Remeron

(Mirtazapine)

ApprovedSmall molecule

Mirtazapine is used to treat depression by helping to balance certain chemicals in the brain. It can also help improve sleep and appetite in people with depression.[2] Remeron is currently approved and in use across 27 indications[4].[1]

Remeron is one of 497 small molecule programs targeting Drug Dependence. It is currently in Approved.

Indications

Total Trials

Active Trials

496

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Drug DependenceApproved

Chemotherapy-Induced Nausea and VomitingApproved

InsomniaActive, not recruiting

Breast CancerApproved

Anorexia NervosaApproved

Heroin DependenceApproved

DementiaApproved

Stomach DiseaseApproved

ParagangliomaApproved

Alcohol DependenceApproved

Drug DependenceApproved

Approved

Chemotherapy-Induced Nausea and VomitingApproved

Approved

InsomniaApproved

Active, not recruiting

Breast CancerApproved

Approved

Anorexia NervosaApproved

Approved

Heroin DependenceApproved

Approved

DementiaApproved

Approved

Stomach DiseaseApproved

Approved

ParagangliomaApproved

Approved

Alcohol DependenceApproved

Approved

Showing 10 of 24 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Remeron

OOrganon and Co

Approved

78 2

Blenoxane

Bristol-Myers Squibb

Preclinical

1 3

Rilvegostomig

AstraZeneca

Preclinical

1 4

Tianeptine

Pfizer

Preclinical

1 5

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 6

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

1 7

Perflutren Lipid Microsphere

IImaRx Therapeutics

Preclinical

1 8

Lapatinib Plus Capecitabine

GSK

Preclinical

2 9

QBX258

Novartis

Preclinical

1 10

Ibrance

Pfizer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Stimulant Use Disorder

NCT06323837

Phase 1Recruiting

Diarrhea

NCT06684470

Phase 2Recruiting

Rett Syndrome

NCT07430046

Q1 2027

N/ANot yet recruiting

Sleep

NCT04728581

Q4 2027

Phase 2Active, not recruiting

Advanced Cancer

NCT00488072

Q4 2030

Phase 2Active, not recruiting

Glioma

NCT03935685

Clinical

Trials by Indication[1]

Weight loss3 trials

Mirtazapine in Alzheimer-associated Weight Loss

Completed·—··NCT01505504·22 enrolled

Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite

Withdrawn·WWashington University School of Medicine·Phase 2·NCT01501396

Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer

Enrolling by invitation·EEnglewood Hospital and Medical Center·Phase 2·NCT05170919·170 enrolled

Anorexia3 trials

Comparison Between Mirtazapine and Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care.

Completed·UUniversity of Sao Paulo·Phase 2·NCT03283488·52 enrolled

Mirtazapine Versus Megestrol Acetate in Treatment of Anorexia-cachexia in Advanced Cancer Patients.

Unknown status·—·Phase 2·NCT05380479·80 enrolled

Mirtazapine for Treatment of Cancer Associated Anorexia-cachexia

Completed·CCatherine Naseef Hunter·Phase 2/3·NCT03254173·120 enrolled

Major Depressive Disorder3 trials

Algorithm Guided Treatment Strategies for Major Depressive Disorder

Unknown status·SShanghai Mental Health Center·Phase 4·NCT01764867·1,080 enrolled

Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia

Completed·NNational Institute of Mental Health, Dhaka·Phase 4·NCT05978219·135 enrolled

A Multi-centre, Double-blind Randomised Controlled Trial to Compare Mirtazapine Versus Placebo Over 12 Weeks in Patients With Multimorbid Major Depression and Inflammatory Bowel Disease (MD-IBD): a Feasibility Study

Completed·KKing's College London·Phase 2·NCT06309472·76 enrolled

Treatment3 trials

Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial

Completed·RResearch Foundation for Mental Hygiene, Inc.·Phase 4·NCT01178671·38 enrolled

A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency

Completed·—·Phase 2·NCT01165541·20 enrolled

Mirtazapine as a Treatment for Co-Occurring Opioid and ATS Dependence in Malaysia

