Clinical Trials

Numerous clinical trials spanning Phase 1 to Phase 4 evaluate phenytoin's therapeutic utility and pharmacokinetic profile across diverse conditions, including status epilepticus, traumatic brain injury, subarachnoid hemorrhage, optic neuritis, multiple sclerosis, and chronic idiopathic axonal polyneuropathy. Supported by academic medical centers, university hospitals, and pharmaceutical industry sponsors such as Merck Sharp & Dohme, Novartis, and Janssen Infectious Diseases, these studies encompass recruitment statuses ranging from active enrollment to completed and terminated protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00162474 RECRUITING
Healthy
Hadassah Medical Organization
 2003-09
NCT03778996 ACTIVE_NOT_RECRUITING
Sarcoma, Ewing; Sarcoma
Sarcoma Oncology Research Center, LLC
 2020-01-03 PHASE2
NCT07590375 NOT_YET_RECRUITING
Gingival Recession
Cairo University
 2026-06-01 PHASE2; PHASE3
NCT07072624 RECRUITING
Seizures; Traumatic Brain Injuries; Traumatic Brain Injury (TBI) Patients
All India Institute of Medical Sciences, Jodhpur
 2025-07-23 PHASE4
NCT05637086 RECRUITING
Epilepsy
Mostafa Bahaa
 2022-12-20 PHASE2
NCT07783503 NOT_YET_RECRUITING
Healthy Participants
Novartis Pharmaceuticals
 2026-08-27 PHASE1
NCT07590102 RECRUITING
Healthy Volunteers
BeOne Medicines
 2026-06-04 PHASE1
NCT07645495 NOT_YET_RECRUITING
Chronic Ulcers
Beni-Suef University
 2026-07
NCT06942468 NOT_YET_RECRUITING
Atrophic Acne Scar
Assiut University
 2025-07-01 PHASE4
NCT04573803 NOT_YET_RECRUITING
Traumatic Brain Injury; Post Traumatic Seizures
Cambridge University Hospitals NHS Foundation Trust
 2021-03-01 PHASE3
NCT07066722 COMPLETED
HIV Infections
ViiV Healthcare
 2025-07-07 PHASE1
NCT07801157 COMPLETED
Postoperative Wound Healing After Oral Cancer Surgery
Mansoura University
 2024-07-01
NCT06919991 COMPLETED
Healthy Participants
Arcus Biosciences, Inc.
 2025-05-02 PHASE1
NCT06906809 COMPLETED
Healthy Volunteers
BeiGene
 2025-04-03 PHASE1
NCT06903715 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2025-03-28 PHASE1
NCT06081283 TERMINATED
Brain Injuries, Acute; Brain Injuries, Traumatic; Brain Ischemia; Brain Hypoxia; Hypoxia-Ischemia, Brain; Heart Arrest; Stroke; Intracranial Hemorrhages; Coma; Persistent Vegetative State
University of North Carolina, Chapel Hill
 2023-11-20 PHASE4
NCT06312254 COMPLETED
Peripheral Neuropathy
Aalborg University
 2024-04-09
NCT06543043 COMPLETED
Not Determined
BeiGene
 2024-08-19 PHASE1
NCT06466473 COMPLETED
Healthy
Pfizer
 2024-07-03 PHASE1
NCT06379958 UNKNOWN
Pharmacokinetics
Modern Biosciences Ltd
 2024-04-08 PHASE1
NCT06403150 UNKNOWN
Status Epilepticus
Dhaka Medical College
 2023-05-15 PHASE4
NCT06719557 COMPLETED
Healthy
Merck Sharp & Dohme LLC
 2024-05-20 PHASE1
NCT05901714 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2023-06-14 PHASE1
NCT05995249 COMPLETED
Healthy Volunteers
Takeda
 2023-08-11 PHASE1
NCT04647877 COMPLETED
Chronic Idiopathic Axonal Polyneuropathy
David J. Kopsky
 2020-09-17 PHASE2; PHASE3
NCT05697614 UNKNOWN
Drug Resistant Epilepsy
Dr Cipto Mangunkusumo General Hospital
 2023-03-01 PHASE4
NCT06403150 Enrolling by invitation
Status Epilepticus
Dhaka Medical College
 2023-05-15 Phase 4
NCT05542589 COMPLETED
Pressure Ulcer
Cairo University
 2022-03-01
NCT06067412 COMPLETED
Status Epilepticus
Shaheed Zulfiqar Ali Bhutto Medical University
 2022-08-01
NCT06633185 COMPLETED
Anal Fissure Chronic; Anal Fissure; Wound Healing
Mansoura University
 2022-01-01 PHASE1
NCT06067412 Completed
Status Epilepticus
Shaheed Zulfiqar Ali Bhutto Medical University
 2022-08-01 Not Applicable
NCT04956627 COMPLETED
Healthy Participants
Bristol-Myers Squibb
 2021-07-28 PHASE1
NCT03512756 TERMINATED
Pancreatic Cancer
Tyme, Inc
 2018-03-27 PHASE2; PHASE3
NCT04829838 UNKNOWN
Status Epilepticus
ayesha tariq
 2019-07-25 PHASE4
NCT04981704 COMPLETED
Healthy
Spectrum Pharmaceuticals, Inc
 2021-04-08 PHASE1
NCT04845646 COMPLETED
Healthy; NAFLD
Gannex Pharma Co., Ltd.
