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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

PubMedDrug and alcohol dependence2026-10-15

Nationwide trends of six medications for alcohol use disorder prescriptions post-discharge in patients hospitalized with alcohol-associated liver disease between 2015 and 2024.

Chan Shu-Yen SY, Yeo Yee Hui YH, Yang Hsien Yao HY, Zhang Wei W et al.

Alcohol associated liver disease (ALD) carries a high risk of hospitalization and recidivism, yet post-discharge medications for alcohol use disorder (MAUD) are not universally prescribed. MAUD prescriptions have been associated with reduced recidivism and hepatic decompensation. However, national data on prescribing patterns is limited. We examined ten-year trends in six MAUD prescriptions after hospitalization for ALD. We identified 150,241 US adults hospitalized with ALD between 2015 and 2024 using electronic health records from TriNetX. Outcomes included annual prevalence, incidence rate, and incidence proportion of post-discharge MAUD prescriptions. FDA-approved agents included disulfiram, acamprosate, and naltrexone; off-label agents included topiramate, baclofen, and gabapentin. Trends were assessed using Joinpoint regression with annual percentage change (APC) and average annual percentage change (AAPC). Subgroup analyses were stratified by cirrhosis status and sex. FDA-approved MAUD had consistently lower prescription rates than off-label agents over the past decade. From 2015-2024, disulfiram was the only FDA-approved agent with a declining trend, while acamprosate (AAPC 20.35%) and naltrexone (AAPC 17.83%) demonstrated significant increases for new prescriptions. By 2024, the prevalence of FDA-approved and off-label MAUD prescriptions were 17.98% and 41.96%, respectively. Patients with cirrhosis had lower prescribing rates but exhibited greater relative increases in FDA-approved MAUD prescriptions. Women were more likely to receive off-label prescriptions, though both sexes showed similar upward trends. Post-discharge MAUD prescribing for ALD has risen significantly, but less than 20% of patients receive FDA-approved MAUD. Expanding access to evidence-based medications is critical to improve outcomes in this high-risk population.

PMID 42879917
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PubMedDrug design, development and therapy2026-10-14

Oral Obesity Medicines in the Era of Cardiovascular-Kidney-Metabolic Syndrome (CKM): Beyond Weight Loss Toward Disease Modification.

Alhazmi Abdulhameed A, Le Roux Carel W CW

Obesity is a major driver of Cardiovascular-Kidney-Metabolic (CKM) syndrome and contributes to the development of atherosclerotic cardiovascular disease, heart failure, atrial fibrillation, chronic kidney disease, and type 2 diabetes. Historically, oral obesity pharmacotherapy was evaluated primarily according to weight loss efficacy. However, the emergence of the CKM framework has shifted therapeutic priorities toward modifying obesity related complications and improving long term clinical outcomes. This review summarizes currently approved oral obesity medications, including first generation agents (orlistat, phentermine/topiramate, and naltrexone/bupropion) and second generation incretin-based therapies (oral semaglutide and orforglipron), within the context of CKM syndrome. First generation agents provide modest-to-moderate weight loss and variable metabolic benefits, but evidence supporting cardiovascular or kidney outcome improvement remains limited and largely observational. In contrast, oral incretin-based therapies demonstrate broader effects across the CKM spectrum, including substantial weight reduction, improved glycemic control, favorable effects on blood pressure and triglycerides, and emerging kidney benefits. Among currently available oral agents, oral semaglutide has the strongest evidence, with the SOUL trial demonstrating a reduction in major adverse cardiovascular events in high-risk individuals with type 2 diabetes. Signals suggesting benefits in heart failure and atrial fibrillation are encouraging but remain exploratory. Orforglipron represents the first non-peptide oral glucagon-like peptide-1 receptor agonist and offers simplified administration with promising metabolic efficacy; however, cardiovascular, kidney, heart failure, and arrhythmia outcome data are still awaited. Collectively, the role of oral obesity pharmacotherapy is evolving from weight management alone toward comprehensive CKM care.

