatment option for patients with suicidal depression and achieving regulatory approval.
Read Announcement- Drug:
- NRX-100
- Announced Date:
- July 29, 2024
- Indication:
- To treat acute depression and suicidality
Announcement
NRx Pharmaceuticals, Inc. announced a communication from the US Food and Drug Administration (FDA) providing feedback and alignment on NRx's proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in the treatment of suicidal depression. Congress required the submission of an iPSP as a precondition to filing a New Drug Application in the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA).[1]
AI Summary
NRx Pharmaceuticals, Inc. announced that the US Food and Drug Administration (FDA) has provided feedback and alignment on its proposed initial Pediatric Study Plan (iPSP) for NRX-100 (ketamine) in treating suicidal depression. This iPSP submission is a key requirement set by the 2012 Food and Drug Administration Safety and Innovation Act before filing a New Drug Application (NDA). The FDA’s response acknowledges the serious need to address suicidal depression among adolescents, specifically targeting those aged 9-17. Based on this guidance, NRx and its partner HOPE Therapeutics plan to conduct a clinical trial in the adolescent population. The companies will also perform additional neurotoxicity studies in juvenile animals to ensure safety. This development is an important step in NRx’s overall plan to expand treatment options for youth struggling with suicidal depression, underlining the FDA’s commitment to public health in this critical area.
Read Announcement
KETAFREE™ FDA Regulatory Timeline and Events
KETAFREE™ is a drug developed by NRx Pharmaceuticals for the following indication: preservative-free ketamine product.
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.
- Drug:
- KETAFREE™
- Announced Date:
- December 2, 2025
- Indication:
- preservative-free ketamine product
Announcement
NRx Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has received the Company's Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free intravenous ketamine formulation.
AI Summary
NRx Pharmaceuticals announced the U.S. Food and Drug Administration has received its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative‑free intravenous ketamine. The FDA said the ANDA is “substantially complete” and set a GDUFA goal date of July 29, 2026 for final review. NRx has also applied to use KETAFREE as a proprietary product name, which remains subject to FDA review.
KETAFREE is presented as the first preservative‑free ketamine formulation that omits potentially toxic preservatives like benzethonium chloride used in current multidose vials. NRx reports it has manufactured initial registration lots and can scale production to about 1 million vials per month. The company noted the global generic ketamine market is roughly $750 million annually, says KETAFREE is intended for existing ketamine indications, and is awaiting an FDA response to a Citizen Petition seeking removal of benzethonium chloride from U.S. ketamine products.
Read Announcement- Drug:
- KETAFREE™
- Announced Date:
- September 29, 2025
- Indication:
- preservative-free ketamine product
Announcement
NRx Pharmaceuticals, announced the re-filing of its Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) for KETAFREE™, its preservative-free IV ketamine formulation, for use in all existing approved indications.
AI Summary
NRx Pharmaceuticals announced it has re-filed an Abbreviated New Drug Application (ANDA) to the FDA for its new preservative-free IV ketamine product, KETAFREE™. This formulation removes toxic preservatives such as benzethonium chloride, offering a safer option for patients and aligning with federal goals to eliminate harmful additives from drugs.
KETAFREE™ is intended for all existing ketamine indications and responds to a severe US ketamine shortage. The product also supports a presidential initiative to reshore critical drug manufacturing. With the current ketamine market at $750 million and projected to grow globally to $3.35 billion by 2034, NRx aims to supply clinics and hospitals seeking stable, preservative-free ketamine and plans to seek priority review for fast market access. NRx plans to manufacture KETAFREE™ in partnership with a US-based facility to ensure reliable domestic supply.
Read Announcement- Drug:
- KETAFREE™
- Announced Date:
- September 24, 2025
- Indication:
- preservative-free ketamine product
Announcement
NRx Pharmaceuticals, announced that it was notified yesterday by the United States Food and Drug Administration that a Suitability Petition has been granted for the strength proposed by the Company for its planned single-patient, preservative-free ketamine product (KETAFREE™).
Read Announcement
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