Drugs / Carbamazepine
Carbamazepine
also known as
CBZ · Tegretol · CBZ-CR · Equetro · Arbil mr · Biston · Carbagen sr · Carbamazepina · +38 more
Small molecule targets CYP3A4 via activation
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed epilepsy, early-onset 1 milestone | |||||
| Filed | US (FDA) | Carbella | epilepsy, early-onset | 2014-03-10 | “FDA has accepted for review a New Drug Application (NDA) for its investigational therapy intravenous carbamazepine” ligand.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | EQUETRO | — | 2016-09-23 | fda.gov ↗ |
| Filed | US (FDA) | — | — | 2016-05-04 | “Lundbeck announced the FDA accepted the resubmission of the NDA for IV carbamazepine.” ligand.com ↗ |
| Label expansions (3) | US (FDA) | TEGRETOL | — | 1986-06-02 – 1995-10-11 | fda.gov ↗ |
| Approved | US (FDA) | TEGRETOL | — | 1968-03-11 | fda.gov ↗ |
Trials 97 · started per year
today
US approved 1968
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04923659 | May 2021 → Jul 2022 overdue | — | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 157 trials · 1 met primary | ||||||
| Phase 1 | NCT07781631 | Sep → Dec 2026 expected | — | Boehringer Ingelheim | Recruiting | No outcome recorded |
| Phase 1 | NCT07570082 | May → Dec 2026 expected | — | Crinetics Pharmaceuticals Inc. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07449390 | Apr → May 2026 | — | Acesion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT07446400 | Mar → Jun 2026 overdue | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07395024 | Feb → Jul 2026 overdue | — | Astellas Pharma Global Development, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT07279233 | Dec 2025 → Feb 2026 | — | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT07198035 | Sep → Dec 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT07100964 | Aug → Sep 2025 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06965881 | May → Jul 2025 | isolated focal cortical dysplasia, tuberous sclerosis | GRIN Therapeutics, Inc. | Terminated | No outcome recorded |
| Phase 1 | NCT06909162 | May 2025 → May 2026 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT06893081 | Apr → Jun 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06897683 | Mar → May 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06914869 | Feb → May 2025 | — | X4 Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT06672900 | Jan → Jul 2025 overdue | — | Aligos Therapeutics | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06633419 | Dec 2024 → Feb 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06751017 | Dec 2024 → Feb 2025 | COVID-19 | Shionogi | Completed | No outcome recorded |
| Phase 1 | NCT06646042 | Oct 2024 → Jan 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06596668 | Oct 2024 → Feb 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT06671405 | Sep 2024 → Feb 2025 | hyperlipidemia | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06547164 | Aug 2024 → Aug 2025 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06370728 | May → Jul 2024 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06348888 | Apr → Jun 2024 | non-small cell lung carcinoma | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT06345794 | Apr → Jun 2024 | — | DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06071442 | Jan → Apr 2024 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06173596 | Jan → Apr 2024 | — | Alexion Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06028464 | Sep → Dec 2023 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06005688 | Aug → Oct 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05965219 | Aug → Nov 2023 | — | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05994807 | Aug → Sep 2023 | — | DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05932303 | Jul → Oct 2023 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT05840952 | Jul 2023 → Apr 2024 | COVID-19 | Aligos Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05860933 | May → Aug 2023 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05824143 | Apr → Jul 2023 | — | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05581823 | Oct 2022 → Jan 2023 | Parkinson disease | Cerevel Therapeutics, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05552196 | Oct 2022 → Mar 2023 | — | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 1 | NCT05594602 | Oct → Dec 2022 | COVID-19 | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT07542847 | Sep → Nov 2022 | — | Otsuka Pharmaceutical Development & Commercialization, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05486949 | Jul → Oct 2022 | — | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05418582 | Jan → Jun 2022 | — | Dizal Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT05248945 | Jan → Jul 2022 | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT05205447 | Jan → Apr 2022 | — | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 1 | NCT05213481 | Dec 2021 → May 2022 | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT05028608 | Sep → Oct 2021 | — | Bayer | Completed | No outcome recorded |
| Phase 1 | NCT04962230 | Jul → Oct 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04840888 | Apr 2021 → Apr 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04784000 | Mar → Apr 2021 | — | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04330248 | Mar 2020 → Jun 2022 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT01967771 | Oct 2013 → Jan 2014 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT01707407 | Sep → Nov 2012 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01629368 | Jun → Sep 2012 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01530022 | May 2012 → Jan 2014 | — | UCB Pharma | Completed | Met primary |
| Phase 1 | NCT01635829 | May → Aug 2012 | — | Janssen Infectious Diseases BVBA | Completed | No outcome recorded |
| Phase 1 | NCT01365403 | Apr → Jul 2011 | — | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT02284854 | Jul → Nov 2009 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01079351 | Apr 2007 → Mar 2009 | epilepsy | Lundbeck LLC | Completed | No outcome recorded |
| Phase 1 | NCT00892125 | Sep 2006 → Mar 2007 | bipolar disorder, schizophrenia | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT02253849 | Nov 2005 → Jun 2006 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT01581918 | Dec 2011 → Mar 2012 | chemotherapy-induced toxicity | Faculdade de Medicina do ABC | Unknown | No outcome recorded |
| Phase 2 | NCT00894010 | May 2009 → Jun 2011 | photosensitive epilepsy | The Epilepsy Study Consortium | Completed | No outcome recorded |
| Phase 2 | NCT00004758 | Nov 1993 → ? | infantile spasms | National Center for Research Resources (NCRR) | Completed | No outcome recorded |
| Phase 2 | NCT00000242 | Oct 1992 → Jan 1997 | cocaine dependence | Medical University of South Carolina | Completed | No outcome recorded |
| Phase 2 | NCT00000191 | Jan 1991 → Feb 1994 | cocaine dependence | University of Pennsylvania | Completed | No outcome recorded |
| Phase 2 | NCT00000217 | Sep 1990 → Oct 1996 | substance-related disorder | University of Kansas | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00913107 | Sep 2007 → Feb 2008 | trigeminal neuralgia | University of Malaya | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT01128959 | Jun 2010 → Jan 2013 | epilepsy | Lundbeck LLC | Completed | No outcome recorded |
| Phase 3 | NCT00150605 | Feb → Oct 2005 | bipolar I disorder | Validus Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00150553 | Jan → Oct 2005 | bipolar disorder | Validus Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT00007670 | Jan 1998 → Mar 2003 | epilepsy | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 3 | NCT00236717 | Sep 1997 → Nov 2000 | epilepsy | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 418 trials · 2 met primary · 2 missed | ||||||
| Phase 4 | NCT03689114 | May 2021 → Jun 2024 | focal epilepsy | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 4 | NCT03307863 | Nov 2017 → Nov 2027 | — | University of Sao Paulo | Suspended | No outcome recorded |
| Phase 4 | NCT03161509 | Jul 2017 → Dec 2018 | — | Rambam Health Care Campus | Terminated | No outcome recorded |
