Luminal

(Phenobarbital)

ApprovedSmall molecule

Phenobarbital is used to treat seizures and epilepsy, and is also sometimes used as a sedative to help people sleep or reduce anxiety.[2] Luminal is currently approved and in use across 4 indications[4].[1]

Luminal is one of 86 small molecule programs targeting Alcohol Withdrawal. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Alcohol WithdrawalActive, not recruiting

Neonatal SeizureActive, not recruiting

EpilepsyActive, not recruiting

SeizureCompleted

Alcohol WithdrawalPreclinical

Active, not recruiting

Neonatal SeizurePreclinical

Active, not recruiting

EpilepsyApproved

Active, not recruiting

SeizureApproved

Completed

Competition

Competitive Landscape

84 competitors in Epilepsy

#DrugCompanyPhaseTrials

Lamictal

GGlaxo Dba Glaxosmithkline

Approved

18 2

Depakote

AbbVie

Approved

3 3

Ritalin

Novartis

Approved

2 4

Rituxan

Roche

Approved

1 5

Briviact

UCB

Phase 3

15 6

Lyrica

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

Approved

2 7

Deltasone

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

Approved

1 8

Klonopin

EEngelhard Arzneimittel GmbH & Co.KG

Approved

—9

Acetadote

AArbor Pharmaceuticals, Inc.

Approved

—10

Kynmobi

SSamson Clinical Operations Pty Ltd

Approved

—

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalNot yet recruiting

Seizure

NCT07284498

Clinical

Trials by Indication[1]

Neonatal seizure5 trials

Effect of CYP2C9/CYP2C19 Polymorphism on Pharmacokinetics of Phenobarbital in Korean Neonatal Seizure Patients.

Completed·YYonsei University·N/A·NCT01224457·52 enrolled

Efficacy of Levetiracetam in Control of Neonatal Seizures Guided by an EEG

Unknown status·—·Phase 4·NCT03107507·40 enrolled

Prophylactic Phenobarbital After Neonatal Seizures

Terminated·UUniversity of Rochester·Phase 4·NCT01089504·13 enrolled

Show 2 more trials

Efficacy of Intravenous Levetiracetam in Neonatal Seizures

Completed·RRichard H. Haas·Phase 1/2·NCT01720667·280 enrolled

Levetiracetam Treatment of Neonatal Seizures

Terminated·—·Phase 1/2·NCT02550028·60 enrolled

Status Epilepticus4 trials

Lacosamide in Neonatal Status Epilepticus

Unknown status·SSherief Abd-Elsalam·Phase 3·NCT05291455·60 enrolled

Childhood Convulsive Status Epilepticus Management In A Resource Limited Setting

Completed·UUniversity of Cape Town·Phase 3·NCT03650270·198 enrolled

Phenobarbital Versus Valproate for Generalized Convulsive Status Epilepticus

Unknown status·XXuanwu Hospital, Beijing·Phase 2·NCT03025906·120 enrolled

Show 1 more trial

Levetiracetam, Lacosamide and Ketamine as Adjunctive Treatment of Refractory Status Epilepticus

Withdrawn·MMid-Atlantic Epilepsy and Sleep Center, LLC·Phase 3·NCT02726867

Seizure3 trials

Evaluation Phenobarbital as Adjunctive Therapy in Participants With Partial Onset Seizures

Completed·WWest-Ward Pharmaceutical·Phase 3·NCT01284556·314 enrolled

Levetiracetam Versus Phenobarbital in Benzodiazepines Unresponsive Paediatric Prolonged Seizures

Recruiting·MMinistry of Health and Sports, Myanmar·N/A·NCT07098728·180 enrolled

Treatment of Seizures in Neonate With HIE

Not yet recruiting·MMansoura University·Phase 4·NCT07284498·66 enrolled

Neonatal Abstinence Syndrome3 trials

Clonidine Versus Phenobarbital as Adjunctive Therapy for Neonatal Abstinence Syndrome

Completed·UUniversity of Tennessee Medical Center·Phase 2·NCT03670160·25 enrolled

Improving Outcomes in Neonatal Abstinence Syndrome

Completed·TTufts Medical Center·Phase 3·NCT01958476·117 enrolled

Clonidine for Neonatal Abstinence Syndrome Study

Terminated·—·N/A·NCT01175668·68 enrolled

Alcohol Withdrawal2 trials

Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit

Unknown status·OOSF Healthcare System·Phase 4·NCT04156464·142 enrolled

Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine

Withdrawn·SSanta Barbara Cottage Hospital·Phase 4·NCT03788889

7 more indications

Intracranial Hemorrhage1 trial

Antenatal Phenobarbital to Prevent Neonatal Intracranial Hemorrhage

Completed·NNICHD Neonatal Research Network·Phase 3·NCT00009620·610 enrolled

Epileptics1 trial

Pharmacokinetics of Antiepileptics in Patients on CRRT

Completed·UUniversity of Maryland, Baltimore··NCT03632915·18 enrolled

Withdrawal1 trial

How to Treat Opiate Withdrawal in Neonates

Completed·UUniversity of Zurich·Phase 3·NCT02810782·120 enrolled

Epilepsy1 trial

Study of Phenobarbital Inhibition of Catamenial Epilepsy

Withdrawn·UUniversity of Toledo Health Science Campus·N/A·NCT00530413

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

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

Lymphoma1 trial

Irinotecan Plus Cyclosporine and Phenobarbital in Treating Patients With Solid Tumors or Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT00002759·3 enrolled

Unspecified1 trial

Pharmacovigilance in Gerontopsychiatric Patients

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

Regulatory

FDA Approval Timeline[5]

Nov 17, 2022

SEZABY

NDA NDA215910

Sources

References

[1]
ClinicalTrials.gov — 24 trial records for Phenobarbital. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Luminal drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Phenobarbital compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Phenobarbital. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215910). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Luminal. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Sun Pharmaceutical Industries, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Sun Pharmaceutical Industries, Inc.

Patent Landscape[6]

Patent Cliff

Apr 7, 2042

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11857683Apr 7, 2042

12636254Apr 7, 2042

Luminal

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Neonatal seizure5 trials

Status Epilepticus4 trials

Seizure3 trials

Neonatal Abstinence Syndrome3 trials

Alcohol Withdrawal2 trials

Intracranial Hemorrhage1 trial

Epileptics1 trial

Withdrawal1 trial

Epilepsy1 trial

Pediatrics1 trial

Lymphoma1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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