Comparative Evaluation of Phenytoin, Metformin and Mineral Trioxide Aggregate as a Direct Pulp Capping Agents Using Cone Beam Computed Tomography - A Randomised Controlled Clinical Trial - NIL

Start Date23 Feb 2026

Sponsor / Collaborator-

NCT07066722

/ CompletedPhase 1

A Phase 1, Open-Label Study to Evaluate the Relative Bioavailability and the Effect of Food on VH4524184 Tablet Formulations, and to Evaluate the Potential for VH4524184 Drug-Drug-Interactions in Healthy Adult Participants

The aim of the study is to gather information on how the drug behaves in healthy adults, how it is absorbed, and how it interacts when taken with other medicines.

Start Date07 Jul 2025

Sponsor / Collaborator

ViiV Healthcare Ltd.

NCT06942468

/ Not yet recruitingPhase 4IIT

Efficacy and Safety of Topical Nano Preparation of Phenytoin Plus Fractional CO2 Laser Versus Fractional CO2 Laser Alone for Treatment of Atrophic Post Acne Scars: A Randomized Split Face Study.

To evaluate the efficacy and safety of topical phenytoin spanlastics as an adjuvant therapy in treatment of atrophic post acne scars.
To compare the efficacy of topical phenytoin spanlastics combined with fractional co2 laser versus fractional co2 laser alone in treatment of atrophic post acne scars.

Start Date01 Jul 2025

Sponsor / Collaborator

Assiut University

100 Clinical Results associated with Phenytoin

100 Translational Medicine associated with Phenytoin

100 Patents (Medical) associated with Phenytoin

19,793

Literatures (Medical) associated with Phenytoin

01 Jun 2026·Neural Regeneration Research

Voltage-gated sodium channels in the nervous system: Molecular physiology to therapeutic interventions

Article

Author: Yao, Kai ; Fu, Xuefei ; Peng, Anna ; Li, Ni ; Qin, Huan ; Yan, Lin

Voltage-gated sodium channels are essential ionic-conductance pathways in the nervous system, which play an irreplaceable role in modulating neuronal excitability and signal transduction. This review comprehensively analyzes the molecular mechanisms and pathophysiological significance of voltage-gated sodium channels, with particular emphasis on elucidating the molecular-action mechanisms of the distinct subtypes of these channels, including Nav1.1, Nav1.2, and Nav1.6, across various neurological disorders such as familial hemiplegic migraine, epilepsy, autism spectrum disorder, and retinal dysfunction. This review also provides a comprehensive overview of the pathogenic mechanisms associated with voltage-gated sodium channels, and systematically clarifies the evolutionary pathway of treatment strategies from conventional to innovative approaches. It analyzes two major categories of conventional sodium channel blockers and their applications: antiepileptic drugs (such as carbamazepine, lamotrigine, and phenytoin) and antiarrhythmic drugs (such as lidocaine, flecainide, and quinidine). However, these conventional blockers show limitations because of the lack of selectivity, driving research toward more precise therapeutic directions. Additionally, this review evaluates gabapentin, cannabidiol, and calcium channel blockers with different mechanisms of action. These drugs modulate neuronal excitability from multiple perspectives, providing diverse options for symptom relief. This review also highlights advances in gene therapy for specific diseases, such as STK-001, which promotes effective splicing of the sodium channel voltage-gated type 1 alpha subunit ( SCN1A ) gene, and ETX101, which utilizes adeno-associated virus 9 vectors to deliver engineered transcription factors. These two agents provide targeted therapeutic solutions for Dravet syndrome. Furthermore, this review summarizes some innovative therapeutic agents in clinical trials, including PRAX-222 (for SCN2A gain-of-function mutation-related epilepsy), which has received Food and Drug Administration orphan drug designation, and the selective Nav1.6 inhibitor NBI-921352 (for SCN8A -related epilepsy). Collectively, this review comprehensively compares the advantages and disadvantages of conventional drugs and gene therapy and envisions future treatment strategies that integrate the strengths of both approaches, facilitating personalized precision medicine to provide more accurate and effective treatment options for patients with ion channel diseases.

