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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

PubMedPain medicine case reports2026-07-15

Lacosamide-Induced Visual and Auditory Hallucinations in an Elderly Patient Treated for Refractory Trigeminal Neuralgia: A Case Report.

Magne Hugues H

Trigeminal neuralgia (TN) is a severe neuropathic facial pain syndrome that mainly affects older adults. Carbamazepine and oxcarbazepine are standard therapies, but their tolerability is often limited in the elderly. Lacosamide is a potential alternative through its modulation of slow sodium channel inactivation, yet its neuropsychiatric adverse effects remain poorly documented. A 71-year-old man with right-sided TN refractory to carbamazepine and intolerant to oxcarbazepine was started on lacosamide. Pain decreased 30% to 40% at 150 mg twice daily, but daytime visual and auditory hallucinations emerged. Clinical, imaging, and laboratory evaluations were normal. Reducing the dose to 100 mg twice daily resolved the hallucinations while maintaining partial pain control. Our case highlights a rare dose-dependent neuropsychiatric adverse effect of lacosamide in an elderly patient with TN. Clinicians should monitor perceptual symptoms during titration and consider dose adjustment rather than discontinuation when such effects occur.

PMID 42456072
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PubMedIntensive care medicine2026-07-15

Antiseizure medication dosing and monitoring in the intensive care unit: a practical narrative review.

Webb Andrew J AJ, Barlow Brooke B, Seto Stephanie L SL, Maciel Carolina B CB et al.

Antiseizure medications (ASMs) are commonly used in the intensive care unit (ICU) and often exhibit pharmacokinetics that differ substantially from those in healthy volunteers or in the outpatient setting. Organ dysfunction, polypharmacy, exogenous devices, and greater severity of illness all influence ASM pharmacokinetics, dosing decisions, and monitoring parameters. It is essential for critical care clinicians to familiarize themselves with the pharmacokinetics, dosing considerations, effects of exogenous devices, and therapeutic drug monitoring (TDM)-all covered in this narrative review-to incorporate in their approach to ASMs in the critical care setting. We identified relevant literature from MEDLINE from inception to March 2026 related to ASMs in the ICU. Data on pharmacokinetics, dosing in the ICU, the effect of renal replacement therapy, extracorporeal membrane oxygenation (ECMO), and plasmapheresis (PLEX) on ASM exposure, and the role of TDM in the ICU were collected and summarized. Considerations for 15 ASMs (brivaracetam, cannabidiol, carbamazepine, cenobamate, clobazam, lacosamide, lamotrigine, levetiracetam, oxcarbazepine, perampanel, phenobarbital, phenytoin, topiramate, valproate, and zonisamide) were included in the review. Dosing considerations for TDM, including indications and target reference ranges, and specific settings such as organ dysfunction, illness severity, renal replacement therapy, ECMO, and PLEX are discussed. The use of ASMs in the ICU require a distinct approach from outpatient settings. Severity of illness, organ dysfunction and replacement devices, and frequent drug-drug interactions warrant tailored agent selection, dosing, and monitoring.

PMID 42455344
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PubMedFrontiers in pharmacology2026-07-14

Pharmacist-led management of suspected drug-provoked seizures and sequential antiseizure medication adverse reactions: a case report.

Wang Mimi M, Wu You Y, Xin Xilin X, Shou Zhangxuan Z et al.

Drug-provoked seizures constitute a clinically significant yet frequently underappreciated complication of pharmacotherapy, particularly among patients receiving antimicrobial agents with established seizurogenic potential. The subsequent management of sequential adverse drug reactions (ADRs) arising from antiseizure medication (ASM) use introduces additional pharmacological and clinical complexity. A 73-year-old man with a remote history of epilepsy, moderate chronic kidney disease (CKD), and decade-long anticonvulsant self-discontinuation experienced two generalised tonic-clonic seizures during sleep on completion of a five-day course of intravenous moxifloxacin 0.4 g once daily and intravenous diprophylline 0.5 g twice daily for an acute COPD exacerbation. The clinical pharmacist identified the events as consistent with suspected drug-provoked seizures, hypothesising that renal impairment-driven diprophylline accumulation may have acted as a pharmacokinetically amplified pro-convulsant mechanism; as serum diprophylline concentrations were not measured, this mechanism is proposed as hypothesis-generating rather than established. Three sequential ASM-associated ADRs were subsequently detected and managed through proactive pharmacist-led pharmacovigilance: suspected sodium valproate-induced rhabdomyolysis (Naranjo score 8; confounded by post-ictal rhabdomyolysis and concurrent statin use), symptomatic oxcarbazepine-induced hyponatraemia requiring drug substitution, and suspected levetiracetam-associated hepatotoxicity not fulfilling formal drug-induced liver injury (DILI) criteria. This case underscores the indispensable role of clinical pharmacist engagement in identifying suspected drug-provoked seizures, applying structured causality assessment in the presence of competing confounders, and systematically managing complex, sequential ASM-related adverse reactions in high-risk patients.

PMID 42445248
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PubMedDiabetes, obesity & metabolism2026-07-08

Efficacy and Safety of Ion Channel Modulators in Painful Diabetic Neuropathy.

Li Dandan D, Ouyang Linqi L, Chen Zhen Z, Long Yuanxiong Y et al.