| Phase 4 | NCT02623504 | Oct 2016 → Nov 2018 | bipolar disorder | Validus Pharmaceuticals | Terminated | No outcome recorded |
| Phase 4 | NCT02912364 | Jul 2016 → Apr 2018 | epilepsy | Stanford University | Completed | Met primary |
| Phase 4 | NCT02705768 | Apr 2016 → Feb 2017 | focal epilepsy | All India Institute of Medical Sciences, Bhubaneswar | Completed | No outcome recorded |
| Phase 4 | NCT04967326 | Jan 2016 → Dec 2018 | epilepsy | Gia Dinh People Hospital | Completed | Met primary |
| Phase 4 | NCT02429596 | May 2012 → May 2015 | epilepsy | IRCCS National Neurological Institute "C. Mondino" Foundation | Unknown | No outcome recorded |
| Phase 4 | NCT01089855 | Dec 2009 → Jul 2010 | neuropathy, painful | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00976794 | Jan 2009 → Jun 2012 | bipolar I disorder | University of Sao Paulo | Completed | Missed primary |
| Phase 4 | NCT00325286 | May 2006 → Mar 2008 | bipolar disorder | Creighton University | Unknown | No outcome recorded |
| Phase 4 | NCT00181870 | Jul 2005 → Aug 2007 | manic bipolar affective disorder | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00260247 | Apr 2005 → Oct 2006 | — | Odense University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00190892 | Sep 2004 → Jun 2006 | bipolar disorder | Eli Lilly and Company | Completed | Missed primary |
| Phase 4 | NCT00153296 | Aug 2004 → Apr 2005 | asthma | Centre of Chinese Medicine, Georgia | Completed | No outcome recorded |
| Phase 4 | NCT00207428 | Aug 1999 → Apr 2000 | asthma | Centre of Chinese Medicine, Georgia | Completed | No outcome recorded |
| Phase 4 | NCT00000218 | ? → Jun 2005 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 4 | NCT00000441 | ? → Dec 2000 | alcohol dependence | National Institute on Alcohol Abuse and Alcoholism (NIAAA) | Completed | No outcome recorded |
| Phase not applicable8 trials · 1 missed | ||||||
| — | NCT07673549 | Aug 2026 → Dec 2027 expected | trigeminal neuralgia | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07074561 | Jul → Dec 2025 overdue | trigeminal neuralgia | Yuanyuan Wu | Not yet recruiting | No outcome recorded |
| — | NCT06357260 | Apr 2024 → Feb 2025 | trigeminal neuralgia | Postgraduate Institute of Dental Sciences Rohtak | Unknown | No outcome recorded |
| — | 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 |
| — | NCT00621751 | Feb 2008 → Sep 2013 | traumatic brain injury | Wake Forest University Health Sciences | Completed | Missed primary |
| — | NCT00208520 | Jul 2003 → Jun 2007 | epilepsy syndrome | Dutch Epilepsy Clinics Foundation | Unknown | No outcome recorded |
| — | NCT00381537 | — | epilepsy | Institute of Child Health | Completed | No outcome recorded |
| Comparator or background therapy36 trials | ||||||
| Phase 1 | NCT06847464 Background | Jan → May 2025 | respiratory syncytial virus infectious disease | Enanta Pharmaceuticals, Inc | Completed | No outcome recorded |
| 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 2 | NCT07304453 Comparator | Jan → Jul 2024 | neuropathy, painful, trigeminal neuralgia | Karbala University | Completed | No outcome recorded |
| Phase 2 | NCT01379469 Comparator | Jan 2012 → Feb 2017 | alpha 1-antitrypsin deficiency, cirrhosis of liver | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 2 | NCT00294892 Comparator | Feb 2006 → Sep 2009 | HIV infectious disease | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT01954121 Comparator | Sep 2013 → Sep 2015 | focal epilepsy | UCB Pharma | Completed | Missed primary |
| Phase 3 | NCT01713946 Background | Apr 2013 → Oct 2017 | tuberous sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT01465997 Comparator | May 2012 → Jan 2017 | epilepsy | UCB BIOSCIENCES, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01243177 Comparator | Apr 2011 → Jul 2015 | epilepsy | UCB BIOSCIENCES, Inc. | Completed | Met primary |
| Phase 3 | NCT00848549 Comparator | Oct 2008 → Jun 2011 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00542802 Comparator | Sep 2007 → Jun 2009 | epilepsy, stroke disorder | Scienze Neurologiche Ospedaliere | Unknown | No outcome recorded |
