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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

PubMedZhonghua er bi yan hou tou jing wai ke za zhi = Chinese journal of otorhinolaryngology head and neck surgery2026-11-11

[Clinical characteristics and comprehensive management strategies for vestibular migraine and recurrent vertigo of childhood].

Guo Z Q ZQ, Shi S Y SY, Zhang X X, Chen J Y JY et al.

Objective: To investigate the clinical characteristics and audio-vestibular features of vestibular migraine of childhood (VMC), probable VMC (PVMC), and recurrent vertigo of childhood (RVC), to analyze factors influencing attack frequency and quality of life, and to preliminarily evaluate the effectiveness of comprehensive management. Methods: A retrospective cohort of 45 VMC, 16 PVMC, and 9 RVC cases were enrolled. Univariate and multivariate logistic regression analyses identified factors influencing high attack frequency (≥5 attacks/month). All patients received baseline treatment (lifestyle modification and management of comorbidities). Additional medications (topiramate, propranolol, or flunarizine) were selected based on attack frequency. Efficacy was assessed using visual analog scale (VAS) and the degree of life impact. Results: The manifestations of vertigo are diverse in VMC and PVMC, but uniform in RVC. The proportion of high attack frequency (46.7%) were significantly higher in the VMC group than that in the PVMC group (6.3%) and RVC group (0%). Cochlear symptoms were common, primarily tinnitus (27.1%) and hearing loss (17.1%). Hearing loss was mild to moderate, affecting low-, mid- and high-frequency hearing thresholds. Most patients exhibited central vestibular dysfunction, with the highest abnormality rate observed in the vestibular autorotation test (60%). Multivariate analysis revealed that high attack frequency was independently influenced by disease type, duration, and age at onset, and was the strongest predictor of reduced quality of life. Basic treatment combined with topiramate significantly improved VAS scores for dizziness and headache as well as the degree of life impact, followed by propranolol and flunarizine. Conclusion: Central vestibular dysfunction is a prominent feature in Chinese pediatric VMC/PVMC and RVC patients, with cochlear symptoms being common. Attack frequency is mainly influenced by disease type and disease duration, and the comprehensive management strategy based on attack frequency demonstrates clinical feasibility.

PMID 43010816
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PubMedJournal of mass spectrometry and advances in the clinical lab2026-11-11

A Multiplex LC-MS/MS Approach for Quantifying Antiepileptic Drugs for Therapeutic Drug Monitoring: Validation of 15 Representative Tests.

Tang Xiaoying X, Wei Ruhan R, Chegwidden Emily E, Giles Richard R et al.

Therapeutic drug monitoring of antiepileptic drugs is critical for optimizing clinical outcomes, minimizing toxicity, assessing drug compliance, and managing overdoses and drug interactions. We developed and validated an LC-MS/MS method for the quantification of 15 antiepileptic drugs (ethosuximide, primidone, pentobarbital, carbamazepine-10,11 epoxide, pregabalin, gabapentin, zonisamide, lacosamide, rufinamide, felbamate, lamotrigine, topiramate, 10,11-dihydro-10-hydroxycarbamazepine, perampanel, and brivaracetam). Antiepileptic drugs were extracted from plasma and serum using methanol-based protein precipitation, followed by dilution. A commercial ClinCal® 3-point calibrator was used for all analytes except pentobarbital, which used a 6-point in-house calibrator. Chromatographic separation was achieved using a reverse-phase C18 column with a 7.31 min elution gradient of water and methanol, both containing 2 mM of ammonium acetate. All analytes required a 5 µL injection volume, except ethosuximide and pentobarbital, which required 20 µL and 10 µL, respectively, for optimal performance. The method demonstrated excellent linearity for all 15 antiepileptic drugs within their respective concentration ranges, with acceptable selectivity, accuracy (80.0-118.3%), and intraday and interassay precision (CV < 7.4%). Stability studies showed that antiepileptic drugs were stable in serum and plasma for up to 24 h at room temperature, 7 days at 4 °C, and 30 days at -20 °C, and after extraction for 7 days at 4 °C. This LC-MS/MS method supports routine quantification of 15 antiepileptic drugs in a clinical laboratory using a common sample preparation and chromatography workflow across all measurements. It was operationalized into three instrument methods to accommodate the different injection volume and calibrator requirements.

