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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

PubMedThe Journal of clinical psychiatry2026-05-20

Systematic Review and Meta-Analysis of Mood Stabilizers in the Treatment of Adolescent Patients With Nonsuicidal Self-Injury in China.

Jin Weidong W, Chen Zhehao Z, Chen Haihan H, Di Letian L et al.

Objective: Nonsuicidal self-injury (NSSI) refers to deliberate, repeated acts of damaging one's own body tissue without suicidal intent. The aim of this systematic review and meta-analysis was to explore the effectiveness of mood stabilizers in treating depressive adolescent patients with NSSI in China. Data Sources: Literature published before June 30, 2025, was included. Chinese databases searched included CBM (Chinese Biomedical Database), CNKI (China National Knowledge Infrastructure), WANFANG (Wanfang Database), and CSSCI (Chinese Social Sciences Citation Index); English databases included MEDLINE, Embase, and the Cochrane Library. Searches used the following keywords: [Bipolar disorder OR depression OR NSSI] AND [Mood stabilizer OR Lithium OR Valproate OR Carbamazepine OR Oxcarbazepine OR Lamotrigine OR Antipsychotic OR Antidepressant]. Study Selection: Chinese and English literature related to the treatment of NSSI with mood stabilizers in adolescent patients in China was searched. Editorials, comments, letters, reviews, and case reports were excluded. Randomized controlled trials conducted in China comparing mood stabilizer augmentation of basic therapy versus basic therapy alone for treating NSSI were included, and studies evaluating mood stabilizer treatment for NSSI using pre-post designs were also included. A total of 9 studies were included, 4 comparative studies by control group and 5 comparative studies of before and after treatment. Data Extraction and Synthesis: Indices of depression, anxiety, impulsivity, self-injury severity, and treatment response were synthesized and analyzed. Mean differences or standardized mean differences and 95% confidence intervals (CIs) were used for symptom change. Odds ratios and their 95% CIs were also used for binary outcomes. Results: Severity of anxiety, depression, impulsivity, and self-injury was significantly reduced following treatment with mood stabilizers. Compared to treatment without mood stabilizers, anxiety, depression, and self-injury were also significantly reduced, and the response rate was significantly improved in adolescents with depression and NSSI. The incidence of self-injury in these patients was significantly reduced by mood stabilizers. Conclusion: These results demonstrate the important role of mood stabilizers in treating NSSI and suggest that mood stabilization may be more critical than mere improvement of affective symptoms.

PMID 42159376
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PubMedMedicine2026-05-19

Successful treatment of anti-LGI1-associated autoimmune encephalitis with efgartigimod: A case report and literature review.

Gao Rui R, Hong Yan Y, Zhou Guanen G

Anti leucine rich glioma inactivated 1 (LGI1)- associated autoimmune encephalitis (AE) is the common form of AE, The treatments for AE may cause many adverse effects and some treatments rely on limited blood resources. Monoclonal antibodies directed against neonatal crystallizable fragment receptor (FcRn), efgartigimod, accelerate autoantibody degradation by blocking IgG recirculation. The efficacy of efgartigimod has been demonstrated in myasthenia gravis. However, there are few case reports on the treatment of anti-LGI1-associated AE with efgartigimod. In this study, we present the case of a patient with anti-LGI1-associated AE who was treated with efgartigimod successfully. A 64-year-old female patient presented with decline in short-term memory and limb tremor. Cranial magnetic resonance imaging (MRI) scan showed hyperintensity and swelling in the medial aspect of the right temporal-occipital lobe on T2- and FLAIR-weighted sequences, without obvious enhancement lesions. The anti-LGI1 antibody titer in serum and CSF was positive. The patient was diagnosed with anti-LGI1-associated AE. Initially, the patient received methylprednisolone pulse therapy. Levetiracetam and oxcarbazepine were both administered orally in the meantime. Following treatment failure, efgartigimod was administered once a week for 3 weeks. After treatment, the patient's limb tremors ceased and her memory improved. The level of anti-LGI1 antibody titer in serum decreased, and the abnormal signals on the MRI attenuated. Efgartigimod is an effective treatment for anti-LGI1-associated AE. This study presents a new approach to treat anti-LGI1-associated AE. However, further research is needed to establish the optimal dosage and frequency of efgartigimod, and to clarify its long-term safety and efficacy.

PMID 42152296
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PubMedInternational journal of pharmaceutics2026-05-18

In vitro - In vivo correlation modeling of an oxcarbezapine extended-release formulation using numerical deconvolution.

Kakhi Maziar M, Chen Hansong H, Chittenden Jason J

An in vitro - in vivo correlation (IVIVC) for an oxcarbazepine (OXC) extended-release formulation, originally submitted as part of a regulatory submission and found to be inadequate, was re-evaluated using two-stage numerical deconvolution and found to be predictively robust by meeting internal and external validation criteria. This result was achieved by enhancing the unit impulse response (UIR) characterization and using nonlinear IVIVC mapping functions. The predictive IVIVC was then applied to determine dissolution acceptance criteria, which showed good agreement with the currently approved criteria for the lower bound of dissolution. Furthermore, IVIVCs that linked in vitro drug release of OXC to the in vivo response of the active metabolite showed higher overall accuracy compared to IVIVCs that linked OXC's in vitro drug release to its own in vivo response. This finding was attributed to the stronger rank-order correlation between the active metabolite's pharmacokinetics and the in vitro data.