To systematically evaluate the efficacy and safety of ion channel modulators for the treatment of painful diabetic neuropathy (PDN). We searched PubMed, Web of Science, Embase, and the Cochrane Library for randomized controlled trials (RCTs) in PDN patients treated with ion channel modulators. The primary outcome was the pain score. Secondary outcomes included the visual analog scale (VAS) score, 30% and 50% pain reduction, patient global impression of change (PGIC), sleep interference score, adverse events, and treatment discontinuation. Independent authors extracted the data and assessed the quality. Heterogeneity among studies was quantified using the I2 statistic. The analyses were in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guidelines. A total of 36 RCTs comprising 6611 participants with PDN were included in the analyses, of which 21 were evaluated with calcium channel blockers, 12 with sodium channel blockers, 2 with TRPA1 antagonists, and 1 with P2X3 antagonists. Compared with placebo, ion channel modulators, particularly calcium channel blockers (mirogabalin, pregabalin, gabapentin, crisugabalin) and sodium channel antagonists (oxcarbazepine, lacosamide, lamotrigine, sodium valproate), can significantly reduce pain, VAS, and sleep interference scores, improve PGIC, and increase the proportion of patients achieving 30% and 50% pain reduction. The therapeutic effects of the TRPA1 antagonists and P2X3 antagonists did not differ significantly from those of the control. The adverse events of ion channel modulators were mild to moderate and well tolerated, but the risk of discontinuation due to adverse events was higher with mirogabalin and oxcarbazepine than with the other modulators. Ion channel modulators, especially calcium channel blockers and sodium channel antagonists, have favourable safety profiles and beneficial effects on reducing pain and improving the quality of life of patients with PDN.

PMID 42417183
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PubMedBritish journal of clinical pharmacology2026-07-03

Anti-seizure medications and DRESS in paediatric patients: A FAERS disproportionality and time-to-onset analysis.

Yang Ting T, Chen Chaoyang C, Zhang Xuanling X, Ma Lingyue L et al.

Anti-seizure medications (ASMs) are in the list of the most common drug culprits of drug reaction with eosinophilia and systemic symptoms (DRESS). However, no study has systematically evaluated DRESS associated with ASMs in a large paediatric cohort. This study aimed to investigate association of DRESS with ASMs and to characterize the onset pattern of ASM-related DRESS in paediatrics using FDA Adverse Event Report System (FAERS) database. FAERS data from the first quarter of 2004 to the second quarter of 2025 were analysed using R software (version 4.5.1). For signal detection of ASM-related DRESS in paediatric patients, disproportionality analysis was performed with four methods, consisting of Reporting Odds Ratio, Proportional Reporting Ratio, Bayesian Confidence Propagation Neural Network and Multi-Item Gamma Poisson Shrinker. Cumulative incidence was estimated using Kaplan-Meier method, and time-to-onset (TTO) analysis was conducted with Weibull distribution test. Nine hundred forty-one reports of ASMs-related DRESS in paediatric population from FAERS database were analysed. Positive signals for DRESS were identified for lamotrigine, carbamazepine, levetiracetam, phenytoin, valproic acid, oxcarbazepine, phenobarbital, zonisamide, clobazam, ethosuximide, perampanel, fosphenytoin and eslicarbazepine. Ninety-eight cases were included in the TTO analysis. Lamotrigine, carbamazepine, levetiracetam and zonisamide demonstrated a wear-out failure-type pattern. Phenytoin, valproic acid and oxcarbazepine presented a random failure-type profile. Significant signals of DRESS associated with 13 ASMs were identified in paediatric populations. Notably, signals were detected for the first time for ethosuximide, perampanel, fosphenytoin and eslicarbazepine by disproportionality analysis. TTO analysis demonstrated wear-out or random failure-type patterns in the occurrence of ASM-associated DRESS.

PMID 42397303
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PubMedSeizure2026-07-01

Switching from oxcarbazepine to eslicarbazepine in patients with focal epilepsy: A systematic review and single-arm meta-analysis.

de Amorim Samuel Oliveira SO, da Silva Nathan Fellipe Cardoso NFC, Ferreira Matheus da Silva MDS, Soares Cid C et al.

Oxcarbazepine (OXC) is widely used in focal epilepsy but is frequently limited by tolerability issues, particularly neurovestibular and sedative adverse events. Switching to eslicarbazepine acetate (ESL) has emerged in clinical practice as a pragmatic strategy to improve tolerability, although the available evidence remains fragmented and predominantly observational. We conducted a systematic review and single-arm meta-analysis of studies reporting outcomes after switching from OXC to ESL in patients with focal epilepsy. PubMed, Embase, Scopus, Cochrane Library, and Web of Science were searched from inception to December 2025. Random-effects models were used to estimate pooled proportions for effectiveness and tolerability outcomes. Heterogeneity was assessed using the I² statistic. Seven studies comprising 312 patients were included. Pooled treatment retention was 74.0% (95% CI: 45.9-90.5; I²=79.2%). Resolution of OXC-related adverse events was observed in 53.1% of patients (95% CI: 12.3-90.1; I²=87.3%), although estimates showed substantial variability across studies. Somnolence improvement was reported in 28.2% (95% CI: 4.3-77.4%). The pooled response rate (≥50% seizure reduction) was 22.1% (95% CI: 6.4-53.9), while seizure freedom was achieved in 14.2% (95% CI: 4.5-37.2). Treatment discontinuation occurred in 15.0% of patients (95% CI: 7.2-28.6). Switching from OXC to ESL may represent a pragmatic strategy for patients with OXC-related intolerance, particularly when treatment retention and tolerability are prioritized. However, the observational nature of the available evidence, together with substantial heterogeneity and wide confidence intervals, limits the precision and generalizability of pooled estimates.

PMID 42385282
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