CLINICAL TRIALS PROFILE FOR CEREBYX

All Clinical Trials for CEREBYX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00510783 ↗	IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures	Completed	UCB Pharma	Phase 4	2007-07-01	This study is looking at three seizure medicines. Patients with seizures are usually treated with phenytoin (Dilantin) or Fosphenytoin. These medicines can be given intravenously (IV)or by mouth. Another seizure medicine, levetiracetam (Keppra) can now be given this way also. This study will compare IV phenytoin (Dilantin) and IV fosphenytoin to levetiracetam (Keppra) in patients who have had a recent seizure. Only patients with a history of seizures can be involved. The patient must present to the emergency department within 4 hours of a seizure. The purpose of this study is to compare these three drugs, phenytoin (Dilantin), fosphenytoin, and levetiracetam (Keppra). The investigators are looking to see if these drugs can prevent another seizure in the next 24 hours. We are also looking for any possible side effects.
NCT00510783 ↗	IV Keppra in the Emergency Department for Prevention of Early Recurrent Seizures	Completed	Emory University	Phase 4	2007-07-01	This study is looking at three seizure medicines. Patients with seizures are usually treated with phenytoin (Dilantin) or Fosphenytoin. These medicines can be given intravenously (IV)or by mouth. Another seizure medicine, levetiracetam (Keppra) can now be given this way also. This study will compare IV phenytoin (Dilantin) and IV fosphenytoin to levetiracetam (Keppra) in patients who have had a recent seizure. Only patients with a history of seizures can be involved. The patient must present to the emergency department within 4 hours of a seizure. The purpose of this study is to compare these three drugs, phenytoin (Dilantin), fosphenytoin, and levetiracetam (Keppra). The investigators are looking to see if these drugs can prevent another seizure in the next 24 hours. We are also looking for any possible side effects.

Clinical Trial Conditions for CEREBYX

Condition Name

Condition Name for CEREBYX
Intervention	Trials
Tonic-clonic Seizure	1

Condition MeSH

Condition MeSH for CEREBYX
Intervention	Trials
Seizures	1
Emergencies	1

Clinical Trial Locations for CEREBYX

Trials by Country

Trials by Country for CEREBYX
Location	Trials
United States	1

Trials by US State

Trials by US State for CEREBYX
Location	Trials
Georgia	1

Clinical Trial Progress for CEREBYX

Clinical Trial Phase

Clinical Trial Phase for CEREBYX
Clinical Trial Phase	Trials
Phase 4	1

Clinical Trial Status

Clinical Trial Status for CEREBYX
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for CEREBYX

Sponsor Name

Sponsor Name for CEREBYX
Sponsor	Trials
UCB Pharma	1
Emory University	1

Sponsor Type

Sponsor Type for CEREBYX
Sponsor	Trials
Industry	1
Other	1

CEREBYX Market Analysis and Financial Projection

Last updated: May 3, 2026

CEREBYX (fosphenytoin): Clinical-Stage Update and Market Outlook

CEREBYX (fosphenytoin) is an FDA-approved prodrug of phenytoin used for treatment of status epilepticus and for short-term IV conversion in patients who are unable to take oral phenytoin. The product is in a mature, supply- and label-constrained market with clinical development largely shifted to line extensions, formulation changes, and biosimilar-like substitution rather than new CNS mechanism pipelines. Near-term growth is tied to inventory cycles, hospital formulary placement, competitive dynamics versus generic IV phenytoin and alternative emergency anti-seizure agents, and global manufacturing availability rather than new late-stage efficacy breakthroughs.

Because CEREBYX is an established, off-patent small-molecule product class and because this request requires a clinical trials update tied to current active studies, the update can be produced only with verified trial identifiers, recruitment status, and endpoints. Those details are not available in the prompt.

If you want a market analysis and projection for CEREBYX specifically, the credible approach is to anchor projections on: (1) current sales base by geography, (2) status of patents/market exclusivity and key regulatory milestones, and (3) competitor substitution rates in IV anti-seizure therapy settings. No underlying sales or exclusivity facts are provided in the prompt.

Given the constraints, this response cannot be completed to the required standard without factual trial-level and market-benchmark inputs.

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What clinical trials update can be stated for CEREBYX?

No trial-level data (trial registry IDs, phase, design, recruitment status, endpoints, readouts) is provided, and no such identifiers can be cited from the prompt. A complete and accurate clinical trials update is therefore not possible within the required operating constraints.

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How does CEREBYX position in the market?

CEREBYX competes in IV treatment of acute seizures/status epilepticus in hospital settings. The commercial value is primarily driven by:

• Acute hospital usage: rapid IV access, clinician familiarity, and pharmacy conversion protocols from phenytoin.
• Formulary dynamics: tender cycles and therapeutic interchange versus generic IV phenytoin products.
• Acquisition and supply: manufacturing availability and contracting.
• Safety and dosing workflows: infusion protocols versus alternative emergency anti-seizure agents.

A defensible market projection requires current baseline revenue by geography, expected share shifts, and competitive assumptions that must be supported by cited facts. None are included in the prompt.

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Market projection: what can be projected from provided information?

No numeric projection can be produced without:

• a current sales base for CEREBYX (or its brand-equivalent unit market) by region,
• time series trend inputs (recent 2-5 year sales),
• expected competitive effects (generic penetration, competitor substitution),
• and evidence of ongoing label expansions or new clinical evidence that changes prescribing.

Those inputs are absent from the prompt, so projections would be non-actionable and non-verifiable.

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Key Takeaways

• CEREBYX is a mature IV anti-seizure therapy with commercial performance driven by hospital formularies, supply continuity, and substitution versus IV generic phenytoin and alternative emergency agents.
• A clinical trials update and a quantified market projection require specific, citable trial registry and sales/market benchmark facts that are not present in the request.

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FAQs

1. What is CEREBYX used for?
   It is used for IV treatment of status epilepticus and as a short-term IV option when patients cannot take oral phenytoin.

2. What drives CEREBYX hospital demand?
   Hospital formulary decisions, substitution policies versus generic IV phenytoin, and procurement and supply reliability.

3. Does CEREBYX have active late-stage development that changes market prospects?
   The request does not include any trial identifiers or phase information, so no current development conclusions can be made.

4. How do generics affect CEREBYX pricing and share?
   In mature IV phenytoin classes, generic substitution typically compresses brand growth unless protected by specific label, supply, or contracted availability.

5. What inputs are required to build a defensible market projection for CEREBYX?
   A current sales base, geographic mix, trend history, and quantified competitive substitution assumptions tied to evidence.

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References

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