Drugs / Phenytoin
Phenytoin
also known as
Dilantin · PHT · Dilantin Infatabs · Epanutin Infatabs · Heal Quick · Phenytoin Sodium
targets CYP3A4
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | DILANTIN-125 | — | 1953-01-06 | fda.gov ↗ |
Trials 51
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 118 trials | ||||||
| Phase 1 | NCT07783503 | Sep → Nov 2026 expected | — | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT07590102 | Jun → Oct 2026 expected | — | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT07066722 | Jul → Dec 2025 | HIV infectious disease | ViiV Healthcare | Completed | No outcome recorded |
| Phase 1 | NCT06919991 | May → Oct 2025 | — | Arcus Biosciences, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06906809 | Apr → Oct 2025 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT06903715 | Mar → May 2025 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT07824193 | Jan → Apr 2025 | — | Epygenix | Completed | No outcome recorded |
| Phase 1 | NCT06543043 | Aug → Oct 2024 | — | BeiGene | Completed | No outcome recorded |
| Phase 1 | NCT06466473 | Jul → Oct 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06719557 | May → Jul 2024 | — | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT05995249 | Aug → Dec 2023 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT05901714 | Jun 2023 → Apr 2024 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT04981704 | Apr → Jun 2021 | — | Spectrum Pharmaceuticals, Inc | Completed | No outcome recorded |
| Phase 1 | NCT04845646 | Mar → Jun 2021 | NAFLD1 | Gannex Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01635829 | May → Aug 2012 | — | Janssen Infectious Diseases BVBA | Completed | No outcome recorded |
| Phase 1 | NCT02283827 | Jan → Mar 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT00647621 | Oct → Dec 2005 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00000285 | May 1996 → Dec 2001 | substance-related disorder | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 26 trials · 1 met primary | ||||||
| Phase 2 | NCT03778996 | Jan 2020 → Dec 2027 expected | Ewing sarcoma | Sarcoma Oncology Research Center, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02939937 | Mar 2017 → Nov 2018 | optic neuritis | Tehran University of Medical Sciences | Completed | No outcome recorded |
| Phase 2 | NCT01730313 | Feb 2016 → Jul 2017 | — | Centers for Disease Control and Prevention | Withdrawn | No outcome recorded |
| Phase 2 | NCT02413658 | Mar 2015 → Apr 2016 | — | Children's Surgical Center, Cambodia | Unknown | No outcome recorded |
| Phase 2 | NCT01451593 | Nov 2011 → Dec 2014 | multiple sclerosis, optic neuritis | University College, London | Completed | Met primary |
| Phase 2 | NCT01187719 | May 2010 → Jun 2012 | HIV infectious disease, infectious embryofetopathy, pregnancy disorder | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04647877 | Sep 2020 → Jun 2023 | chronic idiopathic neuropathy | David J. Kopsky | Completed | No outcome recorded |
| Phase 36 trials · 2 met primary · 1 missed | ||||||
| Phase 3 | NCT04573803 | Mar 2021 → Mar 2026 overdue | post-traumatic epilepsy, traumatic brain injury | Cambridge University Hospitals NHS Foundation Trust | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT03650270 | Mar 2015 → Mar 2018 | epilepsy | University of Cape Town | Completed | Met primary |
| Phase 3 | NCT02374567 | Jan 2015 → Jun 2017 | anxiety disorder, dementia, depressive disorder, schizophrenia +1 | Hannover Medical School | Terminated | No outcome recorded |
| Phase 3 | NCT00591006 | Jan 2008 → Jul 2009 | — | University of Texas Southwestern Medical Center | Completed | Met primary |
| Phase 3 | NCT00210782 | Jun 2004 → Aug 2007 | epilepsy | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Missed primary |
| Phase 3 | NCT00004817 | Feb 1991 → ? | brain injury, post-traumatic epilepsy | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 411 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT06942468 | Jul 2025 → Jul 2026 overdue | skin atrophy | Assiut University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05697614 | Mar → May 2023 | epilepsy | Dr Cipto Mangunkusumo General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03161509 | Jul 2017 → Dec 2018 | — | Rambam Health Care Campus | Terminated | No outcome recorded |
| Phase 4 | NCT04967326 | Jan 2016 → Dec 2018 | epilepsy | Gia Dinh People Hospital | Completed | Met primary |
| Phase 4 | NCT02595723 | Jul 2015 → Nov 2016 | cognitive impairment with or without cerebellar ataxia | University of Texas Southwestern Medical Center | Completed | Met primary |
| Phase 4 | NCT01478035 | Nov 2011 → Mar 2015 | epilepsy, pneumococcal meningitis | M. Carmen Cabellos Minguez | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00366067 | Aug 2006 → Feb 2007 | asthma | Centre of Chinese Medicine, Georgia | Completed | No outcome recorded |
