Drugs / Zonisamide
Zonisamide
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed simple partial epilepsy 1 milestone | |||||
| Filed | EU (EMA) | Zonegran® | simple partial epilepsy | 2012-06-22 | “for use of the antiepileptic agent Zonegran® (zonisamide) in the treatment of pediatric patients has been accepted for review by the European Medicines Agency (EMA).” eisai.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Zonegran | — | 2005-03-10 | europa.eu ↗ |
| Approved | US (FDA) | ZONEGRAN | — | 2000-03-27 | fda.gov ↗ |
Trials 50
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT00687167 | Jan → Mar 2005 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00685139 | Jan → Mar 2005 | — | Mutual Pharmaceutical Company, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00649714 | Dec 2003 → Jan 2004 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00650052 | Nov → Dec 2003 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1/23 trials · 2 missed | ||||||
| Phase 1/2 | NCT02049073 | Oct → Nov 2017 | noise induced hearing loss | Washington University School of Medicine | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT01685996 | Sep 2012 → May 2014 | nicotine dependence | Johns Hopkins University | Completed | Missed primary |
| Phase 1/2 | NCT01137890 | Jun 2010 → Mar 2012 | cocaine dependence | Johns Hopkins University | Completed | Missed primary |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT05134857 | Jan 2022 → Aug 2027 expected | alcohol-related disorders | Washington State University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04774250 | Nov 2021 → Dec 2022 | noise induced hearing loss | Washington University School of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03376139 | Mar → Aug 2019 | alcohol-related disorders, post-traumatic stress disorder | Pharmacotherapies for Alcohol and Substance Use Disorders Alliance | Withdrawn | No outcome recorded |
| Phase 2 | NCT01847469 | Jun 2013 → Jan 2019 | alcohol dependence, post-traumatic stress disorder | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT01566370 | May 2012 → Jul 2013 | alcohol-related disorders, bipolar disorder | Yale University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01765608 | Mar 2010 → Jun 2013 | obesity disorder, obstructive sleep apnea syndrome | Göteborg University | Completed | No outcome recorded |
| Phase 2 | NCT00862563 | May 2009 → Aug 2013 | alcohol abuse, alcohol dependence | Boston Medical Center | Terminated | Met primary Stop: Enrollment |
| Phase 2 | NCT00406692 | Nov 2006 → Aug 2008 | alcohol dependence | Boston University | Completed | Mixed |
| Phase 2 | NCT00223743 | Nov 2004 → Sep 2008 | essential tremor | VA Greater Los Angeles Healthcare System | Completed | No outcome recorded |
| Phase 2 | NCT00055484 | Mar 2002 → May 2003 | migraine disorder | Elan Pharmaceuticals | Completed | No outcome recorded |
| Phase 314 trials · 3 met primary · 2 missed | ||||||
| Phase 3 | NCT06347497 | Apr 2024 → Apr 2026 | migraine disorder | Kafrelsheikh University | Completed | No outcome recorded |
| Phase 3 | NCT06361446 | Mar 2024 → Mar 2025 | migraine disorder | Kafrelsheikh University | Unknown | No outcome recorded |
| Phase 3 | NCT05205811 | Dec 2021 → Jun 2025 | — | Rose Research Center, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04388319 | May 2020 → Jun 2021 | — | Rose Research Center, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02901041 | Sep 2017 → Jan 2022 | alcohol dependence | Boston University Charles River Campus | Completed | Missed primary |
| Phase 3 | NCT02900352 | Oct 2016 → Apr 2021 | alcohol dependence | Virginia Commonwealth University | Completed | Met primary |
| Phase 3 | NCT02368431 | Mar 2015 → Oct 2018 | alcohol-related disorders | VA Office of Research and Development | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01806805 | Feb 2012 → Jul 2014 | myoclonus-dystonia syndrome | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 3 | NCT00566254 | Dec 2008 → Mar 2011 | simple partial epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01136954 | Jul 2008 → Jan 2012 | focal epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00363376 | Jan 2008 → Feb 2011 | — | Lindner Center of HOPE | Completed | Met primary |
