REMERON SOLTAB (mirtazapine)
Remeron SolTab is a medication used for adults who have major depressive disorder. It helps patients with this condition by addressing the symptoms of clinical depression. This drug is prescribed to help manage the mental health needs of adult patients experiencing these depressive episodes.
How REMERON SOLTAB Works
While the exact process is not fully clear, this medication works by acting as an antagonist at specific central presynaptic α2-adrenergic receptors. By blocking these inhibitory receptors, the drug helps enhance both noradrenergic and serotonergic activity within the central nervous system.
Details
- Status
- Prescription
- First Approved
- 2001-01-12
- Routes
- ORAL
- Dosage Forms
- TABLET, ORALLY DISINTEGRATING
REMERON SOLTAB Approval History
What REMERON SOLTAB Treats
1 indicationsREMERON SOLTAB is approved for 1 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
REMERON SOLTAB Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . Mirtazapine tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribi...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1) ] . Mirtazapine tablets are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. Increased risk of suicidal thoughts and behavior in pediatric and young adult patients taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors. Mirtazapine tablets are not approved for use in pediatric patients. ( 5.1 , 8.4 )
REMERON SOLTAB Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to REMERON SOLTAB
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
36 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07430046 MirtaRett | CTIS ID: 28366 2024-515411-21-00 | Ph 2 | recruiting | Repurposing Mirtazapine in Rett Syndrome |
| NCT03852160 | CR108567 2018-001890-26, 54135419TRD3011 | Ph 3 | withdrawn | 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 |
| NCT06323837 MIRROM | 20383 | Ph 2 | recruiting | Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment |
| NCT05452174 ESNAP | STU00215676 R21HD105101 | Ph 1, Ph 2 | withdrawn | Endeavor to Stop Nausea/Vomiting Associated With Pregnancy (E-SNAP) |
| NCT04614584 | 20-30109 | Ph 1 | completed | Mirtazapine and Methamphetamine Drug-drug Interaction Study |
| NCT05170919 | E-21-862 | Ph 2 | enrolling by invitation | Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients with Advanced Stage Cancer |
| NCT06309472 MDIBD | NIHR302528 | Ph 2 | recruiting | Trial of Mirtazapine for Depression in IBD |
| NCT05108688 | FMASU MD 209/2021 | Ph 4 | completed | Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache |
| NCT03283488 | Mirtazapine_Cachexia | Ph 2 | completed | Comparison Between Mirtazapine and Megestrol for the Control of Anorexia-cachexia in Cancer Patients in Palliative Care. |
| NCT04763135 MIR-P | 69HCL20_0032 2020-002994-90 | Ph 3 | terminated | Mirtazapine in Cancer-related Poly-symptomatology |
| NCT03785691 VOMIT | VOMIT | Ph 2 | terminated | Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum |
| NCT04155008 results posted | 2019-10218 | Ph 4 | terminated | Nutrition and Pharmacological Algorithm for Oncology Patients Study |
| NCT02336750 | Fudan BR2014-15 CBCSG019 | Ph 3 | completed | Adding Mirtazapine to Dexamethasone and Aprepitant for Delayed Emesis |
| NCT04908605 | FMASU MS251 /202l | Ph 4 | completed | Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine |
| NCT04799782 results posted | 100712M1F(V) | Ph 2 | completed | Role of Mirtazapine in Ameliorating Sleep Disordered Breathing |
| NCT03031184 SYMBAD | 15/SC/0606 | Ph 3 | completed | Study of Mirtazapine for Agitation in Dementia |
| NCT03675555 | R 47 / 2018 | Ph 4 | completed | Prophylactic Mirtazapine or Dexamethasone for Post-spinal Anesthesia Shivering |
| NCT01465919 | 06-2011-130 | Ph 4 | terminated | Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C |
| NCT01302964 results posted | 2012P001009 | Ph 3 | completed | Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders |
| NCT03679052 | R 48 / 2018 | Ph 4 | completed | Prophylactic Mirtazapine or Clonidine for Post-spinal Anesthesia Shivering |
| NCT01165541 results posted | QM1 | Ph 2 | completed | A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency |
| NCT01888835 | 1R01DA034527 R01DA034527 | Ph 2 | completed | Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0) |
| NCT02374567 GAP | GAP-2014 | Ph 3 | terminated | Pharmacovigilance in Gerontopsychiatric Patients |
| NCT01458626 | MISP # 39888 | Ph 4 | completed | Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early Improvement |
| NCT02185131 PT-MAD results posted | R21AA022123 5R21AA022123-02 | Ph 2 | completed | Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD. |
| NCT02646449 YAAD-P results posted | 1R21AA022863-01A1 | Ph 2 | completed | Treatment of Young Adults With Comorbid AUD/MDD: A Pilot Medication Trial |
| NCT01109693 SUN(^_^)D | sun-d | Ph 4 | completed | Strategic Use of New Generation Antidepressants for Depression |
| NCT01263080 RECOVERY2 | RECOVERY2 | Ph 4 | completed | Evaluation of Mirtazapine and Folic Acid for Schizophrenia: |
| NCT01601002 | HSREB-102574 | Ph 4 | completed | LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression |
| NCT01178671 results posted | R34MH091336 R34MH091336 | Ph 4 | completed | Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial |
| NCT02228239 DRiVESaFe | CR104764 2014-002005-38, ESKETINTRD1006 | Ph 1 | completed | Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants |
| NCT02191124 | 2009-1051 | Ph 4 | completed | The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial |
| NCT01501396 | 201202023 | Ph 2 | withdrawn | Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite |
| NCT00919295 | 323/2551(EC4) | Ph 2 | completed | Study of Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Fibromyalgia Syndrome |
| NCT00782405 | D114432C00027 | Ph 3 | completed | Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine |
| NCT00878540 SMMS | L2/2008 EudraCT-Nr.: 2008-002704-26 | Ph 1 | completed | Short-term Metabolic Effects of Mirtazapine in Healthy Subjects |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REMERON SOLTAB FDA Label Details
Indications & Usage
FDA Label (PDF)REMERON SOLTAB is indicated for the treatment of Major Depressive Disorder.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.