Exploration and mechanism research on the preventive and synergistic therapeutic effects of systematic interpersonal therapy on depressive disorders with mixed characteristics in adolescents

Start Date18 Aug 2025

Sponsor / Collaborator-

CTR20252467

/ CompletedNot Applicable

盐酸鲁拉西酮片在中国成年健康受试者中的一项单中心、随机、开放、空腹和餐后单次给药、两制剂、两序列、四周期、完全重复交叉生物等效性研究

[Translation] A single-center, randomized, open-label, fasting and postprandial single-dose, two-formulation, two-sequence, four-period, fully repeated crossover bioequivalence study of lurasidone hydrochloride tablets in healthy adult Chinese subjects

考察单次口服（空腹/餐后）受试制剂盐酸鲁拉西酮片【规格：40 mg（按C28H36N4O2S·HCl计）】与参比制剂【商品名：罗舒达®，规格：40 mg（按C28H36N4O2S·HCl计）】在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。

[Translation]

The relative bioavailability of the test preparation lurasidone hydrochloride tablets [Specification: 40 mg (calculated as C28H36N4O2S·HCl)] and the reference preparation [trade name: Lurasida®, specification: 40 mg (calculated as C28H36N4O2S·HCl)] in healthy Chinese subjects after a single oral administration (fasting/postprandial) was investigated, the pharmacokinetic parameters of the two preparations were analyzed, and the bioequivalence of the two preparations was evaluated, so as to provide a reference for the application and clinical use of the drug.

Start Date17 Jul 2025

Sponsor / Collaborator

PKU HealthCare Corp., Ltd.

100 Clinical Results associated with Lurasidone Hydrochloride

100 Translational Medicine associated with Lurasidone Hydrochloride

100 Patents (Medical) associated with Lurasidone Hydrochloride

857

Literatures (Medical) associated with Lurasidone Hydrochloride

01 Aug 2026·JOURNAL OF AFFECTIVE DISORDERS

Efficacy and safety of pharmacological interventions for the maintenance of bipolar disorder: A systematic review and dose-related network meta-analysis across different age groups

Review

Author: Daray, Federico Manuel ; Kishi, Taro ; Di Lorenzo, Chiara ; Fornaro, Michele

BACKGROUND:

Bipolar disorder (BD) is a chronic mental illness that requires lifelong treatment. We investigated the comparative efficacy and safety of pharmacological interventions for bipolar maintenance, considering dose effects across different age groups.

METHODS:

We conducted a network meta-analysis (NMA) of randomized controlled trials (RCTs) comparing pharmacological interventions against each other or placebo for the maintenance of BD, searching for records indexed in PubMed/MEDLINE, Embase, Web of Science, and Scopus (from inception through 2026.1.12). Co-primary outcomes were the relapse rate (into an acute episode of any mood polarity) and tolerability (discontinuation due to side effects). Relapse into episodes of specific mood polarities (namely, depressive/manic/mixed polarity), acceptability (discontinuation due to any cause), and rate of specific adverse events were secondary outcomes. Confidence-In-Network-Meta-Analysis was likewise appraised.

RESULTS:

Forty-four RCTs involving 23 distinct treatment combinations encompassed 10,867 participants. Sensitivity analysis retaining only low-risk-of-bias studies and excluding outliers for possible effect modifiers indicated that asenapine 20 mg/day, aripiprazole 20 mg/day, 30 mg/day, quetiapine 300 mg/day, 600 mg/day and 550 mg/day, lithium 800 mg/day, lurasidone 80 mg/day, carbamazepine 400 mg/day and 650 mg/day, valproate 71-125 μg/mL, olanzapine 20 mg/day, long-acting aripiprazole 400 mg/4 weeks, long-acting risperidone 25 mg/2 weeks, aripiprazole 30 mg/day+lamotrigine 200 mg/day outperformed placebo. Several additional drugs might be efficacious, although they either emerged as outliers for the mean age of participants/proportion of females/proportion of BD-I/II patients, baseline severity of mania/depression, and trial duration.

CONCLUSIONS:

Our findings are consistent with previous NMAs and current guidelines, yet they expand current knowledge by concurrently appraising different drugs, doses, and age groups.

01 Aug 2026·CANCER LETTERS

Stress granule assembly represents a therapeutic vulnerability in super-enhancer-driven circMLB-mediated glioblastoma temozolomide resistance

Article

Author: Jiang, Yanyi ; Liu, Jun ; Huang, Ruixiang ; Bian, Erbao ; Xie, Han ; Liang, Mengxia ; Yang, Zhihao ; Tian, Dasheng ; Dong, Yongfei ; Chen, Tao

