Drugs / Oxcarbazepine
Oxcarbazepine
also known as
Trileptal · OXC · GP-47680 · KIN-493 · NSC-758693 · OXC IR · OXC MR · OXC XR · +5 more
Small molecule targets CYP3A4
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | OXTELLAR XR | — | 2018-12-13 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | TRILEPTAL | — | 2003-08-07 – 2005-10-28 | fda.gov ↗ |
| Approved | US (FDA) | TRILEPTAL | — | 2000-01-14 | fda.gov ↗ |
Trials 38 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT03695094 | Sep 2018 → May 2019 | epilepsy | UCB Biopharma S.P.R.L. | Completed | No outcome recorded |
| Phase 1 | NCT02078089 | Mar → Dec 2014 | cancer | Costantine Albany | Terminated | No outcome recorded |
| Phase 1 | NCT00849797 | Jul 2005 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT00850174 | Apr → May 2005 | — | Teva Pharmaceuticals USA | Completed | No outcome recorded |
| Phase 1 | NCT01679002 | Oct → Dec 2003 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01678976 | Mar → Apr 2002 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02104661 | Oct 2014 → Jan 2018 | multiple sclerosis | Queen Mary University of London | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT01051193 | Jan 2010 → Sep 2019 | focal epilepsy | Nobelpharma | Completed | No outcome recorded |
| Phase 2/3 | NCT00975715 | Sep 2009 → Oct 2012 | focal epilepsy | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2/3 | NCT00637234 | Jul 2004 → Apr 2008 | schizophrenia | University of Cologne | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT02219373 | Jun 2026 → Dec 2028 expected | neuropathy, painful | Boston Children's Hospital | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT00908349 | Jun 2009 → Nov 2011 | focal epilepsy | Supernus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00145691 | Sep 2005 → Oct 2006 | — | Innlandet Hospital Trust | Completed | No outcome recorded |
| Phase 3 | NCT00050947 | Jul 2002 → Feb 2004 | epilepsy | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00050934 | Jun 2002 → Jun 2004 | epilepsy | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 418 trials | ||||||
| Phase 4 | NCT06849219 | Sep 2024 → Jan 2025 overdue | trigeminal neuralgia | Jinnah Postgraduate Medical Centre | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04996199 | Sep → Dec 2021 | trigeminal neuralgia | Postgraduate Institute of Dental Sciences Rohtak | Unknown | No outcome recorded |
| Phase 4 | NCT03689114 | May 2021 → Jun 2024 | focal epilepsy | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 4 | NCT03374709 | Dec 2018 | trigeminal neuralgia | University of Colorado, Denver | Withdrawn | No outcome recorded |
| Phase 4 | NCT03567681 | Jun 2018 → Sep 2019 | bipolar depression | Collaborative Care Initiative, LLC | Unknown | No outcome recorded |
| Phase 4 | NCT02705768 | Apr 2016 → Feb 2017 | focal epilepsy | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT02456896 | Jun → Dec 2015 | bipolar disorder | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT01893229 | Sep 2013 → Dec 2015 | bipolar disorder | Guiyun Xu | Unknown | No outcome recorded |
| Phase 4 | NCT02180880 | Nov 2012 → Aug 2014 | neuralgia, spinal cord injury | Ju Seok Ryu | Completed | No outcome recorded |
| Phase 4 | NCT02429596 | May 2012 → May 2015 | epilepsy | IRCCS National Neurological Institute "C. Mondino" Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT01302275 | Feb 2011 → May 2013 | peripheral nerve lesion, polyneuropathy, postherpetic neuralgia | Søren H. Sindrup | Completed | No outcome recorded |
| Phase 4 | NCT00855738 | May 2007 → Jun 2009 | focal epilepsy | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00275912 | Sep 2006 → Sep 2007 | focal epilepsy | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00275925 | Dec 2005 → Mar 2007 | focal epilepsy | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00260247 | Apr 2005 → Oct 2006 | — | Odense University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00154362 | Apr 2003 → Oct 2004 | conduct disorder | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00154323 | Jan 2003 → Jan 2006 | bipolar disorder | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00142025 | Sep 2001 → Mar 2002 | asthma | Centre of Chinese Medicine, Georgia | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT05236166 | Apr 2017 → May 2021 | epilepsy | University Magna Graecia | Completed | No outcome recorded |
| — | NCT02556320 | May 2013 → Aug 2015 | drug allergy, epilepsy | University Hospital, Rouen | Completed | No outcome recorded |
| — | NCT00467753 | Apr 2006 → Dec 2011 | autism | University of Medicine and Dentistry of New Jersey | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00918424 | Jun 2009 → ? | epilepsy | Supernus Pharmaceuticals, Inc. | Approved for marketing | No outcome recorded |
Also used as a comparator or background therapy in 13 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02707965 Comparator | Jun 2017 → Aug 2018 | epilepsy | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT00734864 Background | Jun 2009 → Jun 2010 | anaplastic astrocytoma, anaplastic oligodendroglioma, gliosarcoma | Annick Desjardins | Withdrawn | No outcome recorded |