PMID 42144167
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PubMedFrontiers in pediatrics2026-05-08

Epilepsia partialis continua may be a rare electroclinical feature of anti-Hu encephalitis: a pediatric case report.

Chen Jialei J, Wang Xingyou X, Zhang Jing J, Wang Yanjuan Y et al.

Paraneoplastic neurologic syndromes with anti-Hu antibodies refer to a spectrum of neurologic disorders. Rare cases of extra-limbic encephalitis presenting with seizures have also been reported. However, these seizures rarely manifest as epilepsia partialis continua (EPC). We report an anti-Hu encephalitis pediatric case with EPC. A 3-year-and-4-month-old male presented with EPC after neuroblastoma resection for 6 months. Neuronal antibody testing revealed highly positive anti-Hu antibody in both serum and cerebrospinal fluid. Anti-Hu encephalitis with EPC was diagnosed. Initial immunotherapy including intravenous immunoglobulin and methylprednisolone had a transient effect, and the symptom recurred 1 month later. The EPC still existed even with the treatment of prednisone, mycophenolate mofetil, oxcarbazepine, valproic acid, and clonazepam. EPC may be a rare but underrecognized electroclinical feature of anti-Hu encephalitis. It is important to consider anti-Hu encephalitis in patients presenting with new-onset EPC. The heterogeneity in clinical symptoms, EEG and imaging manifestations may indicate the existence of complex and diverse mechanisms. The prognosis of this disease is speculated to be poor. Antiseizure medications and surgery often fail to control the progression of the disease. Immunotherapy may benefit some patients.

PMID 42099514
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PubMedJournal of medical case reports2026-05-03

Refractory focal seizures occurred in clusters in a girl with a de novo mutation of the ATP6V0A1 gene: a case report.

Peng Longying L, Wei Cuijie C, Zhang Yuehua Y, Zhang Qingping Q et al.

Variants in the ATP6V0A1 gene, which encodes the α1 subunit of the V0 domain of the V-ATPases, are associated with developmental and epileptic encephalopathy 104 (DEE104). This study aimed to characterize the clinical features of a Chinese patient with ATP6V0A1 variants and facilitate the early diagnosis and treatment. We report a case of a 13-month-old Chinese girl with DEE who presented with developmental delay, acute onset of clustered focal seizures, and status epilepticus. Physical examination revealed hypotonia and microcephaly. Brain MRI showed mildly enlarged bilateral lateral ventricles, a thin corpus callosum, and progressive cerebral atrophy. Genetic analysis identified a de novo missense mutation in the ATP6V0A1 gene (c.2222G > A, p.R741Q). While her epilepsy was refractory to multiple antiepileptic drugs, her seizures were controlled effectively with oxcarbazepine (OXC). We identified a patient with DEE104 carrying a de novo ATP6V0A1 mutation, whose clinical presentation included developmental delay, clustered focal seizures, and status epilepticus. Our findings provide further support for considering OXC in the management of ATP6V0A1-related epilepsy.

PMID 42069687
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PubMedBMC neurology2026-05-02

CACNA1A c.5610del in a three-generation family: epilepsy with ataxia/migraine.

Long Zhongyuan Z, Gong Shuxian S, Ji Dongyan D, Guo Xuan X et al.

CACNA1A encodes the Cav2.1 (P/Q-type) channel whose spectrum extends from FHM1/EA2/SCA6 to epilepsy and vertigo, but penetrance-especially sex differences-remains unclear. We report a three-generation family with CACNA1A c.5610del, detail electroclinical features, assess sex-stratified penetrance, and discuss individualised therapy. We retrospectively reviewed histories, neurological exams, EEG, treatments, and follow-up. Trio whole-exome sequencing across 13 relatives was Sanger-confirmed and interpreted per ACMG; gnomAD/ClinVar were queried. Sex-stratified penetrance was summarised with exact binomial 95% CIs. The female proband developed clinically focal seizures with preserved awareness in 2019. Valproate reduced but did not abolish seizures; after oxcarbazepine, EA2-like paroxysmal symptoms emerged and responded to acetazolamide. Since 2023, she has experienced episodic diplopia, vertigo, bilateral tinnitus, and pulsatile temporal headaches consistent with FHM-like features, typically independent of epileptic seizures. Video-EEG monitoring demonstrated generalised, bilaterally synchronous spike-and-slow-wave discharges with frontal predominance, with a reduction in interictal epileptiform burden observed after treatment optimisation. Genetic analysis identified a heterozygous CACNA1A c.5610del (p.His1871IlefsTer30) variant, absent from population databases and classified as pathogenic (PVS1 + PM2 + PP3). Segregation analysis revealed epilepsy or vestibular symptoms among female carriers, whereas male carriers were asymptomatic at last follow-up, suggesting possible sex-biased penetrance within the pedigree. This pedigree supports Cav2.1 loss-of-function presenting with epilepsy, EA2, and FHM features plus BPPV. Within this family, clinical expression to date appears female-skewed while male carriers remained asymptomatic at last follow-up; this observation is hypothesis-generating. Mechanism-aware ASM selection and structured family counselling may aid management; larger cohorts and functional studies are needed.

PMID 42067833
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