Resistance to temozolomide (TMZ) is a major driver of treatment failure and high mortality in patients with glioblastoma (GBM). However, the mechanisms underlying TMZ resistance, especially intrinsic resistance, remain incompletely elucidated. Through integrative multi-omics analyses, we identified a novel super-enhancer-driven circular RNA, circMLB, which is highly overexpressed in TMZ-R GBM. Both in vitro and in vivo studies robustly demonstrate that circMLB significantly enhances TMZ resistance in GBM. Mechanistically, the transcription factor PAF1 forms a protein complex with BRD4 that is enriched in the super-enhancer region, thereby upregulating circMLB expression. Furthermore, highly expressed circMLB directly binds to PKR, triggering stress granule assembly and ultimately reinforcing TMZ resistance in GBM. Importantly, we identified a novel PKR inhibitor, lurasidone, which synergizes with TMZ to exert potent anti-tumor activity against TMZ-R GBM in preclinical models. Our findings uncover a previously unrecognized SE-circMLB-PKR axis mediating intrinsic TMZ resistance and highlight the lurasidone-TMZ combination as a promising therapeutic strategy to surmount TMZ resistance in GBM.

01 Jul 2026·EUROPEAN NEUROPSYCHOPHARMACOLOGY

Treatment of bipolar depression: results from a comprehensive network meta-analysis and updated systematic review

Review

Author: Vieta, Eduard ; Yildiz, Ayşegül ; Leucht, Stefan ; Yalin, Nefize ; Siafis, Spyridon

Depressive episodes present a treatment challenge in bipolar disorder (BD), and an urgent need exists for novel treatment options. This review sought to revisit the results from a recent network meta-analysis (NMA) that examined treatment options for bipolar depression and to update those findings with a complementary systematic review (PROSPERO-ID: CRD42020171726). The NMA was based on the qualitative synthesis of 145 studies and the quantitative analysis of 101 studies investigating acute depression in adults with bipolar depression from inception to April 2023. A complementary systematic review was conducted using MEDLINE, OVID, EMBASE, PsychINFO, CINAHL, LILACS, Cochrane, Web of Science Core Collaboration, and Google Scholar databases from April 2023 to November 2024 to identify the most recent randomized controlled trials on the treatment of bipolar depression. Studies identified via systematic review were subjected to narrative synthesis and quality assessment was completed using revised Cochrane risk of bias tool. The original NMA showed that olanzapine plus fluoxetine, quetiapine, olanzapine, lurasidone, lumateperone, cariprazine, and lamotrigine were more efficacious than placebo in reducing depressive symptoms in BD with good confidence. Several other drugs might also be efficacious, but confidence in the evidence was very low to low. The complementary systematic review identified 24 clinical trials, seven of which had published results suitable for meta-analysis; the remaining 17 studies were either ongoing or completed with no available results. Collectively, the NMA and systematic review findings can inform evidence-based care and the development of international treatment guidelines for bipolar depression.

139

News (Medical) associated with Lurasidone Hydrochloride

28 Jul 2026

·www.businesswire.com

Shionogi Announces U.S. Availability of XOCOVA ® (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure*

