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topiramate (USL255 / Qudexy XR)

✓ Approved

Upsher-Smith Laboratories, LLC. · GRIA1 · Small Molecule

What is topiramate?

topiramate is a small molecule developed by Upsher-Smith Laboratories, LLC.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesUSL255, Qudexy XR
CompanyUpsher-Smith Laboratories, LLC.
Drug ClassSmall Molecule
Molecular TargetGRIA1, SCN5A
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Upsher-Smith Laboratories, LLC.

Mechanism of Action

Molecular Targets

topiramate acts on 2 molecular targets:

GRIA1glutamate ionotropic receptor AMPA type subunit 1 (GLUR1, HBGR1)
SCN5Asodium voltage-gated channel alpha subunit 5 (CMD1E, SSS1)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

topiramate is developed for 2 unique indications across 2 therapeutic areas.

Therapeutic AreaConditionPhase
Nervous system disordersPartial seizures✓ Approved
Surgical and medical proceduresMigraine prophylaxis✓ Approved

Related Research Articles

PubMedInternational journal of pharmaceutical compounding2026-09-17

Stability Evaluation of Compounded Multidrug Oral Liquids in a Dual-Vehicle Suspending System.

Kegele Carolina Schettino CS, Taylor Sarah S, Polonini Hudson H

Extemporaneously compounded oral liquids are essential for patients unable to swallow solid dosage forms, although ensuring stability in aqueous systems remains challenging. This study evaluated the chemical, physical, and microbiological stability of formulations containing topiramate, omeprazole, gabapentin, ondansetron, and levofloxacin prepared in Flavor Sweet™ SF and Flavor Plus™, also known as Syra Sweet™ SF and Syra Plus™. Stability was assessed over 90 days at room temperature and under refrigeration using validated UHPLC methods, along with physical and microbiological analyses. Gabapentin, ondansetron, omeprazole, and topiramate remained stable for 90 days under both conditions, while levofloxacin was stable for 60 days at room temperature and 90 days refrigerated. All formulations showed consistent pH and acceptable microbiological quality, although precipitation in some samples led to discontinuation of analysis. These results support the suitability of the vehicle system and highlight the importance of formulation parameters in stability and beyond-use dating.

PMID 42752430
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PubMedJournal of obstetrics and gynaecology Canada : JOGC = Journal d'obstetrique et gynecologie du Canada : JOGC2026-09-17

SOGC Clinical Practice Guideline No. 471: Alcohol and Pregnancy.

Allen Victoria V, Cook Jocelynn L JL, Chandrasekaran Nirmala N, Christie Janet J et al.

To establish national standards of care for screening and counselling pregnant women and individuals of reproductive age regarding alcohol consumption and alcohol use disorder. Health care providers who care for pregnant women and women of childbearing age. Pregnant women and women of childbearing age and their families. Medline, EMBASE, and CENTRAL databases were searched for "alcohol use and pregnancy". The results were filtered for a publication date between October 2018 and February 2026. The search terms were developed using the MeSH terms and key words including: pre-pregnancy, pregnant, breast feeding, lactation, female, women, preconception care, prenatal care, Fetal Alcohol Spectrum Disorder, prenatal alcohol exposure, drinking behavior, alcohol abstinence, alcohol drinking, binge drinking, Alcohol-Related Disorders, alcoholism, alcohol consumption, alcohol abuse, benzodiazepines, disulfiram, naltrexone, acamprosate, ondansetron, topiramate, cyanamide, calcium carbimide, alcohol deterrents, disease management, detoxification, Alcoholics Anonymous, alcohol counselling, harm reduction, pre-pregnancy care, prenatal care, incidence, prevalence, epidemiological monitoring, brief intervention. Clinical trials, observational studies, reviews, systematic reviews and meta-analysis, guidelines, and conference consensus were included. The table of evidence from the search that supports the recommendations is included as Appendix B. The authors rated the quality of evidence and strength of recommendations using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. See online Appendix A (Tables A1 for definitions and A2 for interpretations of strong and conditional recommendations). Implementation of the recommendations in these guidelines may increase obstetrical care provider recognition of alcohol consumption and problematic alcohol use among women of childbearing age or who are pregnant using validated screening tools and brief intervention approaches. Obstetrician-gynecologists should be given priority access to healthcare professionals with expertise in alcohol cessation for their patients in order to support optimal health and pregnancy outcomes. As they are already responsible for the urgent management of pregnancy-related complications, they must be able to rely on expedited referral pathways to ensure timely interventions. RECOMMENDATIONS: (Recommendations IN BOLD are new to this guideline update; an overview of the updated supporting literature for all recommendations is provided in Appendix B).

