Drugs / Fosphenytoin
Fosphenytoin
also known as
FPHT · ACC-9653-010 (SODIUM SALT) · Cerebyx · CI 982 · FHP · FOS · Fosfenitoina · Fosphenytoin disodium salt · +5 more
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | CEREBYX | — | 2017-03-01 | fda.gov ↗ |
| Approved | US (FDA) | CEREBYX | — | 1996-08-05 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials · 1 met primary | ||||||
| Phase 2 | NCT04139330 | Nov 2019 → Feb 2021 | herpes zoster | Nobelpharma | Terminated | Met primary Stop: Enrollment |
| Phase 2 | NCT01458522 | May 2012 → Jul 2014 | epilepsy | Aatif Husain | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00908453 | May 2009 → Feb 2010 | epilepsy | Nobelpharma | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT06081283 | Nov 2023 → Dec 2024 | brain hypoxia - ischemia, cardiac arrest, intracerebral hemorrhage, traumatic brain injury | University of North Carolina, Chapel Hill | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT00734864 Background | Jun 2009 → Jun 2010 | anaplastic astrocytoma, anaplastic oligodendroglioma, gliosarcoma | Annick Desjardins | Withdrawn | No outcome recorded |
| Phase 2 | NCT06859424 Background | Jul 2025 → Jun 2028 expected | B-cell chronic lymphocytic leukemia, acute myeloid leukemia, chronic myeloid leukemia, chronic myelomonocytic leukemia +3 | Center for International Blood and Marrow Transplant Research | Recruiting | No outcome recorded |
| Phase 3 | NCT01960075 Comparator | Oct 2015 → Feb 2019 | — | University of Virginia | Completed | No outcome recorded |
| Phase 3 | NCT01870024 Comparator | Jun 2013 → Feb 2018 | epilepsy | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT06403150 Comparator | May 2023 → Aug 2024 | — | Dhaka Medical College | Completed | No outcome recorded |
| Phase 4 | NCT00510783 Comparator | Jul 2007 → Dec 2008 | epilepsy with generalized tonic-clonic seizures | Emory University | Completed | No outcome recorded |
| — | NCT01110187 Comparator | May 2010 → May 2012 | traumatic brain injury | University of Alabama at Birmingham | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2008-03-19 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharmaceutical announces USFDA approval to market generic Cerebyx ® sunpharma.com ↗ |
| 2004-11-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Tentative Approval Of Fosphenytoin Sodium Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Fosphenytoin Sodium Injection USP, 50 mg PE/mL (PE = phenytoin sodium equivalents). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-11-06 | Ligand Pharmaceuticals | Ligand’s Partner Sedor Pharmaceuticals Receives FDA Approval for SESQUIENT™ for the Treatment of Status Epilepticus in Adult and Pediatric Patients ligand.com ↗ |
| 2008-03-19 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical announces USFDA approval to market generic Cerebyx ® sunpharma.com ↗ |
| 2007-07-09 | Wockhardt | Wockhardt to launch anti – epileptic injection, Fosphenytoin, in the US wockhardt.com ↗ |
| 2004-11-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval Of Fosphenytoin Sodium Injection tevapharm.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | fosphenytoin | “We administered intravenous fosphenytoin, the prodrug of phenytoin, to patients with acute zoster-associated pain to examine its analgesic efficacy and safety.” PMID 38149403 ↗ Dec 20239“Subjects will receive busulfan seizure prophylaxis with levetiracetam, fosphenytoin, or lorazepam per institutional guidelines.” NCT06859424 ↗ “Fosphenytoin/Cerebyx” NCT00734864 ↗ |
| Known as | ACC-9653-010 (SODIUM SALT) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201336 ↗ |
| Known as | Cerebyx | “Fosphenytoin/Cerebyx” NCT00734864 ↗ |
| Known as | CI 982 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201336 ↗ |
| Known as | FHP | “Few trials have compared the effectiveness and safety of levetiracetam (LEV) and fosphenytoin (FHP) for status epilepticus worldwide.” NCT06403150 ↗ |
| Known as | FOS | “Fosphenytoin (FOS) and its active form, phenytoin (PHT), levetiracetam (LEV), and valproic acid (VPA) are commonly used second-line treatments of status epilepticus.” PMID 33336359 ↗ Jan 2021 |
| Known as | Fosfenitoina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201336 ↗ |
| Known as | Fosphenytoin disodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201336 ↗ |
| Known as | FOSPHENYTOIN SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201336 ↗ |
| Known as | Fosphenytoine | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201336 ↗ |
| Known as | FPHT | “Intravenous fosphenytoin (FPHT) is associated with fewer adverse events such as life-threatening arrhythmia” NCT06403150 ↗ |
| Known as | Np-06 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201336 ↗ |
| Known as | Pro-epanutin | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201336 ↗ |
| Known as | Sesquient | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201336 ↗ |
| Modality | Small molecule | — CHEMBL1201336 ↗ |
| Route | Intravenous | “1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals” NCT00510783 ↗ |