Oxcarbazepine

Summary

Oxcarbazepine (CHEMBL1068) is an approved small-molecule anticonvulsant (ATC N03AF02); indicated across 12 conditions including epilepsy and visual epilepsy.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: N03AF02
• Indications: 12 conditions
• Clinical trials: 44
• Chemistry: 252.27 Da · C15H12N2O2

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL1068
Name	Oxcarbazepine
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	34312
ChEBI	CHEBI:7824
ATC	N03AF02
Molecular formula	C15H12N2O2
Molecular weight	252.27
InChIKey	CTRLABGOLIVAIY-UHFFFAOYSA-N

SMILES: C1C2=CC=CC=C2N(C3=CC=CC=C3C1=O)C(=O)N

IUPAC name: 5-oxo-6H-benzo[b][1]benzazepine-11-carboxamide

ChEBI definition: A dibenzoazepine derivative, having a carbamoyl group at the ring nitrogen, substituted with an oxo group at C-4 of the azepeine ring which is also hydrogenated at C-4 and C-5. It is a anticholinergic anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy.

Pharmacological roles (ChEBI): anticonvulsant, drug allergen.

Also known as: GP-47680, KIN-493, NSC-758693, Oxcarbamazepine, Oxcarbazepina, Oxcarbazepine, Oxtellar xr, SPN-804, Trileptal, SID26719673, SID26747194, SID866068

Patent coverage: 4,334 distinct patent families (16,118 SureChEMBL compound mentions), from 3 matched compound structure(s). One matched structure accounts for 15,756 (98%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 10 (assay-derived). Sample: Microtubule-associated protein tau, Lysine-specific demethylase 4E, Fructose-bisphosphate aldolase, RecQ-like DNA helicase BLM, 4’-phosphopantetheinyl transferase ffp, Polyadenylate-binding protein 1, Histone-lysine N-methyltransferase 2A, Menin/Histone-lysine N-methyltransferase MLL, Cytochrome P450 3A4, Aldehyde dehydrogenase 1A1.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

12 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
epilepsy	4	MONDO:0005027	EFO:0000474
visual epilepsy	4	MONDO:0001386	HP:0001250
focal epilepsy	3	MONDO:0005384	EFO:0004263
anxiety	3	MONDO:0011918	EFO:0005230
dementia	3	MONDO:0001627	HP:0000726
neuralgia	3	MONDO:0021667	EFO:0005762
depressive disorder	3	MONDO:0002050	MONDO:0002050
multiple sclerosis	2	MONDO:0005301	MONDO:0005301
neoplasm	1	MONDO:0005070	MONDO:0004992

3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 44.

Phase distribution

Phase	Trials
PHASE4	15
Not specified	10
PHASE1	9
PHASE3	7
PHASE2/PHASE3	2
PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT06849219	PHASE4	ACTIVE_NOT_RECRUITING	Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia
NCT00142025	PHASE4	COMPLETED	Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma
NCT00154323	PHASE4	COMPLETED	The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Bipolar Disorder I or II This Study is Not Being Conducted in the United States.
NCT00154362	PHASE4	COMPLETED	The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Adolescents With Impulsivity and Aggressive Behavior in Conduct Disorder This Study is Not Being Conducted in the United States.
NCT00260247	PHASE4	COMPLETED	Induction of Drug Metabolism: In Vivo Comparison of Carbamazepine and Oxcarbazepine.
NCT00275912	PHASE4	COMPLETED	Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures
NCT00275925	PHASE4	COMPLETED	Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures
NCT01302275	PHASE4	COMPLETED	Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain
NCT01498822	PHASE4	COMPLETED	Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
NCT01893229	PHASE4	UNKNOWN	Comparative Efficacy and Acceptability of Antimanic Drugs in Acute Mania
NCT02180880	PHASE4	COMPLETED	Symptom Based Treatment of Neuropathic Pain
NCT02456896	PHASE4	COMPLETED	Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder
NCT02705768	PHASE4	COMPLETED	Effect of Carbamazepine and Oxcarbazepine on Serum Neuron-specific Enolase and S100B in Focal Seizures
NCT04996199	PHASE4	UNKNOWN	Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial
NCT05697614	PHASE4	UNKNOWN	The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children
NCT02219373	PHASE3	NOT_YET_RECRUITING	Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study
NCT00050934	PHASE3	COMPLETED	Pediatric Epilepsy Study
NCT00050947	PHASE3	COMPLETED	Pediatric Epilepsy Study
NCT00145691	PHASE3	COMPLETED	The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)
NCT00637234	PHASE2/PHASE3	COMPLETED	Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia
NCT00772603	PHASE3	COMPLETED	Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures
NCT01051193	PHASE2/PHASE3	COMPLETED	Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures
NCT01891890	PHASE3	TERMINATED	Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)
NCT02374567	PHASE3	TERMINATED	Pharmacovigilance in Gerontopsychiatric Patients
NCT02104661	PHASE2	COMPLETED	Protective Role of Oxcarbazepine in Multiple Sclerosis
NCT00849797	PHASE1	COMPLETED	Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions
NCT00850174	PHASE1	COMPLETED	Oxcarbazepine 600 mg Tablets Under Fasting Conditions
NCT00900237	PHASE1	COMPLETED	Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
NCT01678976	PHASE1	COMPLETED	Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
NCT01679002	PHASE1	COMPLETED	Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers
NCT01702623	PHASE1	COMPLETED	Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
NCT01703468	PHASE1	COMPLETED	Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions
NCT02078089	PHASE1	TERMINATED	Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain
NCT03695094	PHASE1	COMPLETED	A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil
NCT05450978	Not specified	RECRUITING	Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding
NCT07252453	Not specified	ACTIVE_NOT_RECRUITING	Comparison b/w Carbamazepine vs Oxcarbazepine in Treatment of Trigeminal Neuralgia
NCT00467753	Not specified	COMPLETED	Oxcarbazepine Versus Placebo in Childhood Autism
NCT00616681	Not specified	COMPLETED	Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions
NCT00616863	Not specified	COMPLETED	Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions
NCT00618046	Not specified	COMPLETED	Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

PharmGKB dosing guidelines (3) — CPIC / DPWG genotype-guided dosing for this drug (drug × pharmacogene):

Guideline	Source	Gene(s)	Dosing	Recommendation
Annotation of CPIC Guideline for oxcarbazepine and HLA-B	CPIC	HLA-B		yes
Annotation of DPWG Guideline for oxcarbazepine and HLA-B	DPWG	HLA-B		yes
Annotation of RNPGx Guideline for carbamazepine, oxcarbazepine and HLA	RNPGx	HLA-A;HLA-B		yes

PharmGKB also curates 20 clinical and 57 variant annotation(s) for this drug (gene-keyed; see PharmGKB).

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).