Cerebyx

(Fosphenytoin)

ApprovedSmall molecule

LLupin Ltd.

Cerebyx is one of 85 small molecule programs targeting Trigeminal Neuralgia. 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

Trigeminal NeuralgiaActive, not recruiting

SeizureActive, not recruiting

Brain InjuryTerminated

Trigeminal NeuralgiaPreclinical

Active, not recruiting

SeizurePreclinical

Active, not recruiting

Brain InjuryApproved

Terminated

Competition

Competitive Landscape

62 competitors in Brain Injury

#DrugCompanyPhaseTrials

Ritalin

Novartis

Approved

4 2

Namenda

AbbVie

Approved

3 3

Buspar

Bristol-Myers Squibb

Approved

2 4

Celexa

AbbVie

Approved

2 5

Vyvanse

Takeda

Approved

1 6

Rozerem

Takeda

Approved

1 7

Exelon

Novartis

Approved

1 8

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Approved

8 9

Inderal

WWyeth-Lederle Vaccines

Approved

7 10

Dobutrex

Eli Lilly

Approved

—

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

Clinical

Trials by Indication[1]

Status Epilepticus3 trials

The Efficacy and Safety of Levetiracetam Versus Fosphenytoin in Convulsive Status Epilepticus

Enrolling by invitation·—·Phase 4·NCT06403150·62 enrolled

Established Status Epilepticus Treatment Trial

Completed·UUniversity of Virginia·Phase 3·NCT01960075·478 enrolled

Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT01870024·434 enrolled

Seizure2 trials

IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures

Completed·EEmory University·Phase 4·NCT00510783·158 enrolled

A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide

Terminated·UUniversity of Alabama at Birmingham·N/A·NCT01110187·11 enrolled

Trigeminal Neuralgia1 trial

Phenytoin as Treatment for Acute Exacerbations of Trigeminal Neuralgia - a Prospective Systematic Study of 20 Patients

Completed·DDanish Headache Center··NCT03712254·15 enrolled

Efficacy1 trial

The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin

Completed·NNobelpharma·Phase 3·NCT00908453·40 enrolled

Brain Injury1 trial

Antiseizure Medication in Seizure Networks at Early Acute Brain Injury

Terminated·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT06081283·5 enrolled

Regulatory

FDA Approval Timeline[4]

Aug 5, 1996

CEREBYX

NDA NDA020450

Nov 5, 2020

SESQUIENT

NDA NDA210864

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Fosphenytoin. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Fosphenytoin compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Fosphenytoin. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA210864). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Cerebyx. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Lupin Ltd. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: LLupin Ltd.

Patent Landscape[5]

Patent Cliff

Mar 13, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9200088Mar 13, 2029

9750822Mar 13, 2029

Cerebyx

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Status Epilepticus3 trials

Seizure2 trials

Trigeminal Neuralgia1 trial

Efficacy1 trial

Brain Injury1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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