A Phase 1, Two-part, Open-label, Drug-drug Interaction Study to Assess the Effect of Phenytoin and Itraconazole on the Pharmacokinetics of Pelabresib in Healthy Participants

The purpose of this study is to assess the effect of multiple doses of phenytoin, a strong cytochrome P450 (CYP)3A4 inducer, and itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetic (PK) profile of DAK539 (hereafter referred to as pelabresib) after a single dose in healthy participants. In addition, the safety and tolerability of a single dose of pelabresib with and without the co-administration of itraconazole or phenytoin will be evaluated.

Start Date02 Sep 2026

Sponsor / Collaborator

Novartis Pharmaceuticals

NCT07590102

/ RecruitingPhase 1

An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants

This study is being done to understand how the body processes the study drug (BGB-58067) when it is taken together with other medicines.
BGB-58067 is mainly broken down in the body by a liver enzyme called CYP3A. Some medicines can affect how this enzyme works. For example, certain medicines can increase the production of the enzyme (called inducers), while others can block or inhibit its activity (called inhibitors). This may change how much of the study drug is present in the bloodstream.
In this study, we will give BGB-58067 together with two commonly used medicines:
* Part A: Phenytoin (inducer), which can increase the production of the enzyme, and
* Part B: Itraconazole (inhibitor), which can inhibit the activity of the enzyme.

Start Date04 Jun 2026

Sponsor / Collaborator

BeOne Medicines Ltd.

NCT07590375

/ Not yet recruitingPhase 2/3IIT

Topical Phenytoin for Management of Gingival Recession: a Randomized Placebo-controlled Trial

Gingival recession (GR) is a term that describes the displacement of the gingival margin apical to the cemento-enamel junction (CEJ) of a tooth. The gold standard of GR treatment is surgical coverage through coronally advanced flap with subepithelial connective tissue graft (CAF+SCTG) (3). But, the need for a non-invasive technique for managing GR has not been frequently addressed.
Phenytoin (PHT), used as an anti-seizure medication, has an established side effect of causing drug-influenced gingival enlargement. Its stimulatory effects on soft tissue metabolism suggested PHT to be tested topically for its effectiveness in wound healing. However, none of the previous studies that investigated topical phenytoin has assessed gingival recession; except for a case series.

Start Date01 Jun 2026

Sponsor / Collaborator

Cairo University

100 Clinical Results associated with Phenytoin

100 Translational Medicine associated with Phenytoin

100 Patents (Medical) associated with Phenytoin

17,060

Literatures (Medical) associated with Phenytoin

01 Dec 2026·Biomaterials advances

Assembly mechanism-instructed precision nanocarriers: Esox lucius apoferritin for hydrophilic or hydrophobic drug loading and smart release

Article

Author: Yan, Wenbo ; Ren, Fazheng ; Guo, Xin ; Zhang, Hao ; Shang, Jiaoqian ; Hu, Ling ; Deng, Xiaorong ; Yan, Yanxai ; Zhang, Jian ; Sun, Fengxia ; Li, Jie ; Wei, Yabo

Ferritin (Fn) nanocages offer significant potential as drug delivery vehicles due to their biocompatibility, well-defined structure, and inherent targeting capabilities. In this study, we isolated Fn from the liver of Esox lucius and prepared its apo-form (apo-Fn) to engineer its reversible disassembly/reassembly for drug encapsulation. We demonstrated that apo-Fn undergoes controlled disassembly under mild acidic conditions (pH 2.0-4.0) or 4 M urea, and efficiently reassembles upon neutralization or urea removal. Thermal treatment below 55 °C also facilitated reversible structural transitions. Based on these properties, three loading strategies were developed. The temperature-gradient method was optimal for hydrophilic drugs (doxorubicin and phenytoin), while the urea-gradient method achieved 42.18% encapsulation for hydrophobic paclitaxel. The resulting formulations showed uniform size, colloidal stability, and minimal leakage at pH 7.4, but exhibited rapid release at acidic pH 5.0. Furthermore, apo-Fn showed high biocompatibility (> 90% cell viability) and exerted intrinsic anti-inflammatory effects by modulating macrophage polarization. This study highlights piscine apo-Fn as a promising platform for targeted drug delivery.

