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Dilantin

(Phenytoin)

ApprovedSmall molecule

VViatris Specialty LLC

Phenytoin is used to prevent and control seizures in people with epilepsy and other seizure disorders. It can also be used to prevent seizures after brain surgery or head injury.[2] Dilantin is currently approved and in use across 15 indications[4].[1]

Dilantin is one of 322 small molecule programs targeting Neuropathic Pain. It is currently in Approved.

15

Indications

53

Total Trials

4

Active Trials

321

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Neuropathic PainActive, not recruiting

CysticercosisActive, not recruiting

Anal FistulaActive, not recruiting

Wound HealingActive, not recruiting

Brain InjuryActive, not recruiting

Cocaine DependenceApproved

Memory ImpairmentActive, not recruiting

Pneumococcal MeningitisActive, not recruiting

SeizureActive, not recruiting

EpilepsyActive, not recruiting

Neuropathic PainPhase 2/Phase 3

Active, not recruiting

CysticercosisPreclinical

Active, not recruiting

Anal FistulaPreclinical

Active, not recruiting

Wound HealingPhase 1

Active, not recruiting

Brain InjuryPhase 1

Active, not recruiting

Cocaine DependenceApproved

Approved

Memory ImpairmentApproved

Active, not recruiting

Pneumococcal MeningitisApproved

Active, not recruiting

SeizureApproved

Active, not recruiting

EpilepsyApproved

Active, not recruiting

Showing 10 of 14 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Dilantin

VViatris Specialty LLC

Veramyst

Xolair

Cinqair

Asmanex

Celexa

Spiriva

Boehringer Ingelheim

Qvar

Chiesi Farmaceutici S.p.A.

Atrovent

Boehringer Ingelheim

Formoterol Fumarate

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

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Study completion

NCT07590102

Q4 2027

Phase 2Recruiting

Epilepsy

NCT05637086

Q1 2028

Post-ApprovalRecruiting

Seizure

NCT07072624

Clinical

Trials by Indication[1]

Interaction6 trials

A Study of the Interaction of TAK-279 With Substances That Have an Impact on Metabolism in Healthy Adults

Completed· Takeda logo

Takeda·Phase 1·NCT05995249·172 enrolled

AED/Statin Interaction Study

Completed· GSK logo

GSK·Phase 1·NCT00627575·119 enrolled

A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults

Completed· GSK logo

GSK·Phase 1·NCT07066722·126 enrolled

Show 3 more trials

Open-label Drug Interaction Study Between Eslicarbazepine Acetate and Phenytoin.

Completed·BBial - Portela C S.A.·Phase 1·NCT02283827·32 enrolled

Drug-Drug Interaction Study of Casdatifan in Healthy Adult Participants (ARC-29)

Completed· Arcus Biosciences logo

Arcus Biosciences·Phase 1·NCT06919991·14 enrolled

A Study to Investigate the Potential Pharmacokinetic Interactions Between Phenytoin or Carbamazepine and Telaprevir

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01635829·24 enrolled

Seizure5 trials

Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

Completed·UUniversity of Cincinnati·Phase 4·NCT00618436·52 enrolled

Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)

Recruiting·—·Phase 4·NCT07072624·1,260 enrolled

Efficacy Evaluation of Intravenous Brivaracetam and Phenytoin in Subjects With Nonconvulsive Electrographic Seizures

Terminated· UCB logo

UCB·Phase 2·NCT02088957·1 enrolled

Show 2 more trials

Comparative Trial of IV Lacosamide Versus Phenytoin for Seizure Management

Terminated·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT02409433·3 enrolled

Phase III Double Blind Trial of Valproate Sodium for Prophylaxis of Post Traumatic Seizures

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 3·NCT00004817·385 enrolled

Adult3 trials

A Study of the Effect of Itraconazole and Phenytoin on Calderasib (MK-1084) in Healthy Adults (MK-1084-008)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06719557·28 enrolled

A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults

Completed· Pfizer logo

Pfizer·Phase 1·NCT06466473·35 enrolled

A Study to Evaluate the Effect of Multiple Doses of Itraconazole, Phenytoin, and Paroxetine on the Single-Dose Pharmacokinetics of Poziotinib in Healthy Adult Participants

Completed· Spectrum Pharmaceuticals, Inc logo

Spectrum Pharmaceuticals, Inc·Phase 1·NCT04981704·74 enrolled

Epilepsy3 trials

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

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

Evaluating the Transporter Protein Inhibitor Probenecid In Patients With Epilepsy

Terminated·JJim McAuley·Phase 4·NCT00610532·8 enrolled

Clinical Study Evaluating Safety of Pentoxifylline and Celecoxib in Patients With Grand-Mal Epilepsy Treated by Phenytoin Monotherapy

Recruiting·MMostafa Bahaa·Phase 2·NCT05637086·90 enrolled

ART2 trials

Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants

Completed· BeiGene logo

BeiGene·Phase 1·NCT06906809·37 enrolled

A Clinical Study of Belzutifan (MK-6482) Alone or With Phenytoin in Healthy Participants (CA46602/MK-6482-035)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06903715·14 enrolled

27 more indications

Randomized2 trials

Phenytoin and Driving Safety: A Randomized, Controlled Cross-Over Study

Completed·UUniversity of Iowa·Phase 4·NCT00581893·20 enrolled

Treatment of Nodding Syndrome - A Randomized Blinded Placebo-Controlled Crossover Trial of Oral Pyridoxine and Conventional Anti-Epileptic Therapy, in Northern Uganda - 2012

