NRx Pharmaceuticals
The company anticipates potential operations in the United States, France, and the United Kingdom.
DRUG PROGRAMS TARGET: Suicidal and bipolar depression, suicide, chronic pain, complex UTIs and PTSD.
SUBSTANCE FOCUS: Ketamine
HTX-100
Ketamine IV
Against Suicidal Depression
DCS
D-Cycloserine
Against Chronic Back Pain
NRX-100
Ketamine
Against suicidal depression
NRX-101
DCS/Lurasidone
Against PTSD, Chronic Nociceptive Pain, Suicidality, Treatment-Resistant Bipolar Depression with Akathisia or Suicidality, Complicated UTI’s including Pelonephritis.
OWNERSHIP:
100% – Hope Therapeutics
Hope Therapeutics wants to acquire and integrate 30+ existing, profitable ketamine clinics through 2025 as it targets a 100 million USD per year run rate with positive EBITDA. It wants to build a national brand with a nationwide Patient Relationship Management (PRM) umbrella, augment ketamine therapy with TMS and Digital Therapeutics which augments the effects from ketamine and develop proprietary products to improve patient outcomes and profitability with oral therapeutics and ketamine analogs being worked on.
NEWS & PARTNERSHIPS:
2015
The active ingredient of the company’s Cyclurad was identified as potentially promising in the treatment of depression by the American Psychiatric Association Task Force on Novel Biomarkers and Therapeutics which concluded the following in the October edition of the American Journal of Psychiatry: “Current data provide compelling evidence that the antidepressant effects of ketamine infusion are both rapid and robust, albeit transient.” The APA Task Force identified D-cycloserine as 1 of only 2 molecules currently on the research horizon that shows promise for repeated administration in the treatment of depression via modulation of the NMDA receptor. D-cycloserine is 1 of the 2 active ingredients of Cyclurad.
2016
The company won first prize in the annual startup competition of the Israel Advanced Technology Industry BIOMED Forum. The prize includes financial support from Israel’s venture community.
The company received a notice of allowance by the US patent office for filing #14/844,021 for the Composition and Method for Treatment of Depression and Psychosis in Humans. The allowed claim relates to D-Cycloserine’s ability to block the symptom of akathisia caused by lurasidone, a drug that is indicated for the treatment of patients with bipolar depression. D-Cycloserine, which exhibits NMDA modulatory effects at the selected doses, is one of the components in NRX-101.
2017
The company signed a cooperative research and development agreement with the US Department of Veterans Affairs and Baylor College of Medicine for a clinical trial of a sequential treatment regimen of NRX-100 and NRX-101 for the treatment of severe bipolar depression in patients with Acute Suicidal Ideation & Behavior. There is currently no approved drug therapy for bipolar depression in patients with Acute Suicidal Ideation and Behavior, the only FDA-approved treatment is electroconvulsive therapy. Most antidepressants actually carry a warning about their potential for increasing the risk of suicide. Results from 2 Phase II clinical studies, involving 26 and 8 patients respectively, have been published in peer-reviewed journals with the first study showing a 50% reduction in symptoms of depression in patients with major depressive disorder. The 2nd study showed a 75% reduction in suicidal ideation in bipolar patients. In both studies, patients were on background antidepressant therapy and were then treated with d‑cycloserine, one of the active ingredients in NRX-101.
The company launched the first global “Voice of the Patient Survey” for those diagnosed with bipolar disorder, in collaboration with leading patient advocacy groups, mental health advocates and expert opinion leaders. The strictly anonymous survey is seeking 1,000 respondents and will allow for a greater understanding of the care people with bipolar disorder received during hospitalization for an acute suicidal crisis or a suicide attempt. This survey will for the first time ever, seek to understand where and what types of care succeeded or failed, to meet the patient’s needs through the eyes of those who have experienced the nightmare of suicidal depression.
2018
The company received a Special Protocol Agreement from the FDA for pivotal studies of NRX-101 to treat Severe Bipolar Depression in patients with Acute Suicidal Ideation & Behavior. The company also received a Letter of Support from the FDA’s Center for Drug Evaluation and Research (CDER) encouraging its efforts in the development of Glutamine+Glutamate (Glx) as a pharmacodynamic biomarker for depression.
