The long-term goal of the clinical trial is to develop effective, safe, and easily administered life-saving treatments for patients with moderate to severe traumatic brain injury (TBI).
Patients with moderate to severe TBI will randomly receive either:
1. Standard of care treatment and normal saline
2. Standard of care treatment and one dose of valproic acid (VPA) at a lower dose or a higher dose

Start Date01 May 2026

Sponsor / Collaborator

Northwestern University

NCT07226141

/ Not yet recruitingPhase 1/2IIT

Valproate for the Treatment of Residual Amblyopia

The goal of this clinical trial is to determine the efficacy of valproate as an adjunct therapy to treat amblyopia beyond the critical period in children aged 8-17 years who have amblyopia of ≥3 lines of interocular best-corrected (with glasses) visual acuity difference.
The main questions it aims to answer are:
* Does valproate enable clinically meaningful and durable visual recovery from amblyopia?
* Do valproate-treated patients show a change in amblyopic eye visual acuity (lines)? Participants will undergo daily patching for 2 hours (standard of care) plus the addition of valproate or placebo for a total of 16 weeks.

Start Date01 Jan 2026

Sponsor / Collaborator

The Children's Hospital Corp.

NCT07140913

/ RecruitingPhase 3

A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Start Date08 Oct 2025

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Valproic Acid

100 Translational Medicine associated with Valproic Acid

100 Patents (Medical) associated with Valproic Acid

25,151

Literatures (Medical) associated with Valproic Acid

01 Jan 2026·WATER RESEARCH

Data-driven persistence correction and environmental health prioritization of pharmaceuticals and personal care products in biological wastewater treatment processes

Article

Author: Gong, Sai ; Liu, Qiuju ; Ren, Xinkun ; Zhu, Boyang ; Wang, Jinfeng ; Yin, Ran ; Zhang, Shubo ; Fan, Yingzheng ; Huang, Yizhan

Pharmaceuticals and personal care products (PPCPs) can accumulate during biological wastewater treatment processes (BWWTPs) and are easily released into the environment, posing serious ecological risks. However, current concentration-based persistence assessments of PPCPs in BWWTPs are inaccurate due to nonlinear biotransformation-adsorption interactions. In this study, we analyzed 28 PPCPs in 768 water samples across influent, biological stages, and effluent from 154 BWWTPs in China. Unsupervised learning and variance partitioning analysis (VPA) were applied to evaluate the biotransformation-related variance share and to correct apparent persistence. An environmental health prioritization index (EHPi) was subsequently developed to rank PPCPs for control based on corrected removal rates. Detection frequencies of 21 PPCPs in effluent exceeded those in influent, and 20 PPCPs exhibited negative removal, with oxic-stage removal significantly lower than that in the anoxic and anaerobic stages, indicating widespread desorption and deconjugation. VPA showed that reversible adsorption accounted for an average of 60.33 % of the variance, suggesting that prioritization based on apparent removal rates was biased. Molecular descriptors and fingerprints further demonstrated that structural features have a strong influence on PPCP biotransformation. The EHPi was created based on the adjusted removal rate weighted by the biotransformation-related variance share. The results showed that the priorities of roxithromycin, ketoprofen, clarithromycin, tetracycline, and sulfadimethoxypyrimidine were incorrectly assessed. Finally, diclofenac, ciprofloxacin, ofloxacin, norfloxacin, roxithromycin, amoxicillin, and ketoprofen were identified as high-priority PPCPs. This framework enables persistence correction and informed prioritization for environmental risk management and wastewater treatment for PPCPs.

01 Jan 2026·TALANTA

Ultrasensitive and rapid dopamine sensing via turn-on fluorescence of a dual-ligand Tb-MOF: Towards point-of-care neurochemical monitoring

Article

Author: Ayad, Miriam F ; Gomaa, Mohammed M ; Yamani, Hend Z ; Safwat, Nardine ; Mahmoud, Amr M ; Abdel-Ghany, Maha F

