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OX

oxcarbazepine (SPN604 / SPN 804 / oxcarbazepine ER)

✓ Approved

Aequus Pharmaceuticals, Inc. · SCN1A · Small Molecule

What is oxcarbazepine?

oxcarbazepine is a small molecule developed by Aequus Pharmaceuticals, Inc.. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesSPN604, SPN 804, oxcarbazepine ER
CompanyAequus Pharmaceuticals, Inc.
Drug ClassSmall Molecule
Molecular TargetSCN1A, SCN2A, SCN3A
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Aequus Pharmaceuticals, Inc.

Mechanism of Action

Molecular Targets

oxcarbazepine acts on 3 molecular targets:

SCN1Asodium voltage-gated channel alpha subunit 1 (DEE6B, FEB3)
SCN2Asodium voltage-gated channel alpha subunit 2 (Na(v)1.2, BFNIS)
SCN3Asodium voltage-gated channel alpha subunit 3 (Nav1.3, NAC3)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

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

Therapeutic AreaConditionPhase
Nervous system disordersPartial seizures✓ Approved
Psychiatric disordersBipolar disorderPhase III

Related Research Articles

PubMedAnnals of the Child Neurology Society2026-09-17

Management Guidelines for the Treatment of Pediatric Brain Tumor-Associated Seizure: A Modified Delphi Consensus Report.

Brosius Stephanie N SN, Ta Jacky J, Gust Juliane J, Malbari Fatema F et al.

Seizures represent a significant source of morbidity for children with brain tumors. The objective of our study was to establish consensus guidelines for managing children with tumor-related epilepsy. The study team assembled a panel of 18 child neurologists specializing in neurological complications of brain tumors including neuro-oncologists, general neurologists, and epileptologists. We utilized a modified Delphi consensus-building methodology that started with a systematic review of literature and a closed-ended survey to address the major issues the team felt was essential for the treatment of seizures in pediatric brain tumor patients. Measures of central tendency and percentage of agreement and disagreement were calculated for each question. A second survey was sent with the modal response and one or two additional frequent responses. Modifications were also made to address panelists' suggestions for clarification of the questions. Consensus was defined a priori as > 75% panelist agreement. The majority response was defined as 50%-75% agreement. Respondents universally agreed to start a patient on anti-seizure medication (ASM) only after their first seizure, with levetiracetam as the first-line and lacosamide or oxcarbazepine as the second-line. Consensus was reached for when ASM should be weaned for patients in different scenarios. Electroencephalography (EEG) should be considered prior to weaning medication if the initial EEG was abnormal. Finally, the presence of cortical dysplasia or mesial temporal sclerosis should prompt an upfront epilepsy surgery evaluation. This study yielded guidelines for pediatric brain tumor-related epilepsy established from the opinions of child neurologists specializing in the care of these patients.

PMID 42751278
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PubMedScientific reports2026-09-16

Validated stability indicating reverse phase liquid chromatography method for oxcarbazepine and its degradation products with greenness evaluation.

Mestareehi Aktham A

Oxcarbazepine is a widely prescribed anticonvulsant used in the management of epilepsy through modulation of abnormal neuronal excitability. The objective of the present study was to synthesize oxcarbazepine in the laboratory and develop a reliable, stability-indicating, and environmentally conscious reverse-phase high-performance liquid chromatography (RP-HPLC) method for its quality assessment, including the quantification of impurities and degradation products. Oxcarbazepine was synthesized and characterized using infrared spectroscopy (IR), nuclear magnetic resonance (NMR), and high-performance liquid chromatography (HPLC) techniques. Chromatographic separation was achieved using a Supelco Discovery C18 column (4.6 × 250 mm, 5 µm) with a mobile phase consisting of 75% potassium phosphate monobasic buffer (pH 5.0) and 25% acetonitrile at a flow rate of 1.0 mL/min. Detection was performed at 257 nm, and oxcarbazepine exhibited a retention time of approximately 11 min. The developed RP-HPLC method was validated according to ICH, USP, and FDA guidelines. Forced degradation studies were conducted under acidic, basic, oxidative, thermal, and photolytic conditions to evaluate the stability-indicating capability of the method. In addition, the environmental impact of the analytical procedure was assessed using Green Analytical Chemistry (GAC) metrics, including the Analytical Eco-Scale, GAPI, and AGREE tools. The developed method demonstrated excellent specificity, linearity, accuracy, precision, robustness, and sensitivity. All degradation products were well resolved from the parent oxcarbazepine peak, confirming the stability-indicating nature of the method. Excellent linearity was observed over the concentration range of 0.24-2000 ppm with a correlation coefficient (R2) of 0.9995. Accuracy values ranged from 99.4% to 101.5%, while the limit of detection (LOD) and limit of quantification (LOQ) were 0.3 ppm and 0.9 ppm, respectively, indicating high sensitivity suitable for trace-level analysis. Robustness studies confirmed the reliability of the method under deliberate variations in chromatographic conditions. Furthermore, greenness assessment revealed an Analytical Eco-Scale score of approximately 75, a GAPI pictogram with predominantly green and yellow zones, and an AGREE score of 0.57/1.0, indicating moderate environmental friendliness. Overall, the validated RP-HPLC method provides a reliable, precise, sensitive, stability-indicating, and environmentally conscious analytical approach for routine quality control, impurity profiling, and stability studies of oxcarbazepine in raw materials and pharmaceutical formulations.

PMID 42744857
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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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PubMedNutricion hospitalaria2026-09-07

[Management of syndrome of inappropriate antidiuretic hormone secretion in outpatients].

