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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

PubMedPharmaceuticals (Basel, Switzerland)2026-08-27

Volumetric Absorptive Microsampling (VAMS) for Therapeutic Drug Monitoring of Antiseizure Medications (ASMs) in Pediatric Patients.

Simeoli Raffaele R, Mancini Alessandro A, Cairoli Sara S, Rossi Chiara C et al.

Background: Volumetric absorptive microsampling (VAMS) is an emerging tool for therapeutic drug monitoring (TDM) of several drugs including antiseizure medications (ASMs). Here, we compared the concentrations of carbamazepine (CBZ), levetiracetam (LEV), lacosamide (LCS), topiramate (TPR) and the benzodiazepine (BZ) clobazam (CLB) in plasma and VAMS samples. Methods: VAMS samples were collected by fingerprick in pediatric patients followed at our center. Patients were also subjected to conventional venous blood sampling. Plasma and VAMS samples were analyzed by using a UHPLC-MS/MS validated kit for AEs and BZs (ClinMass LC-MS/MS Complete Kit®). A cross-validation analysis was performed by using Spearman correlation (rho), Deming regression and Bland-Altman plots. Results: Two analytical methods for measuring selected AEs and BZs in VAMS samples were developed and validated in accordance with the ICH M10 guidelines. Based on Bland-Altman results, a satisfactory agreement was observed between VAMS and plasma for CBZ, LCS, TPR, LEV and N-CLB. Considering the absence of interchangeability between capillary blood and plasma levels for CBZ-Diol, -Epoxi and CLB, a blood to plasma ratio was used to convert VAMS values into estimated plasma concentrations. Comparison of estimated vs. observed plasma results showed a successful predictive performance for this conversion approach. Conclusions: A positive agreement between plasma and VAMS was found for CBZ, LCS, TPR, LEV and N-CLB. Conversely, a conversion factor based on blood to plasma ratio should be adopted to convert CBZ-Diol, -Epoxi and CLB VAMS results into estimated plasma concentrations. This study confirmed the utility of VAMS for TDM of selected ASMs in pediatric patients during routine clinical practice.

PMID 42653685
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PubMedMedicina (Kaunas, Lithuania)2026-08-27

Therapeutic Potential of Anti-Obesity Drugs in Obesity-Associated Female Reproductive Dysfunction: Translating Mechanistic Evidence into Personalized Clinical Strategies.

Varra Fani-Niki FN, Theodosis-Nobelos Panagiotis P, Varra Viktoria-Konstantina VK, Varras Michail M

Obesity is a multifactorial condition that profoundly affects female reproductive health through endocrine, metabolic, and inflammatory mechanisms that disrupt the hypothalamic-pituitary-gonadal (HPG) axis. Women with obesity frequently develop menstrual irregularities, anovulation, amenorrhea, infertility, polycystic ovary syndrome (PCOS), impaired endometrial receptivity, and adverse pregnancy outcomes. Central obesity and insulin resistance contribute to hyperinsulinemia, reduced sex hormone-binding globulin (SHBG) levels, hyperandrogenism, altered gonadotropin secretion, and impaired folliculogenesis, while adipokines such as leptin and chronic inflammation further impair ovarian steroidogenesis and ovulatory function. Obesity-related oxidative stress and lipotoxicity also negatively affect oocyte quality, embryo development, implantation, and assisted reproductive technology outcomes, increasing the risk of gestational diabetes, preeclampsia, miscarriage, and preterm birth. This review evaluates the therapeutic potential of pharmacological weight-loss therapies in obesity-associated female reproductive dysfunction. A comprehensive literature review was conducted using various databases, focusing on anti-obesity pharmacotherapy on obesity, infertility and fertility in reproductive-aged women. Evidence suggests that several FDA-approved and off-label anti-obesity agents, including orlistat, liraglutide, semaglutide, phentermine/topiramate, bupropion/naltrexone, metformin, exenatide, and tirzepatide, may improve reproductive outcomes primarily indirectly through weight reduction and metabolic improvement. GLP-1 receptor agonists, particularly liraglutide, semaglutide, and exenatide, appear especially promising, demonstrating beneficial effects on insulin sensitivity, menstrual regularity, ovulation, androgen levels, and pregnancy rates in women with PCOS. Tirzepatide, a dual GLP-1/GIP receptor agonist, has shown potent weight-loss and metabolic effects with potential indirect fertility benefits. Metformin improves insulin sensitivity and is widely used in PCOS to regulate androgen levels and restore ovulation, although its effects on pregnancy and live birth rates remain controversial. However, evidence for several agents remains limited, and concerns persist regarding reproductive safety during pregnancy. Overall, anti-obesity pharmacotherapy may represent an important adjunctive strategy for improving reproductive and metabolic health in women with obesity, although larger randomized clinical trials are still required.