Dopamine (DPA) plays a critical role in regulating various physiological systems, and its abnormal levels are associated with disorders such as neurodegenerative diseases, psychiatric disorders, drug addiction, and certain cancers. Therefore, the development of reliable, rapid, and sensitive methods for DPA determination is crucial for early diagnosis and effective treatment, particularly in clinical settings and point-of-care testing (POCT). In this study, a "turn-on" fluorescent probe was developed using a terbium-based metal-organic framework (Tb-MOF) constructed from dual ligands. This design addresses the drawbacks of traditional turn-off MOF sensors by enabling fluorescence enhancement upon dopamine (DPA) recognition, leading to improved sensitivity and selectivity. The dual-ligand Tb-MOF design strategically combines terephthalic acid for efficient Tb³⁺ sensitization with 2-methylimidazole facilitating selective dopamine recognition. After only 3 min of incubation in phosphate buffer (pH 7.00) at room temperature, the assay enables immediate detection of DPA in plasma and urine samples following simple protein precipitation, supporting its suitability for POCT. This represents a clear advantage over many previously reported fluorescent probes that require longer incubation times or elevated temperatures. The proposed probe demonstrated high selectivity and sensitivity for DPA determination in human plasma and urine, with a wide linear range of 1.00 × 10^-9 - 1.00 × 10^-7 M and a low limit of detection of 2.05 × 10^-10 M. These advantages highlight the potential of this dual-ligand Tb-MOF probe as a valuable platform for point-of-care testing aimed at early detection and monitoring of DPA-related disorders.

01 Jan 2026·JOURNAL OF COLLOID AND INTERFACE SCIENCE

AI-assisted near-infrared ratiometric fluorescent sensor for ultrafast and portable visual detection of Bacillus anthracis biomarkers

Article

Author: Zhang, Zuyi ; Yang, Yukun ; Wang, Wencai ; Liu, Qiming ; Qian, Hailong ; Zhang, Ying ; Bai, Baoqing ; Yu, Ligang ; Wang, Yongbo ; Wang, Shaojie

Contamination by Bacillus anthracis in food and the environment poses a significant public health risk to both humans and animals, with dipicolinic acid (DPA) serving as an effective biomarker for its detection. In this work, a novel AI-assisted near-infrared ratiometric fluorescent sensing system based on rapid coordination cross-linking and multiple fluorescence response mechanisms was proposed for ultrafast and portable visual detection of Bacillus anthracis biomarkers. A near-infrared (NIR) ratiometric fluorescent probe with multiple fluorescence response mechanisms was developed for sensitive detection of DPA, using carbon dots (B-CDs) and CdTe quantum dots (QD686). Notably, the system exhibits a rapid fluorescence color transition from red to blue within 3 s when exposure to DPA. The strong metal-coordinating ability of DPA enables rapid binding with QD686, inducing nanoparticle aggregation that activates a multi-mechanism synergistic (Fluorescence resonance energy transfer-Inner filter effect, FRET-IFE) quenching effect, thereby enabling highly sensitive and selective fluorescence detection of DPA. Additionally, a portable device leveraging AI (YOLOv12 algorithm) and a smartphone was developed for DPA detection within 10 s, achieving a detection limit of 0.097 μM (S/N = 3) and demonstrating satisfactory accuracy (recovery: 93.6-116.0 %) and precision (RSD: 1.5-3.4 %, n = 5) in validation studies. This work not only provides a novel strategy for DPA sensing but also establishes a reliable protocol for rapid visual detection, showcasing its potential applications in food safety and environmental monitoring.

132

News (Medical) associated with Valproic Acid

05 Dec 2025

·investor.jazzpharma.com

Jazz Pharmaceuticals to Present Extensive New Data and Real-World Evidence Highlighting Epidiolex® (cannabidiol) Outcomes in Treatment-Resistant Epilepsies at the American Epilepsy Society 2025 Annual Meeting