| Phase 3 | NCT00401973 | Nov 2006 → Sep 2008 | schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00327717 | Sep 2006 → May 2008 | focal epilepsy | Eisai Inc. | Completed | Met primary |
| Phase 3 | NCT00056576 | Feb 2002 → Oct 2004 | complex partial epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 415 trials | ||||||
| Phase 4 | NCT06534502 | Sep 2026 → Sep 2027 expected | focal epilepsy | Azurity Pharmaceuticals | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06967012 | Aug 2024 → Jul 2027 expected | epilepsy with generalized tonic-clonic seizures, focal epilepsy | Affiliated Hospital of Nantong University | Recruiting | No outcome recorded |
| Phase 4 | NCT03689114 | May 2021 → Jun 2024 | focal epilepsy | Mario Negri Institute for Pharmacological Research | Completed | No outcome recorded |
| Phase 4 | NCT00659958 | Apr 2008 → Sep 2009 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01140867 | Feb 2008 → Aug 2010 | epilepsy | Eisai Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00855738 | May 2007 → Jun 2009 | focal epilepsy | Viatris Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00595556 | Jul 2006 → May 2009 | alcohol abuse, alcohol dependence | UConn Health | Completed | Mixed |
| Phase 4 | NCT01127256 | May 2006 → May 2009 | epilepsy | Eisai Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01127165 | Mar 2006 → Mar 2009 | epilepsy | Eisai Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00215592 | Oct 2005 → Jul 2007 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00154076 | Sep 2005 → Aug 2008 | epilepsy | Eisai Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00165828 | May 2005 → Feb 2008 | epilepsy | Eisai Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00259636 | Aug 2004 → Jan 2008 | fibromyalgia, migraine disorder | University of Pittsburgh | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00203450 | May 2003 → Mar 2005 | obesity disorder | Tuscaloosa Research & Education Advancement Corporation | Completed | No outcome recorded |
| Phase 4 | NCT00047567 | Jul 2002 | bipolar disorder | Elan Pharmaceuticals | Terminated | No outcome recorded |
| Phase not applicable4 trials · 1 met primary | ||||||
| — | NCT04939675 | Jul 2021 → Jun 2023 | epilepsy | National Taiwan University Hospital | Unknown | No outcome recorded |
| — | NCT05236166 | Apr 2017 → May 2021 | epilepsy | University Magna Graecia | Completed | No outcome recorded |
| — | NCT00398918 | Nov 2006 → Oct 2007 | alcohol dependence | Boston University | Completed | Met primary |
| — | NCT00275834 | Jan 2006 → Sep 2011 | obesity disorder | Duke University | Completed | No outcome recorded |
| Comparator or background therapy23 trials | ||||||
| Phase 1 | NCT02707965 Comparator | Jun 2017 → Aug 2018 | epilepsy | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 2 | NCT04768569 Comparator | Oct 2021 → Sep 2023 | noise induced hearing loss | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 2 | NCT00734435 Comparator | Sep → Dec 2008 | schizoaffective disorder, schizophrenia, schizophreniform disorder | Orexigen Therapeutics, Inc | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00709371 Comparator | Jul 2008 → Apr 2009 | obesity disorder | Orexigen Therapeutics, Inc | Completed | No outcome recorded |
| Phase 2 | NCT00339014 Comparator | May 2006 → Aug 2007 | obesity disorder | Orexigen Therapeutics, Inc | Completed | No outcome recorded |
| Phase 2/3 | NCT01766128 Comparator | Feb 2013 | Parkinson disease | Mazandaran University of Medical Sciences | Withdrawn | No outcome recorded |