FLORHAM PARK, N.J.--(BUSINESS WIRE)--Shionogi Inc., a New Jersey-based subsidiary of Shionogi & Co., Ltd., (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced U.S. availability of XOCOVA® (ensitrelvir), an oral antiviral, approved for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.2 XOCOVA offers a new approach to help prevent COVID-19 by blocking viral replication during the critical window between exposure and COVID-19 symptom onset.4,5 XOCOVA is taken once daily, with three 125 mg tablets (375 mg) taken at the same time on the first day, followed by one 125 mg tablet on days two through five. XOCOVA should be taken as soon as possible and within 72 hours following contact with an individual who has COVID‑19.1 “With XOCOVA, we have a novel oral option to help prevent COVID-19 after exposure, and it is available just in time for the annual late summer spike,” said Charles Vega, MD, FAAFP, Health Sciences Clinical Professor, University of California, Irvine, School of Medicine. “Taking XOCOVA to help prevent COVID-19 in the critical window between exposure and symptom onset makes sense for anyone who wants to try to avoid illness, and it could be especially beneficial for older adults and individuals with health conditions that may put them at higher risk for severe illness. Now, in addition to recommending my patients stay updated with vaccinations, I’ll be talking to them about XOCOVA, so they are ready to act quickly in the event of an exposure.” The U.S. has experienced a COVID-19 summer spike every year since 2020.3 Biobot Analytics, a wastewater intelligence company with continuous and longitudinal data on pathogens from wastewater, reports that SARS-CoV-2 levels are beginning to rise, providing an early, population-level signal that another COVID-19 summer wave may be taking shape.6 Scenario modeling from The U.S. Centers for Disease Control and Prevention indicates there may be increased COVID-19 activity in regions (South and West) which did not experience a substantial level of COVID-19 activity during the most recent fall and winter months.3 “Post-exposure prophylaxis, or PEP for short, has been used successfully with influenza as well as HIV and other sexually transmitted infections, and it has the potential to help reduce the burden of COVID-19,” said David Wohl, MD, Professor of Medicine, The University of North Carolina at Chapel Hill, School of Medicine. “The availability of XOCOVA means that now, for the first time, there’s an oral option that can help prevent COVID-19 after exposure. Since XOCOVA must be taken within 72 hours of exposure, having it on hand can help ensure it is taken within the critical window between exposure and COVID-19 symptom onset.” Having XOCOVA on hand can help appropriate patients be prepared in the event of a COVID-19 exposure. Before taking XOCOVA, individuals should review the dosing and administration instructions and check the expiration date on the blister pack. They should also speak with a healthcare professional if there are any changes to their medications (including prescription and over-the-counter medicines), vitamins or supplements and verify they are not pregnant or breastfeeding. Shionogi is supporting the availability of XOCOVA through professional and consumer education and partnerships with national and regional pharmacies to ensure product availability. Select retail pharmacies across the U.S. will have XOCOVA in stock, and all retail pharmacies can order it from Shionogi’s wholesale distribution partners. Shionogi has a commercial co-pay offer for XOCOVA that helps eligible, commercially insured patients with out-of-pocket costs. Eligible patients may pay as little as $0 per prescription fill. Details about eligibility are available at https://www.xocova.com/. All components of XOCOVA are produced in the U.S. including active pharmaceutical ingredient production, drug product formulation, packaging, quality control, release testing, and supply chain and distribution. The Ongoing Impact of COVID-19 COVID-19 remains highly transmissible, driven by Omicron and its subvariants, and up to 47% of people living with an infected individual may develop COVID-19.7 The U.S. Centers for Disease Control and Prevention estimates that between October 1, 2025, and July 11, 2026, there were 4.2-12.7 million new cases in the U.S., resulting in 840,000 – 2.3 million outpatient visits, 130,000 – 250,000 hospitalizations and 14,000 - 42,000 deaths.8 Beyond acute infection, COVID-19 can have lasting impacts. People diagnosed with COVID-19 had increased rates of both new and worsening neurologic, cardiovascular, respiratory, and chronic kidney conditions during the year following infection.9-,10,11,12,13,14,15,16,17,18 COVID-19 also disproportionately affects older adults with greater risk for severe illness and death in close-community settings, such as long-term care facilities.19 About SCORPIO-PEP The global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety and efficacy of XOCOVA as post-exposure prophylaxis for COVID-19. The study was conducted from June 2023–September 2024. It included 2,387 study participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. The primary analysis included 2,041 household contact participants with a central laboratory-confirmed negative SARS-CoV-2 test at baseline. More than 98% of household contacts tested positive for antibodies against SARS-CoV-2 N (nucleocapsid) or S (spike) proteins, indicating that nearly all had evidence of previous SARS-CoV-2 infection or vaccination, or both.20 Study participants were randomly assigned at a 1:1 ratio to receive XOCOVA (375 mg on Day 1 and 125 mg on Days 2-5) or placebo, once daily, and began treatment within 72 hours of when the household member with COVID-19 began showing symptoms. Participants then continued XOCOVA (125 mg) or placebo for five days. In the primary analysis population, XOCOVA significantly reduced the