Drugs / Clobazam

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ONFI — 2011-10-21 fda.gov ↗

Trials 14

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/21 trial
Phase 1/2 NCT01291316 Apr 2010 → Nov 2011 neuropathy, painful University Hospital, Geneva Completed No outcome recorded
Phase 22 trials · 1 met primary
Phase 2 NCT02565108 Jan → Jul 2016 epilepsy Jazz Pharmaceuticals Completed No outcome recorded
Phase 2 NCT00162981 Oct 2005 → Aug 2006 generalized epilepsy Lundbeck LLC Completed Met primary
Phase 37 trials · 1 met primary
Phase 3 NCT02174094 Mar → Aug 2015 Dravet syndrome H. Lundbeck A/S Withdrawn No outcome recorded Stop: Enrollment
Phase 3 NCT02187809 Mar → Oct 2015 Dravet syndrome H. Lundbeck A/S Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT02374567 Jan 2015 → Jun 2017 anxiety disorder, dementia, depressive disorder, schizophrenia +1 Hannover Medical School Terminated No outcome recorded
Phase 3 NCT02134366 Jul 2014 → Jul 2017 epilepsy syndrome The Cooper Health System Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT01011036 Dec 2009 → Apr 2010 — Insel Gruppe AG, University Hospital Bern Completed No outcome recorded
Phase 3 NCT00518713 Aug 2007 → Dec 2009 generalized epilepsy Lundbeck LLC Completed Met primary
Phase 3 NCT01160770 Dec 2005 → Feb 2012 Lennox-Gastaut syndrome Lundbeck LLC Completed No outcome recorded
Phase 43 trials
Phase 4 NCT03371836 Oct 2017 → Dec 2019 anxiety, epilepsy Hugo W. Moser Research Institute at Kennedy Krieger, Inc. Completed No outcome recorded
Phase 4 NCT02726919 Feb 2015 → Jun 2018 epilepsy Pavel Klein Unknown No outcome recorded
Phase 4 NCT01932502 Feb 2013 → Jun 2017 epilepsy St. Joseph's Hospital and Medical Center, Phoenix Unknown No outcome recorded
Phase not applicable1 trial
— NCT03678129 Dec 2018 → Jun 2025 autism spectrum disorder King's College London Completed No outcome recorded
Comparator or background therapy6 trials
Phase 2 NCT02564952 Background Mar 2016 → Jun 2017 epilepsy Jazz Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01713946 Background Apr 2013 → Oct 2017 tuberous sclerosis Novartis Pharmaceuticals Completed Met primary
Phase 3 NCT01179828 Comparator Jul 2010 → Apr 2015 — Insel Gruppe AG, University Hospital Bern Completed No outcome recorded
Phase 4 NCT05697614 Comparator Mar → May 2023 epilepsy Dr Cipto Mangunkusumo General Hospital Unknown No outcome recorded
Phase 4 NCT02205931 Comparator Jan 2015 → Jun 2018 epilepsy University College, London Unknown No outcome recorded

Press releases naming this drug 10 releases

DateIssuerRelease
2026-04-08 Cosette Pharmaceuticals, Inc. Cosette Pharmaceuticals Expands Branded Portfolio through Acquisition of SYMPAZAN® and Additional Products from Assertio cosettepharma.com ↗
2025-09-15 Assertio Holdings, Inc Assertio Presents First-Ever Real-World Study Showing Patient Experience with SYMPAZAN® (clobazam) Oral Film, CIV assertiotx.com ↗
2025-09-10 Assertio Holdings, Inc Assertio to Present New Data from Real-World Evidence Study of SYMPAZAN® at upcoming 150th Annual Meeting of the American Neurological Association assertiotx.com ↗
2023-01-09 Assertio Holdings, Inc Assertio Holdings, Inc. Announces FDA Orange Book Listing for New Sympazan® Oral Film Patent assertiotx.com ↗
2022-10-27 XenoPort, Inc. Aquestive Therapeutics Licenses Sympazan® (clobazam) Oral Film to Assertio Holdings, Inc. aquestive.com ↗
2022-10-27 Assertio Holdings, Inc Assertio Holdings, Inc. Signs Exclusive License for Sympazan® (clobazam) Oral Film from Aquestive Therapeutics, Inc. assertiotx.com ↗
2018-11-29 XenoPort, Inc. Aquestive Therapeutics Launches SYMPAZAN™ (clobazam) Oral Film with Widespread U.S. Availability aquestive.com ↗
2018-11-02 XenoPort, Inc. Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Approval for SYMPAZAN™ (clobazam) Oral Film aquestive.com ↗
2018-09-04 XenoPort, Inc. Aquestive Therapeutics Reports Second Quarter 2018 Financial Results and Recent Business Highlights, Including Tentative Approval for Sympazan™ aquestive.com ↗
2018-08-31 XenoPort, Inc. Aquestive Therapeutics Announces Tentative FDA Approval for Sympazan™ (clobazam) Oral Film aquestive.com ↗

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 23 sources stand behind the page.

FieldValueCited text
Known as Clobazam “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗
19

“List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin” NCT01713946 ↗

“Clobazam” NCT02205931 ↗

NCT02726919 ↗

NCT02134366 ↗

NCT02374567 ↗

NCT03371836 ↗

NCT02174094 ↗

NCT00518713 ↗

NCT01011036 ↗

NCT03678129 ↗

Show 9 more sources

Known as Colbazam ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as Frisium ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as H 4723 ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as HR 376 ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as LM 2717 ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as Mystan ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as NSC-336279 ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as Onfi “clobazam (Onfi) when it replaces the pre-existing clonazepam therapy” NCT01932502 ↗
Known as Perizam ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as Sympazan ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as Tapclob ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as Urbadan ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Known as Urbanyl ChEMBL registry synonym — accepted as the source's own label CHEMBL70418 ↗
Action Activate “Two agonists at the benzodiazepine-binding site of GABAA-receptors (clobazam and clonazepam) were studied using multiple experimental pain tests.” PMID 23554851 ↗ Mar 2013
Modality Small molecule “clobazam, a 1,5-benzodiazepine, as adjunctive therapy for Lennox-Gastaut syndrome (LGS).” PMID 21956725 ↗ Sep 2011
Route Oral “orally” NCT00162981 ↗