| Phase 3 | NCT01713946 Background | Apr 2013 → Oct 2017 | tuberous sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT00848549 Comparator | Oct 2008 → Jun 2011 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00692003 Comparator | Aug → Nov 2008 | epilepsy | Eisai Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00693017 Comparator | Jun → Nov 2008 | epilepsy | Eisai Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00477295 Comparator | May 2007 → Dec 2010 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00292461 Comparator | Mar 2006 → Aug 2009 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00221442 Comparator | Aug 2005 → Mar 2009 | binge eating disorder | Lindner Center of HOPE | Completed | No outcome recorded |
| Phase 4 | NCT03034538 Comparator | Apr 2016 → Dec 2022 | Parkinson disease, movement disorder | The Cooper Health System | Suspended | No outcome recorded |
| Phase 4 | NCT02205931 Comparator | Jan 2015 → Jun 2018 | epilepsy | University College, London | Unknown | No outcome recorded |
| Phase 4 | NCT01630057 Comparator | Sep 2009 → Jun 2011 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT01546688 Comparator | Nov 2008 → Nov 2010 | epilepsy | Eisai Inc. | Terminated | No outcome recorded |
| Phase 4 | NCT00713622 Comparator | Jun → Dec 2008 | epilepsy | Eisai Inc. | Completed | No outcome recorded |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
| — | NCT03636958 Background | Feb 2021 → Jul 2025 | epilepsy | Assistance Publique Hopitaux De Marseille | Withdrawn | No outcome recorded |
| — | NCT04182399 Comparator | Apr 2020 → Dec 2022 | Parkinson disease | Ain Shams University | Completed | No outcome recorded |
| — | NCT00777218 Comparator | Aug 2007 → Dec 2010 | migraine disorder | University of South Alabama | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00616343 Comparator | Jun 2003 → Oct 2012 | essential tremor | Loma Linda University | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2013-10-03 | Eisai Inc. | Regulatory EISAI RECEIVES EUROPEAN COMMISSION APPROVAL ON USE OF ANTIEPILEPTIC AGENT ZONEGRAN® IN PEDIATRIC PATIENTS eisai.com ↗ |
| 2013-09-12 | Eisai Inc. | Regulatory EISAI ANNOUNCES LAUNCH OF ANTICANCER AGENT HALAVEN® AS COMPANY'S FIRST PRODUCT IN RUSSIA eisai.com ↗
Eisai established Limited Liability Company Eisai (“Eisai Russia”) as a pharmaceutical sales company in Moscow in April 2013 and has also received local marketing approval for the antiepileptic agents Zonegran® (zonasamide) and Exalief® (eslicarbazepine acetate; brand name in the EU: Zebinix®). |
| 2013-07-29 | Eisai Inc. | Regulatory EISAI RECEIVES POSITIVE OPINION FROM EMA'S CHMP ON USE OF ANTIEPILEPTIC AGENT ZONEGRAN® IN PEDIATRIC PATIENTS eisai.com ↗ |
| 2012-07-03 | Eisai Inc. | Regulatory EISAI RECEIVES EMA APPROVAL TO MARKET ZONEGRAN® MONOTHERAPY FOR TREATMENT OF EPILEPSY eisai.com ↗ |
| 2012-07-03 | Eisai Inc. | Regulatory EMA ACCEPTS EISAI'S LICENSE EXTENSION APPLICATION FOR USE OF ANTIEPILEPTC AGENT ZONEGRAN® IN PEDIATRIC PATIENTS eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that the license extension application submitted by its U.K. subsidiary Eisai Europe Ltd. for use of the antiepileptic agent Zonegran® (zonisamide) in the treatment of pediatric patients has been accepted for review by the European Medicines Agency (EMA). |
| 2012-06-27 | Eisai Inc. | Regulatory EISAI RECEIVES RUSSIAN REGULATORY APPROVAL FOR FIRST PRODUCT－ANTIEPILEPTIC AGENT ZONEGRAN® eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that the Ministry of Health and Social Development of the Russian Federation has approved the antiepileptic agent Zonegran® (zonisamide) as an adjunctive therapy in the treatment of adult epilepsy patients with partial seizures. |
| 2012-05-28 | Eisai Inc. | Regulatory EISAI RECEIVES POSITIVE CHMP OPINION FOR ZONEGRAN® (ZONISAMIDE) MONOTHERAPY TREATMENT FOR EPILEPSY eisai.com ↗ |
| 2011-09-01 | Eisai Inc. | Results EISAI PRESENTS NEW RESEARCH ON EPILEPSY PIPELINE, PORTFOLIO AT THE 29TH INTERNATIONAL EPILEPSY CONGRESS Looks to Expand Global Epilepsy Product Portfolio eisai.com ↗