risk of symptomatic COVID-19 by 67% in individuals following exposure to an infected individual through Day 10 compared with placebo (ensitrelvir n=1,030; placebo n=1,011).2 The most common adverse events (regardless of causality) occurring in greater than or equal to 1% of the XOCOVA group and at a greater frequency compared to placebo were headache, diarrhea, and cough.1 There were no reports of altered taste (dysgeusia) attributed to XOCOVA in the trial.2,20 Results from the SCORPIO-PEP trial were published in the New England Journal of Medicine on May 14, 2026. SCORPIO-PEP is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual. About XOCOVA XOCOVA® (ensitrelvir) is a SARS-CoV-2 main protease inhibitor created through joint research between Hokkaido University and Shionogi. SARS-CoV-2 has an enzyme called the main protease, which is essential for the replication of the virus. XOCOVA suppresses the replication of SARS-CoV-2 by selectively inhibiting the main protease. XOCOVA is approved in the U.S. and Japan for post-exposure prophylaxis of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19. XOCOVA received emergency regulatory approval in Japan in November 2022 and full approval in March 2024 for the treatment of COVID-19 in adults and adolescents 12 years of age and older based on results from SCORPIO-SR, a Phase 3 study conducted in Asia during the Omicron-dominant phase of the pandemic. Results from this study were published in JAMA Network Open. XOCOVA received supplemental approval in June 2026 in Japan for pediatric patients aged 6 to under 12 years who weigh at least 20 kg for the treatment of COVID-19. XOCOVA is not approved for the treatment of COVID-19 in the U.S. INDICATION XOCOVA (ensitrelvir) is a prescription medicine used to help prevent coronavirus disease 2019 (COVID-19) in adults and children aged 12 years and older following contact with a person who has COVID-19 (post-exposure prophylaxis). It is not known if XOCOVA is safe and effective in children under age 12. IMPORTANT SAFETY INFORMATION Do not take XOCOVA if you are: allergic to ensitrelvir or any of the ingredients in XOCOVA. take any of the following medicines, as these may interact with XOCOVA and may cause severe or life-threatening side effects or death: apalutamide, carbamazepine, colchicine, dihydroergotamine, enzalutamide, eplerenone, ergotamine, finerenone, ivabradine, lomitapide, lumacaftor/ivacaftor, lurasidone, methylergonovine, phenytoin, pimozide, quinidine, rifampin, St. John’s wort, simvastatin, triazolam or voclosporin. These are not the only medicines that may cause serious or life-threatening side effects if taken with XOCOVA. XOCOVA may increase or decrease the levels of many medicines in your body. Tell your healthcare provider (HCP) about all the medicines you take because additional laboratory tests or dose changes of your other medicines may be necessary during XOCOVA use. Your HCP may tell you about specific symptoms to watch for that may indicate you need to stop or decrease the dose of some of your other medicines. Before taking XOCOVA, tell your HCP about all your medical conditions, including if you: are pregnant or plan to become pregnant. XOCOVA may harm your unborn baby. For females who are able to become pregnant, your HCP will check with you to see if you are pregnant before starting XOCOVA. Use effective birth control (contraception) during XOCOVA use and for 2 weeks after the final dose. Tell your HCP right away if you become pregnant or think you may be pregnant during XOCOVA use. are breastfeeding or plan to breastfeed. It is not known if XOCOVA passes into your breast milk. Do not breastfeed during XOCOVA use and for 2 weeks after the final dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your HCP can tell you if it is safe to take XOCOVA with other medicines. Do not start a new medicine without telling your HCP. What are the possible side effects of XOCOVA? XOCOVA may cause serious side effects, including: Allergic reactions, including severe allergic reactions (anaphylaxis). Stop taking XOCOVA and get medical help right away if you get any of the following allergic reaction symptoms: skin rash; hives; itching; swelling of the mouth, lips, tongue, or face; trouble swallowing or breathing; throat tightness; dizziness or feeling lightheaded; stomach-area (abdomen) pain; or vomiting. The most common side effects of XOCOVA include: headache, diarrhea, and cough. These are not all possible side effects of XOCOVA. For more info, ask your HCP or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. Please see full Prescribing Information, including Patient Information, for XOCOVA. About Shionogi Inc. Shionogi Inc. is a U.S. subsidiary of Shionogi & Co., Ltd., a global research‑driven pharmaceutical company committed to bringing to market the best possible medicines to aid the health and well-being of the patients we serve. Our global expertise in infectious disease began in the 1950s and in addition to discovering and developing multiple innovative antibiotics, today our global portfolio includes an antibiotic for the treatment of serious Gram‑negative bacterial infections, antivirals for COVID-19, HIV and influenza and a therapeutic for rare fungal infections. Our U.S. infectious disease franchise includes both approved and investigational novel anti-infectives, and investigational antivirals for COVID-19 and RSV. In parallel, we are advancing a U.S. rare disease franchise that includes an approved therapy for amyotrophic lateral sclerosis (ALS), along with clinical programs in Fragile X syndrome, Jordan’s syndrome, and Pompe disease. We are also pursuing research in additional high‑unmet need therapeutic areas, including oncology, acute ischemic stroke, sleep apnea, and other quality of life areas. Learn more at shionogi.com. About Shionogi & Co., Ltd. Shionogi & Co., Ltd. is a 148-year-old global, research-driven pharmaceutical