| Phase 1 | NCT00900237 Comparator | Nov → Dec 2008 | focal epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT07625410 Comparator | May 2023 → May 2024 | — | Rehman Medical Institute - RMI | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT01891890 Comparator | Aug 2013 → Oct 2015 | focal epilepsy | Emory University | Terminated | No outcome recorded |
| Phase 3 | NCT00772603 Comparator | Nov 2008 → Apr 2010 | focal epilepsy | Supernus Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00391534 Comparator | Oct 2006 → Nov 2009 | focal epilepsy | Desitin Arzneimittel GmbH | Terminated | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05697614 Comparator | Mar → May 2023 | epilepsy | Dr Cipto Mangunkusumo General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03490487 Background | Jun 2018 → Dec 2020 | self-limited epilepsy with centrotemporal spikes | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT01498822 Comparator | Jun 2011 → Jul 2014 | epilepsy | UCB Pharma | Completed | No outcome recorded |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT07252453 Comparator | May → Nov 2025 overdue | trigeminal neuralgia | Abbasi Shaheed Hospital | Active not recruiting | No outcome recorded |
| — | NCT02300051 Background | Feb 2011 → Apr 2015 | sexual disorder | University of Sao Paulo General Hospital | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2007-12-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval Of Generic Trileptal® Tablets tevapharm.com ↗ |
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 54 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Oxcarbazepine | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗49“Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)” NCT02556320 ↗ “mood stabilizers (topiramate 25 - 200 mg/day, divalproex sodium (500 - 1500 mg/day, oxcarbazepine (300 - 1200 mg/day, and lamotrigine 50 - 200 mg/day).” NCT02300051 ↗ “Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide” NCT05236166 ↗ “Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures” NCT00975715 ↗ “Oxtellar Extended Release (Oxcarbazepine Extended Release) Patients With Trigeminal Neuralgia” NCT03374709 ↗ “carbamazepine, valproic acid, topiramate, oxcarbazepine, levetiracetam or lamotrigine” NCT02429596 ↗ “carbamazepine, valproate, oxcarbazepine or levetiracetam” NCT03490487 ↗ “monotherapy with oxcarbazepine (300 mg twice daily)” NCT07625410 ↗ “Oxcarbazepine: up to 2.400 mg/d” NCT00855738 ↗ “Oxcarbazepine/Trileptal” NCT00734864 ↗ |
| Known as | GP-47680 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1068 ↗ |
| Known as | KIN-493 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1068 ↗ |
| Known as | NSC-758693 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1068 ↗ |
| Known as | OXC | “This open-label, multicenter, randomized phase IV trial (NCT01498822) of noninferiority design compared the long-term effectiveness, safety, and tolerability of levetiracetam...” PMID 28395124 ↗ Apr 20172“BACKGROUND/AIMS: To evaluate the efficacy of oxcarbazepine (OXC) in the treatment of agitation and aggression in patients with Alzheimer's disease, vascular dementia or both.” PMID 19182483 ↗ Feb 2009 “Oxcarbazepine (OXC), 300 mg tablets, up to 600 mg three times daily” NCT00637234 ↗ |
| Known as | OXC IR | “immediate release formulation of oxcarbazepine (OXC IR)” NCT00391534 ↗ |
| Known as | OXC MR | “modified release formulation of oxcarbazepine (OXC MR)” NCT00391534 ↗ |
| Known as | OXC XR | “OXC XR is a once-daily formulation of oxcarbazepine and is given at the same dosage levels.” NCT00918424 ↗ |
| Known as | Oxcarbamazepine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1068 ↗ |
| Known as | Oxcarbazepina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1068 ↗ |
| Known as | Oxtellar XR | “Six week of open treatment with extended release oxcarbazepine (Oxtellar XR)” NCT03567681 ↗ |
| Known as | SPN-804 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00772603 ↗ |
| Known as | TRI476 | “Efficacy, Safety and Tolerability of TRI476 (Oxcarbazepine) in Children With Inadequately Controlled Partial Onset Seizures” NCT00975715 ↗ |
| Known as | Trileptal | “The objective of this study is to evaluate the comparative bioavailability between Oxcarbazepine 600 mg Tablets (test) and Trileptal® 600 mg Tablets (reference) after a...” NCT00850174 ↗5“This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3...” NCT00050934 ↗ “This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.” NCT00050947 ↗ “Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period” NCT00849797 ↗ “Six week of open treatment with Immediate release oxcarbazepine ( Trileptal)” NCT03567681 ↗ “Oxcarbazepine/Trileptal” NCT00734864 ↗ |
| Action | Inhibit | “This active form works by blocking voltage-sensitive sodium channels in the brain” NCT07252453 ↗ |
| Modality | Small molecule | — CHEMBL1068 ↗ |
| Route | Oral | “Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy” NCT00154323 ↗ |
| Target | CYP3A4 | “It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.” NCT00260247 ↗ |