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.
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.
- Drug:
- HTX-100
- Announced Date:
- April 15, 2024
- Indication:
- IV Ketamine
Announcement
NRx Pharmaceuticals, Inc. announced that the Company has developed a novel, proprietary formulation of IV Ketamine for use as HTX-100.
AI Summary
NRx Pharmaceuticals, Inc. has introduced a novel, proprietary formulation of IV ketamine for its HTX-100 treatment. This breakthrough formulation achieves a neutral pH, which sets it apart from the standard acidic ketamine solutions. A neutral pH is important because while diluted acidic ketamine works for IV infusions, it may cause pain and skin irritation when administered subcutaneously. With this innovation, ketamine could be delivered using pump-like devices in clinics, potentially simplifying the treatment process by reducing the need for specialized infusion personnel.
Developed in collaboration with Nephron Pharmaceuticals, a leader in sterile manufacturing, this formulation is expected to be protected by a composition of matter patent. This advancement marks a significant step forward in creating a more patient-friendly and modern approach to ketamine administration.
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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:
- 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 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:
- 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:
- 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.
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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:
- 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 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:
- 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:
- 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- Drug:
- NRX-101
- Announced Date:
- May 6, 2024
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals, Inc. announced a statistically significant safety advantage of NRX-101 compared to the standard of care comparator in its recently completed clinical trial in patients with suicidal bipolar depression.
AI Summary
NRx Pharmaceuticals announced that its clinical trial in patients with suicidal bipolar depression shows that NRX-101 has a significant safety advantage over the standard care comparator. The trial, which followed a protocol agreed with the FDA, demonstrated that NRX-101 reduced symptoms of akathisia by an average of 76% compared to lurasidone, with levels of akathisia nearly disappearing by day 42. The reported effect size was 0.37 with a statistically significant P value of 0.025. Akathisia, a potentially life-threatening side effect present in many standard antidepressants, is closely linked to increased suicidality. Only 2% of patients treated with NRX-101 experienced akathisia compared to 11% with lurasidone. Based on these positive safety findings, NRx Pharmaceuticals plans to seek accelerated FDA approval for NRX-101, particularly for bipolar depression patients at risk for akathisia.
Read Announcement- Drug:
- NRX-101
- Announced Date:
- April 17, 2024
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals, Inc. announced new data that demonstrate that in a rodent model NRX-101 shows no measurable damage to either intestinal or vaginal flora, compared to the significant negative effect caused by drugs such as ciprofloxacin. announced new data that demonstrate that in a rodent model NRX-101 shows no measurable damage to either intestinal or vaginal flora, compared to the significant negative effect caused by drugs such as ciprofloxacin.
AI Summary
NRx Pharmaceuticals announced new data showing that in a rodent model the antibiotic NRX-101 causes no measurable damage to intestinal or vaginal flora. This is a significant finding compared to drugs such as ciprofloxacin, which can notably disrupt these microbial communities. In many cases, common antibiotics disturb the balance of normal bacteria, often leading to complications like Clostridium difficile colitis and vaginal yeast infections. However, NRX-101, which utilizes D-cycloserine that is fully absorbed in the small intestine and excreted unmetabolized in the urine, appears to avoid this issue. These promising results suggest that NRX-101 might offer a safer option for patients suffering from complicated urinary tract infections and pyelonephritis, potentially reducing the risk of secondary infections related to traditional antibiotic treatments.
Read Announcement- Drug:
- NRX-101
- Announced Date:
- April 11, 2024
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals Inc announced that NMDA Modification Therapy And Its Multiple Applications From Mental Health To Chronic Pain
AI Summary
NRx Pharmaceuticals Inc. recently announced its NMDA Modification Therapy, a novel treatment approach with multiple applications from mental health to chronic pain. The company’s lead compound, NRX-101, is an oral fixed-dose combination of two FDA-approved drugs, D-cycloserine and Lurasidone. This combination is designed to modulate the NMDA receptor, which plays a key role in memory function and the formation of new thoughts. In patients with bipolar depression, where excessive NMDA activity can slow thought creation and contribute to suicidal ideation, NRX-101 aims to strike a balance to improve thought processes and reduce risks of self-harm. Beyond treating severe bipolar depression, NRx is exploring the use of its NMDA modification platform in chronic pain, potentially offering a new treatment option for millions who suffer from persistent pain conditions.
Read Announcement- Drug:
- NRX-101
- Announced Date:
- April 8, 2024
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals, Inc. announced that the Company has achieved data-lock in its Phase 2b/3 Suicidal Treatment Resistant Bipolar Depression Study with NRX-101. With data-lock, as forecast in last week's earnings call, the complete data set passed on for statistical analysis
AI Summary
NRx Pharmaceuticals, Inc. announced that it has reached data-lock in its Phase 2b/3 study of NRX-101 for treating suicidal treatment resistant bipolar depression. This milestone means that the complete data set has been finalized and sent for independent statistical analysis, as noted in last week’s earnings call. Top-line data from the analysis is expected to be released in April 2024.
The achievement of data-lock is a key step in the development of NRX-101, an investigational treatment that shows promise in reducing both depression symptoms and suicidal ideation in patients with bipolar depression. With this important progress, NRx Pharmaceuticals is positioning itself for further milestones and continued investment in the drug’s development, which could ultimately expand treatment options for patients suffering from this challenging condition.
Read Announcement- Drug:
- NRX-101
- Announced Date:
- April 8, 2024
- Estimated Event Date Range:
- April 1, 2024 - April 30, 2024
- Target Action Date:
- April 01, 2024
- Indication:
- Bipolar Depression with Sub-Acute Suicidality
Announcement
NRx Pharmaceuticals, Inc. announced that top-line data release expected in April 2024.
AI Summary
NRx Pharmaceuticals, Inc. announced that it has reached data-lock on its Phase 2b/3 study for treating suicidal treatment-resistant bipolar depression using NRX-101. The company has transferred the complete data set for independent statistical analysis. Top-line data from the trial is expected to be released in April 2024. This milestone is important as it marks a significant step forward in the evaluation of NRX-101’s effectiveness for reducing depression symptoms and suicidal ideation in patients with bipolar depression.
The upcoming data release could have meaningful implications for the company and its commercial partners. The results are highly anticipated, as they will help determine the future steps in the development of NRX-101 and contribute to the broader efforts to provide alternative treatment options for patients battling this severe condition.
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