Trileptal

(Oxcarbazepine)

ApprovedSmall molecule

Trileptal is a small molecule that works as a Sodium Channel Alpha Subunit Blocker.[2] It is being used across 10 indications, with its most advanced program in Approved.[1]

Trileptal is one of 230 small molecule programs targeting Trigeminal Neuralgia. It is currently in Approved.

Indications

Total Trials

Active Trials

229

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Trigeminal NeuralgiaUnknown status

AutismActive, not recruiting

Partial EpilepsyApproved

CARCompleted

SeizureCompleted

EpilepsyCompleted

Aggressive BehaviorCompleted

Neuropathic PainCompleted

AsthmaCompleted

Bipolar DisorderCompleted

Trigeminal NeuralgiaApproved

Unknown status

AutismPreclinical

Active, not recruiting

Partial EpilepsyApproved

Approved

CARPreclinical

Completed

SeizureApproved

Completed

EpilepsyApproved

Completed

Aggressive BehaviorApproved

Completed

Neuropathic PainApproved

Completed

AsthmaApproved

Completed

Bipolar DisorderApproved

Completed

Competition

Competitive Landscape

175 competitors in Asthma

#DrugCompanyPhaseTrials

Trileptal

Novartis

Approved

1 2

Celexa

AbbVie

Preclinical

1 3

DUPIXENT

Regeneron

Preclinical

1 4

Paracetamol

GSK

Preclinical

1 5

Blood Withdrawn

Emergent BioSolutions

Preclinical

1 6

Aclidinium Bromide

AstraZeneca

Preclinical

—7

Blood Collection

AAssistance Publique - Hôpitaux de Paris

Preclinical

1 8

Lexapro

SShirley Ryan AbilityLab

Preclinical

1 9

Biological Drug

UUniversitaire Ziekenhuizen KU Leuven

Preclinical

1 10

Guanidine Hydrochloride

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

Recruiting

Pregnancy

NCT05450978

Q4 2028

Phase 3Not yet recruiting

Neuropathic Pain

NCT02219373

Clinical

Trials by Indication[1]

Epilepsy7 trials

The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children

Unknown status·—·Phase 4·NCT05697614·100 enrolled

Long Term Study of the Safety of OXC XR as in Pediatric Epilepsy Subjects

Approved for marketing· Supernus Pharmaceuticals, Inc. logo

Supernus Pharmaceuticals, Inc.··NCT00918424

Characterization of Epilepsy Patients BEEP 2b

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02707965·21 enrolled

Show 4 more trials

Cognitive AED Outcomes in Pediatric Localization Related Epilepsy (COPE)

Terminated·EEmory University·Phase 3·NCT01891890·72 enrolled

A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil

Completed· UCB logo

UCB·Phase 1·NCT03695094·31 enrolled

Pediatric Epilepsy Study

Completed· Novartis logo

Novartis·Phase 3·NCT00050934·132 enrolled

Pediatric Epilepsy Study

Completed· Novartis logo

Novartis·Phase 3·NCT00050947·94 enrolled

Fasting Conditions4 trials

Oxcarbazepine 600 mg Tablets Under Non-Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00849797·120 enrolled

Bioequivalency Study of 600 mg Oxcarbazepine Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00616681·28 enrolled

Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5 mL Under Fasting Conditions

Completed·RRanbaxy Laboratories Limited·N/A·NCT00951600·40 enrolled

Show 1 more trial

Oxcarbazepine 600 mg Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00850174·60 enrolled

CAR4 trials

Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01702623·64 enrolled

Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00618046·48 enrolled

Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fed Conditions

Completed·RRoxane Laboratories·Phase 1·NCT01703468·59 enrolled

Show 1 more trial

Bioequivalency Study of Oxcarbazepine 600 mg Tablets Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00616863·28 enrolled

Seizure4 trials

Effect of Carbamazepine and Oxcarbazepine on Serum Neuron-specific Enolase and S100B in Focal Seizures

Completed·—·Phase 4·NCT02705768·90 enrolled

Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

Completed· Novartis logo

Novartis·Phase 4·NCT00275925·80 enrolled

Efficacy, Safety, and Tolerability of Oxcarbazepine Monotherapy in Children With Partial Seizures

Completed· Novartis logo

Novartis·Phase 4·NCT00275912·60 enrolled

Show 1 more trial

Long-term Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures

Completed·NNobelpharma·Phase 2/3·NCT01051193·88 enrolled

Bipolar Disorder3 trials

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Effect of Oxcarbazepine on Serum Brain Derived Neurotrophic Factor (BDNF) in Bipolar Disorder

Completed·—·Phase 4·NCT02456896·50 enrolled

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.

