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Mirtazapine Tablets
Mirtazapine Tablets is a Tetracyclic antidepressant Small molecule drug developed by National Institute of Mental Health, Dhaka. It is currently FDA-approved for Major depressive disorder, Off-label use for anxiety disorders, insomnia, and appetite stimulation.
Mirtazapine blocks alpha-2 adrenergic receptors and serotonin 5-HT2 and 5-HT3 receptors, increasing noradrenergic and serotonergic neurotransmission in the central nervous system.
Mirtazapine tablets are a small molecule serotonin 2a (5-HT2a) receptor antagonist used to treat various conditions, including major depression disorder and drug withdrawal. They are classified as an antagonist and have been studied in clinical trials for other conditions such as headache and non-small cell lung cancer.
At a glance
| Generic name | Mirtazapine Tablets |
|---|---|
| Sponsor | National Institute of Mental Health, Dhaka |
| Drug class | Tetracyclic antidepressant |
| Target | Alpha-2 adrenergic receptor, 5-HT2 receptor, 5-HT3 receptor |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Mental Health |
| Phase | FDA-approved |
Mechanism of action
As a tetracyclic antidepressant, mirtazapine antagonizes presynaptic alpha-2 adrenergic autoreceptors and heteroreceptors, which disinhibits the release of norepinephrine and serotonin. It also blocks postsynaptic 5-HT2 and 5-HT3 receptors, further enhancing serotonergic signaling. This dual mechanism increases monoamine availability in key brain regions involved in mood regulation.
Approved indications
- Major depressive disorder
- Off-label use for anxiety disorders, insomnia, and appetite stimulation
Common side effects
- Sedation
- Weight gain
- Increased appetite
- Dizziness
- Dry mouth
- Constipation
- Agranulocytosis (rare)
Key clinical trials
- Effects of Mirtazapine on Appetite in Advanced Cancer Patients (PHASE2)
- Mirtazapine for Acute and Chronic Post Mastectomy Pain (EARLY_PHASE1)
- Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP) (PHASE1, PHASE2)
- Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting (EARLY_PHASE1)
- 15 mg Mirtazapine Orally Disintegrating Tablets, Fasting (PHASE1)
- 15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting (PHASE1)
- Mirtazapine for Chronic Insomnia in Older Adults (PHASE1)
- Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Mirtazapine Tablets CI brief — competitive landscape report
- Mirtazapine Tablets updates RSS · CI watch RSS
- National Institute of Mental Health, Dhaka portfolio CI
Frequently asked questions about Mirtazapine Tablets
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Related
- Drug class: All Tetracyclic antidepressant drugs
- Target: All drugs targeting Alpha-2 adrenergic receptor, 5-HT2 receptor, 5-HT3 receptor
- Manufacturer: National Institute of Mental Health, Dhaka — full pipeline
- Therapeutic area: All drugs in Psychiatry / Mental Health
- Indication: Drugs for Major depressive disorder
- Indication: Drugs for Off-label use for anxiety disorders, insomnia, and appetite stimulation
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing