Sabril

(Vigabatrin)

ApprovedSmall molecule

Lundbeck

Sabril is one of 161 small molecule programs targeting Cocaine Dependence. It is currently in Approved.

Indications

Total Trials

Active Trials

160

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cocaine DependenceActive, not recruiting

Autoimmune EncephalitisActive, not recruiting

Alcohol DependenceActive, not recruiting

SeizureActive, not recruiting

Infantile SpasmsActive, not recruiting

Tuberous SclerosisActive, not recruiting

Cocaine DependencePhase 2

Active, not recruiting

Autoimmune EncephalitisPreclinical

Active, not recruiting

Alcohol DependencePhase 2

Active, not recruiting

SeizureApproved

Active, not recruiting

Infantile SpasmsPhase 3

Active, not recruiting

Tuberous SclerosisPhase 2/Phase 3

Active, not recruiting

Competition

Competitive Landscape

116 competitors in Alcohol Dependence

#DrugCompanyPhaseTrials

Sabril

Lundbeck

Approved

1 2

Depakote

Zyprexa

2 4

Wellbutrin

GGlaxo Dba Glaxosmithkline

Phase 3

1 5

Inversine

TTargacept Inc.

Phase 3

1 6

Tums

Otsuka

Phase 3

1 7

Seroquel

AstraZeneca

Phase 3

1 8

Lioresal

Novartis

Phase 2

4 9

Byetta

AstraZeneca

Phase 2

2 10

Epidiolex

Jazz Pharmaceuticals

Phase 2

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Combination Therapy

NCT04302116

Clinical

Trials by Indication[1]

Infantile Spasms5 trials

A Study to Assess Cannabidiol Oral Solution With Vigabatrin as Initial Therapy in Participants With Infantile Spasms

Terminated·RRadius Pharmaceuticals, Inc.·Phase 3·NCT03421496·2 enrolled

A Novel Approach to Infantile Spasms

Suspended·UUniversity of Colorado, Denver·Phase 3·NCT03347526·394 enrolled

An Open-Label, Single and Multiple Oral Dose Pharmacokinetic Study of Vigabatrin in Infants With Infantile Spasms

Withdrawn· Lundbeck logo

Lundbeck·Phase 4·NCT01413711

Show 2 more trials

Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms

Withdrawn·TThe Hospital for Sick Children·Phase 3·NCT02299115

A Study to Evaluate Safety and Efficacy of AMZ002 Treatment, Compared With Vigabatrin in Participants With Infantile Spasms

Withdrawn·AAmzell·Phase 3·NCT05128344

Cocaine Dependence2 trials

Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence

Completed·NNYU Langone Health·Phase 2·NCT00527683·100 enrolled

Vigabatrin for Treatment of Cocaine Dependence

Completed·CCatalyst Pharmaceuticals, Inc.·Phase 2·NCT00611130·186 enrolled

AIN1 trial

Effects of Vigabatrin on Cocaine Self-Administration

Terminated·NNew York State Psychiatric Institute·Phase 2·NCT00373581·1 enrolled

Refractory1 trial

Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette's Disorder

Completed·—·Phase 1/2·NCT01585207·4 enrolled

Alcohol Dependence1 trial

Vigabatrin for Cocaine and Alcohol Dependence

Terminated·UUniversity of Pennsylvania·Phase 2·NCT01335867·32 enrolled

7 more indications

Insulin Sensitivity1 trial

Vigabatrin and Insulin Sensitivity

Completed·WWashington University School of Medicine·Phase 2·NCT04321395·4 enrolled

Seizure1 trial

Sabril for Complex Partial Seizures in Adult Tolerability Study (TS) Patients

Terminated·UUniversity of Pennsylvania·Phase 4·NCT01266291·1 enrolled

Interaction1 trial

Vigabatrin Ph 1 Cocaine Interaction Study

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00626834·24 enrolled

Tuberous Sclerosis1 trial

Efficacy and Safety of Rapamycin Versus Vigabatrin in the Prevention of Tuberous Sclerosis Complex Symptoms in Infants

Recruiting·KKatarzyna Kotulska·Phase 2/3·NCT04987463·60 enrolled

Cocaine Dependency1 trial

Vigabatrin for the Treatment of Cocaine Dependency

Completed·CCatalyst Pharmaceuticals, Inc.·Phase 2/3·NCT01281202·207 enrolled

Combination Therapy1 trial

Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm

Recruiting·KKullasate Sakpichaisakul·N/A·NCT04302116·250 enrolled

Autoimmune Encephalitis1 trial

Effect of Vigabatrin in Refractory Autoimmune Encephalitis Patients

Withdrawn·SSeoul National University Hospital·N/A·NCT03003143

Regulatory

FDA Approval Timeline[4]

Aug 21, 2009

SABRIL

NDA NDA022006

Aug 21, 2009

SABRIL

NDA NDA020427

Jun 17, 2024

VIGAFYDE

NDA NDA217684

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Vigabatrin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Vigabatrin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Vigabatrin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217684). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Sabril. 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

Aug 16, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12016857Aug 16, 2039

12290499Oct 17, 2042

12576054Jun 8, 2043

Sabril

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Infantile Spasms5 trials

Cocaine Dependence2 trials

AIN1 trial

Refractory1 trial

Alcohol Dependence1 trial

Insulin Sensitivity1 trial

Seizure1 trial

Interaction1 trial

Tuberous Sclerosis1 trial

Cocaine Dependency1 trial

Combination Therapy1 trial

Autoimmune Encephalitis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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