01 Nov 2026·EPILEPSY & BEHAVIOR

Time over drug in pediatric status epilepticus: A prospective observational study

Article

Author: Aly Hussein, Rasha Hussein ; Bakry, Nehad Ahmed ; Ageeb, Olivia Elia ; El-Rashidy, Omnia Fathy ; Halim, Michael Nabil ; Osama Shatta, Mennatallah

BACKGROUND:

Convulsive status epilepticus (CSE) is a time-sensitive neurological emergency in which delayed treatment may contribute to pharmacoresistance and poor outcomes. Evidence comparing third-line antiseizure medications in children remains limited. Objective To compare intravenous lacosamide and phenytoin in pediatric refractory CSE and to determine whether treatment timing predicts seizure cessation. Methods This prospective observational cohort study included 100 children aged 1 month-16 years with refractory CSE treated with intravenous lacosamide (n = 46) or phenytoin (n = 54) after failure of benzodiazepines and levetiracetam. The primary objective was to evaluate the effect of treatment delay on seizure cessation. Secondary outcomes included treatment response, electroencephalographic findings, cardiac safety, and predictors of treatment failure. Results Seizure cessation was achieved in 56% of patients and did not differ significantly between lacosamide and phenytoin (60.9% vs. 51.9%, p = 0.365). Treatment delay was the strongest independent predictor of failure; each additional hour from seizure onset to treatment initiation increased the odds of failure by 11% (adjusted OR 1.11, 95% CI 1.03-1.19; p = 0.005). Greater baseline antiseizure medication burden was also independently associated with treatment failure (adjusted OR 2.10, 95% CI 1.05-4.17; p = 0.035). Persistent epileptiform activity on 24-hour EEG was significantly associated with poor outcome (p < 0.001). Both medications were well tolerated. Conclusions Lacosamide and phenytoin demonstrated comparable efficacy and safety. Treatment timing, rather than drug selection, was the principal determinant of seizure cessation, emphasizing the importance of rapid escalation of therapy in pediatric refractory CSE.

01 Nov 2026·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Cryo-emulsion gel patches as versatile platform for dual drug delivery to wounds

Article

Author: Abdel-Mottaleb, M M A ; Wiedemann, Y ; Lunter, D J

Cryo-emulsion gels (C-EGs) represent a promising drug delivery approach that combines the possibility to deliver both, hydrophilic and lipophilic drugs, with the mechanical stability of hydrogel matrices for dermal application. In this study, poly(vinyl alcohol) (PVA) was used as a multifunctional polymer acting as both a polymeric emulsifier and as a gelling agent for cryogelation to minimize formulation complexity. Medium-chain triglycerides, castor oil, and rapeseed oil were identified as suitable candidates for the dispersed phase of the emulsions. The influence of oil type and oil content on the rheological and mechanical properties of the patches was investigated, allowing the definition of a maximum oil content of 30%. Within this range, C-EGs with consistent droplet distribution were obtained. The two-phase structure enabled dual drug loading using hydrophilic N-acetylcysteine and lipophilic phenytoin, which complement each other in wound healing. The system showed controlled drug release over 48 h with release rates depending on the physicochemical properties of the drugs and their location within the patch. Ex vivo penetration studies on intact and wounded skin revealed different penetration profiles according to the drug and skin condition. Cytocompatibility studies demonstrated excellent tolerability of the PVA-based vehicle. Drug incorporation resulted in a synergistic effect between the C-EGs and the drugs, increasing cell viability up to 178%. Peel adhesion testing revealed very low adhesion of the C-EG patches on both bloody and dry wound surfaces. Overall, PVA-based C-EGs provide a stable and cytocompatible platform for incorporating emulsions into cryogel patches, representing an attractive strategy for advanced wound care applications.

