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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

PubMedEpilepsy & behavior : E&B2026-07-24

Infertility treatment in women with epilepsy: A systematic review.

Alshaqi Ola O, Maisenbacher Mathias M, Nofal Yazan Y, Sane Caroline C et al.

The impact of assisted reproductive technologies (ART) on seizure control in women with epilepsy remains incompletely understood. A systematic review was conducted according to PRISMA guidelines. EMBASE, MEDLINE, CINAHL, Scopus, and the Cochrane Library were searched from inception to March 2025. Eligible studies included observational studies and case-based reports involving women undergoing infertility treatment. A total of 1216 publications were identified, of which four studies met the inclusion criteria, including case reports, a case series, and a cohort study. These studies included 16 women aged 25-46 years undergoing infertility treatment, all but one of whom had epilepsy. Interventions involved in vitro fertilization (IVF), ovulation induction, and hormonal therapies. Patients were treated with a range of antiseizure medications (ASMs), including carbamazepine, clobazam, lamotrigine, levetiracetam, oxcarbazepine, valproate, and zonisamide, either as monotherapy or in combination. Seizure frequency was generally stable, with most patients maintaining baseline seizure control. Seizure exacerbations were uncommon and primarily associated with hormonal therapy and reduced ASM levels, particularly reduced lamotrigine levels. Reported events included breakthrough seizures in the setting of decreased lamotrigine concentrations, seizure clusters associated with follitropin beta, and a new-onset seizure following dehydroepiandrosterone exposure. Across studies, multiple ART attempts resulted in live births with different ASM regimens, as well as in patients not receiving ASMs. Available evidence suggests that ART is feasible in women with epilepsy, with most patients maintaining stable seizure control. Hormonal therapy may affect ASM pharmacokinetics and seizure threshold, thereby warranting close monitoring. Larger prospective studies are needed to better define ASM-specific effects and optimize care.

PMID 42492305
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PubMedActa epileptologica2026-07-23

Efficacy of oxcarbazepine in treating focal epilepsy based on resting-state EEG functional connectivity and power spectral analyses.

Cheng Shupeng S, Li Wenkang W, Ning Jing J, Wang Yingfan Y et al.

Objective electroencephalography (EEG)-based biomarkers are needed to assess oxcarbazepine (OXC) response in patients with focal epilepsy. This study aimed to identify resting-state EEG biomarkers associated with oxcarbazepine efficacy in focal epilepsy using power spectral and functional connectivity analyses. In this retrospective cohort study, 27 drug-naïve patients with focal epilepsy underwent resting-state EEG before treatment and approximately 1 year after initiating OXC monotherapy. Nineteen 10-20 system electrodes were recorded at 256/512 Hz, and preprocessed (resampling, detrending, 50 Hz notch, 0.5-70 Hz band-pass, independent component analysis [ICA] artifact removal). Relative power spectral density (rPSD) was estimated via Welch's method (5 s windows, 50% overlap). Functional connectivity (FC) was quantified by amplitude envelope correlation with correction (AEC-C) within canonical bands, yielding 19×19 matrices. Group comparisons used nonparametric tests with Benjamini-Hochberg false discovery rate (FDR) correction for rPSD and network-based statistic (NBS) for FC (5,000 permutations; initial thresholds t = 2.787, P < 0.01, and t = 3.725, P < 0.001). Clinical outcomes were classified as seizure-free (SF) or not seizure-free (NSF) at 6-24 months after OXC initiation. Baseline clinical characteristics did not differ between groups. At the on-treatment follow-up EEG, the NSF group exhibited significantly higher θ-band rPSD at multiple frontal-central electrodes (Fp1, Fp2, F3, F4, C3, C4, F7, F8, Fz, Cz) after FDR correction. FC analysis showed stronger δ-band connectivity in the NSF group across frontal-central nodes at P < 0.01; under the stricter threshold (P < 0.001), a robust edge between P3 and F7 remained significantly stronger in the NSF group. No significant between-group differences were observed in other frequency bands after correction. These findings suggest that the response to oxcarbazepine in focal epilepsy is linked to differential regulation of slow-frequency brain networks. Persistent low-frequency synchronization reflects ongoing network instability and reduced treatment efficacy, whereas attenuation of pathological slow-wave activity indicates effective network stabilization. These band-limited spectral and network features are promising EEG features associated with treatment response to OXC.

PMID 42487138
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PubMedQuintessence international (Berlin, Germany : 1985)2026-07-22

Trigeminal neuralgia: a primer for dental practitioners.

Elsaraj Sherif M SM, Kasha-Blois Raquel R, Wint-White Renée R, Iacopino Anthony M AM et al.

Trigeminal neuralgia (TN) is a severe neuropathic facial pain disorder that is frequently misdiagnosed in dental settings, leading to delays in appropriate management and unnecessary irreversible dental procedures. This narrative review aims to synthesize current knowledge on the pathophysiology, diagnostic challenges, and management of TN, with particular emphasis on issues relevant to dental practitioners involved in the differential diagnosis of orofacial pain. A comprehensive literature search was conducted using the PubMed database, covering studies published between January 2000 and March 2025. Eligible sources comprised controlled clinical trials, systematic reviews, meta-analyses, and selected case reports addressing diagnostic approaches and therapeutic strategies for TN. Findings were synthesized thematically to highlight clinical relevance, emerging therapies, and persisting gaps in care. TN remains a complex disorder with a substantial impact on quality of life. Accurate diagnosis relies on careful clinical history, recognition of characteristic pain features, and exclusion of odontogenic sources of pain, often requiring iterative assessment over time. Pharmacological therapies, including carbamazepine and oxcarbazepine, remain first-line treatments, while surgical interventions-particularly microvascular decompression-offer durable relief in refractory cases. Dental professionals play a critical gatekeeping role in early recognition, exclusion of dental pathology, and timely referral to medical specialists. Optimal management of TN requires an interdisciplinary approach integrating neurology, neurosurgery, dental specialties, and psychosocial care to minimize misdiagnosis, avoid unnecessary dental interventions, and improve patient outcomes.