company headquartered in Osaka, Japan, that is dedicated to bringing benefits to patients based on its corporate philosophy of “supplying the best possible medicine to protect the health and wellbeing of the patients we serve.” The company currently markets products in several therapeutic areas including anti-infectives, pain, CNS disorders and cardiovascular diseases. Shionogi’s research and development currently targets two therapeutic areas: infectious diseases and diseases with unmet medical needs in pain/CNS, including Alzheimer’s disease, oncology, rare diseases, and sleep apnea. For more information on Shionogi & Co., Ltd., please visit https://www.shionogi.com/global/en. Forward-Looking Statements This announcement contains forward-looking statements. These statements are based on expectations in light of the information currently available, assumptions that are subject to risks and uncertainties which could cause actual results to differ materially from these statements. Risks and uncertainties include general domestic and international economic conditions such as general industry and market conditions, and changes of interest rate and currency exchange rate. These risks and uncertainties particularly apply with respect to product-related forward-looking statements. Product risks and uncertainties include, but are not limited to, completion and discontinuation of clinical trials; obtaining regulatory approvals; claims and concerns about product safety and efficacy; technological advances; adverse outcome of important litigation; domestic and foreign healthcare reforms and changes of laws and regulations. Also for existing products, there are manufacturing and marketing risks, which include, but are not limited to, inability to build production capacity to meet demand, lack of availability of raw materials and entry of competitive products. The company disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. *Literature search conducted in May 2026 1 XOCOVA (ensitrelvir) Prescribing Information. Available from: https://www.shionogi.com/content/dam/shionogi/si/products/pdf/xocova.pdf. Accessed July 6, 2026. 2 Hayden FG, Shinkai M, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. N Engl J Med. 2026;394(19):1905-1915. doi:10.1056/NEJMoa2509306. 3 Centers for Disease Control and Prevention [Internet]. 2026 COVID-19 Summer Outlook. 2026. Available from: https://www.cdc.gov/cfa-qualitative-assessments/php/data-research/2026covid-19outlook.html 4 Kawashima S, Matsui Y, et al. Ensitrelvir is effective against SARS-CoV-2 3CL protease mutants circulating globally. Biochem Biophys Res Commun. 2023;645:132-136. doi:10.1016/j.bbrc.2023.01.040. 5 Kuroda T, Nobori H, et al. Efficacy comparison of 3CL protease inhibitors ensitrelvir and nirmatrelvir against SARS-CoV-2 in vitro and in vivo. J Antimicrob Chemother. 2023;78(4):946-952. doi:10.1093/jac/dkad027. 6 Donnelly M [Internet]. Respiratory risk report: week ending in July 4, 2026. Biobot Analytics; 2026. Available from: https://biobotanalytics.substack.com/p/respiratory-risk-report-663 7 Tanaka M, Ruiz C, et al. SARS-CoV-2 transmission dynamics in households with children, Los Angeles, California. Front Pediatr. 2021;9:752993. doi:10.3389/fped.2021.752993. 8 Centers for Disease Control and Prevention [Internet]. Preliminary estimates of COVID-19 burden for 2024-2025. 2026. Available from: https://www.cdc.gov/covid/php/surveillance/burden-estimates.html 9 Centers for Disease Control and Prevention [Internet]. Long COVID basics. 2026. Available from: https://www.cdc.gov/long-covid/about/index.html. 10 Xie Y, Xu E, et al. Long-term cardiovascular outcomes of COVID-19. Nat Med. 2022;28(3):583-590. doi:10.1038/s41591-022-01689-3. 11 Xie Y, Xu E, et al. Risks of mental health outcomes in people with COVID-19: a cohort study. BMJ. 2022;376:e068993. doi:10.1136/bmj-2021-068993. 12 Srivastava S, Garg I. Post-COVID-19 infection: long-term effects on liver and kidneys. World J Meta-Anal. 2021;9(3):220-233. doi:10.13105/wjma.v9.i3.220. 13 Tenforde MW, Kim SS, et al. Symptom duration and risk factors for delayed return to usual health among outpatients with COVID-19 in a multistate health care systems network— United States, March-June 2020. MMWR Morb Mortal Wkly Rep. 2020;69(30):993-998. doi:10.15585/mmwr.mm6930e1. 14 Graham EL, Clark JR, et al. Persistent neurologic symptoms and cognitive dysfunction in non-hospitalized COVID-19 “long haulers.” Ann Clin Transl Neurol. 2021;8(5):1073-1085. doi:10.1002/acn3.51350. 15 Kwok WC, Chau CH, et al. Outcomes among patients with chronic obstructive pulmonary disease after recovery from COVID-19 infection of different severity. Sci Rep. 2024;14(1):13881. doi:10.1038/s41598-024-64670-9. 16 Conway SE, Healy BC, et al. COVID-19 severity is associated with worsened neurological outcomes in multiple sclerosis and related disorders. Mult Scler Relat Disord. 2022;63:103946. doi:10.1016/j.msard.2022.103946. 17 Chen IW, Chang LC, et al. Association between COVID-19 and the development of chronic kidney disease in patients without initial acute kidney injury. Sci Rep. 2025;15(1):10924. doi:10.1038/s41598-025-96032-4. 18 Sax PE, Draica F, et al. New onset conditions, exacerbations and worsening of underlying conditions following COVID-19 infection [poster presentation]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 2026; Denver, CO, United States. 19 Gravenstein S, Cooke C, et al. Current impact of COVID-19 in long-term care facilities in the United States: a systematic literature review [poster presentation]. Presented at: Conference on Retroviruses and Opportunistic Infections (CROI); 2026; Denver, CO, United States. 20 Hayden FG, Shinkai M, et al. Ensitrelvir for COVID-19 postexposure prophylaxis in household contacts. Supplementary Appendix. N Engl J Med. 2026;394(19). Available from: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2509306/suppl_file/nejmoa2509306_appendix.pdf.