Completed· Novartis logo

Novartis·Phase 4·NCT00154323·55 enrolled

16 more indications

Trigeminal Neuralgia3 trials

Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia

Active, not recruiting·JJinnah Postgraduate Medical Centre·Phase 4·NCT06849219·122 enrolled

Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial

Unknown status·PPostgraduate Institute of Dental Sciences Rohtak·Phase 4·NCT04996199·132 enrolled

Comparison b/w Carbamazepine vs Oxcarbazepine in Treatment of Trigeminal Neuralgia

Active, not recruiting·—·N/A·NCT07252453·122 enrolled

Neuropathic Pain2 trials

Gabapentin and Oxcarbazepine for Chronic Neuropathic Pain in Children and Adolescents: A Clinical Effectiveness Study

Not yet recruiting·—·Phase 3·NCT02219373·60 enrolled

Oxcarbazepine for the Treatment of Chronic Peripheral Neuropathic Pain

Completed·SSøren H. Sindrup·Phase 4·NCT01302275·117 enrolled

Oral2 trials

Tolerability and Pharmacokinetics of a Single 900 mg Oral Dose of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Completed·BBial - Portela C S.A.·Phase 1·NCT01678976·13 enrolled

Bioequivalence Study of Oxcarbazepine Oral Suspension 300 mg/5mL Under Fed Condition

Completed·RRanbaxy Laboratories Limited·N/A·NCT00951847·40 enrolled

Tics2 trials

Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers

Completed·BBial - Portela C S.A.·Phase 1·NCT01679002·12 enrolled

Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine

Completed·BBial - Portela C S.A.·Phase 1·NCT00900237·14 enrolled

Partial Epilepsy1 trial

Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy

Completed·KKorea UCB Co., Ltd.·Phase 4·NCT01498822·353 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Cancer Pain1 trial

Oxcarbazepine Plus Morphine in Patients With Refractory Cancer Pain

Terminated·CCostantine Albany·Phase 1·NCT02078089·1 enrolled

Pregnancy1 trial

Physiological-based Pharmacokinetics Approach to Medication Exposure During Pregnancy and Breastfeeding

Recruiting·UUniversity of Pittsburgh··NCT05450978·60 enrolled

Aggressive Behavior1 trial

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.

Completed· Novartis logo

Novartis·Phase 4·NCT00154362·50 enrolled

Multiple Sclerosis1 trial

Protective Role of Oxcarbazepine in Multiple Sclerosis

Completed·QQueen Mary University of London·Phase 2·NCT02104661·30 enrolled

Autism1 trial

Oxcarbazepine Versus Placebo in Childhood Autism

Completed·UUniversity of Medicine and Dentistry of New Jersey·N/A·NCT00467753·5 enrolled

Asthma1 trial

Study of Efficacy of Oxcarbazepine in Therapy of Bronchial Asthma

Completed·CCentre of Chinese Medicine, Georgia·Phase 4·NCT00142025·55 enrolled

Acceptability1 trial

Comparative Efficacy and Acceptability of Antimanic Drugs in Acute Mania

Unknown status·GGuiyun Xu·Phase 4·NCT01893229·120 enrolled

Agitation1 trial

The Effect of Oxcarbazepine in the Treatment of Agitation / Aggression in Dementia (OBAD)

Completed·SSykehuset Innlandet HF·Phase 3·NCT00145691·100 enrolled

Schizophrenia1 trial

Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia

Completed·UUniversity of Cologne·Phase 2/3·NCT00637234·54 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 14, 2000

TRILEPTAL

NDA NDA021014

May 25, 2001

TRILEPTAL

NDA NDA021285

Oct 19, 2012

OXTELLAR XR

NDA NDA202810

Sources

References

[1]
ClinicalTrials.gov — 43 trial records for Oxcarbazepine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Oxcarbazepine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Oxcarbazepine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA202810). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Trileptal. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Alpha Subunit Blocker[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[5]

Patent Cliff

Apr 13, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10220042Apr 13, 2027

9119791Apr 13, 2027

7910131Apr 13, 2027

11896599Apr 13, 2027

11166960Apr 13, 2027

6 more patents

9855278Apr 13, 2027

7722898Apr 13, 2027

9370525Apr 13, 2027

8821930Apr 13, 2027

8617600Apr 13, 2027

9351975Apr 13, 2027

Trileptal

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2028

Q4 2028

Trials by Indication[1]

Epilepsy7 trials

Fasting Conditions4 trials

CAR4 trials

Seizure4 trials

Bipolar Disorder3 trials

Trigeminal Neuralgia3 trials

Neuropathic Pain2 trials

Oral2 trials

Tics2 trials

Partial Epilepsy1 trial

Pediatrics1 trial

Cancer Pain1 trial

Pregnancy1 trial

Aggressive Behavior1 trial

Multiple Sclerosis1 trial

Autism1 trial

Asthma1 trial

Acceptability1 trial

Agitation1 trial

Schizophrenia1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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