01 Jun 2026·BRAIN & DEVELOPMENT

Management of pediatric status epilepticus after hospital arrival in Japan: A nationwide questionnaire survey

Article

Author: Akiyama, Tomoyuki ; Nishiyama, Masahiro ; Matsuura, Ryuki ; Maegaki, Yoshihiro ; Torio, Michiko ; Oikawa, Shizuka ; Shiohama, Tadashi ; Kikuchi, Kenjiro ; Nagase, Hiroaki ; Ueda, Yuki ; Kuki, Ichiro ; Motobayashi, Mitsuo ; Kanai, Sotaro ; Fukuoka, Masataka

BACKGROUND:

Status epilepticus (SE) is a neurological emergency requiring rapid, stepwise treatment. In Japan, the Guidelines for the Treatment of Pediatric Status Epilepticus 2023 (GL2023) were published; however, real-world practice following their publication remains unclear.

METHODS:

We conducted a nationwide, cross-sectional web-based survey of pediatric neurologists between January and March 2025. One representative from each institution reported institutional practices for the in-hospital management of pediatric SE. Institutions were stratified by annual SE case volume (≥20 vs. ≤19 cases). General management strategies, antiseizure medication selection, electroencephalography (EEG) utilization, and approaches to refractory and super-refractory SE (RSE and SRSE) were analyzed.

RESULTS:

A total of 136 institutions responded. Most institutions reported referring to GL2023 and initiating first-line treatment within 10 min of hospital arrival. Midazolam was the most commonly used first-line drug, with widespread use of non-intravenous routes. Phenytoin or fosphenytoin remained the most commonly selected second-line drug, followed by phenobarbital. For RSE, anesthetic coma therapy with midazolam and barbiturates was used at comparable frequencies. Overall, antiseizure medication selection did not differ by institutional case volume. In contrast, institutions managing ≥20 cases annually more frequently reported having institution-specific protocols, utilizing EEG in the emergency department, administering repeat doses of benzodiazepines, and having experience with advanced therapies for SRSE.

CONCLUSIONS:

Pediatric SE management in Japan emphasizes rapid treatment and flexible administration routes. Institutional experience is associated with differences in EEG utilization, protocol development, and SRSE management. Further improvement will require continued evidence generation, timely treatment implementation, and reduction of institutional disparities.

01 May 2026·TALANTA

Valorization of recycled waste in green/white purification and LC-QToF/MS analysis of beverages adulterated with incapacitating drugs

Article

Author: Cengiz, Salih ; Er, Elif Ozturk ; Pekcaliskan, Elif Yılmaz ; Yonar, Fatma Cavus ; Anilanmert, Beril

Incapacitating drugs constitute a growing threat for the community, since victims may drink adulterated beverages without noticing. A validated eco-friendly/economical purification/analysis kit prototype, along with an LC-QToF/MS method has been developed in coke and mixed fruit-juice, for simultaneous determination of 10 drugs used for incapacitating victims (zaleplone, zolpidem, zopiclone, mephedrone, fentanyl, phenytoin, thiopental, sertraline, ketamine and GHB). A combination of two different waste nut-shells which yielded the highest recovery for these drugs were directly used as adsorbent after grinding and modification and a reusable separation apparatus recycled from waste were utilized for the first time in a toxicological analysis. In the method, after adding the adsorbent on to the sample, pH was adjusted. Following 25-min (min) automatic vortexing for adsorption, matrix was removed easily, using the separation apparatus. After 25-min desorption via cold ultrasonication using 500 μL methanol, a 9.5-min LC-QToF/MS analysis was performed. The validated method in fruit-juice and coke, extraordinarily gave successful results also in urine and saliva. Assessment tools for greenness/whiteness and pictograms confirmed the environmental friendliness of the method kit.

