Wednesday, July 8, 2026

Drug profile · INN

mirtazapine

mirtazapine (APX-MIRTAZAPINE) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 1
Pipeline programs 6
News articles 0
Drug details — mirtazapine
US status
approved
Class
Route
ORAL
Patents
1
Programs
6
Data quality
0.89

Quick answer

mirtazapine (APX-MIRTAZAPINE) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN mirtazapine
Brand APX-MIRTAZAPINE
Mechanism Serotonin 2a (5-HT2a) receptor antagonist
Target Adrenergic receptor alpha-2
Route ORAL
Formulation TABLET, ORALLY DISINTEGRATING

Mechanism of action

Serotonin 2a (5-HT2a) receptor antagonist

Primary target: Adrenergic receptor alpha-2

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. INTENSIFY MDD Phase 3 · Disc Medicine · Major depressive disorder
  2. Mirtazapine Phase 2 · BRIGHT MINDS BIOSCIENCES · Amphetamine-Related Disorders
  3. Mirtazapine Phase 2 · BRIGHT MINDS BIOSCIENCES · Cocaine Dependence
  4. Mirtazapine 15 MG Oral Tablet Phase 2 · BRIGHT MINDS BIOSCIENCES · Cocaine Dependence
  5. mirtazapine Phase 2 · BRIGHT MINDS BIOSCIENCES · Substance Abuse
  6. Mirtazapine 15 mg (Orally Disintegrating) Tablets Phase 1 · Teva Pharma · Healthy

Related & competitor drugs

  1. brimonidine tartrate Adrenergic receptor alpha-2 agonist
  2. clonidine hydrochloride Adrenergic receptor alpha-2 agonist
  3. dexmedetomidine hydrochloride Adrenergic receptor alpha-2 agonist
  4. guanfacine hydrochloride Adrenergic receptor alpha-2 agonist
  5. methyldopa Adrenergic receptor alpha-2 agonist
  6. methyldopate hydrochloride Adrenergic receptor alpha-2 agonist
  1. US 6774230

    Methods for the preparation of mirtazapine intermediates

    Expires Mon Aug 05 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is mirtazapine?

mirtazapine (APX-MIRTAZAPINE) is a serotonin 2a (5-ht2a) receptor antagonist. Associated with Alphapharm Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for mirtazapine?

APX-MIRTAZAPINE is a marketed brand name for mirtazapine. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of mirtazapine?

mirtazapine has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.