2019
The company signed an agreement with GEM Global Yield for the provisioning of up to 750 million HKD over a 30-month term following a public listing of NeuroRx’s common stock. The funds will be used to complete its phase 3 clinical trials and GMP manufacturing requirements in both the US and China for NRX-101 as well as phase 2 clinical trials for the treatment of Suicidal PTSD under its Cooperative Research and Development Agreement with the US Department of Veterans Affairs. The company will be able to draw down funds from the capital commitment by issuing shares of NeuroRx’s common stock to GEM and is subject to share lending arrangements in place. The company has no minimum drawdown obligation and the timing as well as the amount is controlled by the company.
2020
The company received a notice of patent allowance covering the Composition of Matter for its drug NRX-101. The allowance is based on US Patent Application 15/987,932 entitled: Composition and Method for Treatment of Depression and Psychosis in Humans.
The company received a notice of patent allowance covering a formulation for the treatment of PTSD. The allowance is based on US Patent Application 15/987,933 entitled: Formulations for Treatment of Post-Traumatic Stress Disorder. The treatment consists of the administration of ketamine, a potent NMDA receptor antagonist, to a subject in need followed by the administration of a pharmaceutical formulation comprising of different dosages of D-cycloserine and an anti-depression or anti-psychosis agent.
The company announced that Houston Methodist Hospital is participating in their Phase 2 clinical trial evaluating RLF-100 as a research intervention for critically ill patients with COVID-19 and respiratory failure. RLF-100 is a patented formulation of Aviptadil which targets alveolar type 2 cells in the lungs that are a major target of the SARS-CoV-2 virus. VIP is known from numerous animal models of lung injury and lung disease to inhibit inflammatory cytokines and to protect pulmonary epithelial cells that line the air sacs of the lungs. The multicenter clinical trial will enroll patients with COVID-19 and respiratory failure in the hopes that RLF-100 can decrease mortality in this condition and help to improve the ability of the patient’s lungs to transfer oxygen to the body.
The company announced that the US FDA awarded Fast Track Designation to NeuroRx for the investigation of RLF-100 for the treatment of acute lung injury/acute respiratory distress syndrome associated with COVID-19. As part of the Fast Track program, the FDA has requested NeuroRx to submit a publicly available expanded access policy, so that physicians may request RLF-100 for their patients who are being treated in hospitals not participating in the ongoing Phase 2/3 clinical trials.
The company and Relief Therapeutics established supply chain agreements and ordered sufficient drug substance for RLF-100TM to prepare to treat 1 million patients with COVID-19, in case pandemic continue. Nephron Pharmaceuticals was contracted to manufacture commercial supplies of RLF-100, in order to ensure that adequate drug inventory will be immediately available, should the clinical trials demonstrate safety and efficacy. Bachem Americas was contracted to manufacture commercial sufficient RLF-100TM drug substance to treat 1 million patients. NeuroRx and Relief have additionally contracted with a leading nationwide pharmaceutical logistics partner to ensure overnight supply to US hospitals, should RLF-100 continue to succeed in clinical trials.
FDA granted the company an Expanded Access Protocol to RLF-100 for the treatment of Respiratory Failure in COVID-19, available for patients who are ineligible for enrollment in the FDA clinical trial of RLF-100, including pregnant women.
2021
The company validated the first commercial formulation of ZYESAMI for intravenous use, allowing for high volume manufacture, with an anticipated one year or greater stability, under appropriate storage conditions. The company has simultaneously achieved a 30-to-50-fold increase in its manufactured lot size of ZYESAMI, with a concurrent 90% reduction in the cost of its peptide supply.
The company entered into a feasibility and material transfer agreement with TFF Pharmaceuticals where the company will deliver ZYESAMI materials to TFF in order to perform feasibility formulation work and testing with the goal of formulating and identifying an optimal, long term-stable formulation of ZYESAMI in a dry powder form which has superior aerosol properties for delivery directly to the lungs.
The company partnered with MannKind Corporation for the development of a dry powder formulation of ZYESAMI.
The company signed an agreement with Cardinal Health to provide third party logistics and distribution of ZYESAMI upon the potential Emergency Use Authorization approval by the US FDA. Cardinal Health Specialty Pharmaceutical Distribution will serve as the exclusive distributor for ZYESAMI, providing broad access to hospitals for this needed medicine upon FDA authorization. With one of the largest healthcare supply chains, Cardinal Health services more than 90% of hospitals in the US and has more than 20 years of experience supporting rapid delivery of lifesaving medicines. CH will also support the warehousing and distribution, full order to cash and necessary title model services.