| Phase 4 | NCT00610532 | Mar 2006 → Jun 2011 | epilepsy | Jim McAuley | Terminated | No outcome recorded |
| Phase 4 | NCT00581893 | Aug 2005 → Dec 2008 | — | University of Iowa | Completed | Missed primary |
| Phase 4 | NCT00146237 | Nov 2003 → Jan 2005 | depressive disorder | Beersheva Mental Health Center | Completed | No outcome recorded |
| Phase 4 | NCT00219479 | Aug 1997 → Dec 2007 | epilepsy | Penn State University | Terminated | No outcome recorded Stop: Enrollment |
| Phase not applicable9 trials · 1 missed | ||||||
| — | NCT07841366 | Dec 2025 → May 2026 | striae distensae, familial | Al-Azhar University | Completed | No outcome recorded |
| — | NCT07801157 | Jul 2024 → Dec 2025 | — | Mansoura University | Completed | No outcome recorded |
| — | NCT05236166 | Apr 2017 → May 2021 | epilepsy | University Magna Graecia | Completed | No outcome recorded |
| — | NCT02056236 | Apr 2014 → Apr 2021 | cardiac arrest | University of Twente | Completed | Missed primary |
| — | NCT03269214 | Sep 2012 → Oct 2016 | osteonecrosis of the jaw | Shiraz University of Medical Sciences | Completed | No outcome recorded |
| — | NCT00333931 | Jun 2006 → ? | impulse control disorder, post-traumatic stress disorder | Michael E. DeBakey VA Medical Center | Unknown | No outcome recorded |
| — | NCT00162474 | Sep 2003 → Dec 2030 expected | — | Hadassah Medical Organization | Recruiting | No outcome recorded |
| — | NCT00226538 | Aug 1999 → ? | — | Hadassah Medical Organization | Completed | No outcome recorded |
| — | NCT00162461 | Aug 1998 → Dec 2020 | — | Hadassah Medical Organization | Unknown | No outcome recorded |
| Comparator or background therapy32 trials | ||||||
| Phase 0 | NCT00598923 Comparator | Nov 2004 → Feb 2009 | epilepsy, traumatic brain injury | University of Pennsylvania | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT06379958 Comparator | Apr → Sep 2024 overdue | — | Modern Biosciences Ltd | Recruiting | No outcome recorded |
| Phase 1 | NCT06633185 Comparator | Jan → Aug 2022 | ulcer of anus and rectum | Mansoura University | Completed | No outcome recorded |
| Phase 1 | NCT02707965 Comparator | Jun 2017 → Aug 2018 | epilepsy | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT01680042 Comparator | Oct 2012 → Mar 2013 | — | Shahid Beheshti University of Medical Sciences | Unknown | No outcome recorded |
| Phase 1 | NCT01355068 Comparator | May → Jun 2011 | — | Viatris Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00734864 Background | Jun 2009 → Jun 2010 | anaplastic astrocytoma, anaplastic oligodendroglioma, gliosarcoma | Annick Desjardins | Withdrawn | No outcome recorded |
| Phase 1 | NCT00627575 Comparator | Feb → Sep 2008 | epilepsy | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01878578 Comparator | Nov 2002 → Mar 2003 | epilepsy | Bial - Portela C S.A. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02796898 Background | Jun 2016 → May 2019 | prostate cancer | Tyme, Inc | Completed | No outcome recorded |
| Phase 1/2 | NCT00801931 Background | Sep 2007 → May 2009 | anemia, immunodeficiency disease, leukemia, lymphoma +1 | Columbia University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT00245037 Background | Jun 2005 → Aug 2015 | leukemia, myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, plasma cell neoplasm +1 | OHSU Knight Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT05637086 Background | Dec 2022 → Dec 2026 expected | epilepsy | Mostafa Bahaa | Recruiting | No outcome recorded |
| Phase 2 | NCT04720664 Background | Sep 2021 → Feb 2023 | hormone receptor-positive breast cancer | Georgetown University | Terminated | No outcome recorded |
| Phase 2 | NCT02088957 Comparator | Mar → Oct 2014 | epilepsy syndrome | UCB BIOSCIENCES, Inc. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00040469 Background | Aug 2000 → Nov 2003 | sickle cell disease, thalassemia | Baylor College of Medicine | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2/3 | NCT07590375 Comparator | Jun 2026 → Sep 2027 expected | gingival recession | Cairo University | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT03512756 Background | Mar 2018 → Dec 2021 | malignant pancreatic neoplasm | Tyme, Inc | Terminated | No outcome recorded |
| Phase 3 | NCT01713946 Background | Apr 2013 → Oct 2017 | tuberous sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 4 | NCT07072624 Comparator | Jul 2025 → Mar 2027 expected | epilepsy, traumatic brain injury | All India Institute of Medical Sciences, Jodhpur | Recruiting | No outcome recorded |
| Phase 4 | NCT04176887 Comparator | Jan 2019 → Feb 2020 | — | Tanta University | Unknown | No outcome recorded |
| Phase 4 | NCT02205931 Comparator | Jan 2015 → Jun 2018 | epilepsy | University College, London | Unknown | No outcome recorded |