PMID 43011968
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PubMedTherapeutic advances in psychopharmacology2026-11-10

Repurposing incretin-based therapies for alcohol use disorder: a systematic review of efficacy and safety relative to standard pharmacotherapies in a recent comparative context.

Alevizopoulos Aristomenis G AG, Vasilakos Vasileios V, Kritikos Iakovos I, Alevizopoulou Maria M et al.

Alcohol use disorder (AUD) affects millions worldwide, but current treatments, such as disulfiram, naltrexone, acamprosate, and topiramate, have limitations in efficacy and tolerability. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs), commonly used for diabetes and obesity, may offer a new approach by targeting brain pathways involved in alcohol cravings. This review aims to systematically evaluate the preliminary efficacy and safety of GLP-1 RAs and other incretin-based therapies in treating AUD within a recent comparative context, alongside standard pharmacotherapies. Systematic review. A comprehensive literature review was conducted by searching the PubMed/Medline, Web of Science, and Scopus databases from February through June 2025. The studies included were either randomized controlled trials (RCTs) or observational studies, written in English. Studies were selected based on their evaluation of GLP-1 RAs or comparator drugs in reducing alcohol consumption or related outcomes in patients with AUD. The selected 12 studies correspond to a population of 95,004 participants, but only 663 were from RCTs, while the majority were from a single registry cohort. Emerging data suggest GLP-1 RAs may reduce heavy drinking days, particularly in individuals with a higher BMI. Furthermore, observational analyses indicate a potential association between GLP-1 RA use and reduced alcohol-related hospitalizations, while metabolic data suggest biologically plausible, albeit unconfirmed, hepatoprotective effects. While the large, aggregated sample size highlights the therapeutic promise of GLP-1 RAs for AUD, particularly for patients with metabolic comorbidities, the heavy reliance on observational data precludes claims of clinical equivalence with established pharmacotherapies. Appropriately powered, dedicated RCTs are required to confirm direct efficacy and long-term safety. Not registered.

PMID 43005319
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PubMedHealth care science2026-11-08

Bridging the Gap in Headache Care: Insights From the International Headache Society Survey in Nepal.

Ojha Rajeev R, Ma Jinjin J, Chapagain Abhisekh A, Timasina Ravi Raj RR et al.

Headache disorders impose a substantial public health burden worldwide, with low- and middle-income countries like Nepal facing pronounced challenges due to limited healthcare infrastructure, inadequate provider training, and restricted access to essential treatments. This study aimed to assess the current state of headache care in Nepal, focusing on the distribution and training of healthcare providers, access to medications, and socioeconomic factors that affect treatment adherence. A cross-sectional survey was conducted as part of a multinational joint initiative by the International Headache Society and Middle East, North Africa and Asia Headache Group. Data were collected from 232 healthcare providers across Nepal using a survey questionnaire. Descriptive and comparative analyses assessed geographic disparities, medication accessibility, and provider preparedness. Most healthcare providers were concentrated in urban centers, with 80.2% reporting some form of training in headache care. However, training gaps persisted among rural and non-specialist providers. Overall, 72.0% of healthcare providers reported that their patients had to pay to access medications, while the median provider-estimated proportion of patients unable to afford medications was 40.0% (20.0%-60.0%). Access to migraine-specific therapies, such as triptans, topiramate, and amitriptyline, was substantially lower in rural areas. Providers in urban settings reported greater medication access and specialized care, while rural providers more frequently served younger, socioeconomically disadvantaged populations with limited treatment options. This study highlights significant disparities in headache care delivery in Nepal, driven by geographic, economic, and educational barriers. Furthermore, financial and geographic barriers to effective headache treatment raise important concerns regarding health equity and patients' rights to appropriate relief from avoidable pain and disability. To bridge these gaps, national policies should prioritize structured headache training, ensure essential headache medications are included in public formularies, and deploy telemedicine-based models in underserved regions.