Unknown status·UUniversiti Sains Malaysia·Phase 3·NCT02541526·80 enrolled

Depression3 trials

Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00021528·4,000 enrolled

A Diagnosis and Treatment Optimization Study of Depression Based on the Neurological Mechanism of Reward System

Unknown status·PPeking University·N/A·NCT03148522·120 enrolled

Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00249444·86 enrolled

51 more indications

Methamphetamine2 trials

Dose Response of Mirtazapine to Methamphetamine Induced Interest, Mood Elevation and Reward

Withdrawn·UUniversity of Virginia·N/A·NCT00600145

Mirtazapine and Methamphetamine Drug-drug Interaction Study

Completed·SSan Francisco Department of Public Health·Phase 1·NCT04614584·15 enrolled

Depressed2 trials

Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects

Completed·—·Phase 2·NCT00322309·24 enrolled

Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Unknown status·SSamsung Medical Center·N/A·NCT01039740·100 enrolled

Anxiety2 trials

Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

Completed·UUniversidad Nacional de Rosario·N/A·NCT00960830·40 enrolled

Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients

Recruiting·LLeila Dargahi. PharmD PhD·Phase 2·NCT06530290·64 enrolled

Major Depression2 trials

Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy

Completed·UUniversity of Erlangen-Nürnberg Medical School·Phase 4·NCT00150839·80 enrolled

Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine

Completed·TTechnical University of Munich·Phase 3·NCT00782405·40 enrolled

Treatment Resistant Depression2 trials

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03852160

Interpersonal Psychotherapy for Treatment Resistant Depression

Unknown status·HHospital de Clinicas de Porto Alegre·N/A·NCT01896349·74 enrolled

Sleep Disorder2 trials

Mirtazapine for Sleep Disorders in Alzheimer's Disease

Unknown status·—·Phase 3·NCT01867775·30 enrolled

Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

Completed·WWayne State University·Phase 2·NCT04799782·18 enrolled

Spinal Anesthesia2 trials

Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering

Completed·—·Phase 4·NCT03675555·300 enrolled

Prophylactic Mirtazapine or Clonidine for Post-spinal Anesthesia Shivering

Completed·—·Phase 4·NCT03679052·300 enrolled

Dyspepsia2 trials

Mirtazapine Versus Placebo in Functional Dyspepsia

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 4·NCT01240096·35 enrolled

Elucidating Mechanisms That Underlie the Symptomatology of Functional Dyspepsia Using Novel Techniques and Its Therapeutic Validation Using Neuromodulators

Unknown status·UUniversiti Sains Malaysia·Phase 1·NCT06213948·54 enrolled

Oral2 trials

15 mg Mirtazapine Orally Disintegrating Tablets, Fasting

Completed· Teva logo

Teva·Phase 1·NCT00835575·32 enrolled

15 mg Mirtazapine Orally Disintegrating Tablets, Non-Fasting

Completed· Teva logo

Teva·Phase 1·NCT00834197·32 enrolled

Agitation2 trials

Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine

Completed·—·Phase 4·NCT04908605·165 enrolled

Study of Mirtazapine for Agitation in Dementia

Completed·—·Phase 3·NCT03031184·207 enrolled

Antidepressants2 trials

Strategic Use of New Generation Antidepressants for Depression

Completed·KKyoto University·Phase 4·NCT01109693·2,011 enrolled

Pilot Study to Evaluate Individualized Choice of Antidepressants in Patients With Cancer

Completed·UUNC Lineberger Comprehensive Cancer Center·Phase 1·NCT01725048·21 enrolled

Dexamethasone1 trial

Adding Mirtazapine to Dexamethasone and Aprepitant for Delayed Emesis

Completed·FFudan University·Phase 3·NCT02336750·212 enrolled

Weight Gain1 trial

LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's·Phase 4·NCT01601002·19 enrolled