159

News (Medical) associated with Phenytoin

24 Sep 2026

·www.biospace.com

Synexis, LLC and Patterson Veterinary Collaborate to offer DHP(R) Technology to Animal Health Professionals Nationwide

Collaboration Advances Access to Continuous Pathogen Control as Part of Modern Veterinary Biosecurity OVERLAND PARK, KS / ACCESS Newswire / September 24, 2026 / Synexis ® , LLC, the leader in touchless, continuous pathogen control technology, today announced a strategic collaboration with Patterson Veterinary to expand access to Synexis DHP ® technology for veterinary and animal health professionals nationwide. This collaboration reflects a growing industry focus on preparedness and the need for more continuous approaches to pathogen management in indoor animal care settings. Emerging research continues to highlight the limitations of traditional cleaning protocols in managing ongoing pathogen exposure between sanitation events, particularly in high-traffic, continuously occupied indoor environments such as veterinary practices, shelters, equine facilities, and specialty care centers. Together, Synexis and Patterson Veterinary are helping animal health professionals implement a more proactive and operationally sustainable approach to biosecurity. Through Patterson Veterinary's national reach, practices can more easily adopt Synexis DHP® technology as an added layer of indoor pathogen control that works continuously in the background to help reduce airborne and surface-level microbes in occupied spaces. "As expectations around indoor environmental preparedness continue to evolve, veterinary professionals are recognizing that pathogen exposure doesn't stop between cleaning events," said Dennis Doyle, CEO of Synexis. "Research is increasingly reinforcing the importance of more continuous approaches to pathogen management, particularly in dynamic indoor spaces where patients, staff, airflow, and surface interaction are constantly changing. Our collaboration with Patterson Veterinary helps make that next generation of preparedness more accessible to animal health facilities across the country." Founded in 1877, Patterson Veterinary is one of the nation's leading providers of veterinary products, technologies, and practice management solutions. Through its extensive distribution infrastructure, technical expertise, and longstanding customer relationships, Patterson Veterinary supports practices across companion animal, equine, production animal, and specialty care environments with solutions designed to strengthen both clinical and operational performance. "At Patterson Veterinary, we are constantly evaluating technologies that help our customers navigate the evolving demands of modern veterinary medicine," said Jon Butz, Director of Equipment and Technical Service. "Synexis has helped pioneer a science-based, continuous approach to indoor environmental pathogen control that complements existing sanitation protocols while helping veterinary organizations strengthen preparedness and operational confidence." Synexis DHP ® technology - touchless, continuous pathogen control, works 24/7/365 to reduce airborne and surface-level pathogens such as viruses, bacteria, fungi, and volatile organic compounds (VOCs). Supported by a growing body of laboratory and field research, Synexis technology has demonstrated effectiveness in real-world environments across healthcare, food production, animal health, and commercial settings. Synexis technology is designed for safe use in occupied spaces and operates continuously without disrupting daily operations. As veterinary and animal care facilities continue to prioritize preparedness, environmental consistency, and operational resilience, this collaboration provides access to a more advanced, research-driven approach to environmental pathogen control and one that works alongside existing protocols to help address risk proactively and continuously. Synexis devices are now available through Patterson Veterinary, enabling animal health professionals nationwide to strengthen biosecurity strategies through continuous environmental pathogen control technology. ### About Synexis Since 2008, Synexis has been an industry leader delivering continuous pathogen control technology that is intentionally designed for occupied environments. Synexis makes customer environments healthier and safer with DHP® patented technology - a continuous, proactive method for reducing surface-level and airborne pathogens. Synexis patented devices have undergone rigorous testing by Underwriters Laboratories (UL) and are certified to meet UL2998 for zero ozone emissions and can run 24/7 within occupied spaces. Synexis systems are regulated by the US Environmental Protection Agency and state governments. Synexis devices are produced in EPA-registered facilities and packaged and labeled in accordance with EPA regulations, appearing at 40 CFR 152.500. Peer-reviewed research and other resources can be found on About Patterson Companies Inc. Patterson Companies Inc. connects dental and animal health customers in North America and the U.K. to the latest products, technologies, services and innovative business solutions that enable operational and professional success. Our comprehensive portfolio, distribution network and supply chain is equaled only by our dedicated, knowledgeable people who deliver unrivalled expertise and unmatched customer service and support. Learn more: Synexis Media Contacts: Victoria Smith Vice President of Global Marketing vsmith@synexis.com John Minnec john@johnnie-london.com 312-543-4957 SOURCE: Synexis View the original press release on ACCESS Newswire

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

26 Jun 2026

·www.biospace.com

Enanta Pharmaceuticals’ Partner AbbVie Receives European Commission Approval of MAVIRET® (Glecaprevir/Pibrentasvir) for People with Acute Hepatitis C Virus

