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Fosphenytoin - Bristol-Myers Squibb/Pfizer

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Drug Profile

Fosphenytoin - Bristol-Myers Squibb/Pfizer

Alternative Names: ACC 9653; ACC 9653-010; Cerebyx; Cereneu; Fosphenytoin sodium; Fostoin; NPC-06; PD 135711-15B; Pro-Epanutin; Prodilantin; Prophenytoin

Latest Information Update: 10 Sep 2026

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer Bristol-Myers Squibb; Nobelpharma; Pfizer
  • Class Analgesics; Antiepileptic drugs; Hydantoins; Small molecules
  • Mechanism of Action Sodium channel antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Epilepsy; Seizures
  • Phase III Pain; Trigeminal neuralgia
  • Phase II Neuropathic pain
  • Discontinued Stroke

Most Recent Events

  • 31 Mar 2026 Phase-III clinical trials in Trigeminal neuralgia in Japan (Parenteral), prior to March 2026 (Nobelpharma pipeline, September 2026)
  • 31 Mar 2026 Nobelpharma and Pfizer anticipate filing a marketing authorisation for Fosphenytoin for Trigeminal neuralgia in Japan, in November 2028 (Nobelpharma pipeline, September 2026)
  • 23 Aug 2023 Nobelpharma completes a phase III trial in Pain in Japan (IV) (NCT05480553)

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