PMID 42871841
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PubMedFrontiers in pain research (Lausanne, Switzerland)2026-10-09

Comparative effectiveness and safety of topiramate versus amitriptyline for the prophylactic management of chronic migraine: a prospective comparative study.

Karami Mohammed Matoog MM, Hassan Amber A, Alkhotani Amal A, Basheikh Mazen M et al.

Chronic migraine is a chronic disabling neurological disease and has a significant impact on quality of life. Topiramate and amitriptyline are commonly used for migraine prevention, but treatment decisions should consider their effectiveness and safety profiles. This study aimed to compare the effectiveness and safety of topiramate and amitriptyline in chronic migraine. We conducted a quasi-experimental study at a specialised healthcare facility in Lahore, Pakistan, over a one-year period from March 2023 to March 2024. A total of 330 patients meeting the ICHD-3 criteria for chronic migraine were enrolled, including group (a) 165 patients treated with topiramate and group (b) 165 treated with amitriptyline. We used monthly headache frequency and the Headache Impact Test-6 (HIT-6) score to measure headache frequency and headache-related disability at baseline and at Weeks 4, 8, and 12. Adverse events were noted during the study period. We analysed the data using independent-samples t-tests, paired-samples t-tests, and the Chi-Square test, respectively. The mean age of both groups (a) and (b) was 32.37 ± 8.48 years and 34.49 ± 9.02 years, respectively. Both treatments effectively decreased headache frequency and HIT-6 scores during the 12-week follow-up. Mean headache frequency was significantly reduced in group (a) vs. group (b) at week 12 (0.85 ± 0.63 vs. 1.22 ± 0.81 headache days per month, respectively, p < 0.001). Similarly, at Week 12, the mean HIT-6 score was significantly lower in the topiramate group than in the amitriptyline group (49.58 ± 6.16 vs. 51.64 ± 5.94, respectively; p = 0.002). Overall headache frequency decreased from 20.39 ± 4.23 episodes/month at baseline to 1.03 ± 0.75 episodes/month at week 12 (p < 0.001), while HIT-6 scores decreased from 68.14 ± 4.44 to 50.61 ± 6.13 (p < 0.001). Adverse events were reported in 25.5% of the patients taking topiramate and 35.8% of the patients taking amitriptyline (p = 0.042). Topiramate and amitriptyline both were effective in decreasing headache frequency and headache-related disability among chronic migraine patients. Topiramate was slightly more effective and better tolerated than amitriptyline.

PMID 42851587
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PubMedAlcohol and alcoholism (Oxford, Oxfordshire)2026-10-05

Pharmacological interventions for alcohol use disorder on quality of life: a meta-analysis of randomized controlled trials.

Fluyau Dimy D, Revadigar Neelambika N, Kim Paul P

Quality of life (QoL), a critical factor for sustaining recovery from alcohol use disorder (AUD), has been examined as an AUD-related outcome in randomized controlled trials (RCTs) that evaluated pharmacotherapy for AUD. This review evaluates the efficacy of this therapy in improving mental and physical health-related QoL. RCTs were identified across seven databases. Study quality was evaluated using the Cochrane risk-of-bias tool for randomized trials version 2. A systematic review with meta-analysis was conducted. The review adhered to Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines and was registered with PROSPERO (CRD420261277890). Eighteen RCTs with 4376 participants were evaluated. Naltrexone was linked to improvements in both mental QoL (d = 0.30, 95% CI: 0.08-0.52) and physical QoL (d = 0.16, 95% CI: 0.01-0.31). Nalmefene improved physical QoL (d = 0.13, 95% CI: 0.02-0.25) but not mental QoL (d = 0.18, 95% CI: -0.004 to 0.354). Topiramate showed no improvement in either domain. However, further analysis indicated that topiramate was associated with a small improvement in physical QoL, which could correlate with a reduced percentage of heavy drinking days. Interpret these findings with caution. Acamprosate, sertraline, and psilocybin were associated with improved mental or physical QoL, whereas ketamine, varenicline, levetiracetam XR, and quetiapine were not. Interpretation is limited to single trials-no eligible RCTs reporting the specified QoL outcomes for disulfiram. Certain medications for AUD are linked with improved mental and physical QoL, but evidence remains limited. Future RCTs should assess QoL and establish whether improvements are clinically meaningful.