The company announced the signing of a MOU with the government of Israel to license exclusive worldwide development, manufacturing and marketing rights to a novel Coronavirus vaccine developed by the Israel Institute for Biological Research. The BriLife vaccine is based on a previous FDA-approved vaccine platform that was further optimized by IIBR and targeted towards COVID-19. IIBR will provide technical assistance and receive customary royalty and milestone payments for its intellectual property. NRx has further committed to supplying all required doses of the vaccine for the population of Israel.
The company announced that the Nation of Georgia’s Prime Minister and Minister of Health have issued an Emergency Use Authorization for intravenous ZYESAMI for the treatment of Critical COVID-19. The first training of doctors in Georgia as well as doses of ZYESAMI arrived in the nation of Georgia within 24 hours, and discussions started with the Ministry of Health to provide access to ZYESAMI to Georgians suffering with critical COVID-19.
The company’s Zyesami (Aviptadil) was identified by the National Institutes of Health as 1 of 2 drugs selected for inclusion in a phase III multicenter clinical trial that will include the US and multiple foreign countries. The other drug was Veklury (Remdesivir) from Gilead Sciences. The primary endpoint of the trial will be participant recovery from respiratory failure over 90 days.
The company announced future collaboration with the Ministries of Health of Georgia, Hungary, and Ukraine to conduct phase III development of ZYESAM in coordination with the Senator Richard Lugar Research Institute. Costs of around 60 million USD will be shared by the company and Denk Pharma in Georgia. The company signed a master services agreement with Cromos Pharma to conduct phase 3 clinical trials of COVID-19 related drugs and vaccines in Central Europe and the Caucasus Region. Cromos Pharma and Denk Pharma will jointly oversee clinical development and distribution. Cromos will support the company in the development of ZYESAMI for home treatment of COVID-19, working to reduce the incidence of hospitalization and death.
2022
The company produced its first batches of US-made NRX-101.
The company announced that they had entered into definitive settlement agreements to resolve their pending litigation with Relief Therapeutics. The companies dismissed their pending litigation and as per the terms of the settlement, the company transferred to Relief all of the assets it used in the NRx aviptadil development program, including the regulatory filings, patent applications, clinical data, and the formulation of the aviptadil product it was previously developing and in turn giving Relief the exclusive right and control going forward and the obligation to use commercially reasonable efforts to develop and commercialize an aviptadil product. Relief agreed to use commercially reasonable efforts to continue the existing Right to Try Program for aviptadil in the US for at least 2 years and Relief will pay NeuroRx milestone payments if it can successfully obtain commercial approval of an aviptadil product (whether for COVID-19 or any other indication) and the company has agreed with NeuroRx not to compete in the development of an aviptadil product in the future.
2023
The company signed a license data and technical information agreement with Columbia University for rights to data from a randomized, active-controlled trial of 80 patients hospitalized for Acute Suicidality in Depression.
The US Patent and Trademark Office issued U.S. Patent No. 11,576,911. to Glytech and the patent is exclusively licensed to NeuroRx under the terms of a license agreement giving the company has the sole rights to this and other patents, both in the US and internationally. The licensed patents cover certain pharmaceutical formulations and their uses in treating a variety of neuropsychiatric conditions, including bipolar depression, major depressive disorder, PTSD, and suicidality. In particular, the claims of the new patent cover methods for treating a patient suffering from depression, including bipolar depression or major depression, with or without suicidality by administering to the patient an effective amount of the Company’s lead product candidate, NRX-101. The ‘patent represents the U.S. version of a third patent family owned by or exclusively licensed to NeuroRx that covers the NRX-101 formulation or its methods of use in treating depressive disorders, and such patent coverage is expected to remain in force through at least July 2033 prior to any patent term extensions available under federal law.
The company announced a global collaboration agreement with Lotus Pharmaceuticals and Alvogen for the development and commercialization of NRX-101 for suicidal treatment-resistant bipolar depression for global markets. Lotus will acquire worldwide rights for NRX-101 for S-TRBD and will be responsible for commercialization of NRX-101 in markets outside the US through Lotus’s direct presence in certain Asian markets or through their export division, which currently has partnerships in numerous markets, including in Europe, Japan, China, Australia and Latin America. Alvogen will be responsible for US commercialization of NRX-101 through its CNS-focused Almatica division.
