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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 research2026-08-28

Risk factors for adverse maternal‑neonatal outcomes in pregnant women with epilepsy and the impact of different anti-seizure medications exposures on neonatal birth weight.

Fang Chun C, Yang Heqin H, Yang Yongmei Y

To investigate the risk factors for adverse maternal‑neonatal outcomes in pregnant women with epilepsy and to analyze the effects of different anti-seizure medications (ASMs) on neonatal birth weight, thereby providing clinical evidence for the management of epilepsy during pregnancy. A total of 218 pregnant women with epilepsy who delivered at our hospital between January 2021 and December 2025 were enrolled. Demographic data, epilepsy‑related clinical characteristics, ASM regimens, pregnancy complications, and maternal‑neonatal outcomes were collected. Patients were divided into an adverse outcome group (n = 74) and a favorable outcome group (n = 144) based on the occurrence of adverse maternal‑neonatal outcomes (including preterm birth, low birth weight, fetal distress, and neonatal malformations). Logistic regression analysis was performed to identify independent risk factors for adverse outcomes. Among patients receiving monotherapy (n = 131, 60.09%), they were categorized into lamotrigine, levetiracetam, carbamazepine, oxcarbazepine, and valproate groups according to ASM exposure during pregnancy; a separate polytherapy group (n = 87, 39.91%) was also included. Analysis of variance (ANOVA) was used to compare neonatal birth weight across groups. Multivariate logistic regression showed that uncontrolled epilepsy before and during pregnancy (presence of seizures within six months before pregnancy: OR=4.300, P < 0.001; any seizure during pregnancy: OR=3.661, P < 0.001; increased seizure frequency during pregnancy: OR=3.781, P < 0.001), focal epilepsy (OR=2.245, P = 0.005), polytherapy (OR=2.046, P = 0.014), and gestational hypertension (OR=2.764, P = 0.008) were independent risk factors for adverse maternal‑neonatal outcomes. Regarding neonatal birth weight, the monotherapy group had a significantly higher mean birth weight (3170 ± 452 g) than the polytherapy group (2963 ± 501 g, P = 0.002). Among monotherapy regimens, the valproate group had the lowest mean birth weight (2805.50 ± 395.53 g), which was significantly lower than that of the lamotrigine group (3273.51 ± 429.49 g, P = 0.012) and the levetiracetam group (3236.51 ± 407.47 g, P = 0.023). No significant differences were observed among the lamotrigine, levetiracetam, carbamazepine, and oxcarbazepine groups (ANOVA: F=3.822, P = 0.006). Uncontrolled epilepsy before and during pregnancy, polytherapy, focal epilepsy, and gestational hypertension are independent risk factors for adverse maternal‑neonatal outcomes in pregnant women with epilepsy. Different ASMs have differential effects on neonatal birth weight; valproate and polytherapy are associated with significantly lower birth weight. Physicians should counsel women with epilepsy that achieving at least six months of seizure freedom before conception is associated with improved maternal-neonatal outcomes. Lamotrigine or levetiracetam monotherapy should be prioritized whenever possible, and close monitoring should be maintained throughout pregnancy.

PMID 42659781
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PubMedBMJ supportive & palliative care2026-08-26

Sodium channel blocker rotation for refractory neuropathic pain.

Huguet Max M, Curtin John J, Broderick Marianne M, Howard Paul P

To investigate the efficacy and safety of sodium channel blocker (SCB) rotation and/or combined use for neuropathic pain where the initial SCB is ineffective or poorly tolerated. A retrospective chart review of SCB rotation in a single palliative care centre. We reviewed the notes of those receiving two or more SCBs for pain. All clinical notes and medication administration records were examined to ascertain efficacy and tolerability. We found 45 examples of SCB rotation in 32 patients. Most (81%) had metastatic cancer. All had tried multiple other analgesics. Most (29/45) were rotated for persistent pain; the remainder for poor tolerability (11/45) or to change the route (5/45), for example, an SCB that could not be given parenterally when the oral route was lost. SCB rotation appeared helpful for the majority (69%). Switches appeared effective in both directions between lacosamide and oxcarbazepine; thus, neither SCB appeared 'superior'. A minority (7/32) received two SCBs together having had insufficient analgesia from SCB monotherapy; dual SCB therapy was well tolerated and appeared effective in 6/7. Rotation appeared effective and well tolerated for neuropathic pain where an initial SCB was ineffective or poorly tolerated. Further, in those with the most analgesic-refractory pains, we found preliminary evidence that combining SCBs with different characteristics might be beneficial, for example, combining slow channel inactivators with fast channel inactivators. Thus, we believe that SCBs should not be considered a homogenous analgesic class and that further research into both SCB rotation and dual SCB therapy is justified.