156

News (Medical) associated with Phenytoin

05 May 2026

·www.biospace.com

AbbVie Highlights New Long-Term Data Advancing Treatment Standards in Inflammatory Bowel Diseases (IBD) at 2026 Digestive Disease Week®

AbbVie presents 18 abstracts in Crohn's disease and ulcerative colitis Breadth of data from real-world evidence and clinical trials reinforce risankizumab and upadacitinib efficacy, safety profile, and durability NORTH CHICAGO, Ill. , May 5, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the presentation of new data across its gastroenterology portfolio at the 2026 Digestive Disease Week (DDW) Annual Meeting, May 2-5 in Chicago. AbbVie will present 18 abstracts, including real-world evidence and long-term findings for SKYRIZI ® (risankizumab-rzaa) and RINVOQ ® (upadacitinib) in Crohn's disease and ulcerative colitis. "As a leader in gastroenterology, AbbVie remains focused on advancing the understanding of IBD and helping raise the standard of care through scientific innovation and a broad portfolio of marketed and investigational therapies," said Andrew Anisfeld, Ph.D., vice president, global medical affairs, immunology, AbbVie . "Our research presented at DDW adds to the growing body of evidence demonstrating the sustained durability of clinical and endoscopic response, as well as the established safety profile, of risankizumab and upadacitinib for people living with IBD." Real-World Data for Patients on Risankizumab in Crohn's Disease Sustained symptom relief and reduced need for concomitant therapy: A 52-week follow-up of adults with moderately to severely active Crohn's disease treated with risankizumab from the ASPIRE-CD study showed rapid and sustained improvements in abdominal pain, bowel urgency and liquid/soft stools. Among patients with extraintestinal manifestations of arthritis and skin conditions, 25% and 46%, respectively, reported experiencing relief at Week 52. By Week 52, the use of corticosteroids decreased from 34% at baseline to 7%, and over-the-counter therapies had decreased from 72% at baseline to 49%. Improved quality of life: In an analysis of health-related quality of life (HRQL) and treatment satisfaction after initiating risankizumab in patients enrolled in the ASPIRE-CD study, 77% reported improvement in life enjoyment by Week 52. In addition, patients had improved general wellbeing, including improved sexual health and improved work productivity and daily activity levels one year after starting risankizumab. Overall satisfaction with Crohn's disease treatments improved among all patients (from 50% at baseline to nearly 87% at Week 52), particularly patients who were still being treated with risankizumab at Week 52 (92% satisfaction). Low Switch Rate for Risankizumab Among Crohn's Disease Patients Treatment persistence: A real-world study of US claims data analyzed the switch rates over a 24-month period among patients with Crohn's disease initiating a new biologic therapy. It found the switch rate was 14% for risankizumab, compared with 21% for ustekinumab, 30% for vedolizumab, 33% for infliximab, and 36% for adalimumab. This pattern was also seen among biologic-naïve patients. Lower Odds of Hospitalization Observed After Switch to Upadacitinib Biologic dose-escalation vs. switching to upadacitinib in a real-world setting: A retrospective analysis of US claims data found that among patients with Crohn's disease or ulcerative colitis treated with a biologic therapy, patients who were switched to upadacitinib had a 31% lower odds of hospitalization and 26% lower odds of emergency department visits than those who increased average weekly dose of the biologic therapy. Endoscopic Improvements in Difficult-to-Treat Crohn's Disease Treating patients with Perianal Fistulizing Crohn's disease: Among patients with Perianal Fistulizing Crohn's disease (PFCD), in two Phase 3 trials, those who responded to upadacitinib 45 mg were re-randomized to receive maintenance treatment with upadacitinib (15 mg or 30 mg) or placebo for 52 weeks. In this post-hoc analysis, upadacitinib-treated patients showed endoscopic improvements through 52 weeks, regardless of fistula response, as demonstrated by reductions in Simple Endoscopic Score for Crohn's disease (SES-CD). Majority of these patients were without an adequate response to anti-tumor necrosis factor (TNF) therapy. Select AbbVie abstracts are highlighted below, and all the 2026 DDW Annual Meeting posters are available here : Abstract Title Presentation Number Real-World Switching Rates Among Patients with Crohn's Disease Treated with Biologics in the United States Su1657 Improvements in Simple Endoscopic Scores for Crohn's Disease in Upadacitinib-Treated Patients with Perianal Fistulizing Disease: Post Hoc Analysis of the Phase 3 Trials Su1495 Risankizumab Reduces Crohn's Disease-Related Symptoms and Concomitant Therapy Use in Adults with Crohn's Disease: Year 1 Results From the ASPIRE-CD Study Sa1504 Risankizumab Improves Health-Related Quality of Life in Adults with Crohn's Disease: Year 1 Results from the ASPIRE-CD Study Mo1674 Comparative Real-World Outcomes Following Dose Escalation of Current Biologic Therapy Versus Switching to Upadacitinib Among Patients with Crohn's Disease or Ulcerative Colitis: A Propensity Score Matched Analysis Tu1655 About SKYRIZI ® (risankizumab-rzaa) SKYRIZI is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by selectively binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. 1 SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderately to severely active ulcerative colitis, plaque psoriasis, psoriatic arthritis and Crohn's disease. 