The percentage of patients who completed the study was comparable between the zonisamide and placebo groups (86.9 percent of patients on zonisamide and 90 percent of patients on placebo). |
| 2011-07-28 | Eisai Inc. | Regulatory EMA ACCEPTS EISAI'S LICENSE EXTENSION APPLICATION FOR ANTIEPILEPTIC AGENT ZONEGRAN® AS A MONOTHERAPY eisai.com ↗
Eisai Co., Ltd. (Headquarters: Tokyo, President & CEO: Haruo Naito, “Eisai”) announced today that the European Medicines Agency (EMA) has accepted for review the company's application to extend the use of the antiepileptic agent Zonegran® (zonisamide) as a monotherapy. |
All press releases naming this drug 12 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 76 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zonisamide | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗70“Intravenous injection; initial daily dose of 50 mg zonisamide (2x25 mg) in both treatment groups; following a prospective or retrospective baseline phase of 8 weeks the study...” NCT00165828 ↗ “Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958 ↗ “List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin” NCT01713946 ↗ “Zonisamide is an antiepileptic drug which could bring a therapeutic profit in Myoclonus Dystonia on the severity of the myoclonus.” NCT01806805 ↗ “Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide” NCT05236166 ↗ “Open Label, Zonegran (Zonisamide) In Partial Onset Seizures” NCT00215592 ↗ “zonegran (zonisamide)” NCT00221442 ↗ “Zonisamide” NCT02205931 ↗ |
| Known as | 1,2-Benzisoxazole-3-methanesulfonamide | “Zonisamide (ZNS) (1,2-Benzisoxazole-3-methanesulfonamide) is an anti-epileptic drug.” NCT04182399 ↗ |
| Known as | AD-810 | ChEMBL registry synonym — accepted as the source's own label CHEMBL750 ↗ |
| Known as | CI-912 | ChEMBL registry synonym — accepted as the source's own label CHEMBL750 ↗ |
| Known as | Excegran | ChEMBL registry synonym — accepted as the source's own label CHEMBL750 ↗ |
| Known as | N03AX15 | ChEMBL registry synonym — accepted as the source's own label CHEMBL750 ↗ |
| Known as | PD-110843 | ChEMBL registry synonym — accepted as the source's own label CHEMBL750 ↗ |
| Known as | ZNS | “Zonisamide (ZNS) (1,2-Benzisoxazole-3-methanesulfonamide) is an anti-epileptic drug.” NCT04182399 ↗ |
| Known as | ZON | “A phase II randomized, double-blind, placebo-controlled clinical trial (RCT) to evaluate the ability of zonisamide (ZON) to decrease alcohol use among treatment-seeking adults...” NCT05134857 ↗1“There is preliminary evidence that the anticonvulsant medication Zonisamide (ZON) may be an effective, well-tolerated treatment for alcohol use disorder.” PMID 39306870 ↗ Sep 2024 |
| Known as | Zonegran | “A Double-Blind, Randomized, Multicenter, Parallel Group Study to Establish Dose-Response, Safety, and Efficacy of Zonegran (Zonisamide) as Monotherapy in Patients With Newly...” NCT00056576 ↗8“Zonisamide (Zonegran ®) and its placebo appear under the shape of virgin capsules of size 1.” NCT01806805 ↗ “Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules” NCT00650052 ↗ “Mylan's zonisamide, 100 mg capsules to Elan's Zonegran® 100 mg capsules” NCT00649714 ↗ “Zonegran” NCT04774250 ↗ |
| Known as | Zonisade | ChEMBL registry synonym — accepted as the source's own label CHEMBL750 ↗ |
| Known as | Zonisamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL750 ↗ |
| Known as | Zonisamide mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL750 ↗ |
| Known as | Zonisamide oral suspension | “The purpose of this research is to determine the optimal dose, safety and tolerability of zonisamide oral suspension in children ages 1 month to 17 years of age who have...” NCT06534502 ↗ |
| Action | Inhibit | “antagonism of voltage-gated sodium and T-type calcium channels” NCT00221442 ↗ |
| Modality | Other / unclassified | “Zonisamide is a structurally related anticonvulsant that is a promising agent for the treatment of AD and may have greater tolerability than topiramate.” PMID 25427171 ↗ Feb 2015 |
| Route | Intravenous | “Intravenous injection” NCT00165828 ↗ |