| Phase 3 | NCT00477295 Comparator | May 2007 → Dec 2010 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00266630 Background | Nov 2005 → May 2009 | manic bipolar affective disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00175903 Comparator | Feb 2005 → Oct 2007 | epilepsy | UCB Pharma | Completed | Missed primary |
| Phase 4 | NCT06849219 Comparator | Sep 2024 → Jan 2025 overdue | trigeminal neuralgia | Jinnah Postgraduate Medical Centre | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05748236 Comparator | Nov 2022 → Oct 2023 | focal epilepsy | Dhaka Medical College | Unknown | No outcome recorded |
| Phase 4 | NCT04996199 Comparator | Sep → Dec 2021 | trigeminal neuralgia | Postgraduate Institute of Dental Sciences Rohtak | Unknown | No outcome recorded |
| Phase 4 | NCT04610879 Comparator | Aug 2019 → Sep 2020 | self-limited epilepsy with centrotemporal spikes | King's College London | Terminated | 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 | NCT02205931 Comparator | Jan 2015 → Jun 2018 | epilepsy | University College, London | Unknown | No outcome recorded |
| Phase 4 | NCT02214615 Comparator | Apr 2014 → Jul 2016 | erythromelalgia | VA Connecticut Healthcare System | Completed | No outcome recorded |
| Phase 4 | NCT02208492 Comparator | Sep 2011 → Dec 2013 | focal epilepsy | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT02870283 Comparator | May 2010 → Nov 2014 | bipolar disorder | Federal University of Rio Grande do Sul | Completed | No outcome recorded |
| Phase 4 | NCT00807989 Comparator | Mar 2008 → May 2012 | epilepsy | Yonsei University | Completed | No outcome recorded |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00438451 Comparator | Jan 2007 → Jul 2010 | focal epilepsy | Johannes Gutenberg University Mainz | Completed | No outcome recorded |
| Phase 4 | NCT00350857 Comparator | Jul 2006 → Oct 2007 | bipolar I disorder | Validus Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT01127256 Comparator | May 2006 → May 2009 | epilepsy | Eisai Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00896987 Comparator | May 2006 → Dec 2008 | epilepsy | Korean Epilepsy Society | Completed | No outcome recorded |
| Phase 4 | NCT00203567 Comparator | Aug 2005 → Feb 2007 | bipolar depression | Tuscaloosa Research & Education Advancement Corporation | Completed | No outcome recorded |
| — | NCT06977932 Comparator | Mar 2026 → Dec 2028 expected | trigeminal neuralgia | Yuanyuan Wu | Not yet recruiting | No outcome recorded |
| — | NCT07252453 Comparator | May → Nov 2025 overdue | trigeminal neuralgia | Abbasi Shaheed Hospital | Active not recruiting | No outcome recorded |
| — | NCT03636958 Background | Feb 2021 → Jul 2025 | epilepsy | Assistance Publique Hopitaux De Marseille | Withdrawn | No outcome recorded |
| — | NCT01382017 Comparator | Jun 2011 → Aug 2012 | — | University of Kiel | Completed | No outcome recorded |
| — | NCT00952432 Comparator | May 2009 → May 2011 | carpal tunnel syndrome | Taipei Medical University WanFang Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-04-01 | Alembic Pharmaceuticals Ltd. | Regulatory Press Release FA for Carbamazepine Tablets USP, 200 mg alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbamazepine Tablets USP, 200 mg. |
| 2019-02-08 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Carbamazepine Extended-Release Tablets USP zyduslife.com ↗ |
| 2016-10-07 | Ligand Pharmaceuticals | Regulatory Ligand Partner Lundbeck Receives FDA Approval of Carnexiv™ (carbamazepine) Injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types ligand.com ↗
Lundbeck announced today that the U.S. Food and Drug Administration (FDA) has approved Carnexiv™ (carbamazepine) injection as a short-term replacement therapy for oral carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible. |
| 2014-03-10 | Ligand Pharmaceuticals | Regulatory Captisol® Licensee Lundbeck Announces FDA Acceptance of NDA Submission for Carbamazepine IV ligand.com ↗
