NDAORALSUSPENSION
Approved
Apr 2016
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
20
Data completeness
5/8 — Partial
FYCOMPA (perampanel) by Catalyst Pharmaceuticals is ampa receptor antagonists [moa]. First approved in 2016.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FYCOMPA (perampanel) is an oral noncompetitive AMPA glutamate receptor antagonist approved in 2016 as an adjunctive treatment for seizure disorders. It works by blocking AMPA receptors to reduce neuronal excitability and prevent seizure propagation. The suspension formulation enables flexible dosing, particularly for patients who cannot tolerate tablets.
LOE Approaching0mo to LOE
Approaching loss of exclusivity in July 2026 signals declining team expansion and increased focus on cost containment versus growth initiatives.
Mechanism of Action
AMPA Receptor Antagonists
Pharmacologic Class:
Noncompetitive AMPA Glutamate Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Evaluate the Safety of Fycompa Injection in Participants With Partial-Onset Seizures or Primary Generalized Tonic- Clonic Seizures
Started Nov 2024
110 enrolled
Partial-Onset SeizuresPrimary Generalized Tonic-clonic Seizures
A Study to Evaluate the Efficacy and Safety of Perampanel Monotherapy in Untreated Participants With Focal Onset Seizures With or Without Focal to Bilateral Tonic-clonic Seizures
Started Oct 2022
125 enrolled
Epilepsy
Fycompa in Catamenial Epilepsy
Started Mar 2022
7 enrolled
Catamenial Epilepsy
Perampanel Titration and Cognitive Effects
Started Oct 2021
29 enrolled
Epilepsy
Effect of Perampanel on Peritumoral Hyperexcitability in HGG
Started Nov 2020
12 enrolled
Glioma, MalignantSurgerySeizures
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.