1 On April 27, 2026, AbbVie announced submission of an application to the FDA seeking approval of SKYRIZI ® for subcutaneous induction for the treatment of adult patients with moderately to severely active CD. SKYRIZI ® (risankizumab-rzaa) U.S. Uses and Important Safety Information 1 SKYRIZI is a prescription medicine used to treat adults with: moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy). active psoriatic arthritis. moderate to severe Crohn's disease. moderate to severe ulcerative colitis. IMPORTANT SAFETY INFORMATION What is the most important information I should know about SKYRIZI ® (risankizumab-rzaa)? SKYRIZI is a prescription medicine that may cause serious side effects, including: Serious allergic reactions: Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: fainting, dizziness, feeling lightheaded (low blood pressure) swelling of your face, eyelids, lips, mouth, tongue, or throat trouble breathing or throat tightness chest tightness skin rash, hives itching Infections: SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: fever, sweats, or chills cough shortness of breath blood in your mucus (phlegm) muscle aches warm, red, or painful skin or sores on your body different from your psoriasis weight loss diarrhea or stomach pain burning when you urinate or urinating more often than normal Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you: have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?" have an infection that does not go away or that keeps coming back. have TB or have been in close contact with someone with TB. have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine. are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk. become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What are the possible side effects of SKYRIZI? SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?" Liver problems may happen while being treated for Crohn's disease or ulcerative colitis: A person with Crohn's disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and at least up to 12 weeks of treatment, and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine. The most common side effects of SKYRIZI in people treated for Crohn's disease and ulcerative colitis include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, urinary tract infection, and rash. The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections. These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects. Use SKYRIZI exactly as your healthcare provider tells you to use it. SKYRIZI (risankizumab-rzaa) is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector. This is the most important information to know about SKYRIZI. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide . About RINVOQ ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3 and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus and vitiligo. The use of upadacitinib for these diseases is not FDA approved, and its safety and efficacy has not been established for these diseases. RINVOQ ® (upadacitinib) U.S. Uses and Important Safety Information 2 RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. Adults with giant cell arteritis (GCA) . Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis. RINVOQ/RINVOQ LQ is a prescription medicine used to treat: Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Children 2 to less than 18 years of age with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis. IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib) What is the most important information I should know about RINVOQ*? RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor. Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away. Tears in the stomach or intestines . This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting. Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results. Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. What should I tell my HCP BEFORE starting RINVOQ? Tell your HCP if you: Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as: Fever, sweating, or chills Shortness of breath Warm, red, or painful skin or sores on your body Muscle aches Feeling tired Blood in phlegm Diarrhea or stomach pain Cough Weight loss Burning when urinating or urinating more often than normal Have TB or have been in close contact with someone with TB. Are a current or past smoker. Have had a heart attack, other heart problems, or stroke. Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines. Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP. Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose. There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110. Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects. Especially tell your HCP if you take: Medicines for fungal or bacterial infections Rifampicin or phenytoin Medicines that affect your immune system If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. What should I avoid while taking RINVOQ? Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects. What should I do or tell my HCP AFTER starting RINVOQ? Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weakness in one part or on one side of your body Slurred speech Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: Swelling Pain or tenderness in one or both legs Sudden unexplained chest or upper back pain Shortness of breath or difficulty breathing Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits. What are other possible side effects of RINVOQ? Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, swelling of the feet and hands (peripheral edema), increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis). A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ. Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP. These are not all the possible side effects of RINVOQ. How should I take RINVOQ/RINVOQ LQ? RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP. *Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ. This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References SKYRIZI [Package Insert]. North Chicago, IL: AbbVie Inc.; 2026. RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025 Global Media: Giovanna Chandler giovanna.chandler@abbvie.com U.S. Media: Stephanie Tennessen stephanie.tennessen@abbvie.com Investors: Liz Shea liz.shea@abbvie.com View original content: SOURCE AbbVie