New interim results from the EpiCom trial, a prospective evaluation of behavioral outcomes in patients with tuberous sclerosis complex, suggest improvements in non-seizure outcomes Eight abstracts, including four late-breaking abstracts, underscore Jazz's continued commitment to the epilepsy community and advancing the comprehensive treatment for rare forms of epilepsy For U.S. media and investors only DUBLIN , Dec. 5, 2025 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that eight abstracts, including four that are late-breaking, will be presented on Epidiolex® (cannabidiol) at the American Epilepsy Society (AES) 2025 Annual Meeting, being held December 5-9, 2025 , in Atlanta, Georgia . Notable data include new results from the EpiCom trial, an ongoing Phase 3b/4 study evaluating behavioral and other non-seizure outcomes after initiation of adjunctive Epidiolex treatment in participants with tuberous sclerosis complex (TSC)-associated seizures. Notably, the prespecified 6-month intermediate analysis of EpiCom demonstrated promising reductions in the TSC–Associated Neuropsychiatric Disorders Self-Report Quantified Checklist (TAND-SQ) and Aberrant Behavior Checklist (ABC) subscale scores, as well as in the severity of behavioral problems reported by caregivers and clinicians after 26 weeks of Epidiolex treatment. "We are proud to share extensive research at AES 2025, including findings from the innovative EpiCom trial which utilized novel endpoints focused on individualized outcomes, including each participant's respective most problematic behavior as identified by caregivers and clinicians to ensure our research addresses the priorities of those we serve," said Jessa Alexander , Ph.D., neuroscience therapeutic area head, global medical and scientific affairs of Jazz Pharmaceuticals . "Data from EpiCom and real-world insights continue to expand our understanding of the complex realities faced by patients living with rare epilepsy disorders while further underscoring Epidiolex's ability to contribute to meaningful, holistic management." Additional highlights at AES 2025 include: A late-breaking poster featuring results from a Phase 1 clinical study evaluating bidirectional pharmacokinetic (PK) drug-drug interactions between Epidiolex and cenobamate, which did not find PK interactions between cannabidiol and cenobamate parent molecules when concomitantly administered at clinically relevant dosages. A late-breaking poster showcasing preclinical data that demonstrates a novel synergistic pharmacodynamic interaction between Epidiolex and cenobamate in effectiveness in the mouse maximal electroshock seizure model of acute generalized seizures. Two presentations highlight real-world effectiveness of Epidiolex using data from the U.S. Optum® Market Clarity Database (an integrated electronic health record and claims database). One late-breaking poster features data that shows Epidiolex initiation in CBD-naïve patients with Dravet Syndrome (DS), LGS or TSC is associated with reduced polypharmacy and healthcare resource utilization (HCRU) at 12 months, with further reductions among early-line Epidiolex initiators. The other poster highlights data that indicates Epidiolex initiation also reduces antiseizure medication cycling at 12 months, as well as decreased polypharmacy and HCRU in both pediatric and adult patients. A poster presentation featuring post-hoc analysis from the Expanded Access Program demonstrates Epidiolex treatment is associated with reductions in convulsive and total seizure frequency in patients with developmental and epileptic encephalopathies (DEEs) and rare epilepsy syndromes. The comparative effectiveness analysis confirms the superiority of Epidiolex in reducing seizure frequency from baseline compared to an external placebo control arm. A poster presentation highlighting a subgroup analysis of Epidiolex pivotal clinical trial data showing participants with Lennox-Gastaut syndrome (LGS) diagnoses, which are secondary to a genetic DEE, experienced consistent efficacy and safety as compared to the overall LGS pivotal trial populations. A late-breaking poster presentation on data from the Epilepsy Learning Healthcare System (ELHS), an Epilepsy Foundation -sponsored initiative, highlights its potential to provide real-world treatment insights beyond clinical trials and claims data. All AES 2025 abstracts are available online at the following link: aesnet.org/education/annual-meeting/aes-abstract-search. A full list of Jazz Pharmaceuticals' presentations follows below: Presentation Title Presenting Author Poster Details | Date & Time (ET) Cannabidiol Efficacy in Patients With Lennox-Gastaut Syndrome With Developmental and Epileptic Encephalopathy-Associated Genetic Variants: A Subgroup Analysis E Thiele Poster Number: 1.382 Session Date/Time: Saturday December 6 , 12:00-2:00pm Phase 1, Open-Label, Fixed-Sequence, Bidirectional, Pharmacokinetic Drug-Drug Interaction Study Between Cannabidiol and Cenobamate in Healthy Adult Participants A Vijan Poster Number: 1.545 Session Date/Time: Saturday December 6 , 12:00-2:00pm An Assessment of Acute Pharmacodynamic Drug-Drug Interactions Between Cannabidiol and Cenobamate in a Mouse Model of Generalized Tonic Seizures W Hind Poster Number: 1.546 Session Date/Time: Saturday December 6 , 12:00-2:00pm A Population Health Study of Patients Prescribed Cannabidiol in the Epilepsy Learning Healthcare System (ELHS) Registry KM Farrell Poster Number: 1.549 Session Date/Time: Saturday December 6 , 12:00-2:00pm Effectiveness of Cannabidiol in Patients With Rare Epilepsies Compared to External Placebo Control: A Post-Hoc Analysis From the Expanded Access Program Y Park