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phenytoin

Trade name: mesantoin

Small moleculeapproved

Approved

Jan 6, 1953

Phenytoin is an anti-epileptic drug. Phenytoin has been used with much clinical success against all types of epileptiform seizures, except petit mal epilepsy. Phenytoin is a available for oral administration (tablets, capsules, suspension). CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. CEREBYX should be used only when oral phenytoin administration is not possible. Although several potential targets for phenytoin action have been identified within the CNS (Na-K-ATPase, the GABAA receptor complex, ionotropic glutamate receptors, calcium channels and sigma binding sites) to date, though, the best evidence hinges on the inhibition of voltage-sensitive Na+ channels in the plasma membrane of neurons undergoing seizure activity. — NCATS

Clinical trial activity

75 trials · 109 clinical orgs · 34 marketing orgs

Phase 1
29
Phase 2
17
Phase 3
6
Phase 4
18

Earliest trial started Feb 1, 1991 (NCT00004817)

Timeline

1950s

  1. Jan 6, 1953

    Parke-Davis — Earliest FDA Approval

  2. Jan 6, 1953

    Viatris — Marketing Organization

  3. Jan 6, 1953

    Parke-Davis — NDA Organization

  4. Jan 6, 1953

    Upjohn — Marketing Organization

  5. Jan 6, 1953

    Viatris — NDA Secondary Org

1970s

  1. Jul 16, 1975

    Hikma — Marketing Organization

  2. Jul 16, 1975

    West-Ward Pharmaceutical — Marketing Organization

  3. Aug 27, 1976

    Parke-Davis — Marketing Organization

  4. Dec 3, 1976

    Chartwell Pharmaceuticals — Marketing Organization

  5. Apr 15, 1977

    Lannett Company, Inc. — Marketing Organization

  6. Mar 3, 1978

    Watson Pharmaceuticals — Marketing Organization

  7. Apr 6, 1978

    Ani Pharmaceuticals — Marketing Organization

  8. Feb 26, 1979

    Pfizer — Marketing Organization

  9. Feb 26, 1979

    Pharmacia — Marketing Organization

1980s

  1. May 31, 1985

    Fresenius — Marketing Organization

  2. Mar 17, 1987

    Hospira — Marketing Organization

  3. Oct 13, 1987

    Marsam Pharmaceuticals — Marketing Organization

1990s

  1. Jan 1, 1991

    Earliest Phase 3 Sponsor(trial)

  2. Sep 25, 1992

    Actavis — Marketing Organization

  3. Jan 1, 1996

    Earliest Phase 1 Sponsor(trial)

