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 · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | Oxtellar XR | — | 2020-05-15 | “submission by Apotex of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval for oxcarbazepine extended-release tablets.” supernus.com ↗ “by submitting to the U.S. Food and Drug Administration (FDA) an Abbreviated New Drug Application (ANDA) seeking to market a generic version of Oxtellar XR” supernus.com ↗ |
| 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 39
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials · 2 met primary | ||||||
| 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 Stop: Enrollment |
| Phase 1 | NCT00849797 | Jul 2005 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| Phase 1 | NCT00850174 | Apr → May 2005 | — | Teva Pharmaceuticals USA | Completed | Met primary |
| 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 · 1 missed | ||||||
| Phase 3 | NCT02219373 | Jun 2026 → Dec 2028 | neuropathy, painful | Boston Children's Hospital | Withdrawn | 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 | Missed primary |
| 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 419 trials · 1 missed | ||||||
| Phase 4 | NCT07795593 | Oct 2026 → May 2031 expected | diabetic kidney disease, diabetic neuropathy | University of Michigan | Not yet recruiting | No outcome recorded |
| 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 | Missed primary |
| 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 |
| Comparator or background therapy13 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 2/3 | NCT07625410 Comparator | May 2023 → May 2024 | — | Rehman Medical Institute - RMI | Completed | No outcome recorded |
| Phase 3 | NCT01891890 Comparator | Aug 2013 → Oct 2015 | focal epilepsy | Emory University | Terminated | No outcome recorded Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 | Met primary |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
| — | 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 |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2025-06-07 | Lupin Limited | Regulatory Lupin Receives Tentative Approval from U.S. FDA for Oxcarbazepine ER Tablets lupin.com ↗
Lupin Limited (Lupin) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Oxcarbazepine Extended-Release (ER) Tablets, 150 mg, 300 mg, and 600 mg. |
| 2023-07-04 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Oxcarbazepine Tablets USP, 150 mg, 300 mg and 600 mg zyduslife.com ↗
Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and Drug Administration (USFDA) for Oxcarbazepine Tablets USP, 150 mg, 300 mg and 600 mg (USRLD: Trileptal ® Tablets, 150 mg, 300 mg, and 600 mg). |
| 2020-05-15 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces Paragraph IV ANDA Filing for Oxtellar XR® supernus.com ↗
the Company received a Paragraph IV Notice Letter from Apotex Inc. and Apotex Corp advising Supernus of the submission by Apotex of an Abbreviated New Drug Application |
| 2018-12-14 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces FDA Approval of sNDA to Expand Oxtellar XR® Label to Include Monotherapy supernus.com ↗ |
| 2007-12-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval Of Generic Trileptal® Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' antiepileptic therapy Trileptal® (Oxcarbazepine) Tablets, 150 mg, 300 mg and 600 mg. |
| 2007-10-10 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA approval to market generic Trileptal® Tablets, 180 day marketing exclusivity sunpharma.com ↗
Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the company’s Abbreviated New Drug Application (ANDA) to market its generic version of Novartis Trileptal®, oxcarbazepine tablets. |
All press releases naming this drug 8 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 55 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 ↗50“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 ↗ “Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide” NCT07795593 ↗ “carbamazepine, valproate, oxcarbazepine or levetiracetam” NCT03490487 ↗ “monotherapy with oxcarbazepine (300 mg twice daily)” NCT07625410 ↗ “Oxcarbazepine: up to 2.400 mg/d” NCT00855738 ↗ |
| 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 ↗ |