Efficacy and Safety1 trial

Efficacy and Safety Analyses of Mirtazapine in NSCLC Patients With Depression

Unknown status·SSun Yat-sen University·Phase 2·NCT02650544·236 enrolled

Neuroimaging1 trial

PET Neuroimaging of [11C]Mirtazapine

Completed·UUniversity of Aarhus·Phase 4·NCT00288782·24 enrolled

Mood Disorder1 trial

Treatment of Geriatric Bipolar Mood Disorders: A Pilot Study

Completed·UUniversity of Pittsburgh·Phase 4·NCT00177567·60 enrolled

Methamphetamine Use1 trial

Mirtazapine to Reduce Methamphetamine Use Among MSM With High-risk HIV Behaviors

Completed·SSan Francisco Department of Public Health·Phase 2·NCT00497081·60 enrolled

Non-Small Cell Lung Cancer1 trial

Effect of Mirtazapine Versus Placebo in Patients With Non-small Cell Lung Cancer and Anorexia

Completed·IInstituto Nacional de Cancerologia de Mexico·N/A·NCT04748523·86 enrolled

Effectiveness1 trial

Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early Improvement

Completed·—·Phase 4·NCT01458626·525 enrolled

Pervasive Developmental Disorder1 trial

Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders

Completed·MMassachusetts General Hospital·Phase 3·NCT01302964·30 enrolled

Advanced Cancer1 trial

Effects of Mirtazapine on Appetite in Advanced Cancer Patients

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT00488072·98 enrolled

Esketamine1 trial

Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02228239·26 enrolled

Hyperemesis Gravidarum1 trial

Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum

Terminated·NNordsjaellands Hospital·Phase 2·NCT03785691·58 enrolled

Diarrhea1 trial

Novel Pilot Study to Treat Symptoms of IBS With Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator

Recruiting·MMayo Clinic·Phase 1·NCT06684470·20 enrolled

Double-blind1 trial

Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.

Completed·UUniversity of Pittsburgh·Phase 2·NCT02185131·16 enrolled

Hepatitis C1 trial

Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C

Terminated·SSeoul National University Boramae Hospital·Phase 4·NCT01465919·5 enrolled

Morbidity1 trial

A Policy Relevant US Trauma Care System Pragmatic Trial for PTSD and Comorbidity

Completed·UUniversity of Washington·N/A·NCT02655354·635 enrolled

Cocaine Dependence1 trial

5HT2CR Balance in Brain Connectivity in Cocaine Dependence

Completed·VVirginia Commonwealth University·Phase 1/2·NCT03921151·90 enrolled

Rett syndrome1 trial

Repurposing Mirtazapine in Rett Syndrome

Recruiting·UUniversity of Trieste·Phase 2·NCT07430046·54 enrolled

Bipolar Disorder1 trial

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Depressive Disorder1 trial

The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial

Completed·—·Phase 4·NCT02191124·164 enrolled

Cancer1 trial

Mirtazapine in Cancer-related Poly-symptomatology

Terminated·HHospices Civils de Lyon·Phase 3·NCT04763135·1 enrolled

Cohort Study1 trial

Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea

Completed· Pfizer logo

Pfizer··NCT04446039·370,212 enrolled

Sleep1 trial

Improving Sleep After TKA Using Mirtazapine and Quetiapine

Not yet recruiting·SSt. Anna Ziekenhuis, Geldrop, Netherlands·N/A·NCT04728581·165 enrolled

Mastectomy1 trial

Mirtazapine for Acute and Chronic Post Mastectomy Pain

Completed·—·Phase 1·NCT06499090·62 enrolled

Glioma1 trial

Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ

Active, not recruiting·UUniversity of California, Irvine·Phase 2·NCT03935685·120 enrolled

Craving1 trial

Clinical Studies on the Therapeutic Effects of Mirtazapine on Drug-craving in Cocaine Addicts.

