Mirtazapine
Other / unclassified targets HTR2A, HTR2C via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | REMERON | — | 2002-04-09 | fda.gov ↗ |
| Approved | US (FDA) | REMERON | — | 1996-06-14 | fda.gov ↗ |
Trials 62 · started per year
Also used as a comparator or background therapy in 43 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06499090 Comparator | Mar 2024 → Dec 2025 | breast cancer | Assiut University | Completed | No outcome recorded |
| Phase 0 | NCT04547842 Comparator | Sep 2020 → Jul 2023 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 0 | NCT01725048 Comparator | Jan 2011 → May 2012 | major depressive disorder, neoplasm | UNC Lineberger Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT04799782 Comparator | Jan 2017 → May 2019 | sleep apnea syndrome, spinal cord injury | Wayne State University | Completed | No outcome recorded |
| Phase 2 | NCT02646449 Comparator | Jun 2015 → Dec 2016 | alcohol-related disorders, major depressive disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 2 | NCT02185131 Comparator | Sep 2013 → Jul 2016 | alcohol-related disorders, major depressive disorder | University of Pittsburgh | Completed | No outcome recorded |
| Phase 2 | NCT01888835 Comparator | Aug 2013 → Oct 2017 | methamphetamine dependence | Phillip Coffin, MD, MIA | Completed | No outcome recorded |
| Phase 2 | NCT00919295 Comparator | Dec 2008 → Oct 2011 | fibromyalgia | Mahidol University | Completed | No outcome recorded |
| Phase 2 | NCT00497081 Comparator | May 2007 → Mar 2010 | HIV infectious disease, substance abuse | San Francisco Department of Public Health | Completed | No outcome recorded |
| Phase 2 | NCT00249444 Comparator | May 2006 → Dec 2012 | cocaine dependence, depressive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03254173 Comparator | Mar 2018 → Oct 2019 | — | Catherine Naseef Hunter | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT03852160 Background | Dec 2019 → Jul 2021 | major depressive disorder | Janssen-Cilag International NV | Withdrawn | No outcome recorded |
| Phase 3 | NCT02400346 Background | Mar 2015 → Jun 2016 | major depressive disorder | H. Lundbeck A/S | Completed | No outcome recorded |
| Phase 3 | NCT01867775 Comparator | May 2012 → Dec 2013 | Alzheimer disease, sleep disorder | Brasilia University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT00782405 Comparator | Oct 2008 → Apr 2011 | — | Technical University of Munich | Completed | No outcome recorded |
| Phase 416 trials | ||||||
| Phase 4 | NCT05108688 Comparator | Nov 2021 → Dec 2023 | headache disorder | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT04908605 Comparator | Jun 2021 → Mar 2022 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT04013386 Comparator | Jul → Dec 2019 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT03675555 Comparator | Mar → Aug 2018 | benign shuddering attacks | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT03679052 Comparator | Mar → Aug 2018 | benign shuddering attacks | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT01458626 Comparator | Nov 2012 → Aug 2016 | major depressive disorder | Capital Medical University | Completed | No outcome recorded |
| Phase 4 | NCT01764867 Comparator | Jun 2012 → Oct 2014 | major depressive disorder | Shanghai Mental Health Center | Unknown | No outcome recorded |
| Phase 4 | NCT01109693 Comparator | Dec 2010 → Sep 2015 | major depressive disorder | Kyoto University | Completed | No outcome recorded |
| Phase 4 | NCT01263080 Comparator | Nov 2010 → Dec 2012 | schizophrenia | Capital Medical University | Completed | No outcome recorded |
| Phase 4 | NCT01119924 Comparator | Dec 2009 → Aug 2010 | depressive disorder | Nang Kuang Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT01305707 Comparator | Jul 2009 → Jul 2014 | major depressive disorder | Hospital Universitari de Bellvitge | Terminated | No outcome recorded |
| Phase 4 | NCT00926835 Comparator | May 2009 → May 2015 | major depressive disorder | Ministry of Health & Welfare, Korea | Terminated | No outcome recorded |