PMID 42753357
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PubMedCureus2026-09-16

Metabolic-Protective Strategies for Antipsychotic-Associated Weight Gain in Children and Adolescents: A Systematic Review.

Alhagawy Ali J AJ, Alhiqwi Ibrahim J IJ, Majrabi Hamad A HA, Salami Ayoub H AH et al.

Second-generation antipsychotics are effective for a range of pediatric psychiatric and behavioral conditions but are commonly associated with weight gain and metabolic dysfunction. Metformin is the most extensively studied pharmacological strategy for preventing or treating this adverse effect; however, the randomized evidence base has evolved substantially with the publication of recent large trials. This study aimed to systematically review and meta-analyze randomized controlled trials of metformin and other metabolic-protective strategies, including topiramate, melatonin, and antipsychotic switching, for preventing or treating antipsychotic-associated weight gain in children and adolescents. PubMed/MEDLINE, Scopus, Web of Science, and Cochrane Central Register of Controlled Trials were searched for records published between January 2000 and June 2026. Randomized controlled trials enrolling participants aged 19 years or younger who were receiving a second-generation antipsychotic were eligible. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Random-effects meta-analyses using restricted maximum likelihood estimation with the Hartung-Knapp adjustment pooled mean differences and risk ratios when at least two trials contributed comparable data; prevention and treatment indications were analyzed separately. Seven unique randomized controlled trials reported across eight publications met eligibility criteria, including 1,871 participants: five trials evaluated metformin, one evaluated topiramate, and one evaluated melatonin. The pooled effect of metformin on body mass index (BMI) z-score, the primary outcome, favored treatment at all time windows but was not statistically significant (short-term, three trials: mean difference [MD] = -0.093, 95% confidence interval [CI] -0.250 to 0.063; medium-term, two trials: MD = -0.090, 95% CI -0.346 to 0.166; long-term, one trial: MD = -0.07, 95% CI -0.145 to 0.005). Short-term body weight was significantly reduced with metformin (three trials: MD = -2.30 kg, 95% CI -4.28 to -0.32). Metabolic laboratory outcomes were imprecise and inconsistent in direction, and diarrhea was numerically more frequent with metformin. Evidence for topiramate, melatonin, and antipsychotic switching was limited to single trials or trial arms. No included trial was rated as having an overall low risk of bias. Metformin has the largest randomized pediatric evidence base among metabolic-protective strategies and consistently attenuated weight gain compared with control; however, its pooled effect on the primary outcome did not reach statistical significance at any time window, and metabolic benefits could not be confirmed. Decisions regarding metabolic-protective strategies should be individualized rather than universally applied, and larger, longer, standardized pediatric trials are needed.

PMID 42746377
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PubMedJournal of child psychology and psychiatry, and allied disciplines2026-09-15

Risks of neurodevelopmental disorders after prenatal exposure to antiepileptic drugs.

Lu Mong-Liang ML, Hung Tai-Hsin TH, Chen Vincent Chin-Hung VC, Chen Yi-Lung YL

To determine whether in utero exposure to antiepileptic drugs (AEDs) is associated with autism spectrum disorder (ASD), attention-deficit/hyperactivity disorder (ADHD), and intellectual disability (ID) in offspring and to test robustness to familial confounding. We conducted a nationwide population-based cohort of all live births between January 1, 2004, and December 31, 2016, with follow-up through 2021, linking birth, prescription, and health registries. Exposure was maternal dispensing of AEDs during pregnancy. We estimated hazard ratios with Cox models adjusted for parental demographics and psychiatric/medical comorbidities. To address shared familial factors, we performed sibling comparisons using stratified Cox models with mother as the stratum. We further conducted trimester-specific analyses, restricted to any neurodevelopmental disorder because of limited numbers for individual outcomes, by separately defining maternal AED dispensing during the first, second, and third trimesters to evaluate whether associations differed according to the timing of prenatal exposure. Among 2,196,156 births, 9,809 (0.45%) were exposed to AEDs during pregnancy. In adjusted population-wide analyses, carbamazepine, oxcarbazepine, valproic acid, and topiramate were associated with increased risk of any neurodevelopmental disorder, with some drug-specific associations also observed for ASD, ADHD, and ID. However, these associations were not observed in sibling comparison analyses. Trimester-specific sibling analyses showed no increased risk for first-trimester exposure, although several imprecise associations were observed for second- and third-trimester exposure. Sensitivity analyses were generally consistent with the main sibling comparison findings, except for an increased risk associated with topiramate when the exposure window was extended to 90 days before conception. Population-wide associations between prenatal AED exposure and neurodevelopmental disorders were largely attenuated in sibling comparison analyses, suggesting that shared familial factors may explain much of the observed risk. These findings support careful individualized prescribing during pregnancy while highlighting the need for further research on specific AEDs and exposure windows.