PMID 42654342
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PubMedFrontiers in neurology2026-08-26

Treatment patterns and access among people with epilepsy of childbearing potential in Peru.

Allen Samantha E SE, Wardle Melissa T MT, Moyano Luz M LM, Vilchez Percy P et al.

People with epilepsy of childbearing potential in low-resource settings face unique challenges related to anti-seizure medication (ASM) selection and access. These challenges may be particularly pronounced in regions where neurocysticercosis (NCC), a leading cause of acquired epilepsy worldwide, contributes substantially to the burden of disease. We characterized ASM prescribing patterns and factors associated with the use of higher-risk medications among people with epilepsy of childbearing potential in northern Peru. We analyzed data from females aged 15-49 years who were enrolled in a prospective, population-based epilepsy cohort in Tumbes, Peru, from 2006 to 2020. ASMs were categorized according to pregnancy-associated safety profiles as Lower-risk (lamotrigine, levetiracetam, oxcarbazepine, clonazepam, diazepam), Intermediate-High risk (carbamazepine, phenytoin, phenobarbital, topiramate), and Highest-risk (valproic acid). We evaluated ASM utilization, polytherapy, and factors associated with valproate use, the highest-risk medication. Among 1,975 individuals with epilepsy, 685 were of childbearing potential. Approximately one-third met criteria for probable or definite NCC (34.9%). Nearly all participants (98.6%) were prescribed carbamazepine, phenytoin, phenobarbital, or valproic acid, while use of newer-generation agents was rare. Most prescriptions (86.3%) were classified as Intermediate-High-risk, and 12.8% as Highest-risk. In multivariable analyses, prior ASM use and polytherapy were independently associated with receipt of valproate. In this population-based epilepsy cohort from northern Peru, ASM treatment among people of childbearing potential was overwhelmingly limited to older medications with an elevated risk of teratogenicity. These prescribing patterns likely reflect medication availability rather than clinical preference and highlight the challenges of implementing guideline-recommended epilepsy care in resource-constrained settings. Given the substantial burden of NCC-related epilepsy in this population, improving access to safer and more diverse ASM options may represent an important strategy for reducing treatment inequities among people with epilepsy of childbearing potential.

PMID 42643218
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PubMedPharmacopsychiatry2026-08-25

Mood destabilizers?: A review of mood stabilizer-associated mania.

Schwartz Shaina E SE, Hundley Allyson M AM, Chan Chak Yui M CYM, Baalmann Angela R AR

Mania is associated with significant morbidity and mortality. Mood stabilizing medications are typically used to prevent manic episodes, yet in some cases can precipitate them. The literature on this rare but potentially serious paradoxical reaction is lacking. A structured literature review was performed to identify case reports of adults experiencing manic symptoms associated with the routine use of medications with mood stabilizing properties (i.e., valproate, lithium, carbamazepine, lamotrigine, oxcarbazepine, and topiramate). A total of eight articles describing 12 unique patients were included in the analysis. The majority of patients (58%) had a previous diagnosis of bipolar spectrum disorder. The most frequent offending agent was lamotrigine (58%), followed by topiramate (33%), and carbamazepine (8%). Most patients (92%) were taking concomitant medications, mainly antipsychotics (50%) and other mood stabilizers (50%). The mean time between treatment initiation or dose escalation of the mood stabilizer and the onset of mania was 7 days. In all but two cases, the mood stabilizer was discontinued upon presentation. Improvement in symptoms was observed within a mean of 9 days following intervention. Mood stabilizer-associated mania appears to be relatively acute in onset and can be reversed by discontinuation. It commonly, but not exclusively, occurs in patients with a history of bipolar spectrum disorder who are already prescribed medications with mood stabilizing properties. In cases of new onset or worsening mania following the initiation or dose escalation of a mood stabilizer (especially lamotrigine and topiramate), this paradoxical reaction should be considered.