| Phase 4 | NCT00590863 Comparator | Mar 2008 → Sep 2009 | major depressive disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 4 | NCT01240096 Comparator | Sep 2006 → Aug 2011 | dyspepsia | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT00302107 Comparator | Apr 2006 → May 2011 | anxiety, post-traumatic stress disorder | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase 4 | NCT00150839 Comparator | Mar 2006 → Dec 2009 | major depressive disorder | University of Erlangen-Nürnberg Medical School | Completed | No outcome recorded |
| Phase not applicable12 trials | ||||||
| — | NCT04748523 Comparator | Aug 2018 → Jul 2022 | eating disorder, non-small cell lung carcinoma | National Cancer Institute of Mexico | Completed | No outcome recorded |
| — | NCT02655354 Background | Oct 2015 → Nov 2019 | alcohol-related disorders, brain injury, cognitive impairment with or without cerebellar ataxia, depressive disorder +1 | University of Washington | Completed | No outcome recorded |
| — | NCT01943435 Comparator | Nov 2013 → Jun 2016 | lumbar spinal stenosis | Michael Schneider, DC, PhD | Completed | No outcome recorded |
| — | NCT01944657 Comparator | Sep 2013 → Dec 2015 | major depressive disorder | Sheppard Pratt Health System | Withdrawn | No outcome recorded |
| — | NCT01896349 Background | Apr 2013 → Aug 2014 | — | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| — | NCT01962753 Background | May 2012 → Jan 2020 | major depressive disorder | University Hospital, Tours | Completed | No outcome recorded |
| — | NCT01488266 Comparator | Nov 2011 → Jan 2013 | major depressive disorder | Korea University | Unknown | No outcome recorded |
| — | NCT00564278 Background | Feb 2008 → Aug 2013 | depressive disorder | New York State Psychiatric Institute | Completed | No outcome recorded |
| — | NCT00960830 Comparator | Apr 2007 → Apr 2008 | anxiety, depressive disorder | Universidad Nacional de Rosario | Completed | No outcome recorded |
| — | NCT00817011 Comparator | Apr 2006 → Dec 2016 | depressive disorder | Samsung Medical Center | Unknown | No outcome recorded |
| — | NCT00817375 Comparator | Feb 2003 → Dec 2018 | depressive disorder | Samsung Medical Center | Unknown | No outcome recorded |
| — | NCT01228357 Comparator | Feb 2003 → Dec 2018 | depressive disorder | Samsung Medical Center | Unknown | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2005-06-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Final Approval Of Mirtazapine Orally Disintegrating Tablets tevapharm.com ↗ |
| 2003-06-19 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Mirtazapine Tablets, 45 mg tevapharm.com ↗ |
| 2003-01-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Final Approval of Mirtazapine 15mg, 30mg 180-day Marketing Exclusivity tevapharm.com ↗ |
| 2002-12-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces the Grant of Summary Judgement for Mirtazapine Tablets, Generic Version of Remeron tevapharm.com ↗ |
| 2002-01-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Tentative Approval of Mirtazapine 15mg, 30mg and 45mg tevapharm.com ↗ |
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 107 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Mirtazapine | “we have restricted the IMPACT list of antidepressants to SSRIs (sertraline, escitalopram, paroxetine, fluoxetine, citalopram), duloxetine, bupropion, and mirtazapine. These...” NCT02458690 ↗105“Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR),...” NCT00564278 ↗ “Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine,...” NCT02400346 ↗ “Antidepressant medications may include any of the following: citalopram, escitalopram, paroxetine, sertraline, venlafaxine XR, bupropion SR, duloxetine, nortriptyline, and mirtazapine.” NCT00742573 ↗ “Admnistration of 18FAV45 if patient is compliant with one of those treatment: Seroplex, Zoloft, Deroxat, Venlafaxine, Mirtazapine, Moclamine,” NCT01962753 ↗ “Mirtazapine 15mg/day or placebo once a day on the fist week, then 30 mg/day or placebo once a day, and then for 7 consecutive weeks” NCT01119924 ↗ “In case of non-response, after 6 weeks, treatment will be switched to either Mirtazapine, Duloxetine or Venlafaxine” NCT02711215 ↗ “non-SSRI treated group is depressive patients treated with milnacipran, venlafaxine, nortriptyline, or