Sympazan

(Clobazam)

ApprovedSmall molecule

Lundbeck

Sympazan is one of 88 small molecule programs targeting Autism Spectrum Disorder. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Autism Spectrum DisorderActive, not recruiting

EpilepsyUnknown status

Autism Spectrum DisorderPreclinical

Active, not recruiting

EpilepsyApproved

Unknown status

Competition

Competitive Landscape

84 competitors in Epilepsy

#DrugCompanyPhaseTrials

Vimpat

UCB

Approved

11 2

Fycompa

CCatalyst Biosciences

Approved

14 3

Diamox

Briviact

15 5

Zoloft

VViatris Specialty LLC

Approved

2 6

Ketalar

AAultman Health Foundation

Approved

1 7

Prometrium

Glucophage

Coreg

Versed

CConrado Roberto Hoffmann Filho

Approved

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Epilepsy4 trials

The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children

Unknown status·—·Phase 4·NCT05697614·100 enrolled

Evaluation of Onfi Conversion Therapy Replacing Clonazepam in Patients With Medically Refractory Epilepsy

Unknown status·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 4·NCT01932502·21 enrolled

Clobazam Adjunctive Treatment of Adults With Refractory Focal Epilepsy

Unknown status·PPavel Klein·Phase 4·NCT02726919·20 enrolled

Show 1 more trial

Use of Clobazam for Epilepsy and Anxiety

Completed·HHugo W. Moser Research Institute at Kennedy Krieger, Inc.·Phase 4·NCT03371836·20 enrolled

Dravet syndrome2 trials

Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

Withdrawn· Lundbeck logo

Lundbeck·Phase 3·NCT02174094

Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome

Terminated· Lundbeck logo

Lundbeck·Phase 3·NCT02187809·3 enrolled

Randomized Controlled Trial1 trial

A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol

Completed· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 2·NCT02565108·20 enrolled

Lennox-Gastaut syndrome1 trial

Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT01160770·267 enrolled

Experimental1 trial

Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT01011036·17 enrolled

7 more indications

Epilepsia Partialis Continua1 trial

Clobazam Use in Epilepsia Partialis Continua - Pilot Study

Terminated·TThe Cooper Health System·Phase 3·NCT02134366·7 enrolled

Drug Interactions1 trial

An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol

Completed· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 2·NCT02564952·18 enrolled

Central Sensitisation1 trial

GABAergic Modulation in Pain Transmission in Human: Effect of the GABAA Agonist Clobazam on Peripheral and Central Sensitisation

Completed·UUniversity Hospital, Geneva·Phase 1/2·NCT01291316·25 enrolled

Autism Spectrum Disorder1 trial

GABA Pathways in Autism Spectrum Disorder (ASD)

Completed·KKing's College London·N/A·NCT03678129·109 enrolled

Low back pain1 trial

Linking Altered Central Pain Processing and Genetic Polymorphism to Drug Efficacy in Chronic Low Back Pain (Predictio)

Completed·IInsel Gruppe AG, University Hospital Bern·Phase 3·NCT01179828·150 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Regulatory

FDA Approval Timeline[4]

Oct 21, 2011

ONFI

NDA NDA202067

Dec 14, 2012

ONFI

NDA NDA203993

Nov 1, 2018

SYMPAZAN

NDA NDA210833

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Clobazam. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Clobazam compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Clobazam. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210833). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Sympazan. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Lundbeck company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Lundbeck

Patent Landscape[5]

Patent Cliff

Sep 5, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12403090Sep 5, 2039

12290597Sep 5, 2039

11541002Jan 31, 2040

Sympazan

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Epilepsy4 trials

Dravet syndrome2 trials

Randomized Controlled Trial1 trial

Lennox-Gastaut syndrome1 trial

Experimental1 trial

Epilepsia Partialis Continua1 trial

Drug Interactions1 trial

Central Sensitisation1 trial

Autism Spectrum Disorder1 trial

Low back pain1 trial

Pediatrics1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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