MedPath

Phenytoin

Generic Name
Phenytoin
Brand Names
Dilantin, Phenytek
Drug Type
Small Molecule
Chemical Formula
C15H12N2O2
CAS Number
57-41-0
Unique Ingredient Identifier
6158TKW0C5
Background

Phenytoin is classified as a hydantoin derivative and despite its narrow therapeutic index, it is one of the most commonly used anticonvulsants. Since it's introduction about 80 years ago, phenytoin has not only been established as an effective anti-epileptic, but has also been investigated for several other indications such as bipolar disorder, retina protection, and wound healing.

Clinicians are advised to initiate therapeutic drug monitoring in patients who require phenytoin since even small deviations from the recommended therapeutic range can lead to suboptimal treatment, or adverse effects. Both parenteral and oral formulations of phenytoin are available on the market.

Indication

Phenytoin is indicated to treat grand mal seizures, complex partial seizures, and to prevent and treat seizures during or following neurosurgery. Injectable phenytoin and Fosphenytoin, which is the phosphate ester prodrug formulation of phenytoin, are indicated to treat tonic-clonic status epilepticus, and for the prevention and treatment of seizures occurring during neurosurgery.

Associated Conditions
Complex Partial Seizure Disorder, Generalized Tonic-Clonic Seizures, Grand Mal Status Epilepticus, Jacksonian epilepsy, Partial-Onset Seizures, Petit Mal Epilepsy, Seizure Disorder, Post Traumatic, Seizures, Status; Epilepticus, Tonic-clonic, Temporal Lobe Epilepsy (TLE), Convulsive disorders

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

Phase 1
Recruiting
Conditions
Healthy Participants
Interventions
First Posted Date
2025-04-09
Last Posted Date
2025-05-18
Lead Sponsor
Arcus Biosciences, Inc.
Target Recruit Count
14
Registration Number
NCT06919991
Locations
🇺🇸

Celerion, Tempe, Arizona, United States

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

Phase 1
Recruiting
Conditions
Healthy Volunteers
Interventions
First Posted Date
2025-04-02
Last Posted Date
2025-05-01
Lead Sponsor
BeiGene
Target Recruit Count
30
Registration Number
NCT06906809
Locations
🇺🇸

Fortrea Clinical Research Unit Inc, Madison, Wisconsin, United States

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

Phase 1
Active, not recruiting
Conditions
Healthy
Interventions
First Posted Date
2025-04-01
Last Posted Date
2025-05-01
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
14
Registration Number
NCT06903715
Locations
🇺🇸

Celerion, Inc. ( Site 0001), Tempe, Arizona, United States

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

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2024-12-06
Last Posted Date
2024-12-06
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
28
Registration Number
NCT06719557
Locations
🇺🇸

Celerion (Site 0001), Lincoln, Nebraska, United States

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

Phase 1
Completed
Conditions
Anal Fissure Chronic
Anal Fissure
Wound Healing
Interventions
First Posted Date
2024-10-09
Last Posted Date
2024-10-09
Lead Sponsor
Mansoura University
Target Recruit Count
50
Registration Number
NCT06633185
Locations
🇪🇬

Mansoura university, Mansoura, Dakahlia, Egypt

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

Phase 1
Completed
Conditions
Not Determined
Interventions
First Posted Date
2024-08-07
Last Posted Date
2024-11-27
Lead Sponsor
BeiGene
Target Recruit Count
30
Registration Number
NCT06543043
Locations
🇺🇸

Quotient Sciences, Miami, Florida, United States

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

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2024-06-20
Last Posted Date
2024-10-08
Lead Sponsor
Pfizer
Target Recruit Count
35
Registration Number
NCT06466473
Locations
🇺🇸

Pfizer Clinical Research Unit - New Haven, New Haven, Connecticut, United States

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

Phase 1
Recruiting
Conditions
Pharmacokinetics
Interventions
First Posted Date
2024-04-23
Last Posted Date
2024-08-09
Lead Sponsor
Modern Biosciences Ltd
Target Recruit Count
48
Registration Number
NCT06379958
Locations
🇬🇧

Celerion, Belfast, United Kingdom

Pharmacological Modulation of Peripheral Nerve Excitability

Not Applicable
Completed
Conditions
Peripheral Neuropathy
Interventions
First Posted Date
2024-03-15
Last Posted Date
2025-04-30
Lead Sponsor
Aalborg University
Target Recruit Count
20
Registration Number
NCT06312254
Locations
🇩🇰

Center for Neuroplasticity and Pain, Aalborg, Denmark

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

Not Applicable
Completed
Conditions
Status Epilepticus
Interventions
First Posted Date
2023-10-04
Last Posted Date
2023-10-04
Lead Sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Target Recruit Count
70
Registration Number
NCT06067412
Locations
🇵🇰

Children Hopsital Faisalabad, Faisalābad, Punjab, Pakistan

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