Phase 3Clinical ResultDrug Approval

25 Jun 2026

·ir.nrxpharma.com

NRx Pharmaceuticals Responds to Recent Public Statements Regarding Kadima Dispute

WILMINGTON, Del., June 25, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx” or the “Company”) today issued the following statement in response to recent public claims made by Kadima Neuropsychiatry Institute (“Kadima”). Kadima issued a public statement on June 24, 2026 making a series of unfounded allegations related to the non-acquisition of Kadima by HOPE Therapeutics, Inc., a majority-owned subsidiary of the Company (“HOPE”). As disclosed in recent filings with the Securities and Exchange Commission (the “SEC”), NRx has compelled arbitration with Kadima over Kadima’s failure to meet key closing conditions contemplated in the related transaction documents including, but not necessarily limited to, the delivery of clear title to Kadima’s assets and a material adverse change in the condition of the business. Kadima signed a binding arbitration agreement and entered into active arbitration in which the parties clearly intended to separate from one another. Management believes that specific performance, whereby HOPE would acquire Kadima and retain Dr. Feifel as HOPE’s Chief Medical Innovation Officer, would not be in the best interests of either the patients or shareholders of the Company and HOPE. Moreover, despite Kadima’s allegations, management does not believe that the acquisition or non-acquisition of any individual clinic would be material to HOPE’s overall business model. Rather, the future success of the Company and HOPE depends on its ability to develop new drugs and medical technologies with national and international reach that deliver superior outcomes for patients affected by depression, PTSD and other serious medical conditions in need of care. Subsequent to the commencement of the arbitration by and between the Company and Kadima, the scientific direction of HOPE evolved to align more closely with current thought leaders in support of precise, personalized medicine with a particular emphasis on neuronavigated Transcranial Magnetic Stimulation (TMS) (which is contrary to the approach and technologies supported by Dr. Feifel) used in conjunction with neuroplastic drugs, such as NRX-101. To that end, the Company continues to execute on new initiatives including a partnership with Zeta Surgical, which demonstrated the first fully functional robotic neuronavigated TMS system with submillimeter precision at the recent Clinical Transcranial Magnetic Stimulation Society (CTMSS) meeting and subsequent treatment of the first patients at HOPE locations in Florida, as well as the recently announced FDA clearance of the Investigational New Drug (IND) application for the SPARC-TMS trial combining NRX-101 with robotic neuronavigated TMS to be conducted at civilian and military treatment facilities starting in the fall in support of recently published peer-reviewed studies that suggest the neuroplastic properties of D-cycloserine (the active ingredient in NRX-101) has the potential to significantly augment the effects of TMS. While NRx appreciates Dr. Feifel’s desire to be part of the HOPE network as evidenced by yesterday’s attempt to compel HOPE Therapeutics to incorporate his practice into the HOPE network (i.e., his suit for specific performance), management does not believe that such litigation is likely to be a valid venue. Moreover, the Company does not believe that Dr. Feifel’s professional experience and orientation remain aligned with HOPE’s current scientific direction. We are confident that Dr. Feifel and his counsel will be directed back to arbitration by the San Diego courts and that this matter will be resolved equitably in a manner that is non-material to NRx and its shareholders. We wish Dr. Feifel the best of success in his future endeavors. About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. (www.nrxpharma.com), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of suicidal ideation in depression, including bipolar depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. About HOPE Therapeutics HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals (Nasdaq: NRXP), is a provider of advanced psychiatric and neurological care, specializing in evidence-based treatments for major depressive disorder, anxiety, and other complex neurological conditions. Operating out of state-of-the-art clinics, HOPE Therapeutics focuses on improving patient outcomes through the application of modern medical technologies and clinical practices. For more information, please visit www.hopetherapeutics.com. Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “look forward,” and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. For further information: Brian Korb Managing Partner, astr partners (917) 653-5122 brian.korb@astrpartners.com

Fast TrackBreakthrough Therapy

25 Jun 2026

·www.biospace.com

NRx Pharmaceuticals (Nasdaq: NRXP) Subsidiary HOPE Therapeutics Treats First Patients Using Zeta Surgical’s FDA-Cleared Zeta TMS Navigation System