MAVIRET® (Glecaprevir/Pibrentasvir) is the Only Treatment Approved in the European Union for Both Acute and Chronic Hepatitis C Virus (HCV) Infection Approval Allows Providers to Treat HCV Patients Immediately at Time of Diagnosis; Early Diagnosis and Treatment Help Reduce Transmission, Long-Term Liver-Related Complications, and Support HCV Elimination Efforts Glecaprevir, One of the Two Direct-Acting Antivirals in MAVIRET ® , was Discovered by Enanta and Developed and Commercialized by AbbVie WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc . (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced that the European Commission has approved MAVIRET ® (glecaprevir/pibrentasvir), an oral pangenotypic direct-acting antiviral (DAA) therapy, for the treatment of acute HCV infection without cirrhosis or with compensated cirrhosis in adults and children aged 3 years and older. MAVIRET is now the only treatment approved in the European Union (EU) for both acute and chronic HCV infection. “The European Commission’s approval of MAVIRET for acute HCV infection is a meaningful step for the more than 12 million individuals in Europe living with HCV, by enabling earlier treatment and supporting timely intervention at a stage when the disease may be asymptomatic and can go undetected,” said Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. “Given acute HCV is typically diagnosed incidentally, starting treatment before a patient has advanced to chronic HCV can be difficult. Today’s approval supports public health efforts by accelerating treatment, reducing transmission and addressing unmet need. We take pride in the role our discovery of glecaprevir has played in bringing forward a therapy that continues to benefit HCV patients worldwide. We are pleased that AbbVie continues to collaborate with global regulatory authorities to support access to MAVIRET for people who have acute HCV infection.” The EU approval for acute HCV infection was supported by data from the Phase 3, multicenter, single-arm prospective study evaluating the safety and efficacy of MAVIRET eight-week treatment in patients with acute HCV infection. 1 The study results showed MAVIRET to be a highly efficacious treatment for people with acute HCV. 1 The majority of the adverse events reported were mild or moderate in severity. 1 The most common adverse events were fatigue, diarrhea, headache, and asthenia. 1 HCV is a highly infectious, blood-borne disease that affects the liver and if left untreated can lead to serious complications, including liver cirrhosis and cancer. 2 Acute HCV infection is frequently asymptomatic and many people remain unaware of the infection until it has progressed to a later stage. 2 Clinical guidelines support treating nearly all individuals with acute or chronic HCV. 3 Globally, hepatitis C imposes a substantial health and economic burden 4 , underscoring the importance of early diagnosis and timely access to treatment. About the Phase 3 M20-350 Study 1 The multicenter, single-arm prospective Phase 3 M20-350 clinical trial was designed to evaluate the safety and efficacy of MAVIRET (glecaprevir/pibrentasvir) eight-week treatment in adults and adolescent participants aged 12 years and older with acute HCV infection. The study enrolled 286 treatment-naïve adult patients with acute HCV infection across 70 locations globally. Patients received oral tablets of MAVIRET once daily for eight weeks and were followed for 12 weeks after the end of treatment. The primary endpoint was the percentage of patients with sustained virological response 12 weeks post-treatment (SVR 12 ) in the intent-to-treat population (ITT). The study met its primary endpoint, with 96.2% of patients in the ITT population achieving SVR 12 (p<0.0001). The key secondary endpoint was also met with 100% of patients in the modified ITT-Virologic Failure population achieving SVR 12 (p<0.0001). The overall safety pro in the M20-350 study was similar to that observed in patients with chronic HCV infection. No serious adverse reactions or adverse reactions leading to treatment discontinuation were observed among patients with acute HCV infection. The most commonly reported adverse reactions were fatigue (3%), asthenia (2%), headache (2%), and diarrhea (2%). No on-treatment virologic failures or post-treatment relapses were observed, and post-treatment reinfection occurred in 0.7% of patients. More information on the study can be found at (NCT04903626). About MAVIRET ® (glecaprevir/pibrentasvir) MAVIRET ® (glecaprevir/pibrentasvir) is an oral, pangenotypic, once-daily, ribavirin-free direct-acting antiviral treatment for chronic hepatitis C virus (HCV) infection. MAVIRET combines glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, and is administered once daily with food. In the European Union, MAVIRET is approved for the treatment of chronic HCV infection in adults and children aged 3 years and older. In adults