NDAORALSUSPENSION
Approved
Jul 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
ZONISADE (zonisamide) by R-Pharm US is carbonic anhydrase inhibitors [moa]. Approved for epilepsy, partial seizures. First approved in 2022.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZONISADE (zonisamide) is an oral anti-epileptic suspension approved in 2022 that works as a carbonic anhydrase inhibitor. It is indicated for epilepsy and partial seizures as a primary indication, with expanding use in fibromyalgia, migraine, schizophrenia, essential tremor, PTSD, alcohol use disorder, hearing loss, sleep apnea, and obesity. The mechanism involves carbonic anhydrase inhibition, which modulates neuronal excitability across multiple therapeutic domains.
$2MPart D
Peak12.3 years to LOEEarly-stage commercial product in peak phase with modest Part D spending suggests a small to mid-sized team focused on indication expansion and label broadening.
Mechanism of Action
Carbonic Anhydrase Inhibitors
Pharmacologic Class:
Anti-epileptic Agent
Indications (2)
Clinical Trials (20)
Zonisamide Outpatient Study
Started Mar 2019
0Post Traumatic Stress DisorderAlcohol Use Disorder
Zonisamide in Addition to E-CPT-C for Veterans With PTSD and Comorbid Alcohol Dependence
Started Jun 2013
24 enrolled
Alcohol DependencePost-Traumatic Stress Disorder (PTSD)
A Post-marketing Observational Study Of The Use Of Zonisamide (ZNS) in the Adjunctive Treatment Of Adult Patients With Partial Onset Seizures (Study E2090-E044-410) (ZOOM)
Started Mar 2012
104 enrolled
Partial Onset Seizures
A Study to Evaluate the Safety and Efficacy of Zonisamide an Antiepileptic Drug as Monotherapy or Adjunctive Therapy in Treatment of Adult Patients With Partial, Generalized or Combined Seizures.
Started Jan 2011
655 enrolled
Partial, Generalized and Combined Seizures
Zonisamide for the Treatment of Obstructive Sleep Apnea in Overweight/Obese Patients
Started Mar 2010
50 enrolled
Sleep ApneaObstructive Sleep ApneaObesity
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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.