PMID 42648885
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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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PubMedCurrent pharmaceutical design2026-08-24

Exploration of Drug-Drug Interactions and Initial Dosage Administration of Oxcarbazepine in Elderly Patients with Epilepsy.

Zhang Hai-Bo HB, He Su-Mei SM, Wang Jie J, Wang Dong-Dong DD et al.

This study aimed to investigate whether there were potential drug-drug interactions (DDI) of oxcarbazepine in elderly patients with epilepsy during clinical combination therapy and explore the optimal initial dosage regimen of oxcarbazepine for elderly patients with epilepsy. The effectiveness of oxcarbazepine was mainly determined by measuring the concentrations of its active metabolite, 10-hydroxycarbazepine (MHD). The study developed an MHD population pharmacokinetic (PPK) model for elderly patients with epilepsy using nonlinear mixed-effect modelling (NONMEM). It was found that no combined medications significantly affected the pharmacokinetic processes of MHD. Further, we simulated and recommended the optimal initial dosages of oxcarbazepine suitable for elderly patients with epilepsy. Dosages of 20, 15, 10, and 5 mg/kg oxcarbazepine were recommended for elderly patients with epilepsy who weighed 40-46 kg, 46-55 kg, 55-76 kg, and 76-100 kg, respectively. At the same time, in accordance with the above administration plan, the probabilities of achieving the target concentrations of the oxcarbazepine active metabolite in elderly patients with epilepsy were 99.0-99.4%, 99.0-99.5%, 98.7-99.6%, and 98.7-99.7%, respectively. The study explored potential DDIs and the initial dosage administration of oxcarbazepine in elderly patients with epilepsy for the first time. Combined medications did not cause DDI when used by elderly patients with epilepsy for treatment, demonstrating the high safety of oxcarbazepine in the treatment of elderly patients with epilepsy. This study recommended the initial dosages of oxcarbazepine for elderly patients with epilepsy. To achieve the same therapeutic concentration ranges, the dosages for elderly patients with epilepsy may need to be reduced.

PMID 42634519
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PubMedBrain : a journal of neurology2026-08-18

Early sodium channel blocker initiation is associated with better outcomes in KCNQ2 disorders.

Millevert Charissa C, Hairabedian Megan M, Dahan Samuel S, Lemke Johannes J et al.

Pathogenic KCNQ2 variants are the most common genetic cause of neonatal-onset epilepsies, with phenotypes ranging from self-limited (familial) neonatal epilepsy (SeL(F)NE) to severe developmental and epileptic encephalopathy (KCNQ2-DEE). Sodium channel blockers (SCBs) have shown promise for seizure control in these disorders, but their impact on neurodevelopmental outcomes and possible relationship with timing of initiation remain incompletely understood. We leveraged a large, multicentre international cohort comprising 282 individuals with pathogenic KCNQ2 variants to retrospectively assess the effectiveness of antiseizure medications (ASMs), particularly SCBs, on seizure control and neurodevelopment. Individuals were grouped according to the predicted variant-specific functional effects: loss-of-function (LOF) variants known to be associated with SeL(F)NE or DEE respectively, and gain-of-function (GOF) variants. Epilepsy course, ASM effectiveness, and neurodevelopmental milestones were systematically collected and analysed, including time-to-event and adjusted outcome analyses. SCBs, especially carbamazepine (CBZ) and oxcarbazepine (OXC), emerged as the most effective ASMs in both LOF groups. In LOF KCNQ2-DEE, time-to-event analyses showed that early SCB initiation (≤1 month) was associated with earlier seizure offset. Early SCB initiation was also associated with significantly more favourable neurodevelopmental outcomes, including higher rates of attaining major motor milestones. This association remained significant after adjustment for seizure control by 1 month and total ASM burden. Considerable phenotypic variability persisted, with some individuals experiencing severe impairment despite early seizure control and SCB initiation, suggesting that variant severity and additional genetic or biological modifiers contribute to outcome heterogeneity.Our results support the use of SCBs, particularly CBZ and OXC, as first-line therapy in (LOF) KCNQ2-DEE and SeL(F)NE. Earlier SCB initiation was associated with earlier seizure offset and more favourable developmental outcomes, underscoring the importance of early genetic diagnosis and timely SCB therapy. We however emphasise that early treatment is not universally transformative and further prospective work, including exploration of targeted therapies and standardised neurodevelopmental assessments, is needed to optimise long-term outcomes in this heterogeneous population.

PMID 42610455
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