Fernández Jiménez Juan J

the syndrome of inappropriate antidiuretic hormone secretion (SIADH) is the most frequent cause of hyponatremia in the outpatient setting, presenting significant diagnostic and therapeutic challenges due to the difficulty of performing laboratory monitoring and poor patient compliance with fluid restriction. we report the case of an institutionalized and polymedicated 59-year-old male, with a history of congenital epilepsy, who developed moderate euvolemic hyponatremia ([Na+] 124 mEq/l) secondary to oxcarbazepine therapy. Given the risk of a progressive decline in serum sodium, treatment with oral urea (30 g/day) was initiated, achieving a controlled and progressive increase in natremia to safe limits (133 mEq/l), even before the withdrawal of the culprit drug. Following the subsequent discontinuation of oxcarbazepine by neurology, natremia fully normalized ([Na+] 138 mEq/l), allowing a successful withdrawal of urea. oral urea stands out as the only fully effective, safe, and well-tolerated medium- and long-term therapeutic strategy available for managing outpatient SIADH.

PMID 42704005
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PubMedNeurology2026-09-03

Gestational Changes in Antiseizure Medication Concentrations and the Impact of Polytherapy: A Prospective Multicenter Cohort Study in China.

Duan Yifei Y, Huang Sikai S, Sha Leihao L, Fu Yutong Y et al.

Pregnancy alters the pharmacokinetics of antiseizure medications (ASMs). The aim of this study was to quantify gestational changes in ASM concentrations and identify independent covariates among women with epilepsy in China. In this prospective, multicenter observational cohort study in China, women with epilepsy aged 18-45 years were enrolled and followed longitudinally. Steady-state trough ASM concentrations were measured, with concentration-to-dose (C/D) ratio as the primary pharmacokinetic parameter. Linear mixed-effects models with model averaging were used to evaluate the independent effects of gestational age, concomitant ASMs, and demographic covariates on ASM C/D ratios. A total of 947 women were included and contributed 1,638 samples between 2019 and 2025, including 1,187 samples collected during nonpregnant periods (821 women, mean age 29.31 ± 8.38 years) and 451 during pregnancy (228 women, mean age 28.67 ± 4.30 years), with 64.3% receiving polytherapy. Lamotrigine exhibited the greatest gestational effect, with C/D ratios declining by 28.8% (β = -0.339; 95% CI -0.508 to -0.339; p < 0.001), 54.3% (β = -0.784; 95% CI -0.938 to -0.629; p < 0.001), and 63.2% (β = -1.001; 95% CI -1.192 to -0.809; p < 0.001) in the first, second, and third trimesters, respectively, reaching a nadir of -65.8% at 32 weeks. Levetiracetam declined by 26.2% (β = -0.303; 95% CI -0.446 to -0.160; p < 0.001), 40.1% (β = -0.512; 95% CI -0.645 to -0.379; p < 0.001), and 31.0% (β = -0.371; 95% CI -0.525 to -0.217; p < 0.001), reaching a nadir of -35.5% at 24 weeks. The metabolite of oxcarbazepine declined by 23.1% (β = -0.262; 95% CI -0.373 to -0.152; p < 0.001), 32.6% (β = -0.394; 95% CI -0.489 to -0.299; p < 0.001), and 44.3% (β = -0.585; 95% CI -0.695 to -0.475; p < 0.001). Lacosamide significantly decreased in the second trimester (-10.8%; β = -0.207; 95% CI -0.399 to -0.014; p = 0.035). Perampanel showed an increasing trend but was limited by sample and polytherapy. Concomitant ASMs primarily shifted baseline C/D ratios without altering gestational changes, and several drug-drug interactions were identified. Higher body weight was associated with lower C/D ratios for most ASMs, except for perampanel. Interindividual variability remained the dominant factor determining C/D ratios over measured covariates. Pregnancy was the primary driver of declining C/D ratios, and concomitant ASMs and body weight acted as secondary modifiers. These findings support individual therapeutic drug monitoring. ChiCTR2100046318 (Chinese Clinical Trial Registry, chictr.org.cn).

PMID 42685297
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PubMedCureus2026-09-02

Movement-Provoked Paroxysmal Neuralgia Following Longitudinally Extensive Transverse Myelitis in Neuromyelitis Optica Spectrum Disorder: A Presumed Ephaptic Spinal Cord Phenomenon.

Philips Angela A, Sosa De La Cruz Johan J, Ungerer Robert R, Betha Prudvi Tarun PT

Neuromyelitis optica spectrum disorder (NMOSD) is an autoimmune astrocytopathy frequently complicated by neuropathic pain. Paroxysmal symptoms likely arise from ephaptic transmission within demyelinated spinal cord tracts and are underdescribed when presenting as isolated sensory phenomena, unlike the well-characterized tonic spasms. We report a 76-year-old woman with aquaporin-4 (AQP4) antibody-positive NMOSD recovering from her first disease flare, which initially manifested as longitudinally extensive transverse myelitis (LETM). Weeks later, she developed sudden, excruciating, movement-provoked paroxysmal burning pain in the lower extremities. Episodes lasted 4-8 seconds and occurred approximately 20 times daily. Serial neurologic examinations revealed no new deficits suggestive of relapse, and repeat MRI was deferred as relapse was considered clinically unlikely. Symptoms were refractory to gabapentin but improved dramatically within 24 hours of initiating oxcarbazepine 300 mg twice daily. The clinical phenotype and rapid response to sodium channel blockade support a sodium channel-mediated mechanism, most likely ephaptic transmission, rather than trigger-independent ectopic firing, which remains sparsely described in the literature. Recognition of this phenomenon is crucial to avoid misclassification as relapse, unnecessary imaging, and unwarranted escalation of immunotherapy.

PMID 42683220
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