Poster Number: 2.337 Session Date/Time: Sunday December 7 , 12:00-2:00pm Real-World Polypharmacy and Healthcare Resource Utilization After Early-Line Treatment With Cannabidiol for Lennox-Gastaut Syndrome, Dravet Syndrome, and Tuberous Sclerosis Complex M Navetta Poster Number: 2.433 Session Date/Time: Sunday December 7 , 12:00-2:00pm Tuberous Sclerosis Complex (TSC)–Associated Neuropsychiatric Disorders (TAND) Outcomes Following Adjunctive Cannabidiol (CBD) Treatment: 6-Month Intermediate Analysis of the EpiCom Trial J Stevens Poster Number: 3.351 Session Date/Time: Monday December 8 , 12:00-1:45pm Real-World Effectiveness of Cannabidiol on Antiseizure Medication Cycling, Polypharmacy, and Healthcare Resource Utilization: A US Claims Analysis A Sillah Poster Number: 3.368 Session Date/Time: Monday December 8 , 12:00-1:45pm About Tuberous Sclerosis Complex Tuberous sclerosis complex (TSC) is a rare genetic condition.1 The condition causes mostly benign tumors to grow in vital organs of the body including the brain, skin, heart, eyes, kidneys and lungs2 and is a leading cause of genetic epilepsy.3 People with TSC may experience a variety of seizure types. One of the most common is infantile spasms that typically present in the first year of life; focal (or partial) seizures are also very common.4 TSC is associated with an increased risk of autism and intellectual disability5 and the severity of the condition can vary widely. In some children the disease is very mild, while others may experience life-threatening complications.4 Epilepsy is present in about 85% of patients with TSC and may progress to become intractable to medication.4,6,7 More than 60% of individuals with TSC do not achieve seizure control8 with standard treatments such as antiepileptic drugs, epilepsy surgery, ketogenic diet, or vagus nerve stimulation8 compared to 30%-40% of individuals with epilepsy who do not have TSC who are drug resistant.9,10 About Dravet SyndromeDravet syndrome (DS) is a rare genetic condition that appears during the first year of life with frequent fever-related seizures (febrile seizures). Later, other types of seizures typically arise, including myoclonic seizures (involuntary muscle spasms).11 Additionally, status epilepticus, a potentially life-threatening state of continuous seizure activity requiring emergency medical care, may occur. Children with DS typically experience poor development of language and motor skills, hyperactivity and difficulty relating to others. About Lennox-Gastaut SyndromeLennox-Gastaut syndrome (LGS) begins in childhood. It is characterized by multiple types of seizures. People with LGS begin having frequent seizures in early childhood, usually between ages 3 and 5.12 More than three-quarters of affected individuals have tonic seizures, which cause the muscles to contract uncontrollably. Almost all children with LGS develop learning problems and intellectual disability. Many also have delayed development of motor skills such as sitting and crawling. Most people with LGS require help with usual activities of daily living. About Epidiolex®/Epidyolex® (cannabidiol)Epidiolex/Epidyolex is a prescription, plant-derived cannabis-based medicine administered as an oral solution which contains highly purified cannabidiol (CBD). Cannabidiol, the active ingredient in Epidiolex, is a cannabinoid that naturally occurs in the Cannabis sativa L. plant. The precise mechanisms by which Epidiolex exerts its anticonvulsant effect in humans are unknown. Epidiolex was approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. , the European Commission (EC) for use in Europe , the Medicines and Healthcare products Regulatory Agency (MHRA) for use in Great Britain , the Therapeutic Goods Administration for use in Australia , Swissmedic for use in Switzerland , the Food & Nutrition Services of the Israel Ministry of Health for use in Israel , and the New Zealand Medicines and Medical Devices Safety Authority for use in New Zealand , is an oral solution which contains highly purified cannabidiol (CBD). In the U.S. , Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS) or tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex has received approval in the European Union under the tradename Epidyolex for adjunctive use in conjunction with clobazam to treat seizures associated with LGS and DS in patients two years and older, and for adjunctive use to treat seizures associated with TSC, in patients two years of age and older. Epidiolex has received Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of seizures associated with LGS, DS, and TSC. Similarly, Epidyolex received ODD from the European Medicines Agency (EMA) for the same indications. Epidiolex is also being studied in additional forms of epilepsy, including the EpiFOS exploratory study (NCT07233239) in focal-onset seizures. Important Safety Information & Indications CONTRAINDICATION: HYPERSENSITIVITY EPIDIOLEX (cannabidiol) oral solution is contraindicated in patients with a history of hypersensitivity to cannabidiol or any ingredients in the product. WARNINGS & PRECAUTIONS Hepatic Injury:EPIDIOLEX can cause dose-related transaminase elevations. Concomitant use of valproate and elevated transaminase levels at baseline increase this risk. Obtain transaminase and bilirubin levels prior to starting treatment, at 1, 3, and 6 months after initiation of treatment, and periodically thereafter, or as clinically indicated. Resolution of transaminase elevations occurred with discontinuation of EPIDIOLEX, reduction of EPIDIOLEX and/or concomitant valproate, or without dose reduction. For patients with elevated transaminase levels, consider dose reduction or discontinuation