First Zeta-navigated TMS treatments have begun at HOPE Therapeutics clinics in West Palm Beach and Sarasota, Florida, marking the transition from research deployment to active patient care AI-powered, sub-millimetric image guidance is now being applied in HOPE's outpatient TMS workflows for patients with Major Depressive Disorder and other CNS conditions Milestone advances HOPE's interventional psychiatry platform and aligns with NRx's planned trial of NRX-101 in combination with robotic-enabled TMS in civilian and military treatment facilities (the SPARC-TMS trial). WILMINGTON, Del., June 25, 2026 (GLOBE NEWSWIRE) -- NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) ("NRx Pharmaceuticals", "NRx" or the "Company"), a clinical-stage biopharmaceutical company, today announced that its subsidiary, HOPE Therapeutics, Inc. ("HOPE"), has treated its first patients using Zeta Surgical's FDA-cleared Zeta TMS Navigation System. HOPE has installed Zeta TMS Navigation Systems at its clinics in West Palm Beach and Sarasota, Florida, with Zeta-navigated patient treatments now underway at both locations. The first treatments mark HOPE's transition from system deployment to active patient care, bringing AI-powered, sub-millimetric image guidance into routine outpatient TMS workflows for patients with Major Depressive Disorder and other neurological conditions. The Zeta TMS Navigation System uses proprietary RealTrack™ technology to provide real-time, markerless image guidance for TMS procedures, applying artificial intelligence and computer vision to register a patient's MRI or CT imaging to their facial anatomy in under two minutes and to continuously track the position of the TMS coil relative to the planned brain target with sub-millimetric accuracy. "Treating our first patients with the Zeta TMS Navigation System moves the integrated treatment model we are building at HOPE from concept to clinical reality," said Jonathan Javitt, MD, MPH, Chairman and CEO of NRx Pharmaceuticals and HOPE Therapeutics. "Bringing neurosurgical-grade targeting precision into the outpatient setting is exactly the kind of capability that distinguishes the HOPE network, and it directly supports our planned trial of NRX-101 in combination with robotic-enabled TMS in patients with depression and suicidality. Our goal has always been to deliver measurable remission to patients who have run out of options, and precision-guided TMS is a meaningful step toward that goal." TMS is a non-invasive therapy used primarily for treatment-resistant depression, which affects approximately one-third of patients with major depressive disorder. It is also used in other neuropsychiatric conditions, including obsessive-compulsive disorder and other disorders involving brain circuit dysfunction. Because TMS is intended to modulate specific brain regions and neural circuits, accurate and repeatable targeting of patient-specific treatment sites is an important component of treatment delivery, which is the gap the Zeta system is designed to address. The deployment complements HOPE's broader interventional psychiatry platform, which includes ketamine and Spravato® delivery, TMS, Hyperbaric Oxygen Therapy, and other neuroplastic therapies offered across the HOPE network of clinics. It also aligns with NRx's previously announced clinical trial program of NRX-101 (oral D-cycloserine/lurasidone) in combination with robotic-enabled TMS for patients with depression and suicidality, which is planned to be conducted across a leading US academic teaching hospital, three HOPE Therapeutics clinics, and two military treatment facilities. About NRx Pharmaceuticals, Inc. NRx Pharmaceuticals, Inc. ( ), is a clinical-stage biopharmaceutical company developing therapeutics based on its NMDA platform for the treatment of central nervous system disorders, specifically suicidal depression, chronic pain, and PTSD. The Company is developing NRX-100 (preservative-free intravenous ketamine) and NRX-101, (oral D-cycloserine/lurasidone). NRX-100 has been awarded Fast Track Designation for the treatment of Suicidal ideation in Depression, including Bipolar Depression. NRX-101 has been awarded Breakthrough Therapy Designation for the treatment of suicidal bipolar depression. NRx has filed an Abbreviated New Drug Application (ANDA), and initiated a New Drug Application filing for NRX-100 with an application for the Commissioner’s National Priority Voucher Program for the treatment of suicidal ideation in patients with depression, including bipolar depression. About HOPE Therapeutics HOPE Therapeutics, a subsidiary of NRx Pharmaceuticals (Nasdaq: NRXP), is a provider of advanced psychiatric and neurological care, specializing in evidence-based treatments for major depressive disorder, anxiety, and other complex neurological conditions. Operating out of state-of-the-art clinics, HOPE Therapeutics focuses on improving patient outcomes through the application of modern medical technologies and clinical practices. For more information, please visit . About ZETA SURGICAL ZETA SURGICAL is redefining the standard of care for image-guided surgery and targeted neuro-therapeutics. Its navigation and robotics platform applies advanced artificial intelligence and computer vision to enable high-accuracy image guidance across virtually any point of care in minutes, unlocking less invasive and more precise targeted therapies. The Zeta Navigation System and Zeta TMS Navigation System are cleared by the FDA and commercially available in the United States. For more information, please visit . Media Contact -- media@zetasurgical.com Notice Regarding Forward-Looking Statements The information contained herein includes forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "plan," "believe," "intend," "look forward," and other similar expressions among others. These statements relate to future events or to the Company's future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause the Company's actual results to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. The Company has reported regulatory milestones as they have been achieved but has not predicted the outcome of any future regulatory determination. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects the Company's current views with respect to future events and is subject to these and other risks, including uncertainties and assumptions relating to the Company's operations, results of operations, growth strategy, and, among other things, liquidity. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's most recent Annual Report on Form 10-K and other filings with the Securities and Exchange Commission. Investors and security holders are urged to read these documents free of charge on the SEC's website at . Except as may be required by applicable law, the Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, whether as a result of new information, future events or otherwise. For further information: Brian Korb Managing Partner, astr partners (917) 653-5122 brian.korb@astrpartners.com

Fast TrackClinical StudyBreakthrough Therapy

100 Deals associated with Lurasidone Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D04820	Lurasidone Hydrochloride	N05AE05	DB08815

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Depressive Disorder, Major	South Korea	Bukwang Pharmaceutical Co., Ltd.	23 Nov 2023
Bipolar Disorder	Japan	Sumitomo Pharma Co., Ltd.	25 Mar 2020
Bipolar I disorder	United States	Sumitomo Pharma America, Inc.	27 Jan 2017
Schizophrenia	United States	Sumitomo Pharma America, Inc.	28 Oct 2010

