NDAORALTABLET
Approved
Jun 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
12
Data completeness
4/8 — Partial
REMERON (mirtazapine) by Merck & Co. is disorder, is unclear. First approved in 1996.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REMERON (mirtazapine) is an oral antidepressant approved in 1996 that works by antagonizing central presynaptic α2-adrenergic autoreceptors and heteroreceptors, thereby enhancing noradrenergic and serotonergic activity. It treats depression, insomnia, sleep disorders, bipolar disorder, vasomotor symptoms, and off-label uses including methamphetamine use disorder and advanced cancer-related symptoms.
$0.791MPart D
LOE ApproachingProduct is in LOE-approaching phase with modest Part D spending; brand team will likely focus on defending generic erosion and may be streamlined or consolidated.
Mechanism of Action
disorder, is unclear. However, its efficacy could be mediated through its activity as an antagonist at central presynaptic α 2 -adrenergic inhibitory autoreceptors and heteroreceptors and enhancing central noradrenergic and serotonergic activity.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Mirtazapine and Methamphetamine Drug-drug Interaction Study
Started May 2021
15 enrolled
Methamphetamine Use DisorderDrug InteractionCardiovascular Abnormalities
Phase II Study of Remeron for Cancer Patients Losing More Than 10% of Their Body Weight
Started Nov 2008
13 enrolled
Advanced Cancer
Twenty-six Week Extension Trial of Org 50081 (Esmirtazapine) in Outpatients With Chronic Primary Insomnia (176003/P05721/MK-8265-007)
Started Oct 2008
184 enrolled
Sleep Initiation and Maintenance DisordersMental DisordersDyssomnias+2 more
A Long-Term Safety Study of Org 50081 (Esmirtazapine) in Elderly Outpatients With Chronic Primary Insomnia (176005/P05697/MK-8265-001)
Started Jan 2008
259 enrolled
Sleep Initiation and Maintenance Disorder; ElderlyMental DisorderDyssomnias+2 more
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
Started Nov 2007
538 enrolled
InsomniaSleep Initiation and Maintenance DisordersMental Disorders+2 more
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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.