The company signed a license agreement for US Patent 8,653,120 that claims the use of D-cycloserine for the treatment of chronic pain in exchange for a commitment to pay milestones and royalties as development milestones are reached in the field of chronic pain.
The company received clearance from the US FDA for the use of NRX-101 for the treatment of Complicated Urinary Tract Infections.
The company signed a development and manufacturing agreement to manufacture a presentation of ketamine suitable for treating suicidal depression with Nephron Pharmaceuticals under FDA manufacturing regulations.
The company announced a strategic acceleration of its plans to develop a commercial form of NRX-100 to treat acute depression and suicidality, based on recent data cooperation agreements and changes in the regulatory environment.
2024
The company announced plans to acquire a network of interventional psychiatry clinics, focusing on ketamine treatments. The clinics will focus on treating conditions like suicidal depression, treatment-resistant depression and PTSD. HOPE Therapeutics aims to create a unified, patient-centered approach, combining pharmaceutical therapies and FDA-approved technologies like Transcranial Magnetic Stimulation.
The company signed a non-binding term sheet for 5 operational clinics in the Western United States generating over $10 million in annual revenue.
The company announced the completion of a Memorandum of Understanding with Conversio Health, a national 503a pharmacy as well as an ongoing partnership with Nephron Pharmaceuticals, a manufacturer of Ketamine and 503b pharmacy. The company developed a novel, proprietary formulation of IV Ketamine for use as HTX-100, with their partner Nephron Pharmaceuticals, with the new formula having the key advantage of achieving neutral pH, in contrast to the acidic pH of generic formulations of ketamine. HTX-100 will be marketed by HOPE Therapeutics.
The company entered into a business relationship with an organization that serves the business needs of 100+ ketamine clinics nationwide in the US which the company will sell ketamine to licensed end users.
2025
The company oversaw an investment from Smith and Sauer of 27 million USD to its subsidiary HOPE Therapeutics to enable a nationwide rollup of Interventional Psychiatry Clinics in order to treat patients suffering from suicidal depression and PTSD with treatments combining ketamine and other psychedelic medications with Transcranial Magnetic Stimulation and FDA-approved Digital Therapeutics.
Hope Therapeutics acquired Kadima Neuropsychiatry Institute which will serve as the company’s flagship clinic for its planned US network of clinics dedicated to treating depression and PTSD.
Dr. David Feifel, founder of the Kadima Neuropsychiatry Institute appeared on a CNN program hosted by Dr. Sanjay Gupta regarding the science and stigma of ketamine.
HOPE Therapeutics signed a definitive agreement to acquire Florida-based Dura Medical.
HOPE Therapeutics entered into a non-binding term sheet for a $2.5 million investment from a global medical device manufacturer at a $50 million pre-money valuation.
The FDA granted a $4.3 million filing fee waiver for the company’s New Drug Application for NRX-100.
The company filed a citizen petition with the FDA requesting the removal of benzethonium chloride, a known neurotoxic and cytotoxic preservative which is not Generally Recognized as Safe for parenteral use, from all intravenous ketamine products sold in the US.
The FDA has granted Fast Track designation to NRX-100 for the treatment of suicidal ideation in patients with depression. Following this, the company established an expanded access policy for NRX-100. This program allows physicians to request the investigative treatment for patients suffering from serious or life-threatening suicidal depression who have not responded to or cannot tolerate standard therapies.
HOPE Therapeutics acquired Dura Medical, a Florida-based provider of interventional psychiatry services. Dura’s founder, Stephen Durand was appointed Director of Florida Clinic Operations.
The company received notification that the FDA granted a Suitability Petition for its proposed preservative-free ketamine product, KETAFREE. This regulatory approval allowed NRx to move forward with the re-filing of its Abbreviated New Drug Application.
HOPE Therapeutics acquired 49% of Cohen and Associates in Sarasota, Florida, and officially incorporated the clinic into the HOPE Network. Dr. Rebecca Cohen joined the HOPE leadership team as Medical Director, where she will oversee clinical standards across all Florida locations.
HOPE Therapeutics became the first network in Florida to deploy the Ampa “ONE-D” protocol, an innovative treatment for resistant depression that utilizes an FDA-cleared device to achieve remission in a single day. By combining this TMS technology with physician-prescribed D-cycloserine and lisdexamfetamine, the protocol aims to drastically shorten the standard 90-day TMS treatment course. Under the leadership of Medical Director Dr. Rebecca Cohen, the company has already initiated patient care at multiple Florida locations, with plans to expand to 6 sites by the end of 2025.