of EPIDIOLEX or concomitant medications known to affect the liver (e.g., valproate or clobazam). Dose adjustment and slower dose titration is recommended in patients with moderate or severe hepatic impairment. Consider not initiating EPIDIOLEX in patients with evidence of significant liver injury. There have been postmarketing reports of cholestatic or mixed patterns of liver injury. Elevated ammonia levels were reported in some patients with transaminase elevations; most taking concomitant valproate, clobazam, or both. Consider discontinuation or dose adjustment of valproate or clobazam if ammonia is elevated. Somnolence and Sedation:EPIDIOLEX can cause somnolence and sedation that generally occurs early in treatment and may diminish over time; these effects occur more commonly in patients using clobazam and may be potentiated by other CNS depressants. Suicidal Behavior and Ideation:Antiepileptic drugs (AEDs), including EPIDIOLEX, increase the risk of suicidal thoughts or behavior. Inform patients, caregivers, and families of the risk and advise them to monitor and report any signs of depression, suicidal thoughts or behavior, or unusual changes in mood or behavior. If these symptoms occur, consider if they are related to the AED or the underlying illness. Withdrawal of Antiepileptic Drugs:As with most AEDs, EPIDIOLEX should generally be withdrawn gradually because of the risk of increased seizure frequency and status epilepticus. ADVERSE REACTIONS:The most common adverse reactions in patients receiving EPIDIOLEX (≥10% and greater than placebo) include transaminase elevations; somnolence; decreased appetite; diarrhea; pyrexia; vomiting; fatigue, malaise, and asthenia; rash; insomnia, sleep disorder and poor-quality sleep; and infections. Hematologic abnormalities were also observed. PREGNANCY:EPIDIOLEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage women who are taking EPIDIOLEX during pregnancy to enroll in the EPIDIOLEX Pregnancy Surveillance Program and the North American Antiepileptic Drug (NAAED) Pregnancy Registry. DRUG INTERACTIONS:Strong inducers of CYP3A4 and CYP2C19 may affect EPIDIOLEX exposure. EPIDIOLEX may affect exposure to CYP2C19 substrates (e.g., clobazam, diazepam, stiripentol), orally administered P-gp substrates, or other substrates (see full Prescribing Information). Consider dose reduction of orally administered everolimus, with appropriate therapeutic drug monitoring, when everolimus is combined with EPIDIOLEX. A lower starting dose of everolimus is recommended when added to EPIDIOLEX therapy. Concomitant use of EPIDIOLEX and valproate increases the incidence of liver enzyme elevations. Pneumonia was observed more frequently with concomitant use of EPIDIOLEX and clobazam. Dosage adjustment of EPIDIOLEX or other concomitant medications may be necessary. INDICATIONS:EPIDIOLEX (cannabidiol) oral solution is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. Please read the EPIDIOLEX full Prescribing Information for additional important information here. About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (Nasdaq: JAZZ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing potentially life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information. Contacts: Media: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc CorporateAffairsMediaInfo@jazzpharma.com Ireland +353 1 637 2141 U.S. +1 215 867 4948 Investors: Jack Spinks Executive Director, Investor Relations Jazz Pharmaceuticals plc investorinfo@jazzpharma.com Ireland +353 1 634 3211U.S. +1 650 496 2717 References: ____________________ 1 TSC Alliance. What is TSC? https://www.tscalliance.org/understanding-tsc/what-is-tsc/. Accessed December 2025 . 2 National Institute of Neurological Disorders and Stroke. Tuberous Sclerosis Complex . https://www-ninds-nih-gov.libproxy1.nus.edu.sg/health-information/disorders/tuberous-sclerosis-complex. Accessed December 2025 . 3 TSC Alliance. An introduction to tuberous sclerosis complex. https://www.tscalliance.org/wp-content/uploads/2023/12/An-introduction-to-TSC-2021.pdf. Accessed December 2025 . 4 Kingswood JC, d'Augères GB, Belousova E, et al. TuberOus SClerosis registry to increase disease Awareness (TOSCA) - baseline data on 2093 patients. 2017;12(1):2. 5 de Vries PJ, Belousova E, Benedik MP, et al. TSC-associated neuropsychiatric disorders (TAND): findings from the TOSCA natural history study. Orphanet J Rare Dis. 2018;13(1):157. 6 Tuberous Sclerosis Alliance. Diagnostic criteria. https://www.tscalliance.org/understanding-tsc/diagnosis-criteria/. Accessed December 2025 . 7 Jeong A, Wong M. Systemic disease manifestations associated with epilepsy in tuberous sclerosis complex. Epilepsia. 2016;57(9):1443-1449. 8 Chu-Shore CJ, Major P, Camposano S, Muzykewicz D, Thiele EA. The natural history of epilepsy in tuberous sclerosis complex. Epilepsia. 2010;51(7):1236-1241. 9 Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000;342(5):314-319. 10 French JA. Refractory epilepsy: clinical overview. Epilepsia. 2007;48 Suppl 1:3-7. 11 Epilepsy Foundation. Dravet Syndrome. https://www.epilepsy.com/what-is-epilepsy/syndromes/dravet-syndrome. Accessed December 2025 . 12 National Organization for Rare Disorders, Inc. Lennox-Gastaut Syndrome: Signs & Symptoms. https://rarediseases.org/rare-diseases/lennox-gastaut-syndrome/. Accessed December 2025 . View original content to download multimedia:https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-to-present-extensive-new-data-and-real-world-evidence-highlighting-epidiolex-cannabidiol-outcomes-in-treatment-resistant-epilepsies-at-the-american-epilepsy-society-2025-annual-meeting-302633648.html SOURCE Jazz Pharmaceuticals plc