 2021-03-16 PHASE1
NCT00162461 UNKNOWN
Healthy
Hadassah Medical Organization
 1998-08
NCT04647877 Completed
Chronic Idiopathic Axonal Polyneuropathy
David J. Kopsky|Princess Beatrix Muscle Foundation|Dr. C.J. Vaillant Fonds|UMC Utrecht
 2020-09-17 Phase 2|Phase 3
NCT04176887 UNKNOWN
Comparison; the Efficacy of Levetireacetam; Phenytoin; Management of Pediatric Status Epilepticus
Tanta University
 2019-01-01 PHASE4
NCT04829838 Unknown status
Status Epilepticus
ayesha tariq|King Edward Medical University
 2019-07-25 Phase 4
NCT04967326 COMPLETED
Epilepsy
Gia Dinh People Hospital
 2016-01-01 PHASE4
NCT03161509 TERMINATED
Bariatric Surgery Candidate
Rambam Health Care Campus
 2017-07-01 PHASE4
NCT02939937 COMPLETED
Optic Neuritis
Tehran University of Medical Sciences
 2017-03-09 PHASE2
NCT02707965 COMPLETED
Epilepsy
Food and Drug Administration (FDA)
 2017-06-08 PHASE1
NCT01870024 COMPLETED
Status Epilepticus; Epilepsy
Assistance Publique - Hôpitaux de Paris
 2013-06-26 PHASE3
NCT03096522 UNKNOWN
Anal Fistula
Mansoura University
 2017-02-20
NCT01730313 WITHDRAWN
Nodding Syndrome
Centers for Disease Control and Prevention
 2016-02 PHASE2
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02595723 COMPLETED
Cognitive Impairment
University of Texas Southwestern Medical Center
 2015-07 PHASE4
NCT03269214 COMPLETED
Osteonecrosis Due to Drugs, Jaw
Shiraz University of Medical Sciences
 2012-09-01
NCT02413658 UNKNOWN
Wound; Re-Epithelialization
Children's Surgical Center, Cambodia
 2015-03 PHASE2
NCT02409433 TERMINATED
Seizures
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2014-08 PHASE4
NCT00245037 COMPLETED
Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Precancerous Condition
OHSU Knight Cancer Institute
 2005-06 PHASE1; PHASE2
NCT01478035 TERMINATED
Seizures; Pneumococcal Meningitis
M. Carmen Cabellos Minguez
 2011-11 PHASE4
NCT01451593 COMPLETED
Optic Neuritis; Multiple Sclerosis
University College, London
 2011-11 PHASE2
NCT02088957 TERMINATED
Nonconvulsive Electrographic Seizures
UCB BIOSCIENCES, Inc.