2026
NRx Pharmaceuticals and neurocare Group AG have formed a strategic partnership to establish a nationwide network of clinics offering integrated neuroplastic care for depression, PTSD, and other mental health disorders. By combining NRx’s expertise in neuroplastic drug development with neurocare’s neuromodulation technology, software platforms, and clinic base, the partners aim to provide a fully integrated, accountable-care solution for patients across the United States. The collaboration will leverage existing neurocare and HOPE Therapeutics locations alongside a massive base of Apollo TMS devices, with the goal of offering comprehensive treatment programs to patients and payers within driving distance of any American home by the end of 2026.
The company licensed a real-world evidence dataset from Osmind, covering over 70,000 patients treated with intravenous ketamine or nasal esketamine, to support the FDA accelerated approval of NRX-100. This regulatory-grade data provides longitudinal insights into the safety and effectiveness of ketamine in treating depression and suicidal ideation, a condition for which no other medicine is currently FDA-approved beyond electroshock therapy.
The company reached a significant regulatory milestone for its Abbreviated New Drug Application (ANDA) after the FDA Office of Generic Drugs determined there were no bioequivalence deficiencies in its preservative-free ketamine product. This preliminary finding validates the safety and quality of NRx’s proprietary formulation, which eliminates the toxic preservative benzethonium chloride found in traditional multi-dose vials.
Hope Therapeutics partnered with Emobot Health to deploy an AI-driven emotional monitoring platform across its network of interventional psychiatry clinics. By passively tracking biomarkers like facial expressions, vocal tones and activity levels via smartphone, the “Depression Thermometer” aims to eliminate the “blind spot” between clinic visits where nearly half of patients currently relapse. This integration allows clinicians to receive objective, real-time data to identify early relapse signals and initiate timely “recapture” interventions, such as maintenance TMS or ketamine sessions and thereby significantly increasing long-term patient success rates.
HOPE Therapeutics opened a new flagship clinic in Palm Beach, Florida, offering an integrated treatment approach for depression and PTSD. The clinic utilizes advanced modalities, including ketamine, transcranial magnetic stimulation (TMS), and hyperbaric oxygen therapy, combined with physician-led psychotherapy to move beyond the limitations of traditional, often ineffective oral antidepressants.
The company incorporated NRx Defense System, an R&D subsidiary led by former high-ranking defense official Dr. Dennis K. McBride. The subsidiary focuses on developing neuroplastic treatments, specifically the combination of D-cycloserine (NRX-101) with robotic-enabled Transcranial Magnetic Stimulation to address depression and PTSD in military personnel and first responders. By partnering with Zeta Surgical to leverage AI-powered neuronavigation, the initiative aims to create mobile, non-invasive and field-deployable mental health solutions that can restore personnel to duty without the disqualifying side effects often associated with traditional antidepressants.
The FDA Office of Generic Drugs issued a positive Discipline Review Letter for its preservative-free ketamine Abbreviated New Drug Application, identifying only minor administrative requirements.
In anticipation of a Summer 2026 approval, NRx Pharmaceuticals has initiated commercial manufacturing of its preservative-free ketamine, utilizing a US-based partner and a high-throughput blow-fill-seal process.
The company received FDA clearance to initiate the MIND1 clinical trial, a Phase 2/3 study evaluating NRX-101 as an adjunctive therapy to robotic-assisted Transcranial Magnetic Stimulation in patients with treatment-resistant depression and suicidality. The trial will be conducted by the newly formed NRx Defense Systems across a combination of academic teaching hospitals, HOPE Therapeutics clinics, and U.S. military treatment facilities. By testing the ability of D-cycloserine to augment TMS effectiveness, the study seeks to validate a short-term, non-invasive treatment paradigm that could significantly improve force readiness and clinical outcomes for the military and civilian populations.
HOPE Therapeutics became the first commercial provider to deploy the FDA-cleared Zeta TMS Navigation System at its West Palm Beach clinic. This AI-powered technology utilizes real-time computer vision to provide sub-millimetric image guidance for TMS treatments, significantly increasing precision and reducing setup times for patients with major depressive disorder.
The FDA approved an Intermediate Population Expanded Access Protocol, allowing NRx Pharmaceuticals to provide NRX-101 to patients who qualify for compassionate care outside of the ongoing pivotal clinical trials.