Drug ApprovalPhase 1Clinical ResultOrphan Drug

28 Nov 2025

·www.sciencedaily.com

A major review across 73 countries finds that access to antiseizure medications is rising, but safe prescribing isn’t keeping pace. Valproate—linked to serious birth defects—remains widely used in many regions despite WHO warnings. Limited access to newer drugs means millions may still be at risk. Researchers urge global education and stronger safeguards.Researchers Dr. Adrienne Chan and Professor Ian Wong of Aston University examined how antiseizure medications are used around the world. Growing Access to Seizure Medicines and New Safety Concerns A study conducted with support from the World Health Organization has revealed that although more people in low- and middle-income countries are gaining access to antiseizure medications, these treatments are not always being used in ways that protect patient safety. Dr. Adrienne Chan and Professor Ian Wong examined antiseizure medication trends across 73 countries from 2012 to 2022. They note that the increasing availability of these medicines suggests progress in access to essential neurological treatments. However, they also found that valproate remains the most commonly used option, even though it can lead to birth defects and neurodevelopmental issues when taken during pregnancy. Reported problems include spina bifida, cleft palate, and a range of intellectual, communication, behavior and memory disorders. WHO Flags Valproate as a Major Global Risk The World Health Organization (WHO) includes valproate on its list of "essential medicines." Despite this, the agency advises against its use for women and girls who could become pregnant because of the potential for birth defects. WHO has identified disorders linked to prenatal valproate exposure as a serious worldwide concern. Uneven Global Progress in Safe Prescribing The study's authors say there is an urgent need for widespread education to ensure that healthcare providers understand the risks and can offer safer alternatives when appropriate. In many higher-income countries, stricter regulations and pregnancy prevention programs have led to declines in valproate use. In other regions where newer antiseizure therapies remain too costly or difficult to obtain, valproate is still prescribed more often. The WHO commissioned this research to support its broader goal of promoting safe, fair, and consistent access to essential neurological medicines around the world. Next Steps to Protect Patients and Future Children The study relied on sales data from each participating country. The researchers state that further work is needed to examine how these medicines are being used within specific populations and to assess whether safety guidelines are actually being followed. This will help clarify how often these drugs are being prescribed to women of childbearing age and what risks this may pose to unborn children. Dr. Chan said: "Our findings show that access to antiseizure medicines is expanding globally, which is good news for patients who previously had little or no treatment options. But the continued widespread use of valproate in some parts of the world is concerning, given its known risks during pregnancy. Greater global alignment on safe prescribing and education is urgently needed to protect future generations."

