NDAORALSUSPENSION
Approved
Jul 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
ZONISADE (zonisamide) by R-Pharm US is carbonic anhydrase inhibitors [moa]. First approved in 2022.
Drug data last refreshed 35m ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZONISADE is an oral suspension formulation of zonisamide, a carbonic anhydrase inhibitor approved in July 2022 for anti-epileptic use. It works by inhibiting carbonic anhydrase and modulating sodium and calcium channels to reduce neuronal excitability. The suspension formulation represents a patient-convenience innovation over existing oral solid dosage forms.
$0.002BPart D
Peak11.9 years to LOEEarly-stage niche product in peak commercial phase with modest Part D claims; teams are likely lean and focused on market penetration in underserved suspension-dependent patient populations.
Mechanism of Action
Carbonic Anhydrase Inhibitors
Pharmacologic Class:
Anti-epileptic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.