Fosphenytoin

Overview

Fosphenytoin is a water-soluble phenytoin prodrug used only in hospitals for the treatment of epileptic seizures. It works by slowing down impulses in the brain that cause seizures. Its main mechanism is to block frequency-dependent, use-dependent and voltage-dependent neuronal sodium channels, and therefore limit repetitive firing of action potentials.

Indication

Fosphenytoin is indicated for the treatment of generalized tonic-clonic status epilepticus and for the prevention and treatment of seizures occurring during neurosurgery in adult patients. It can also be substituted, short-term, for oral phenytoin in patients aged two years and older when oral phenytoin administration is not possible.

Associated Conditions

Oral phenytoin treatment
Seizures
Status Epilepticus
Generalized tonic-clonic status epilepticus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Efficacy and Safety of Levetiracetam Versus Fosphenytoin in Convulsive Status Epilepticus	2024/05/07	NCT06403150	Phase 4	ENROLLING_BY_INVITATION	Dhaka Medical College
NPC-06 to Pain Associated With Acute Herpes Zoster	2022/07/29	NCT05480553	Phase 3	Completed	Nobelpharma
NPC-06 to Acute Pain in Herpes Zoster	2019/10/25	NCT04139330	Phase 2	Terminated	Nobelpharma
Phase II Clinical Trial of NPC-06 in Patients With Neuropathic Pain in Cancer	2018/12/12	NCT03773055	Phase 2	Terminated	Nobelpharma
Phenytoin as Treatment for Acute Exacerbations of Trigeminal Neuralgia - a Prospective Systematic Study of 20 Patients	2018/10/19	NCT03712254	N/A	Completed	Danish Headache Center
Established Status Epilepticus Treatment Trial	2013/10/10	NCT01960075	Phase 3	Completed	University of Virginia
Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus	2013/06/05	NCT01870024	Phase 3	Completed	Assistance Publique - Hôpitaux de Paris
A Pilot Study of NSICU Assessment of Seizure Prophylaxis With Lacosamide	2010/04/26	NCT01110187	Not Applicable	Terminated	University of Alabama at Birmingham
The Study of NPC-06 - Investigation of Safety, Efficacy and Pharmacokinetics of Fosphenytoin	2009/05/25	NCT00908453	Phase 3	Completed	Nobelpharma
IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures	2007/08/02	NCT00510783	Phase 4	Completed	Emory University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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