PMID 42999663
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PubMedJournal of medical economics2026-11-06

Cost-effectiveness of onabotulinumtoxinA versus topiramate in chronic migraine in the US: an economic analysis of the FORWARD randomized trial.

Ronquest Naoko N, Zhang Yiwei Y, Park Tae Jin TJ, Campbell Kelly K et al.

Assess the cost-effectiveness of onabotulinumtoxinA (OnabotA) versus topiramate for the preventive treatment of chronic migraine in US adult patients from a payer perspective. A multistate Markov model evaluated the incremental costs per headache-day avoided and quality adjusted life-year (QALY) over a 2-year period in patients treated with OnabotA versus topiramate. The FORWARD trial data informed model inputs, including reductions in headache-days, while patients receive OnabotA/topiramate. Treatment discontinuation for topiramate was modeled with data from FORWARD and a randomized controlled trial (RCT) to test a range of values for topiramate. Costs of drug acquisition, administration, and monitoring were calculated from prescribing information and physician fee schedules. The model estimated costs of healthcare resource utilization (HCRU) and acute migraine treatment by response level. Sensitivity and scenario analyses explored cost drivers and assessed model robustness. Our model estimated that OnabotA-treated patients experience 122.56 fewer headache-days (0.34 years) than topiramate-treated patients over the 2-year time horizon. With an incremental cost of $4,639, the incremental cost per headache-day avoided was ∼ $37.85/day, and the incremental cost per QALY gained was $63,646. The estimated cost per avoided headache-day was less than half for patients treated with OnabotA in comparison with topiramate ($116 vs. $246). Sensitivity analyses showed that the incremental cost per headache-day avoided remained below $50 and the incremental cost per QALY gained remained below $100,000 across all tested ranges. Results were similar when using a lower, RCT-supported discontinuation rate for topiramate. In scenario analyses, a longer time horizon and a greater price discount for OnabotA substantially reduced the incremental cost-effectiveness ratios. OnabotA was a cost-effective preventive treatment of chronic migraine versus topiramate. Although OnabotA had higher drug acquisition costs, these were offset by reduced HCRU costs due to fewer migraines, resulting in a low incremental cost per headache-day avoided versus topiramate.

PMID 42989979
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PubMedKidney medicine2026-11-06

Topiramate-Induced Fanconi Syndrome: A Case Report.

Berlinkova Daniela D, Rohatgi Ria R, Rohatgi Rajeev R, Jiatu Angela Z AZ

Topiramate (TPM), originally approved in 1996 for epilepsy, is now widely administered to prevent migraines, induce weight loss, and suppress alcohol cravings. Common renal adverse side effects include metabolic acidosis and nephrolithiasis; however, acute kidney injury (AKI) is uncommon or underreported. In this report, we present a case of a 41-year-old man with a history of hypertension, obesity, tonic-clonic seizures, and migraines who developed AKI associated with Fanconi syndrome while administered TPM 100 mg daily for migraine prevention. The Naranjo Adverse Drug Reaction Probability Scale, a measure of the likelihood that a drug is causing an adverse reaction, indicated that TPM probably (score of 8) caused AKI with Fanconi syndrome. After supportive therapy and drug cessation the patient's kidney function normalized and the Fanconi syndrome resolved. This case is important for several reasons: (1) this is the third case of AKI and second case associated with Fanconi syndrome, which implies a relationship with TPM, (2) the cases illustrate that early recognition and discontinuation of TPM resolves AKI, and (3) common elements between the cases relay plausible risk factors. Thus, clinicians who prescribe TPM should consider monitoring patients for AKI and electrolyte abnormalities.

PMID 42991482
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