PMID 42831801
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PubMedACS pharmacology & translational science2026-10-04

Topiramate Impairs Spermatogenesis, Sperm Parameters, and Epididymal Duct Contractility in Rats.

de Sena Maele Oliveira MO, da Silva Maria Santana MS, Carvalho Yanka do Vale YDV, Cunha Chaves Herick Jose HJ et al.

Topiramate is a widely prescribed antiepileptic drug with a multimodal mechanism of action. However, its effects on male reproductive function remain poorly characterized. This study was conducted to investigate the impact of this drug on testicular and epididymal function in adult male Wistar rats. Animals were treated orally for 21 days with topiramate at 40 or 160 mg/kg. Serum testosterone levels, testicular histomorphology, spermatogenic indices, sperm parameters, and epididymal duct contractility were subsequently evaluated. The treatment did not alter serum testosterone levels at either dose. However, both doses reduced Sertoli cell and round spermatid numbers, increased primary spermatocyte counts, and decreased meiotic and overall spermatogenic yields, whereas only the higher dose (160 mg/kg) reduced Sertoli cell efficiency and daily sperm production. The lower dose (40 mg/kg) increased sperm morphological abnormalities, whereas the higher dose reduced total and progressive sperm motility and induced both head and tail defects. Additionally, treatment with topiramate at 160 mg/kg prolonged sperm transit time in the cauda epididymis and reduced contractile responses of the distal cauda epididymal duct to KCl, noradrenaline, and carbachol, suggesting impaired epididymal transport and potential ejaculatory dysfunction. Altogether, these findings demonstrate that topiramate adversely affects male reproductive function. Given its widespread use in individuals of reproductive age, these results underscore the need for translational studies in humans to assess potential reproductive risks associated with this therapy.

PMID 42828368
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PubMedAlcohol and alcoholism (Oxford, Oxfordshire)2026-10-01

Polygenic risk scores as predictors of topiramate's effect in treating alcohol use disorder.

Arias Albert J AJ, Siegel Carole C, Laska Eugene E, Wanderling Joseph J et al.

Topiramate is efficacious for treating alcohol use disorder (AUD), but treatment response varies considerably. To advance precision treatment, we used machine-learning methods integrating clinical trial and genetic data to estimate expected response to topiramate. Random forest (RF) regression models were used to estimate expected topiramate response using randomized clinical trial data from 278 participants and 23 pre-treatment features: four alcohol polygenic risk scores (PRS), nine alcohol drinking measures, and 10 clinical and sociodemographic variables. RF importance scores quantified each feature's contribution to predictive performance. Likely Responders (LRs) were identified using quintiles of predicted treatment response and counterfactual placebo response, with LRs defined as quintiles in which randomized trial data demonstrated topiramate superiority over placebo. Variable Selection Using Random Forests (VSURF) was used to eliminate less informative and redundant predictors. Two pre-treatment drinking measures consistently had the highest importance scores across all VSURF levels. The final parsimonious model retained three predictors: average drinks per day, percent heavy drinking days, and the PRS for "Time Until Relapse," with bias-corrected R2 = 0.30. LRs comprised the top four predicted response quintiles (80% of the sample) across models. Compared with unlikely responders, LRs had lower baseline drinking severity and higher "Time Until Relapse" PRS. The "Time Until Relapse" PRS contributed meaningfully to estimating expected response, LR stratification, and observed topiramate treatment effects, although pre-treatment drinking measures remained the strongest predictors. These findings support incorporation of pharmacogenomic markers into machine-learning models to advance precision prescribing for AUD.

PMID 42822858
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