17 Nov 2025

·pharma.economictimes.indiatimes.com

Lupin launches generic injection in US with 180-day exclusivity

Mumbai: Drug maker Lupin on Friday said it has launched a generic medication to treat schizophrenia in the US with 180 days of exclusivity. The company has launched Risperidone for extended-release injectable suspension , 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials, with 180-day CGT exclusivity in the US, the Mumbai-based drug maker said in a statement. This follows the recent approval received from the US Food and Drug Administration (USFDA). This is the company's first product using proprietary technology from PrecisionSphere, the Long-acting Injectable (LAI) platform developed by its subsidiary Nanomi BV. Risperidone for extended-release injectable suspension is bioequivalent and therapeutically equivalent to the reference listed drug Risperdal Consta LAI. It is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder in adults. As per IQVIA MAT September 2025 data, Risperidone for extended-release injectable suspension has estimated sales of USD 187 million combined for 25 mg, 37.5 mg and 50 mg in the US. "It highlights our commitment to expanding our portfolio of differentiated, complex products, marking a significant step forward in our pursuit of developing novel long-acting injectables across diverse therapeutic areas," Lupin President US Generics Spiro Gavaris stated. Shares of the drug maker were trading 0.37 per cent down at Rs 2,045.40 apiece on BSE.

Drug Approval

100 Deals associated with Valproic Acid

External Link

KEGG	Wiki	ATC	Drug Bank
D00399	Valproic Acid	N03AG01	DB00313

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Mania	United States	Bionpharma, Inc.	29 Jul 2008
Migraine Disorders	United States	Bionpharma, Inc.	29 Jul 2008
Epilepsy	United States	AbbVie, Inc.	28 Feb 1978