Withdrawn·CCenters for Disease Control and Prevention·Phase 2·NCT01730313

Optic Neuritis2 trials

Neuroprotection With Phenytoin in Optic Neuritis

Completed·UUniversity College, London·Phase 2·NCT01451593·92 enrolled

Effect of Phenytoin on the Ganglion Cell Layer in Patients With Optic Neuritis

Completed·TTehran University of Medical Sciences·Phase 2·NCT02939937·71 enrolled

Status Epilepticus2 trials

Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus

Unknown status·TTanta University·Phase 4·NCT04176887·60 enrolled

Efficacy of Phenytoin vs Levetiracetam in Status Epilepticus at Institute of Child Health,Faisalabad

Completed·SShaheed Zulfiqar Ali Bhutto Medical University·N/A·NCT06067412·70 enrolled

Resistance1 trial

The Effect of Phenytoin on the Pharmacokinetics of Nevirapine and the Development of Nevirapine Resistance

Completed·RRadboud University Medical Center·Phase 2·NCT01187719·66 enrolled

Epileptics1 trial

Pharmacokinetics of Antiepileptics in Patients on CRRT

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

Drug Interactions1 trial

Prediction of Drug Interactions With CYP2C9 Substrates

Completed·HHadassah Medical Organization·N/A·NCT00226538·16 enrolled

Non-malignant Disorders1 trial

Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders

Terminated·—·Phase 1/2·NCT00801931·1 enrolled

Aggression1 trial

Pilot Trial of Neural Correlates of Response to Treatment of PTSD-Associated Impulsive Aggression

Unknown status·MMichael E. DeBakey VA Medical Center·N/A·NCT00333931·12 enrolled

Cysticercosis1 trial

Randomized Study of Albendazole in Patients With Epilepsy Due to Neurocysticercosis

Completed·JJohns Hopkins University·N/A·NCT00004403·120 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

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

Midazolam1 trial

A Study to Assess the Effect of Phenytoin on the Drug Levels of Afimetoran and the Effect of Afimetoran on the Drug Levels of Midazolam

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05901714·65 enrolled

Asthma1 trial

Study of Efficacy of Phenytoin in Therapy of Children With Bronchial Asthma

Completed·CCentre of Chinese Medicine, Georgia·Phase 4·NCT00366067·50 enrolled

Humans1 trial

Effects of Phenytoin on Cocaine Use in Humans - 2

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00000285

Adult Subject1 trial

Drug-Drug Interaction (DDI) Study of Leramistat in Healthy Adult Subjects

Recruiting·MModern Biosciences Ltd·Phase 1·NCT06379958·48 enrolled

Function1 trial

Phenytoin as a Neuroprotective Agent Against Corticosteroid-induced Functional Imaging Changes

Completed·UUniversity of Texas Southwestern Medical Center·Phase 3·NCT00591006·17 enrolled

Neuropathic Pain1 trial

Phenytoin Cream for the Treatment of Neuropathic Pain

Completed·—·Phase 2/3·NCT04647877·81 enrolled

Memory Impairment1 trial

Phenytoin for Memory Impairment Secondary to Megestrol

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02595723·21 enrolled

Wound Healing1 trial

Effect of Phenytoin Cream on Wound Healing After Anal Fissure Surgery.

Completed·MMansoura University·Phase 1·NCT06633185·50 enrolled

Brain Injury1 trial

Preventing Epilepsy After Traumatic Brain Injury With Topiramate

Terminated·UUniversity of Pennsylvania·Phase 1·NCT00598923·6 enrolled

Pneumococcal Meningitis1 trial

Study on the Efficacy of Phenytoin in the Prophylaxis of Seizures of Patients With Pneumococcal Meningitis at Least 50 Yrs Old.

Terminated·MM. Carmen Cabellos Minguez·Phase 4·NCT01478035·26 enrolled

NAFLD1 trial

DDI Study of ASC41 in HV and the PK, Safety and Tolerability in Subjects With NAFLD.

Completed·GGannex Pharma Co., Ltd.·Phase 1·NCT04845646·24 enrolled

Fasting Conditions1 trial

Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT01122953·34 enrolled

Stem Cell Transplant1 trial

Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

Completed·OOHSU Knight Cancer Institute·Phase 1/2·NCT00245037·147 enrolled

Drug1 trial

Antiepileptic Drugs and Vascular Risk Markers

Terminated·TThomas Jefferson University·N/A·NCT00774306·52 enrolled

Surgical Wounds1 trial

Phenytoin in the Healing of Clean Surgical Wounds

Unknown status·CChildren's Surgical Center, Cambodia·Phase 2·NCT02413658·100 enrolled

Metabolism1 trial

Determinants of Warfarin Metabolism

Unknown status·HHadassah Medical Organization·N/A·NCT00162474·600 enrolled

Unspecified5 trials

Phenytoin as an Augmentation for SSRI Failures

Completed·—·Phase 4·NCT00146237·40 enrolled

The Effect of BIA 2-093 on the Steady-state Pharmacokinetic Profile of Phenytoin in Patients

Terminated·BBial - Portela C S.A.·Phase 1·NCT01878578·4 enrolled

A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers

Completed· BeiGene logo

BeiGene·Phase 1·NCT06543043·30 enrolled

Show 2 more trials

Pharmacovigilance in Gerontopsychiatric Patients

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

An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants

Recruiting·BBeOne Medicines·Phase 1·NCT07590102·30 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

DILANTIN

NDA NDA010151

Jan 1, 1982

DILANTIN-125

NDA NDA008762

Sources

References

[1]
ClinicalTrials.gov — 53 trial records for Phenytoin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Dilantin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Phenytoin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Phenytoin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA010151). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Viatris Specialty LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Alpha Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VViatris Specialty LLC

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