and adolescents aged 12 years and older, or children weighing at least 45 kg, the recommended dose is three 100 mg/40 mg tablets once daily with food. In children aged 3 years to less than 12 years and weighing 12 kg to less than 45 kg, MAVIRET is available as coated granules in sachets, with dosing based on body weight. MAVIRET is approved for use in patients with chronic HCV infection with compensated liver disease, including those with compensated cirrhosis, and in patients with severe renal impairment, including those on dialysis, according to the approved EU label. Important EU Safety Information: CONTRAINDICATIONS: MAVIRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C). Concomitant use with atazanavir-containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John’s wort [Hypericum perforatum], phenobarbital, phenytoin, and primidone). SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Hepatitis B virus reactivation Cases of hepatitis B virus (HBV) reactivation, some of them fatal, have been reported during or after treatment with direct-acting antiviral agents. HBV screening should be performed in all patients before initiation of treatment. HBV/HCV co-infected patients are at risk of HBV reactivation, and should, therefore, be monitored and managed according to current clinical guidelines. Hepatic impairment MAVIRET is not recommended in patients with moderate hepatic impairment (Child-Pugh B). Patients who failed a prior regimen containing an NS5A and/or an NS3/4A inhibitor MAVIRET is not recommended for the re-treatment of patients with prior exposure to NS3/4A and/or NS5A inhibitors. Use in diabetic patients Diabetics may experience improved glucose control and potential symptomatic hypoglycaemia after initiating HCV direct acting antiviral treatment. Glucose levels should be closely monitored, particularly within the first 3 months of treatment. ADVERSE REACTIONS Most common (≥10%) adverse reactions for MAVIRET were headache and fatigue. This is not a complete summary of all safety information. See MAVIRET full summary of product characteristics (SmPC) at . Globally, prescribing information varies; refer to the individual country product label for complete information. About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for viral infections and immunological diseases. In virology, Enanta’s clinical programs are focused on the development of first-in-disease and best-in-disease treatments for respiratory syncytial virus (RSV). The Company’s immunology pipeline aims to develop treatments for inflammatory diseases by targeting key drivers of the type 2 immune response, with KIT, STAT6 and MRGPRX2 inhibition. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing hepatitis C virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET ® (U.S.) and MAVIRET ® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit for more information. Forward Looking Statements Disclaimer This press release contains forward-looking statements, including statements with respect to the prospects for AbbVie sales of Enanta’s licensed products. Statements that are not historical facts are based on management’s current expectations, estimates, forecasts and projections about Enanta’s business and the industry in which it operates and management’s beliefs and assumptions. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors and risks that may affect actual results include: Enanta’s royalty revenues are dependent upon the continued success of AbbVie’s commercialization of its MAVYRET/MAVIRET regimen; the impact of development, regulatory and marketing efforts of others with respect to competitive treatments for HCV; reimbursement and pricing actions affecting MAVYRET/MAVIRET or any competitive treatment for HCV; Enanta’s need to obtain and maintain patent protection for its product candidates and avoid potential infringement of the intellectual property rights of others; and other risk factors described or referred to in “Risk Factors” in Enanta’s Form 10-K for the fiscal year ended September 30, 2025, and any other periodic reports filed more recently with the Securities and Exchange Commission. Enanta cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Enanta undertakes no obligation to update or revise these statements, except as may be required by law. References 1 MAVIRET ® Summary of Product Characteristics. AbbVie; 2026. 2 Hepatitis C. World Health Organization. Available at: . Last accessed: June 2026. 3 European Association for the Study of the Liver, et al. EASL recommendations on treatment of hepatitis C: Final update of the series. J Hepatol. 2020 Nov;73(5):1170-1218. 4 Cacoub P. Comment on Nuño Solinís R, et al. “Value of Treating All Stages of Chronic Hepatitis C: A Comprehensive Review of Clinical and Economic Evidence". Infect Dis Ther . 2017 Jun;6(2):297-301. Contacts Media and Investor Contact Jennifer Viera 617-744-3848 jviera@enanta.com