PMID 42484626
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PubMedThe primary care companion for CNS disorders2026-07-20

Mirtazapine-Induced Severe Hyponatremia in a Young Man Taking Oxcarbazepine.

Luzum Nathan R NR, Munjal Sahil S

PMID 42475754
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PubMedThe journal of headache and pain2026-07-19

Exploratory development of prediction models for pharmacotherapy outcomes in trigeminal neuralgia: a combined analysis based on multi-source data.

Yang Hongan H, Sun Baijintao B, Li Mingtao M, Yang Xuezhao X et al.

Drug-refractory trigeminal neuralgia (DRTN) represents a formidable challenge in clinical management, with approximately 30%-50% of patients eventually progressing to DRTN. Early identification of high-risk DRTN populations and prediction of the timing of pharmacotherapy failure are crucial for optimizing clinical treatment strategies. This retrospective study enrolled 163 primary trigeminal neuralgia patients receiving carbamazepine/oxcarbazepine with comprehensive imaging. A partially-blinded approach was used for data extraction: 135 patients (December 2022-December 2024) formed the primary cohort and 28 patients (December 2021-December 2022) served as the temporally separated validation cohort. Data comprised clinical baseline characteristics, pain and emotional scale scores, and imaging parameters. A nested cross-validation framework (20 random seeds) was used for model development, with feature selection confined to the training cohort within each seed. Five machine learning models were compared via pooled ROC curves aggregated across seeds, and SHAP analysis interpreted the optimal model at the median-performing seed. Age-unadjusted and age-adjusted multivariate Cox regression models were constructed, with four parallel univariate screening thresholds evaluated in sensitivity analyses. Model performance was assessed by Kaplan-Meier analysis, time-dependent ROC curves, and the concordance index. The support vector machine with radial basis function kernel (SVM-RBF) achieved the optimal performance, with average AUCs of 0.927 ± 0.041, 0.824 ± 0.049, and 0.806 ± 0.058 in the training, test, and validation cohort, respectively. In a sensitivity analysis using four univariate Cox screening thresholds, with age at first pain onset forced into all multivariate models, pain involved extent and medial temporal lobe atrophy (MTA) score were both identified as significant, independent candidate prognostic markers. Both Cox models showed moderate discriminative capacity for short-to-medium-term DRTN prognosis but attenuated long-term predictive efficacy. The SVM-RBF model, integrating multi-source heterogeneous data, demonstrated promising predictive performance for DRTN onset risk across the present cohort. The Cox models showed moderate discriminative capacity for short-to-medium-term prognosis, though long-term predictive accuracy was attenuated. These findings provide preliminary evidence for early risk stratification and individualized treatment of DRTN, while underscoring the need for improved survival prediction strategies to address the limited long-term performance of the current Cox models.

PMID 42471550
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PubMedNeurology2026-07-17

Risk of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis After Initiation of Antiseizure Medication: A Danish Nationwide Cohort Study.

Heerfordt Ida M IM, Mogensen Mette M, Horwitz Anna A, Andersen Jon Trærup JT et al.

Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are serious cutaneous adverse reactions associated with several antiseizure medications, particularly lamotrigine and carbamazepine. We assessed the 90-day absolute risk of SJS/TEN after initiation of antiseizure medications in a nationwide Danish cohort and compared medication-specific risks with the general population background risk. All Danish residents initiating any of 25 antiseizure medications between 1995 and 2024 were included. Initiations and incident SJS/TEN diagnoses were identified through Danish registries. For each medication, we calculated the 90-day risk of SJS/TEN (cases per 100,000 initiators) with 95% CIs. Among cases, time from initiation to diagnosis was summarized using cumulative percentages, and 1-year mortality was assessed. General-population SJS/TEN cases were identified to estimate the 90-day background risk. Among 1,388,397 antiseizure medication initiations, the median age was 55.3 years (interquartile range [IQR] 40.2-69.9), and 56% were in female individuals. Within 90 days after initiation, 83 SJS/TEN cases occurred, most within the first weeks. One-year mortality among cases was 17%. Overall, these 83 cases accounted for 7% of all incident SJS/TEN cases in Denmark during the study period. The highest observed absolute risk was for lamotrigine (29.31 per 100,000 initiators; 95% CI 21.46-39.09), followed by carbamazepine (16.66; 95% CI 8.32-29.80), phenobarbital (15.84; 95% CI 5.14-36.96), oxcarbazepine (11.25; 95% CI 3.65-26.25), and valproic acid (7.31; 95% CI 2.68-15.91). Risks were lower for gabapentinoids, including pregabalin (2.26; 95% CI 0.83-4.92) and gabapentin (1.24; 95% CI 0.50-2.56). No SJS/TEN cases were observed for several newer antiseizure medications, although limited exposure for some precludes firm conclusions. The estimated 90-day background risk in the general population was 0.17 per 100,000 individuals (95% CI 0.16-0.18). This nationwide Danish study provides updated, population-based absolute risk estimates of SJS/TEN within 90 days of initiating 25 antiseizure medications in routine care and places these risks in the context of the general-population background risk. These estimates update and extend older evidence and provide a contemporary reference for SJS/TEN risk in antiseizure pharmacotherapy, including newer agents. The findings may also support risk communication around antiseizure medication initiation.

PMID 42467870
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