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alcoholism	Phase 3	United States	AstraZeneca PLC	01 Jan 2006
Epilepsies, Partial	Phase 3	United States	Abbott Laboratories	01 Jul 2003
Bipolar II disorder	Phase 3	Germany	AstraZeneca PLC	01 Jan 2002
Epilepsy, Temporal Lobe	Phase 2	Australia	Cerebral Therapeutics, Inc.	01 Aug 2016
Secondarily generalized seizures	Phase 2	Australia	Cerebral Therapeutics, Inc.	01 Aug 2016
Seizures	Phase 2	Australia	Cerebral Therapeutics, Inc.	01 Aug 2016
Spinal Muscular Atrophy	Phase 2	United States	Abbott Laboratories	01 Jul 2007
Contraception	Phase 1	United Kingdom	Estetra SRL	12 Apr 2018
Wounds, Nonpenetrating	Phase 1	United States	University of Michigan	01 Nov 2016
Shock, Hemorrhagic	Phase 1	United States	University of Michigan	01 Sep 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03689114 (STANDLOW, CTgov)	Phase 4	Epilepsies, Partial	58	Low dose oxcarbazepine+Low dose topiramate+Low dose carbamazepine+Low dose levetiracetam+Low dose valproate+Low dose lamotrigine+Low dose zonisamide+Low dose gabapentin (Low Dose)	ymicbkxnfu = nywkehsgjd dwndvdwske (codtkwpeuf, kvrwzpwepk - qkeuuxpkjd) View more	-	08 Jul 2025
				oxcarbazepine+topiramate+carbamazepine+levetiracetam+valproate+lamotrigine+gabapentin+zonisamide (Standard Dose)	ymicbkxnfu = zfgewalrcd dwndvdwske (codtkwpeuf, oczactohrb - pzaphtzohb) View more
NCT06248931 (Pubmed \| J Clin Neurosci)	Phase 3	Migraine Disorders	574	Valproate	grtfpzuvkl(duoaeyniqh) = gsknzrxzdz ifhkmbtytd (dfqjgkdwek )	Positive	01 May 2025
				Topiramate	grtfpzuvkl(duoaeyniqh) = qgjftqbern ifhkmbtytd (dfqjgkdwek )
P9-9.015 (AAN2025)	Not Applicable	Excessive Daytime Sleepiness	207	Clonazepam	zjcnbndony(kzbvwhbcvg) = Among newer ASMs, there are differences in their tendency to cause excessive daytime sleepiness, with Clonazepam and Levetiracetam being more commonly associated with this side effect, thus warranting caution. Conversely, Perampanel and Lacosamide are less likely to cause daytime sleepiness, and ASM selection should be tailored to the sleep characteristics of epileptic patients. uqdxgqdbiv (zptaiwpsxp )	Positive	07 Apr 2025
				Levetiracetam
CTNI-45 (SNO2024)	Phase 2	Recurrent Malignant Glioma GRP78 (HSPA5) \| PDGFRa	33	Sorafenib	dqvkrkdobf(ywnlpibzwk) = one grade 3 toxicity for maculopapular rash (6.4%) beyxpgxzft (oixstjikqk ) View more	Positive	11 Nov 2024
617 (SITC2024)	Phase 2	Neoplasms galectin-9 \| IL8 \| IL18 ... View more	39	Valproate (VPA) + Avelumab	vlysqoyrmk(hjaqfjcgbe) = bstsqkgomz yopbsutmjk (kmeaiulvin ) View more	Positive	05 Nov 2024
NCT05821556 (VESPA, Pubmed \| BMC Cancer)	Phase 2	Pancreatic adenocarcinoma metastatic CA 19.9	240	VPA/SIM plus gemcitabine/nab-paclitaxel-based regimens	thlkizbyzc(ykaddikcid) = ibkxuhgkic koivhnlmlk (lhftjuudso )	-	19 Sep 2024
				Chemotherapy alone	thlkizbyzc(ykaddikcid) = bwpwsbhafz koivhnlmlk (lhftjuudso )
CRD42022363844 (AAN2024)	Not Applicable	Seizures	18,676	Phenytoin	gaqhuzxgyw(vigtggtxpc) = wopyttwldz xfofjgcekh (fmgbtyenpj, 23.2–52.8)	Positive	09 Apr 2024
				Carbamazepine	gaqhuzxgyw(vigtggtxpc) = aoxfaxjzah xfofjgcekh (fmgbtyenpj, 1.7–5.3)
CNS2023	Phase 1/2	Migraine Disorders	17	Normal Saline, Prochlorperazine, Ketorolac	rpekidpokp(kogtodidbs) = krszvvtaxr iznkxrqlsu (gcwoicimtv ) View more	Positive	01 Oct 2023
NCT01552434 (Pubmed)	Phase 1	Advanced Malignant Solid Neoplasm	47	Bevacizumab	qqkacgmius(vvjnnkbrop) = grade 3 infection, rash, mucositis, bowel perforation, elevated lipase, and grade 4 cerebrovascular ischemia xuhhaxvbcm (vhwkqdaggr ) View more	-	13 Jun 2023
NCMP-08 (SNO2022)	Not Applicable	Glioma	1,435	Levetiracetam + Valproic Acid + Clobazam	flpqipewpu(wtvslmxapj) = utcpxbjoon qmklmhjswe (ahrsjqomzr, 48 - 78)	Positive	14 Nov 2022
				Other ASM Triple Therapy	flpqipewpu(wtvslmxapj) = gaajzxazpm qmklmhjswe (ahrsjqomzr, 47 - 75)

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