Completed·IInstituto Nacional de Psiquiatría Dr. Ramón de la Fuente·Phase 2·NCT01949571·64 enrolled

Nausea and vomiting1 trial

Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting

Completed·—·Phase 1·NCT04547842·90 enrolled

Oncology Patients1 trial

Nutrition and Pharmacological Algorithm for Oncology Patients Study

Terminated·MMontefiore Medical Center·Phase 4·NCT04155008·1 enrolled

Pregnancy1 trial

Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP)

Withdrawn·NNorthwestern University·Phase 1/2·NCT05452174

Suicide1 trial

Treatment of Adolescent Suicide Attempters (TASA)

Completed·NNew York State Psychiatric Institute·Phase 2/3·NCT00080158·120 enrolled

Fibromyalgia1 trial

Study of Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Fibromyalgia Syndrome

Completed·MMahidol University·Phase 2·NCT00919295·80 enrolled

Obstructive Sleep Apnea1 trial

New Pharmacological Treatment for Obstructive Sleep Apnea

Completed·UUS Department of Veterans Affairs·Phase 1·NCT00108498

Medication1 trial

Treatment of Young Adults With Comorbid AUD/MDD: A Pilot Medication Trial

Completed·UUniversity of Pittsburgh·Phase 2·NCT02646449·11 enrolled

Headache1 trial

Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Completed·—·Phase 4·NCT05108688·210 enrolled

Schizophrenia1 trial

Evaluation of Mirtazapine and Folic Acid for Schizophrenia:

Completed·—·Phase 4·NCT01263080·333 enrolled

PTSD1 trial

A Placebo-Controlled Study of Mirtazapine for PTSD

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00302107·78 enrolled

Methamphetamine Dependence1 trial

Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)

Completed·—·Phase 2·NCT01888835·120 enrolled

Alcohol Consumption1 trial

The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers

Completed·SSahlgrenska University Hospital·Phase 2·NCT00874003·59 enrolled

Stimulant Use Disorder1 trial

A Phase II Randomized, Double-blind, Placebo-controlled Clinical Trial (RCT) to Evaluate the Ability of Mirtazapine (MZP) to Increase Methamphetamine (MA) Abstinence Among Treatment-seeking Medication for Opioid Use Disorder (MOUD) Adults

Recruiting·WWashington State University·Phase 2·NCT06323837·60 enrolled

Unspecified2 trials

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

Completed·MMax-Planck-Institute of Psychiatry·Phase 1·NCT00878540·12 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 14, 1996

REMERON

NDA NDA020415

Jan 12, 2001

REMERON SOLTAB

NDA NDA021208

Sources

References

[1]
ClinicalTrials.gov — 78 trial records for Mirtazapine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Remeron drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Mirtazapine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Mirtazapine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021208). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Organon and Co company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 2a (5-Ht2a) Receptor Antagonist; Serotonin 2c (5-Ht2c) Receptor Antagonist; Adrenergic Receptor Alpha-2 Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: OOrganon and Co

Remeron

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q4 2030

Trials by Indication[1]

Weight loss3 trials

Anorexia3 trials

Major Depressive Disorder3 trials

Treatment3 trials

Depression3 trials

Methamphetamine2 trials

Depressed2 trials

Anxiety2 trials

Major Depression2 trials

Treatment Resistant Depression2 trials

Sleep Disorder2 trials

Spinal Anesthesia2 trials

Dyspepsia2 trials

Oral2 trials

Agitation2 trials

Antidepressants2 trials

Dexamethasone1 trial

Weight Gain1 trial

Efficacy and Safety1 trial

Neuroimaging1 trial

Mood Disorder1 trial

Methamphetamine Use1 trial

Non-Small Cell Lung Cancer1 trial

Effectiveness1 trial

Pervasive Developmental Disorder1 trial

Advanced Cancer1 trial

Esketamine1 trial

Hyperemesis Gravidarum1 trial

Diarrhea1 trial

Double-blind1 trial

Hepatitis C1 trial

Morbidity1 trial

Cocaine Dependence1 trial

Rett syndrome1 trial

Bipolar Disorder1 trial

Depressive Disorder1 trial

Cancer1 trial

Cohort Study1 trial

Sleep1 trial

Mastectomy1 trial

Glioma1 trial

Craving1 trial

Nausea and vomiting1 trial

Oncology Patients1 trial

Pregnancy1 trial

Suicide1 trial

Fibromyalgia1 trial

Obstructive Sleep Apnea1 trial

Medication1 trial

Headache1 trial

Schizophrenia1 trial

PTSD1 trial

Methamphetamine Dependence1 trial

Alcohol Consumption1 trial

Stimulant Use Disorder1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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