 2014-03 PHASE2
NCT01680042 UNKNOWN
Wound Healing; Pain
Shahid Beheshti University of Medical Sciences
 2012-10 PHASE1
NCT01635829 COMPLETED
Healthy Participants
Janssen Infectious Diseases BVBA
 2012-05 PHASE1
NCT01187719 COMPLETED
HIV-infection; Pregnancy; Mother to Child Transmission
Radboud University Medical Center
 2010-05 PHASE2
NCT00774306 TERMINATED
Subarachnoid Hemorrhage
Thomas Jefferson University
 2009-04
NCT01110187 TERMINATED
Traumatic Brain Injury
University of Alabama at Birmingham
 2010-05
NCT01635829 Completed
Healthy Participants
Janssen Infectious Diseases BVBA
 2012-05 Phase 1
NCT01355068 COMPLETED
Healthy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2011-05 PHASE1
NCT00610532 TERMINATED
Epilepsy
Jim McAuley
 2006-03 PHASE4
NCT01122940 COMPLETED
Healthy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2010-07 PHASE1
NCT00823264 COMPLETED
Phenytoin Toxicity
Emory University
 2008-08
NCT01122953 COMPLETED
Healthy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2010-04 PHASE1
NCT00908453 COMPLETED
Epilepsy
Nobelpharma
 2009-05 PHASE3
NCT00618436 COMPLETED
Traumatic Brain Injury; Subarachnoid Hemorrhage
University of Cincinnati
 2007-08 PHASE4
NCT00591006 COMPLETED
Healthy
University of Texas Southwestern Medical Center
 2008-01 PHASE3
NCT00801931 TERMINATED
Leukemia; Lymphoma; Neuroblastoma; Immunodeficiencies; Anemia
Columbia University
 2007-09-06 PHASE1; PHASE2
NCT00598923 TERMINATED
Traumatic Brain Injury; Epilepsy
University of Pennsylvania
 2004-11 EARLY_PHASE1
NCT00781196 COMPLETED
Gingival Overgrowth
All India Institute of Medical Sciences
 2008-05 PHASE3
NCT00581893 COMPLETED
Cognitive Measures; Driving Simulator Performance
University of Iowa
 2005-08 PHASE4
NCT00510783 COMPLETED
Tonic-clonic Seizure
Emory University
 2007-07 PHASE4
NCT00627575 COMPLETED
Epilepsy
GlaxoSmithKline
 2008-02-04 PHASE1
NCT00219479 TERMINATED
Seizures
Penn State University
 1997-08 PHASE4
NCT02283827 COMPLETED
Epilepsy
Bial - Portela C S.A.
 2007-01 PHASE1
NCT00426673 COMPLETED
Epilepsy
UCB Pharma
 2005-04 PHASE1
NCT00647621 COMPLETED
Healthy
Mylan Pharmaceuticals Inc
 2005-10 PHASE1
NCT00146237 COMPLETED
Depression
Beersheva Mental Health Center
 2003-11 PHASE4
NCT01878578 TERMINATED
Epilepsy
Bial - Portela C S.A.
 2002-11 PHASE1
NCT00210782 COMPLETED
Epilepsy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
 2004-06 PHASE3
NCT00366067 COMPLETED
Bronchial Asthma
Centre of Chinese Medicine, Georgia
 2006-08 PHASE4
NCT00004817 COMPLETED
Post-Traumatic Seizure Disorder; Head Injuries
National Institute of Neurological Disorders and Stroke (NINDS)
 1991-02 PHASE3
NCT00226538 COMPLETED
Healthy Volunteers
Hadassah Medical Organization
 1999-08
NCT00327028 COMPLETED
Bronchial Asthma
Centre of Chinese Medicine, Georgia
 2005-09 PHASE4
NCT00333931 UNKNOWN
Impulsive Aggression; Posttraumatic Stress Disorder
Michael E. DeBakey VA Medical Center
 2006-06
NCT00000285 COMPLETED
Cocaine-Related Disorders
National Institute on Drug Abuse (NIDA)
 1996-05 PHASE1
NCT00011063 COMPLETED
Healthy
National Institutes of Health Clinical Center (CC)
 2001-02 PHASE1
NCT00004403 COMPLETED
Epilepsy; Cysticercosis
Johns Hopkins University
 2000-05

(data from https://clinicaltrials.gov, updated on 2026-04-21)

Check the Phenytoin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Phenytoin functions as a voltage-gated sodium channel stabilizer that selectively binds to inactive sodium channels, inhibiting high-frequency repetitive action potential discharge and reducing electrical conductance between neurons. By suppressing abnormal hypersynchronous neuronal firing and limiting the propagation of electrical activity, this pharmacological mechanism prevents seizure activity in convulsive status epilepticus and provides therapeutic efficacy in neuropathic conditions.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.