PMID 42736039
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PubMedPsychopharmacology2026-09-14

Topiramate effects on ethanol and sucrose binge-like intake, anxiety- and compulsive-like behavior in non-dependent male and female C57BL/6J mice.

Rodríguez-Ortega Elisa E, Cubero Inmaculada I

Repetitive binge episodes are early-stage patterns in the addiction cycle associated with elevated anxiety and compulsive traits. Despite their high comorbidity and the growing off-label use of topiramate for binge-related disorders, its effects in non-dependent individuals remain poorly characterized and studies systematically comparing both sexes under identical experimental conditions remain scarce. To evaluate the effects of topiramate on ethanol (EtOH) and sucrose binge-like intake, anxiety- and compulsive-like responses in non-dependent male and female C57BL/6J mice. EtOH (20% v/v) and sucrose (10% w/v) binge-like intake were assessed in a standard Drinking in the Dark (DID) procedure following intraperitoneal topiramate (0, 30, or 60 mg/kg). Blood EtOH concentrations (BECs) were determined after EtOH DID. Anxiety-like and compulsive-like behaviors were assessed using the Elevated Plus Maze (EPM) and Marble Burying (MB) test. Topiramate significantly reduced EtOH binge-like intake at 60 mg/kg and BECs at 30 and 60 mg/kg, while males consumed more EtOH and showed higher BECs than females. Topiramate did not significantly alter sucrose binge-like intake, with females consuming less sucrose than males. Topiramate significantly reduced anxiety-like behavior in the EPM regardless of sex. In the MB test, the topiramate effect differed significantly across sexes, although these results most likely reflect a floor effect in vehicle-treated females. These findings provide preliminary evidence that topiramate reduces EtOH binge-like intake, anxiety- and compulsive-like behavior in non-dependent mice with a non-significant attenuation of sucrose binge-like intake. Further research is warranted to establish the translational relevance and to evaluate the preventive potential of topiramate in binge-related disorders.

PMID 42733100
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PubMedEuropean journal of drug metabolism and pharmacokinetics2026-09-13

Potential Role of CYP3A4 in Determining In Vivo Exposure to Cannabidiol (CBD) and its Active Metabolite 7-OH-CBD: Evidence from an In Vitro Study.

Jaisupa Nattapon N, Birgersson Sofia S, Ashton Michael M

Plasma concentration of cannabidiol (CBD) is a determining factor for its antiseizure efficacy. Since CBD bioavailability decreases with increasing dose, pharmacokinetic drug-drug interactions that reduce its metabolic clearance may represent an alternative strategy to increase systemic exposure without further dose escalation. To investigate in vitro how combinations of antiseizure medications (ASMs) with varying cytochrome P450 (CYP450) inhibitory properties influence the metabolism of CBD and 7-OH-CBD. CBD was incubated with human liver microsomes (HLMs) either alone or in the presence of combinations of two to four commonly prescribed ASMs. These ASMs included valproic acid, clobazam, stiripentol, topiramate, zonisamide, felbamate, perampanel, ethosuximide, rufinamide, lamotrigine, levetiracetam and gabapentin. CBD, 7-OH-CBD and 7-COOH-CBD concentrations were quantified at eight time points by high performance liquid chromatography coupled to tandem mass spectrometry (HPLC-MS/MS). Depletion kinetics, metabolite formation rates, and in vitro intrinsic clearance (CLint) were determined. Ketoconazole, ticlopidine and sulfaphenazole were included as positive controls for CYP3A4, CYP2C19 and CYP2C9 inhibition, respectively. Ketoconazole markedly reduced the CLint of both CBD and its active metabolite, 7-OH-CBD. In contrast, CYP2C19 and CYP2C9 inhibitors produced only minor reductions in CBD CLint. Co-incubation with four CYP3A4-substrate ASMs resulted in a greater reduction in 7-OH-CBD CLint than in CBD CLint. Stiripentol also substantially decreased CBD CLint and markedly reduced the formation of both 7-OH-CBD and 7-COOH-CBD. ASMs with CYP3A4-inhibitory potential may alter systemic exposure to both CBD and its active metabolite, 7-OH-CBD, as demonstrated in vitro. However, co-administration of CBD with CYP3A4-substrate ASMs or CYP2C19 inhibitors is predicted to result in only modest increases in CBD exposure.

PMID 42728549
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