Drug Database
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

PubMedBritish journal of pain2026-10-12

Trigeminal neuralgia management: What are patients saying?

Grafton Paige P, Lew Kylie K, Ranalli Carlotta C, Sharma Krish K et al.

Social media offers a window into how patients with trigeminal neuralgia (TN) discuss and interpret information about treatment. We performed a qualitative analysis of publicly available posts from Reddit to characterize patient perspectives on the platform and identify potential educational gaps in TN management. Posts published between September 2, 2020, and August 15, 2025, were collected using the Python Reddit API Wrapper and coded manually for treatment, purpose (question or informational), topic, poster perspective (patient or caregiver, pre- or post-treatment), and sentiment. Among 3,627 posts, 39.3% (n = 1,424) discussed medications and 60.7% (n = 2,203) addressed surgical treatment. Surgical discussions focused on microvascular decompression (53.3%) and stereotactic radiosurgery (26.7%), with percutaneous procedures rarely mentioned (8.5%). Carbamazepine (50.4%), oxcarbazepine (16.2%), and gabapentinoids (gabapentin 14.3%; pregabalin 10.8%) were the most frequently referenced medications. Overall, 1,019 posts were questions, primarily about surgery (n = 703) and commonly by patients prior to intervention (44.2%) inquiring about outcomes (57.6%) and candidacy (28.6%). Medication questions (n = 316) were typically from users already receiving treatment (71.2%) and most often addressed side effects (40.8%) or use (32%), including dosage and drug interactions. Sentiment differed significantly between treatment types, with surgical-related posts having a higher proportion of positive sentiment (χ2 2 = 328.1, p < 0.001). Overall, patients use social media throughout the course of TN treatment to seek guidance, share experiences, and clarify management options. Limited discussion of percutaneous procedures suggests gaps in public awareness, while uncertainty about surgical eligibility highlights opportunities for improved patient education. Additionally, the predominance of negative sentiment toward medications compared with surgery on social media forums may influence treatment preferences.

PMID 42861001
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PubMedProgress in neuro-psychopharmacology & biological psychiatry2026-10-09

Comparison of the efficacy and safety of lacosamide and oxcarbazepine monotherapy in young children aged 1 month to 4 years with focal epilepsy: An ambispective cohort study based on real-world clinical practice in China.

Xiong Miao M, Yang Lu L, Zeng Qiao Q, Chen Xiaoqi X et al.

In the context of off-label use, this study aimed to compare the efficacy and safety of lacosamide (LCM) and oxcarbazepine (OXC) monotherapy in children aged 1 month to 4 years with focal epilepsy. This non-randomized, open-label, real-world study included 134 LCM-treated and 132 OXC-treated children. The primary endpoint was the 12-month efficacy rate (≥50% reduction in seizures). Mantel-Haenszel analysis and E-values controlled and assessed confounding; ANCOVA compared Gesell developmental quotients between groups. LCM efficacy rates at 3, 6, 9, and 12 months were 76.9%, 76.9%, 72.4%, and 64.9%, respectively; OXC rates were 84.1%, 87.9%, 88.6%, and 73.5%, with no significant between-group differences. At 12 months, the adjusted ORs ranged from 0.603 to 0.645, with E-values of 1.55 to 1.60. LCM improved all five Gesell domains from baseline (P < 0.05). The language domain favored LCM after baseline adjustment (difference = 2.59, P = 0.043), but this was attenuated after further adjustment. Epilepsy duration and baseline seizure frequency predicted poorer LCM response. The 12-month retention rates were 75.4% and 84.1%, and adverse event rates were 7.46% and 4.55% in the LCM and OXC groups, respectively; most events were mild. In real-world clinical practice in China, LCM monotherapy demonstrated efficacy and safety comparable to those of OXC in young children with focal epilepsy, suggesting that LCM may represent an alternative option for off-label use in this age group. Its potential benefit for language development warrants further investigation.

PMID 42855030
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PubMedFrontiers in pharmacology2026-10-07

From time-series deep learning to physics-constrained population pharmacokinetics: AI-driven prediction of drug concentrations and exposure for model-informed dosing.

Xu Yichao Y, Ruan Zourong Z, Jiang Bo B

Therapeutic drug monitoring (TDM) starts from a single measured concentration, which population pharmacokinetics (PopPK) with Bayesian maximum a posteriori (MAPB) estimation converts into a revised dose. Since roughly 2021, two research lines have been converging. Time-series deep learning models read longitudinal electronic health record (EHR) data and predict concentrations directly, led by long short-term memory (LSTM) networks, neural ordinary differential equations (neural-ODEs), and attention-based architectures. Physics-informed neural networks (PINNs), scientific machine learning (SciML), and related mechanism-aware approaches embed pharmacokinetic knowledge into neural networks, chasing accuracy without giving up interpretability. We survey both strands from 2019 to 2026, covering foundational papers, representative applications, and the open-source ecosystem. We organize the mechanism-learning relationship into three levels: loose coupling feeds pharmacokinetic-derived features into a machine learning model; medium coupling builds mechanistic structure into the architecture; tight coupling writes the mechanism into the loss function as differentiable constraints. We compare the three across predictive accuracy, extrapolation, interpretability, data needs, computational cost, and clinical acceptability. A study-level evidence map and a critical appraisal of the primary statistics underpin a nuanced picture: mechanism constraints consistently improve extrapolation and identifiability and keep the physics consistent, but in-distribution accuracy gains over well-tuned PopPK + MAPB are modest, and several headline results rest on preprints or synthetic-data validation. We also locate each study on an evidence hierarchy separating concentration prediction from dose recommendation and clinical benefit. Open problems include data sparsity, identifiability, uncertainty quantification, multi-drug generalization, regulatory acceptance, and foundation models. We close with a roadmap toward mechanism-informed, clinically deployable precision-dosing systems. Throughout, pediatric antiepileptic drug (AED) TDM, above all lacosamide, lamotrigine, and oxcarbazepine, serves as the guiding clinical scenario; narrow therapeutic windows, developmentally heterogeneous sampling, and multi-drug comorbidity make it the clearest proving ground for the coupling framework, and we map the evidence gaps for these drugs.

PMID 42840665
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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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