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Phenytoin

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KEGG	Wiki	ATC	Drug Bank
D00512	Phenytoin	N03AB02	DB00252

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Indication	Country/Location	Organization	Date
Epilepsy	Japan	Fujinaga Pharm Co. Ltd.	05 Dec 1996
Seizures	Japan	Sumitomo Pharma Co., Ltd.	18 May 1978
Epilepsy, Temporal Lobe	United States	Viatris Specialty LLC	06 Jan 1953
Epilepsy, Tonic-Clonic	United States	Viatris Specialty LLC	06 Jan 1953

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01451593 (Pubmed \| Neurology)	Phase 2	Optic Neuritis	80	Phenytoin	puysuucdyc(xnwytiyual) = bryblbspus zfwnwtwsps (fznrtzkide )	Positive	21 Oct 2025
				Placebo	puysuucdyc(xnwytiyual) = lpiiaipptp zfwnwtwsps (fznrtzkide )
CRD42022363844 (AAN2024)	Not Applicable	Seizures	18,676	Phenytoin	wimosvfnqc(idluuazgwb) = rdtwbglzzp yszvngjvei (jayfpsrzyv, 23.2–52.8)	Positive	09 Apr 2024
				Carbamazepine	wimosvfnqc(idluuazgwb) = ppaerlgujq yszvngjvei (jayfpsrzyv, 1.7–5.3)
phenytoin trial (ECTRIMS2023)	Phase 2	GCIPL thickness	-	Phenytoin	sosnlamxdf(uksnqdblau) = oxohxwzoib jjatarhsmt (suyqhjokcf )	Positive	30 Sep 2023
				Placebo	sosnlamxdf(uksnqdblau) = updpvbrulz jjatarhsmt (suyqhjokcf )
NCT00581893 (CTgov)	Phase 4	Cognition	20	Phenytoin (Phenytoin)	zfkjowcpja = guzchoxnfl goxhmekumr (yalztbnwzk, kvrauistcn - pgcgwycrzm) View more	-	01 Jul 2021
				Placebo (Placebo)	zfkjowcpja = wgtetxqtvn goxhmekumr (yalztbnwzk, lkyaxfpset - comadvfway) View more
NCMP-08 (SNO2020)	Not Applicable	Epilepsy \| Glioma	64	Phenytoin	yiflrrzhzt(yceuydxoqe) = icbcljmzng hdgdikntke (fyotisqbsn )	Positive	09 Nov 2020
				Pregabalin	yiflrrzhzt(yceuydxoqe) = exdbkvdofh hdgdikntke (fyotisqbsn )
NCT02595723 (CTgov)	Phase 4	Cognitive Dysfunction	21	Megestrol 800 mg liquid+Phenytoin 200 mg capsule (Phenytoin, Then Megestrol)	xiphabeiuy(avhblouljj) = syygemaoey btcbhheecv (xwkvliqphx, 8.08) View more	-	09 Sep 2019
				Phenytoin-matched Placebo capsule+Megestrol 800 mg liquid (Placebo, Then Megestrol)	xiphabeiuy(avhblouljj) = yhopzcdryu btcbhheecv (xwkvliqphx, 10.40) View more
NCT02939937 (CTgov)	Phase 2	Optic Neuritis	71	Phenytoin (Phenytoin)	qgdnywqfao(kphssrkkxr) = hfiokxjxra ioogozgrwt (pnpfdcjkjm, 6.61) View more	-	12 Aug 2019
				placebo (Placebo)	qgdnywqfao(kphssrkkxr) = wdogpvmipc ioogozgrwt (pnpfdcjkjm, 8.49) View more
NCT00801931 (CTgov)	Phase 1/2	Anemia \| Leukemia \| Immunologic Deficiency Syndromes ... View more	1	busulfan+fludarabine+tacrolimus+MMF+alemtuzumab	asrrxjhske(nslzteticm) = kzorceofwm vrnzzofwtk (kceniwoznh, fpmwdrurjz - lfxmatimbg) View more	-	27 Mar 2019
NCT01451593 (Pubmed \| Lancet Neurol) Manual	Phase 2	Optic Neuritis	86	Phenytoin	mvgdswtatq(mvtnsdtoms) = bsrrgbhpsh crhhjybnws (onqowemwws, -16.69) View more	Positive	01 Mar 2016
				Placebo	mvgdswtatq(mvtnsdtoms) = bmpxbyivyb crhhjybnws (onqowemwws, -23.79) View more
EAN2015	Phase 2	-	86	Phenytoin	ztkzishtco(ybepafyvqm) = gpbiqxaiuu sfddcfjgtv (ygregjwxip ) View more	Positive	29 Jun 2015

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