Sabril

(Vigabatrin)

ApprovedSmall molecule

Lundbeck

Sabril is one of 38 small molecule programs targeting Autoimmune Encephalitis. 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

Autoimmune EncephalitisActive, not recruiting

SeizureActive, not recruiting

Autoimmune EncephalitisPreclinical

Active, not recruiting

SeizureApproved

Active, not recruiting

Competition

Competitive Landscape

32 competitors in Seizure

#DrugCompanyPhaseTrials

Keppra

UCB

Approved

27 2

Vimpat

UCB

Approved

23 3

Lyrica

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Approved

19 4

Epidiolex

Jazz Pharmaceuticals

Approved

5 5

Tegretol

Novartis

Approved

4 6

Trileptal

Novartis

Approved

4 7

Fycompa

CCatalyst Biosciences

Approved

15 8

Zonegran

AAzurity Pharmaceuticals

Approved

10 9

Topamax

WWim Janssens

Approved

5 10

Lamictal

GGlaxo Dba Glaxosmithkline

Approved

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

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Combination Therapy

NCT04302116

Q4 2028

PreclinicalRecruiting

Tuberous Sclerosis

NCT04987463

Clinical

Trials by Indication[1]

Infantile Spasms5 trials

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

Withdrawn· Lundbeck logo

Lundbeck·Phase 4·NCT01413711

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

Withdrawn·TThe Hospital for Sick Children·Phase 3·NCT02299115

A Novel Approach to Infantile Spasms

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

Show 2 more trials

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

Withdrawn·AAmzell·Phase 3·NCT05128344

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

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

Alcohol Dependence1 trial

Vigabatrin for Cocaine and Alcohol Dependence

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

Insulin Sensitivity1 trial

Vigabatrin and Insulin Sensitivity

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

7 more indications

Seizure1 trial

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

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

Interaction1 trial

Vigabatrin Ph 1 Cocaine Interaction Study

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

AIN1 trial

Effects of Vigabatrin on Cocaine Self-Administration

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

Tuberous Sclerosis1 trial

Randomized, Placebo-controlled, Double-blind and Double-dummy Clinical Trial Comparing the Safety, Tolerability, and Efficacy of Vigabatrin and Rapamycin in a Preventive Treatment of Infants With Tuberous Sclerosis Complex

Recruiting·KKatarzyna Kotulska·Preclinical·NCT04987463·60 enrolled

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

Q4 2028

Trials by Indication[1]

Infantile Spasms5 trials

Cocaine Dependence2 trials

Alcohol Dependence1 trial

Refractory1 trial

Insulin Sensitivity1 trial

Seizure1 trial

Cocaine Dependency1 trial

Combination Therapy1 trial

Autoimmune Encephalitis1 trial

Interaction1 trial

AIN1 trial

Tuberous Sclerosis1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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