PMID 42641645
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PubMedEpileptic disorders : international epilepsy journal with videotape2026-08-25

The effect of antiseizure medications on the exposure to combined oral contraceptives: A systematic review and network meta-analysis.

Cohen Hagar H, Mahajna Amnah Omar AO, Ben-Shushan Tomer T, Matok Ilan I et al.

Current recommendations for prescribing combined oral contraceptives (COCs) to people with epilepsy are often conflicting, particularly for weak inducers of cytochrome P450 3A4. We aimed to critically review the literature and compare the antiseizure medication (ASM)-induced changes in exposure to COC components. In this systematic review and network meta-analysis (PROSPERO: CRD42024513792), in accordance with PRISMA 2015/2020, we searched PubMed, EMBASE, Cochrane, and FDA documents up to January 2026. Eligible studies were clinical trials assessing induction (≥ 5 days) of ethinylestradiol combined with progestins by ASMs. The areas under the concentration-time curve (AUC) of individual hormones with/without the ASM were indirectly compared. The point estimate was the standardized mean difference (SMD; significant when the 95% confidence interval does not encompass zero). Bias risk was assessed using the PKclin tool. The 17 studies (16 reports) involving 399 individuals and 15 ASMs were all conducted with COCs containing the two progestins least sensitive to enzyme induction and ≥ 30 μg ethinylestradiol. Nine ASMs were studied at doses 13-75% lower than the recommended maximum (median 50%). Brivaracetam (100 mg/day) reduced the exposure to ethinylestradiol more than 1000 mg/day levetiracetam (SMD -10; 95% confidence interval - 0.20-0). The effects of 300 mg/day lamotrigine on ethinylestradiol and levonorgestrel were greater than those of 400 mg/day lacosamide (0.18; 0.11-0.25, 0.28; 0.20-0.37). Low-dose (50 mg/day) and high-dose (200 mg/day) topiramate were comparable in their effects on ethinylestradiol and norethindrone, and the low dose did not differ from weak inducers in altering ethinylestradiol exposure. Current recommendations may underestimate ASM effects on exposure to COC components, especially those in newer COCs. Greater caution is recommended with low-dose topiramate. For individuals treated with weak COC inducers without additional contraceptive means, COCs containing levonorgestrel or norethindrone might be preferable given their lower vulnerability to induction.

PMID 42640179
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PubMedSpecial care in dentistry : official publication of the American Association of Hospital Dentists, the Academy of Dentistry for the Handicapped, and the American Society for Geriatric Dentistry2026-08-24

When Surgical Intervention Becomes a Risk: Severe Drug-Induced Gingival Overgrowth and Clinical Decision-Making in Alpers-Huttenlocher Syndrome.

Bueno Marcus Vinícius MV, Delgado Renata Zoraida Rizental RZR, Ortega Karem K, Franco Juliana Bertoldi JB

Alpers-Huttenlocher syndrome (AHS) is an ultra-rare, autosomal recessive mitochondrial encephalopathy caused by pathogenic POLG variants, characterized by refractory epilepsy, hepatic dysfunction, and progressive neurodegeneration. Drug-induced gingival overgrowth (DIGO) is a recognized complication of anticonvulsant and immunosuppressive therapy, particularly in medically complex patients. This report describes severe DIGO in a child with genetically confirmed AHS and explores the implications for multidisciplinary dental management. A CARE-compliant case analysis was conducted in a five-year-old girl with AHS, status post living-donor liver transplantation, chronically hospitalized in a long-term intensive care unit. Clinical findings, pharmacologic exposures, multidisciplinary decision-making, and conservative oral management strategies were systematically documented. The patient, ventilator-dependent and gastrostomy-fed, had prolonged exposure to phenytoin, sodium valproate, topiramate, and tacrolimus without prior dental surveillance. Examination revealed severe fibrotic maxillary gingival overgrowth, delayed tooth eruption, and functional compromise. Given her profound systemic fragility, gingivoplasty under general anesthesia was contraindicated. A structured conservative protocol including 0.12% chlorhexidine, mucosal care, and continuous dental follow-up was implemented to reduce inflammatory and infectious burden. This case underscores the necessity of integrating dental care into the multidisciplinary management of rare mitochondrial disorders and represents, to our knowledge, the first reported association between AHS and severe DIGO.

PMID 42635616
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