With acceptance of the NDA filing, Ligand earns a $200,000 milestone payment. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-01 | Alembic Pharmaceuticals Ltd. | Press Release FA for Carbamazepine Tablets USP, 200 mg alembicpharmaceuticals.com ↗ |
| 2021-08-20 | Upsher-Smith Laboratories | Upsher-Smith Launches Carbamazepine Extended-Release Tablets, USP upsher-smith.com ↗ |
| 2019-02-08 | Zydus Lifesciences Limited | Zydus receives final approval from the USFDA for Carbamazepine Extended-Release Tablets USP zyduslife.com ↗ |
| 2016-10-07 | Ligand Pharmaceuticals | Ligand Partner Lundbeck Receives FDA Approval of Carnexiv™ (carbamazepine) Injection as Intravenous Short-Term Replacement Therapy for Certain Seizure Types ligand.com ↗ |
| 2014-03-10 | Ligand Pharmaceuticals | Captisol® Licensee Lundbeck Announces FDA Acceptance of NDA Submission for Carbamazepine IV ligand.com ↗ |
Evidence & citations 51 cited values
Every value below carries the sentence it was read from. 140 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | carbamazepine | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗132“Carbamazepine, a first-generation antiepileptic medication, stabilizes the inactivated state of voltage-gated sodium channels, making fewer of these channels available to...” NCT02208492 ↗ “Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958 ↗ “Carbamazepine (CBZ) is a potent inducer of these enzymes; thus, the effect of oral extended-release CBZ on DTG pharmacokinetics (PK) was evaluated to provide dose...” PMID 26898568 ↗ Feb 2016 “List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin” NCT01713946 ↗ “200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years)” NCT01465997 ↗ “In this study, we evaluated the efficacy and occurrence of side effects of lamotrigine (LTG) in comparison with carbamazepine (CBZ), in trigeminal neuralgia (TN) patients.” PMID 21621166 ↗ May 2011 “Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)” NCT02556320 ↗ “Following enrollment, the patient's carbamazepine dosage remained consistent with the pre-enrollment dosage. Orally administered for two consecutive weeks.” NCT06977932 ↗ “patients received oral carbamazepine (CBZ) at a dosage of 100 mg per tablet three times daily (TID) after meals for 4 consecutive weeks” NCT07074561 ↗ “Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide” NCT05236166 ↗ |
| Known as | Arbil mr | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Biston | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Carbagen sr | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Carbamazepina | “Carbamazepina tablets 200 mg.” NCT00542802 ↗ |
| Known as | Carbamazepine (generic name for Tegretol) | “Carbamazepine (generic name for Tegretol®)” NCT00913107 ↗ |
| Known as | Carbamazepine anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | carbamazepine ER | “Drug: carbamazepine ER” NCT06646042 ↗ |
| Known as | Carbamazepine extended release | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | carbamazepine-CR | “carbamazepine (carbamazepine-CR) twice daily” PMID 27889312 ↗ Nov 2016 |
| Known as | carbamazepine-slow release | “To evaluate the tolerability and efficacy of levetiracetam (LEV) in newly diagnosed elderly patients (aged 60 yrs or above) with focal epilepsy compared to lamotrigine (LTG) or...” NCT00438451 ↗ |
| Known as | Carbamazepinum | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Carbarmazepine | “Carbarmazepine” NCT06977932 ↗ |
| Known as | Carbatrol | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Carmazepine | “The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A...” NCT02208492 ↗ |
