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Phenytoin

Phase 3

Undisclosed | Small molecule | Other |Pfizer, Inc.|Trials Updated: Oct 8, 2024

Phenytoin development status

Highest phase Phase 3 run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (NCT00210782)
Phase scored for PFEPhase 1
Registered trials 16 across 14 sponsors since Sep 2005

Phenytoin target and mechanism

Molecular targetSCN1A, SCN5A, SCN4A, SCN7A, SCN2A, SCN9A
Target classBlocker
ModalitySmall molecule
ChEMBLCHEMBL16

Also known as Phenytoin (Ascoli)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment69

FDA Designations

No designations recorded

Phenytoin clinical trials

Phenytoin · 2 trials · 1 indication

Phase 1 2
NCT06466473A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy AdultsHealthy
COMPLETED35 Analytics
NCT01122953Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting ConditionsHealthy
COMPLETED34 Analytics
PHASE1COMPLETED
A Study to Learn How Different Forms of The Study Medicine Called Phenytoin Are Taken up Into the Blood in Healthy Adults
HealthyUnlock trial analytics
PHASE1COMPLETED
Bioequivalence Study Of PHENYTOIN Suspension Made By Pfizer, Versus EPAMIN® Made By McNeil LA LLC In Healthy Volunteers Under Fasting Conditions
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Area Under the Plasma Concentration-time Profile From Time Zero to the Time of Last Quantifiable Concentration (AUClast)
72 hours
Maximum Observed Plasma Concentration (Cmax) of Phenytoin
72 hours
Area under the curve (AUC): The AUC from administration to the last sampling time will be determined by the trapezoid method.
0-168 h
Maximum Concentration (Cmax): The maximum plasmatic concentration (Cmax) will be obtained as the highest concentration observed in the sampling interval.
0-168 h
Time maximum concentration (tmax) is observed. Will be reported as the time at which the maximum concentration is observed.
0-168 h

Secondary Endpoints

Number of Participants With Adverse Events (AEs) According to Seriousness
Baseline, up to 35 days post last dose.
Constant of elimination (ke): Will be determined as the slope from the linear logarithmic regression of the terminal phase of the logarithmic graph of concentration over time.
0-168 h
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
Phenytoin manufactured at Vega Baja siteACTIVE_COMPARATOR -
Phenytoin manufactored at Ascoli siteEXPERIMENTAL -
PhenytoinEXPERIMENTAL -
EpaminACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Phenytoin (Ascoli)DRUGPhenytoin 50mg chewable tablets
Phenytoin (Vega Baja)DRUGPhenytoin 50mg chewable tablets
PhenytoinDRUGSingle dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.
EpaminDRUGSingle dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male participants and female participants of non-childbearing potential aged 18 years or older determined by medical evaluation including detailed medical history, complete physical examination, blood pressure (BP) and pulse rate measurement, 12-lead electrocardiogram...

Countries:United StatesMexico
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Frequently asked questions about Phenytoin

What is Phenytoin?

Phenytoin is a small molecule drug developed by Pfizer, Inc. (ticker: PFE). It is currently in Phase 1 clinical development. The specific medical conditions it is being studied for have not been disclosed. Phenytoin is also known as Phenytoin (Ascoli).

What does Phenytoin target?

Phenytoin targets several sodium channel proteins: SCN1A, SCN5A, SCN4A, SCN7A, SCN2A, and SCN9A. It acts as a blocker of these targets. This mechanism of action is based on its molecular target profile.

Who makes Phenytoin?

Phenytoin is developed by Pfizer, Inc., which trades under the ticker symbol PFE. Pfizer is the company responsible for the clinical development of this drug candidate.

What phase is Phenytoin in?

Phenytoin is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trials are designed to study its pharmacokinetics and bioequivalence in healthy volunteers.

What clinical trials is Phenytoin in?

Phenytoin has been studied in two completed Phase 1 clinical trials: NCT06466473 and NCT01122953. NCT06466473 enrolled 35 healthy adults in the United States to study how different forms of phenytoin are absorbed. NCT01122953 enrolled 34 healthy volunteers in Mexico to compare the bioequivalence of Pfizer's phenytoin suspension with Epamin.

Is Phenytoin the same as Phenytoin (Ascoli)?

Yes, Phenytoin is also known as Phenytoin (Ascoli). Both names refer to the same drug candidate developed by Pfizer, Inc. (ticker: PFE).