NDAORALTABLET
Approved
Aug 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
2/8 — Basic
Drug data last refreshed 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MAZANOR (mazindol) is an oral tablet small-molecule CNS stimulant approved in 1980 for narcolepsy, excessive daytime sleepiness, and attention deficit disorder with hyperactivity. The mechanism of action is not fully characterized in available data. Patients with narcolepsy or hypersomnolence disorders requiring daytime wakefulness enhancement are typical users.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling small-to-mid-size brand team focused on defensive strategies and generic transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1
Started Jul 2024
48 enrolled
Narcolepsy Type 1Narcolepsy With Cataplexy
An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy
Started Oct 2021
52 enrolled
Narcolepsy With CataplexyNarcolepsyNarcolepsy Without Cataplexy
Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy
Started Sep 2021
67 enrolled
NarcolepsyExcessive Daytime SleepinessCataplexy Narcolepsy
Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Started Aug 2016
84 enrolled
Attention Deficit Disorder With Hyperactivity
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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.