Clinical ResultPhase 3Drug Approval

28 Apr 2026

·www.prnewswire.com

AbbVie Submits Application to FDA for Upadacitinib (RINVOQ®) for Adults and Adolescents with Severe Alopecia Areata

Submission is supported by data from the Phase 3 UP-AA clinical program in which upadacitinib achieved the primary endpoint of severity of alopecia tool (SALT) score ≤ 20 at week 24, with additional efficacy results observed at week 521-3 Upadacitinib is also the first JAK inhibitor to meet the ranked secondary endpoint of complete scalp hair regrowth (SALT = 0) at week 241-3 NORTH CHICAGO, Ill., April 28, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for upadacitinib (RINVOQ®; 15 mg and 30 mg, once daily) for the treatment of adult and adolescent patients with severe alopecia areata (AA), based on results from the Phase 3 UP-AA clinical program.1-3 "Alopecia areata is a chronic immune-mediated disease in which the physical and psychological burden patients can experience goes far beyond hair loss, impacting their day-to-day lives," said Kori Wallace, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. "In the UP-AA clinical program, upadacitinib showed early and substantial scalp hair growth, including complete scalp hair coverage, which is a significant outcome for those living with this often-overlooked disease." UP-AA Clinical Trial Summary 1-3 UP-AA includes two replicate studies with Period A as a double-blind, placebo-controlled phase for 24 weeks, followed by Period B, a blinded extension through 52 weeks. Results from Period B are summarized descriptively. The mean baseline SALT score across the trials was 84 and approximately 51% of patients (n=716 out of 1,399) had SALT score ≥ 95 at baseline, representing a population with near-total or total scalp hair loss. SALT ≤ 20 (primary endpoint) and SALT = 0 (key ranked secondary endpoint) were met at week 24 for both upadacitinib doses (15 mg and 30 mg) and response rates improved through week 52 as shown below. The safety profile of upadacitinib 15 mg and 30 mg through week 52 was consistent with that observed at week 24 and shared in previously announced results.1-3 Use of upadacitinib in AA is not approved; its safety and efficacy are under regulatory review by the U.S. FDA and the European Medicines Agency. About UP-AA Clinical Trial 1-3 UP-AA M23-716 was conducted as a single protocol that includes two replicate pivotal studies (Study 1 and Study 2) with randomization, investigative sites, data collection, analysis and reporting independent for each study. These Phase 3 randomized, placebo-controlled, double-blind studies evaluate the efficacy and safety of upadacitinib in adult and adolescent patients with severe alopecia areata. In Study 1 and Study 2 Period A, participants were randomized to one of three groups to receive upadacitinib 15 mg, upadacitinib 30 mg or placebo for 24 weeks. In Study 1 and Study 2 Period B, participants originally randomized to upadacitinib dose groups in Period A continued their same treatment in Period B for 28 additional weeks. Participants originally randomized to placebo in Period A either remained on placebo in Period B or were re-randomized to either upadacitinib 15 or upadacitinib 30 mg, based on their SALT score at week 24. In total, Study 1 and Study 2 Periods A and B span 52 weeks. Results from Period B are summarized descriptively. Participants who complete Study 1 or Study 2 can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks, where data is summarized descriptively. The two trials randomized 1,399 participants with severe AA ages 12 to 63 across 248 sites worldwide. More information on this trial can be found at (NCT06012240). About Alopecia Areata Alopecia areata (AA) is an unpredictable autoimmune disease causing a range of hair loss patterns, from sudden, round bald patches on the scalp to complete loss of all body hair, including scalp, face, eyebrows and eyelashes.4,5 Despite its immune-mediated nature, AA is often considered a cosmetic problem, which can lead to stigma and have an impact on patients' lives.6,7 About RINVOQ ® (upadacitinib) Discovered and developed by AbbVie scientists, RINVOQ is a JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2. The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known. Upadacitinib (RINVOQ) is being studied in Phase 3 clinical trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo. The use of upadacitinib in alopecia areata is not approved; its safety and efficacy are under regulatory review by the U.S. FDA and the European Medicines Agency. RINVOQ (upadacitinib) U.S. Uses and Important Safety Information 8 RINVOQ is a prescription medicine used to treat: Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated. Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated. Adults with giant cell arteritis (GCA). Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. Adults with moderate to severe Crohn's disease (CD) when 1 or more medicines called TNF blockers have been used and did not work well or could not be tolerated, or after taking a different injection or pill (systemic therapy) when your healthcare provider does not recommend TNF blockers. It is not known if RINVOQ is safe and effective in children with ankylosing spondylitis, non-radiographic axial spondyloarthritis, ulcerative colitis, or Crohn's disease. Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended. It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis. It is not known if RINVOQ LQ is safe and effective in children with atopic dermatitis. RINVOQ/RINVOQ LQ is a prescription medicine used to treat: Children 2 years of age and older with active polyarticular juvenile idiopathic arthritis (pJIA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. Children 2 to less than 18 years of age with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated. It is not known if RINVOQ/RINVOQ LQ is safe and effective in children under 2 years of age with polyarticular juvenile idiopathic arthritis or psoriatic arthritis. IMPORTANT SAFETY INFORMATION FOR RINVOQ/RINVOQ LQ (upadacitinib) What is the most important information I should know about RINVOQ* ? RINVOQ may cause serious side effects, including: Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster). Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor. Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker. Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor. Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away. Tears in the stomach or intestines. This happens most often in people who take nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids. Get medical help right away if you get stomach-area pain, fever, chills, nausea, or vomiting. Changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results. Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients. What should I tell my HCP BEFORE starting RINVOQ? Tell your HCP if you: Are being treated for an infection, have an infection that won't go away or keeps coming back, or have symptoms of an infection, such as: Have TB or have been in close contact with someone with TB. Are a current or past smoker. Have had a heart attack, other heart problems, or stroke. Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines. Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system. Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you've been to these types of areas, ask your HCP. Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines. Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose. There is a pregnancy surveillance program for RINVOQ. The purpose of the program is to collect information about the health of you and your baby. If you become pregnant while taking RINVOQ, you are encouraged to report the pregnancy by calling 1-800-633-9110. Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose. Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects. Especially tell your HCP if you take: Medicines for fungal or bacterial infections Rifampicin or phenytoin Medicines that affect your immune system If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist. What should I avoid while taking RINVOQ? Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects. What should I do or tell my HCP AFTER starting RINVOQ? Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse. Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including: Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw Pain or discomfort in your arms, back, neck, jaw, or stomach Shortness of breath with or without chest discomfort Breaking out in a cold sweat Nausea or vomiting Feeling lightheaded Weakness in one part or on one side of your body Slurred speech Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including: Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits. What are other possible side effects of RINVOQ? Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, swelling of the feet and hands (peripheral edema), increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia, leukopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, increased liver enzyme levels, pneumonia, low number of red blood cells (anemia), and infection of the stomach and intestine (gastroenteritis). A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ. Some people taking RINVOQ may see medicine residue (a whole tablet or tablet pieces) in their stool. If this happens, call your HCP. These are not all the possible side effects of RINVOQ. How should I take RINVOQ/RINVOQ LQ? RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets. RINVOQ LQ is taken twice a day with or without food. RINVOQ LQ is available in a 1 mg/mL oral solution. RINVOQ LQ is not the same as RINVOQ tablets. Do not switch between RINVOQ LQ and RINVOQ tablets unless the change has been made by your HCP. *Unless otherwise stated, "RINVOQ" in the IMPORTANT SAFETY INFORMATION refers to RINVOQ and RINVOQ LQ. This is the most important information to know about RINVOQ. For more information, talk to your HCP. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more. Please click here for the Full Prescribing Information and Medication Guide. Globally, prescribing information varies; refer to the individual country product label for complete information. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. References AbbVie. Data on file ABVRRTI81580. AbbVie. Data on file ABVRRTI81456. AbbVie. Data on file ABVRRTI83115. Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Alopecia areata update: Part I. Clinical picture, histopathology, and pathogenesis. J Am Acad Dermatol. 2010;62(2):177-188, quiz 189-190. Pratt CH, King LE, Messenger AG, Christiano AM, Sundberg JP. Alopecia areata. Nat Rev Dis Primers. 2017;3(1):17011 Davey L, Clarke V, Jenkinson E. Living with alopecia areata: an online qualitative survey study. Br J Dermatol. 2019;180(6):1377-1389 Bain KA, McDonald E, Moffat F, et al. Alopecia areata is characterized by dysregulation in systemic type 17 and type 2 cytokines, which may contribute to disease-associated psychological morbidity. Br J Dermatol. 2020;182(1):130-137 RINVOQ [Package Insert]. North Chicago, IL: AbbVie Inc.; 2025 SOURCE AbbVie 21% more press release views with Request a Demo