| Phase 4 | NCT02409433 Comparator | Aug 2014 → Nov 2015 | epilepsy | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00552526 Comparator | Nov 2007 → Jan 2011 | epilepsy | Oslo University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00618436 Comparator | Aug 2007 → Sep 2009 | subarachnoid hemorrhage, traumatic brain injury | University of Cincinnati | Completed | No outcome recorded |
| Phase 4 | NCT00510783 Comparator | Jul 2007 → Dec 2008 | epilepsy with generalized tonic-clonic seizures | Emory University | Completed | No outcome recorded |
| — | NCT06312254 Comparator | Apr → Dec 2024 | peripheral neuropathy | Aalborg University | Completed | No outcome recorded |
| — | NCT06067412 Comparator | Aug 2022 → Jan 2023 | — | Shaheed Zulfiqar Ali Bhutto Medical University | Completed | No outcome recorded |
| — | NCT03636958 Background | Feb 2021 → Jul 2025 | epilepsy | Assistance Publique Hopitaux De Marseille | Withdrawn | No outcome recorded |
| — | NCT03096522 Comparator | Feb 2017 → Jan 2018 | anal fistula | Mansoura University | Unknown | No outcome recorded |
| — | NCT00774306 Comparator | Apr 2009 → Jun 2012 | subarachnoid hemorrhage | Thomas Jefferson University | Terminated | No outcome recorded |
| — | NCT00004403 Background | May 2000 → Mar 2002 | cysticercosis, epilepsy | Johns Hopkins University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-07-17 | ViiV Healthcare | Results ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 viivhealthcare.com ↗
After three years of therapy, dolutegravir/lamivudine maintained non-inferior virologic efficacy compared with a TBR, with no confirmed virologic withdrawals or resistance development noted in the dolutegravir/lamivudine treatment arm. |
| 2019-10-01 | Lupin Limited | Regulatory Lupin receives U.S. FDA approval for Extended Phenytoin Sodium Capsules USP lupin.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-07-17 | ViiV Healthcare | ViiV Healthcare to present new data from diverse portfolio and pipeline of 2-drug and long-acting regimens for HIV treatment and prevention at IAS 2021 viivhealthcare.com ↗ |
| 2019-10-01 | Lupin Limited | Lupin receives U.S. FDA approval for Extended Phenytoin Sodium Capsules USP lupin.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 84 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Phenytoin | “Drugs from ACT groups N03A, N05BA, N05CD, H02A or S01EC will be used including prednisolon,levetiracetam, valproate, carbamazepine, oxcarbazepine, topiramate, felbamate,...” NCT00552526 ↗79“Patients will receive the recommended phase 2 dose (RP2D) of SM-88 (460 mg by mouth [PO] twice a day [BID] D1 - 28) as well as three conditioning agents (MPS): methoxsalen (10...” NCT04720664 ↗ “Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958 ↗ “List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin” NCT01713946 ↗ “Racemetyrosine (SM-88) is an amino-acid analogue used with methoxsalen, phenytoin, and sirolimus (MPS) to enhance SM-88 activity.” PMID 32924093 ↗ Sep 2020 “Drugs: carbamazepine, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, topiramate, valproic acid, zonisamide” NCT05236166 ↗ “Step 1: Phenytoin (loading dose 15-20 mg/kg iv, maintenance doses 150 mg iv twice per day)” NCT02056236 ↗ “a single parenteral infusion of phenytoin followed by an infusion of parenteral midazolam” NCT03650270 ↗ “Phenytoin/Dilantin” NCT00734864 ↗ “Phenytoin” NCT02205931 ↗ |
| Known as | Dilantin | “a single dose of phenytoin (Dilantin® is a brand name anticonvulsant which has phenytoin as its active ingredient)” NCT00610532 ↗4“Phenytoin (Dilantin) levels during change in enteral feeding” NCT00219479 ↗ “Phenytoin/Dilantin” NCT00734864 ↗ |
| Known as | Dilantin Infatabs | “Dilantin Infatabs (Phenytoin)” NCT01355068 ↗ |
| Known as | Epanutin Infatabs | “Epanutin Infatabs (Phenytoin)” NCT01355068 ↗ |
| Known as | Heal Quick | “group I (treatment group) will be treated with lateral internal sphincterotomy with topical application of phenytoin 2% (Heal Quick®, Al hadidi pharm, Egypt)” NCT06633185 ↗ |
| Known as | Phenytoin Sodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04573803 ↗ |
| Known as | PHT | “Phenytoin (PHT), used as an anti-seizure medication, has an established side effect of causing drug-influenced gingival enlargement.” NCT07590375 ↗2“Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses.” NCT00774306 ↗ “To evaluate topiramate (TPM) and phenytoin (PHT) monotherapy following rapid oral initiation in new-onset epilepsy.” PMID 20633037 ↗ Oct 2010 |
| Action | Activate | “Phenytoin (inducer), which can increase the production of the enzyme” NCT07590102 ↗ |
| Route | Oral | “received an oral loading dose (20mg/kg)” NCT00000285 ↗ |
| Target | CYP3A4 | “phenytoin, a strong cytochrome P450 (CYP)3A4 inducer” NCT07783503 ↗ |