  4. Dec 28, 1998

    Mylan — Marketing Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 31, 2001

    VistaPharm, Inc. — Marketing Organization

  3. Apr 19, 2002

    Pharmaceutical Associates — Marketing Organization

  4. Mar 8, 2004

    Taro Pharmaceuticals — Marketing Organization

  5. Sep 13, 2006

    Acella Pharmaceuticals — Marketing Organization

  6. Dec 4, 2007

    Lutipold — Marketing Organization

  7. Dec 4, 2007

    Sankyo — Marketing Organization

  8. Dec 4, 2007

    Daiichi Sankyo — Marketing Organization

  9. Dec 18, 2007

    Wockhardt — Marketing Organization

  10. Jun 30, 2008

    Sun Pharmaceuticals — Marketing Organization

  11. Nov 12, 2008

    Amneal Pharmaceuticals — Marketing Organization

2010s

  1. Dec 26, 2012

    Rising Pharmaceuticals — Marketing Organization

  2. Nov 28, 2014

    Epic Pharma Llc — Marketing Organization

  3. Jun 10, 2015

    Aurobindo Pharma — Marketing Organization

  4. Sep 30, 2019

    Lupin — Marketing Organization

2020s

  1. Oct 13, 2022

    Unichem — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJan 6, 1953

Chemistry & pharmacology

Loading structure…

SMILES

O=C1NC(=O)C(c2ccccc2)(c2ccccc2)N1
Mol. weight
252.27 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 5,5-diphenyl-imidazolidine-2,4-dione
  • 5,5-diphenyl-imidazolidine-2,4-dione
  • 5,5-diphenylimidazolidine-2,4-dione
  • 5,5-diphenylimidazolidine-2,4-dione
  • 5,5-diphenyltetrahydro-1h-2,4-imidazoledione
  • 5,5-diphenyltetrahydro-1h-2,4-imidazoledione
  • dilabid
  • dilabid
  • dilantin
  • dilantin
  • dilantin
  • dilantin
  • dilantin-125
  • dilantin-125
  • dilantin-30
  • dilantin-30
  • diphantoin
  • diphenylan
  • diphenylan sodium
  • diphenylan sodium
  • diphenylhydantoin
  • diphenylhydantoin
  • diphenylhydantoin
  • diphenylhydantoin
  • diphenylhydantoin sodium
  • diphenylhydantoin sodium
  • extended phenytoin sodium
  • extended phenytoin sodium
  • fenitoin
  • fenitoin
  • fenitoin
  • fenitoin
  • fenitoin
  • fenitoin
  • fenitoina
  • fenitoina
  • fenytoin
  • fenytoin
  • hydantol
  • hydantol
  • pentran
  • pentran
  • phentytoin
  • phentytoin
  • phentytoin
  • phenytek
  • phenytek
  • phenytex
  • phenytex
  • phenytoin
  • phenytoin
  • phenytoin
  • phenytoin
  • phenytoin
  • phenytoin
  • phenytoin
  • phenytoin
  • phenytoin
  • phenytoine
  • phenytoine
  • phenytoine
  • phenytoin sodium
  • phenytoin sodium
  • phenytoin sodium
  • phenytoin sodium
  • phenytoin sodium
  • phenytoinum
  • phenytoinum
  • phenytoinum
  • prompt phenytoin sodium
  • prompt phenytoin sodium
  • sodium diphenylhydantoinate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07072624Phase 4Jul 23, 2025All India Institute of Medical Sciences, Indian Council of Medical Research, Postgraduate Institute of Medical Education and Research
NCT07066722Phase 1Jul 7, 2025ViiV Healthcare
NCT06942468Phase 4Jul 1, 2025Assiut University
NCT06919991Phase 1May 2, 2025Arcus Biosciences, Inc.
NCT06906809Phase 1Apr 3, 2025BeOne Medicines
NCT06903715Phase 1Mar 28, 2025Merck
NCT06543043Phase 1Aug 19, 2024BeOne Medicines, Quotient
NCT06466473Phase 1Jul 3, 2024Pfizer
NCT06719557Phase 1May 20, 2024Merck
NCT06312254N/AApr 30, 2024Aalborg University
NCT06379958Phase 1Apr 8, 2024Modern Biosciences plc
NCT05995249Phase 1Aug 11, 2023Takeda
NCT05901714Phase 1Jun 19, 2023Bristol-Myers Squibb
NCT05637086Phase 2Dec 20, 2022Horus University, Tanta University
NCT06067412N/AAug 1, 2022Rawalpindi Medical College, Pakistan, Shaheed Zulfiqar Ali Bhutto Medical University
NCT05542589N/AMar 1, 2022Cairo University
NCT06633185Phase 1Jan 1, 2022Mansoura University
NCT04956627Phase 1Jul 28, 2021Bristol-Myers Squibb
NCT04981704Phase 1Apr 8, 2021Spectrum Pharmaceuticals
NCT04845646Phase 1Mar 16, 2021Gannex Pharma Co., Ltd.
Showing 20 of 75 trials
Page 1 / 4

Organizations

Research & Development (109)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit4412010
Bristol-Myers SquibbFor profit3212009
Hebrew UniversityAcademic/Hospital3311998
Hoosier Cancer Research NetworkAcademic/Hospital3122007
Tyme, IncFor profit3212016
BeOne MedicinesFor profit2212024
BialFor profit2212002
Johnson and JohnsonFor profit2222004
Mansoura UniversityAcademic/Hospital2222017
MerckFor profit2212024
National Cancer Institute (NCI)Government2022005
Radboud UniversityAcademic/Hospital2122010
Shahid Beheshti University of Medical SciencesAcademic/Hospital2122012
Tanta UniversityAcademic/Hospital2222019
The Rogosin InstituteAcademic/Hospital2022003
The University of Texas, DallasAcademic/Hospital2222008
University of CambridgeAcademic/Hospital2122015
University of LondonAcademic/Hospital2222011
University of MarylandAcademic/Hospital2112017
Aalborg UniversityAcademic/Hospital1112024
109 organizations
Page 1 / 6

Marketing (44)

OrganizationOrg typeRelationshipDate
Acella PharmaceuticalsFor profitMKTGSep 13, 2006
Acella PharmaceuticalsFor profitSYNSep 13, 2006
ActavisFor profitMKTGSep 25, 1992
Amneal PharmaceuticalsFor profitMKTGNov 12, 2008
Ani PharmaceuticalsFor profitMKTGApr 6, 1978
Ani PharmaceuticalsFor profitSYNApr 6, 1978
Aurobindo PharmaFor profitMKTGJun 10, 2015
Aurobindo PharmaFor profitSYNJun 10, 2015
Chartwell PharmaceuticalsFor profitMKTGDec 3, 1976
Daiichi SankyoFor profitMKTGDec 4, 2007
Epic Pharma LlcFor profitMKTGNov 28, 2014
FreseniusFor profitMKTGMay 31, 1985
HikmaFor profitMKTGJul 16, 1975
HospiraFor profitMKTGMar 17, 1987
Lannett Company, Inc.For profitSYNDec 3, 1976
Lannett Company, Inc.For profitMKTGApr 15, 1977
LupinFor profitMKTGSep 30, 2019
LutipoldFor profitMKTGDec 4, 2007
Marsam PharmaceuticalsFor profitMKTGOct 13, 1987
MylanFor profitMKTGDec 28, 1998
MylanFor profitSYNDec 26, 2012
Parke-DavisFor profitMKTGAug 27, 1976
Parke-DavisFor profitNDAJan 6, 1953
PfizerFor profitMKTGFeb 26, 1979
Pharmaceutical AssociatesFor profitMKTGApr 19, 2002
PharmaciaFor profitMKTGFeb 26, 1979
Rising PharmaceuticalsFor profitMKTGDec 26, 2012
SOLOPAKFor profitMKTG—
SankyoFor profitMKTGDec 4, 2007
Smith & NephewFor profitMKTG—
Sun PharmaceuticalsFor profitMKTGJun 30, 2008
Sun PharmaceuticalsFor profitSYNDec 11, 2006
Taro PharmaceuticalsFor profitMKTGMar 8, 2004
UnichemFor profitMKTGOct 13, 2022
UpjohnFor profitMKTGJan 6, 1953
ViatrisFor profitMKTGJan 6, 1953
ViatrisFor profitNDA2Jan 6, 1953
VistaPharm, Inc.For profitMKTGJan 31, 2001
Warner ChilcottFor profitMKTG—
Watson PharmaceuticalsFor profitMKTGMar 3, 1978
West-Ward PharmaceuticalFor profitMKTGJul 16, 1975
WockhardtFor profitMKTGDec 18, 2007
WockhardtFor profitSYNApr 19, 2002
WockhardtFor profitSYNJan 30, 2008