Clinical ResultPhase 3Phase 2

19 Mar 2026

·www.drugs.com

Prenatal Valproate Exposure Tied to Offspring Neurodevelopmental Risks

THURSDAY, March 19, 2026 -- Prenatal valproate exposure is associated with increased neurodevelopmental risks among offspring, according to a study published online March 11 in The BMJ . In a study using health care use data from 2000 to 2021, Loreen Straub, M.D., from Brigham and Women's Hospital and Harvard Medical School in Boston, and colleagues examined whether prenatal exposure to specific antiseizure drugs increases the risk for neurodevelopmental disorders in children. A total of 8,887 children who were unexposed prenatally were included in the cohort; exposed pregnancies ranged from 219 to 5,261 for lacosamide and levetiracetam, respectively. The researchers observed associations with several outcomes for valproate and zonisamide (adjusted hazard ratio range, 1.26 to 4.50), while no associations with an increased risk for any outcome were seen for levetiracetam and phenytoin. A twofold to fourfold increase in risk for intellectual disability was seen in association with several drugs; due to the small number of children with this disorder, the estimates were imprecise. Across most outcomes, no meaningful associations were seen for topiramate and lamotrigine, but a potential signal was seen for intellectual disability (both drugs) and learning difficulty (topiramate only; hazard ratio, 1.23 based on small numbers). A modest increase in risk for attention-deficit/hyperactivity disorder and behavioral disorders was seen in association with carbamazepine and oxcarbazepine (hazard ratio range, 1.23 to 1.40). "Our findings raise potential concerns for zonisamide, which was associated with several neurodevelopmental disorders in the main analysis," the authors write. "However, these estimates are based on small numbers and should be interpreted with caution." Several authors disclosed ties to the pharmaceutical industry. Abstract/Full Text