| Known as | Carnexiv | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | CBZ | “The purpose of this study is to assess the safety and tolerability of intravenous (IV) carbamazepine (CBZ) administered as multiple 15 minute infusions and a single 5 minute...” NCT01128959 ↗8“OBJECTIVE: To prospectively evaluate the neuropsychological effect of levetiracetam (LVT) in comparison with carbamazepine (CBZ) and its efficacy and tolerability as a...” PMID 25948717 ↗ May 2015 “To evaluate the tolerability and efficacy of levetiracetam (LEV) in newly diagnosed elderly patients (aged 60 yrs or above) with focal epilepsy compared to lamotrigine (LTG) or...” NCT00438451 ↗ “This is a multicenter, randomized, double-simulation, placebo-controlled trial designed to compare the efficacy of EA plus placebo with sham EA plus carbamazepine (CBZ) for TN.” PMID 42261299 ↗ Jun 2026 “In this study, we evaluated the efficacy and occurrence of side effects of lamotrigine (LTG) in comparison with carbamazepine (CBZ), in trigeminal neuralgia (TN) patients.” PMID 21621166 ↗ May 2011 “patients received oral carbamazepine (CBZ) at a dosage of 100 mg per tablet three times daily (TID) after meals for 4 consecutive weeks” NCT07074561 ↗ “A Study of Carbamazepine (CBZ) and MK-8527 in Healthy Adult Participants (MK-8527-012)” NCT06893081 ↗ “carbamazepine (CBZ)” NCT01382017 ↗ |
| Known as | CBZ-CR | “controlled-release carbamazepine (CBZ-CR) as monotherapy in patients aged ≥ 60 years with newly diagnosed epilepsy.” PMID 27552848 ↗ Aug 20161“Carbamazepine-Controlled Release (CBZ-CR)” NCT01465997 ↗ |
| Known as | CBZ-IR | “The primary objective of this Phase 1 crossover study is to evaluate the neuropsychological effects of Lacosamide (LCM) compared to Carbamazepine Immediate Release (CBZ-IR)...” NCT01530022 ↗ |
| Known as | Epimaz | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Epimaz ret | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Epitol | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Equetro | “Open Label Prophylaxis Study of Lithium Plus Extended- Release Carbamazepine (Equetro®) Combination for Rapid Cycling Bipolar Disorder” NCT00325286 ↗1“up to 1200 mg/day of carbamazepine ER (Equetro)” NCT00181870 ↗ |
| Known as | ERC-CBZ | “Patients with Bipolar I or II Disorder with a Major Depressive Episode who sign informed consent and meet eligibility criteria will begin treatment with extended release...” NCT00203567 ↗ |
| Known as | Finlepsin | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | G-32883 | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | GEIGY 32883 | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Karbamazepin | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Karbelex | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Neurotol | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Neurotop | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | NSC-169864 | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Sirtal | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Sirtal ret | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Stazepine | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Tegretal | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Tegretol | “The Effects on Cognitive Function of Levetiracetam (Keppra®) Compared to Carbamazepine (Tegretol®, Carmazepine®) as Monotherapy for Children With Partial Seizure; A...” NCT02208492 ↗ |
| Known as | Tegretol chewtab | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Tegretol prolonged release | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Tegretol XR | “One arm receives Drug-Carbamazepine (Tegretol XR).All subjects have severe liver disease due to alpha-1-antitrypsin deficiency.” NCT01379469 ↗ |
| Known as | Tegretol-XR Carbamazepine extended release tablets. | “Tegretol-XR Carbamazepine extended release tablets.” NCT01379469 ↗ |
| Known as | Telesmin | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Teril | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Teril ret | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Timonil | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Timonil 200 ret | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Known as | Timonil 400 ret | ChEMBL registry synonym — accepted as the source's own label CHEMBL108 ↗ |
| Action | Inhibit | “sodium channel blocker” NCT04923659 ↗ |
| Modality | Small molecule | — CHEMBL108 ↗ |
| Route | Oral | “Daily dose of 600-1600 mg CR oral tablets, 200 mg and 400 mg twice daily.” NCT00175903 ↗ |
| Target | CYP3A4 | “It is the hypothesis that oxcarbazepine induces CYP3A4 to a lesser degree than carbamazepine.” NCT00260247 ↗ |