mirtazapine” NCT00817375 ↗ “Adjunctive antidepressant agents: nortriptyline, duloxetine, sertraline, trazodone, or mirtazapine” NCT01943435 ↗ “AD: aripiprazole, bupropion, duloxetine, escitalopram, mirtazapine, sertraline, venlafaxine” NCT04747314 ↗ “mirtazapine_Avanza, Zispin, Remeron” NCT00817011 ↗ “mirtazapine_Avanza, Zispin, Remeron” NCT01228357 ↗ “mirtazapine_Avanza, Zispin, Remeron” NCT01352572 ↗ “mirtazapine_Avanza, Zispin, Remeron” NCT01352559 ↗ “- Mirtazapine 15-45 mg/d. N06AX11” NCT01305707 ↗ “mirtazapine (Remeron and others)” NCT01944657 ↗ “combination (mirtazapine)” NCT06054321 ↗ “Mirtazapine, Remeron” NCT01916824 ↗ “Mirtazapine” NCT00865696 ↗ “mirtazapine” NCT01488266 ↗ |
| Known as | 6-azamianserin | ChEMBL registry synonym — accepted as the source's own label CHEMBL654 ↗ |
| Known as | Avanza | “mirtazapine_Avanza, Zispin, Remeron” NCT00817011 ↗ |
| Known as | Merta | “The M (Mirtazapine) (Merta) group:(n=100)” NCT03675555 ↗ |
| Known as | Mirataz | ChEMBL registry synonym — accepted as the source's own label CHEMBL654 ↗ |
| Known as | Mirtazapin | ChEMBL registry synonym — accepted as the source's own label CHEMBL654 ↗ |
| Known as | Mirtazapina | ChEMBL registry synonym — accepted as the source's own label CHEMBL654 ↗ |
| Known as | Mirtazapine anhydrous | ChEMBL registry synonym — accepted as the source's own label CHEMBL654 ↗ |
| Known as | mirtazapine is Remergon | “mirtazapine is Remergon” NCT01240096 ↗ |
| Known as | Mirtazapine, Remeron | “mirtazapine (Remeron)” NCT01165541 ↗1“Mirtazapine, Remeron” NCT01916824 ↗ |
| Known as | MTZ | “mirtazapine (MTZ) was investigated, a noradrenergic and specific serotonergic antidepressant (NaSSA) for its potential benefits in RTT.” NCT07430046 ↗ |
| Known as | MZP | “This project will evaluate the ability of Mirtazapine (MZP), a pharmacologically unique medication with a growing body of evidence to support its efficacy and safety for the...” NCT06323837 ↗ |
| Known as | Norset | ChEMBL registry synonym — accepted as the source's own label CHEMBL654 ↗ |
| Known as | ORG 3770 | ChEMBL registry synonym — accepted as the source's own label CHEMBL654 ↗ |
| Known as | Promyrtil | ChEMBL registry synonym — accepted as the source's own label CHEMBL654 ↗ |
| Known as | Remeron | “Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR),...” NCT00564278 ↗9“the antidepressant mirtazapine (Remeron) in patients who have been prescribed this medication for major depressive disorder and sleep disruption.” NCT00385437 ↗ “Oral mirtazapine ( REMERON , RD , 30 mg tablets , Organon ) will be the original FDA approved drugs that will be used in the study.” NCT03254173 ↗ “Mirtazapine, sold under the brand name Remeron, is an atypical antidepressant, and as such is used primarily to treat depression.” NCT05452174 ↗ “the clinically effective antidepressant drug mirtazapine (Remeron®)” NCT00288782 ↗ “Mirtazapine (REMERON, Schering-Plough-Organon)” NCT01949571 ↗ “15 mg REMERON® Tablets by Organon Inc.” NCT00865696 ↗ “mirtazapine_Avanza, Zispin, Remeron” NCT00817011 ↗ “mirtazapine (Remeron and others)” NCT01944657 ↗ “Mirtazapine (Remeron)” NCT03935685 ↗ |
| Known as | REMERON SolTab | “15 mg REMERON SolTab® Orally Disintegrating Tablets manufactured for Organon Inc. by CIMA Labs Inc.” NCT00835575 ↗1“Mirtazapine * Commercial name: Remeron® SolTab” NCT06213948 ↗ |
| Known as | Rexer | ChEMBL registry synonym — accepted as the source's own label CHEMBL654 ↗ |
| Known as | Zispin | “mirtazapine_Avanza, Zispin, Remeron” NCT00817011 ↗ |
| Action | Inhibit | “Mirtazapine works through serotinergic (5-HT) mechanisms 5HT 2 and 3, alpha 2 and H1 antagonist and has been noted to decrease excitatory responses in methamphetamine...” NCT00600145 ↗2“Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL654 ↗ “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL654 ↗ |
| Modality | Other / unclassified | “a tetracyclic antidepressant” PMID 33084254 ↗ Oct 2020 |
| Route | Oral | “15 mg by mouth (PO) daily x 15 days; Day 22-29, increased to 30 mg PO daily.” NCT00488072 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL654 ↗ |
| Target | HTR2C | “Serotonin 2c (5-HT2c) receptor antagonist” CHEMBL654 ↗ |