Clinical Result

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

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01451593 (Pubmed \| Neurology)	Phase 2	Optic Neuritis	80	Phenytoin	ckvxvwhuxj(vtsbentiye) = foixhdcqho tcxtexseli (unohfykewm )	Positive	21 Oct 2025
				Placebo	ckvxvwhuxj(vtsbentiye) = saapjknhep tcxtexseli (unohfykewm )
CRD42022363844 (AAN2024)	Not Applicable	Seizures	18,676	Phenytoin	zmbmyuvjkg(afmnqcsyyg) = verwhmcrur mimlqbxnhv (vejxfgwgmr, 23.2–52.8)	Positive	09 Apr 2024
				Carbamazepine	zmbmyuvjkg(afmnqcsyyg) = scrnnvyatw mimlqbxnhv (vejxfgwgmr, 1.7–5.3)
phenytoin trial (ECTRIMS2023)	Phase 2	GCIPL thickness	-	Phenytoin	rzwklrcbvd(zmiidsdxxy) = xuuwfzphbt spkmnyerwq (chbmqhtfew )	Positive	30 Sep 2023
				Placebo	rzwklrcbvd(zmiidsdxxy) = lmkkvaiqgc spkmnyerwq (chbmqhtfew )
NCT00581893 (CTgov)	Phase 4	Cognition	20	Phenytoin (Phenytoin)	baxftqlypa = vkiznazdkv imzzedgsue (ilgkhdzjhl, aumoyaqlpv - xidtqvseqc) View more	-	01 Jul 2021
				Placebo (Placebo)	baxftqlypa = fofubzgydu imzzedgsue (ilgkhdzjhl, isynrzyiax - qwziijplgj) View more
NCMP-08 (SNO2020)	Not Applicable	Epilepsy \| Glioma	64	Phenytoin	faivhwiebz(htwhgbhojq) = tmrrlorfar ihdcsiwbnd (busdukbrnp )	Positive	09 Nov 2020
				Pregabalin	faivhwiebz(htwhgbhojq) = jbdqfbkedu ihdcsiwbnd (busdukbrnp )
NCT02595723 (CTgov)	Phase 4	Cognitive Dysfunction	21	Megestrol 800 mg liquid+Phenytoin 200 mg capsule (Phenytoin, Then Megestrol)	elqmuqtadg(ndyxracqxl) = cozolfkcfb yebcjbvdvw (gtwnoqkxom, 8.08) View more	-	09 Sep 2019
				Phenytoin-matched Placebo capsule+Megestrol 800 mg liquid (Placebo, Then Megestrol)	elqmuqtadg(ndyxracqxl) = mpktqjsiop yebcjbvdvw (gtwnoqkxom, 10.40) View more
NCT02939937 (CTgov)	Phase 2	Optic Neuritis	71	Phenytoin (Phenytoin)	hiwvhhkhmy(lcqjeuvgfj) = lrtcowggkv nrlrzwhtwo (ggrqgjzhjg, 6.61) View more	-	12 Aug 2019
				placebo (Placebo)	hiwvhhkhmy(lcqjeuvgfj) = pksczyfucv nrlrzwhtwo (ggrqgjzhjg, 8.49) View more
NCT00801931 (CTgov)	Phase 1/2	Anemia \| Leukemia \| Immunologic Deficiency Syndromes ... View more	1	busulfan+fludarabine+tacrolimus+MMF+alemtuzumab	vencgnwvxw(hrqnkzvgtl) = mwgnhqwcbj plfsbzamkf (wpgkkybguv, krkzaqnhps - jcjytjjdvx) View more	-	27 Mar 2019
NCT01451593 (Pubmed \| Lancet Neurol) Manual	Phase 2	Optic Neuritis	86	Phenytoin	jbytkfptmn(zsdqsdxfef) = akqjbtfkda vrrwrygrcy (xqgrbbnaiz, -16.69) View more	Positive	01 Mar 2016
				Placebo	jbytkfptmn(zsdqsdxfef) = psbqyccbvf vrrwrygrcy (xqgrbbnaiz, -23.79) View more
EAN2015	Phase 2	-	86	Phenytoin	kcavzsaoaj(nzahfouxau) = bkamrteknd mipgbdjtib (mdiegdqzed ) View more	Positive	29 Jun 2015

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