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Bipolar and Related Disorders	Phase 3	China	Marubeni Pharmaceuticals (Suzhou) Co., Ltd.	30 Jan 2022
Autistic Disorder	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Aug 2013
Irritable Mood	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Aug 2013
Recurrent major depressive disorder with atypical features	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Sep 2011
Recurrent major depressive disorder with atypical features	Phase 3	Russia	Sumitomo Pharma America, Inc.	01 Sep 2011
Recurrent major depressive disorder with atypical features	Phase 3	Serbia	Sumitomo Pharma America, Inc.	01 Sep 2011
Recurrent major depressive disorder with atypical features	Phase 3	Ukraine	Sumitomo Pharma America, Inc.	01 Sep 2011
Recurrent major depressive disorder with atypical features	Phase 3	United Kingdom	Sumitomo Pharma America, Inc.	01 Sep 2011
Chronic schizophrenia	Phase 3	United States	Sumitomo Pharma America, Inc.	01 Dec 2008
Chronic schizophrenia	Phase 3	Colombia	Sumitomo Pharma America, Inc.	01 Dec 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01569659 (HDL, CTgov)	Phase 4	Schizophrenia, Treatment-Resistant	101	Lurasidone (Standard Dose of Lurasidone)	sutnywwpki(gceiqwyzex) = rhlwbdrizy pnthpalqbn (jmoytaibnu, 3.3) View more	-	28 Feb 2025
NCT01569659 (HDL, CTgov)	Phase 4	Schizophrenia, Treatment-Resistant	101	Lurasidone (High Dose of Lurasidone)	sutnywwpki(gceiqwyzex) = nmejmiqgzr pnthpalqbn (jmoytaibnu, 4.3) View more	-	28 Feb 2025
NCT06527885 (Pubmed \| Ann Gen Psychiatry)	Not Applicable	Schizophrenia	-	Lurasidone	gwabadaiwo(pitvinhczp) = reaching a mean change from baseline of 9.8 at the end of the study wdufegipsb (pyozykrzjj ) View more	Positive	05 Nov 2024
NCT01986101 (Pubmed)	Not Applicable	Bipolar Disorder	-	Lurasidone	phnilbagmk(qyapcavnbw) = qdvjcealhf btqxetbfqv (hpnccnnvmb ) View more	-	12 Jan 2023
EUCTR2016-000060-42-SK \| EUCTR2016-000060-42-PL (Pubmed) Manual	Phase 3	Schizophrenia	289	Lurasidone Hydrochloride (80 mg/day)	bmqrqzqjws(nyszurhedg) = tklcvfwqzh gknmpbfdfa (lhvlsxpqom ) View more	Positive	09 Nov 2022
	Phase 3	Schizophrenia	289	Lurasidone Hydrochloride (40 mg/day)	bmqrqzqjws(nyszurhedg) = kqeinazaki gknmpbfdfa (lhvlsxpqom ) View more	Positive	09 Nov 2022
NCT01914393 (Pubmed \| J Child Adolesc Psychopharmacol) Manual	Phase 3	Depressive Disorder	306	Lurasidone	snhnsgjtte(mkfvznbzmv) = qyuhautjil falebmyfoi (ohgiwahlxw ) View more	Positive	01 Sep 2021
NCT01986114 (Pubmed \| Int J Bipolar Disord) Manual	Phase 3	Bipolar I disorder	-	lurasidone	zsgmcipcmf(hkvkjgmqea) = akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%) qivydvrspm (rvmwjxgvso ) View more	Positive	02 Aug 2021
NCT02199743 (CTgov)	Phase 4	Schizoaffective disorder \| Schizophrenia	35	Perphenazine+Lurasidone+Haloperidol	yywtfnhekg(mjxjfpouur) = novopcyipy cudftzueqa (rhnzbxvlqk, 0.741430931) View more	-	01 Mar 2021
NCT00641745 (Pubmed \| BMC Psychiatry)	Phase 3	Schizoaffective disorder \| Schizophrenia	223	Continuing Lurasidone	bkocagdikp(zbsjpocdkl) = vgumxxuxie ephdopskbw (exdhedvwyv ) View more	-	01 Dec 2020
NCT00641745 (Pubmed \| BMC Psychiatry)	Phase 3	Schizoaffective disorder \| Schizophrenia	223	Switching from Risperidone to Lurasidone	tmhzqkvspd(thvfuupyjh) = rkfgiakdqc zvansbxxat (jxomadwdgl ) View more	-	01 Dec 2020
NCT00641745 (Pubmed \| Neurol Ther)	Phase 3	Schizophrenia	629	Lurasidone	cyewjborrz(qzhcgfvgzr) = kyopwfdxdt ucbqwxeovs (ylgjecevkw )	-	24 Oct 2020
NCT00641745 (Pubmed \| Neurol Ther)	Phase 3	Schizophrenia	629	Risperidone	cyewjborrz(qzhcgfvgzr) = nfidqjybmb ucbqwxeovs (ylgjecevkw )	-	24 Oct 2020
NCT03902613 (CTgov)	Phase 4	Bipolar Disorder \| Bipolar II disorder \| Bipolar I disorder	1	Lurasidone	kgaqsfynar(tksblgdwep) = bdahztatjx gejgsemqqv (ynlapuxgqk, tusopbbxpq - odhgvztmtd) View more	-	06 Oct 2020

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