Drugs / Mirtazapine
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Mirtazapine

Other / unclassified targets HTR2A, HTR2C via inhibition

Developed for
major depressive disorder · depressive disorder · eating disorder · insomnia · alcohol dependence · anxiety · cancer of unknown primary site · cocaine dependence
+37 more · dementia · hyperemesis gravidarum · malignant pancreatic neoplasm · amphetamine abuse · anorexia nervosa · autism spectrum disorder · bipolar disorder · brain glioma · cancer · chronic pain syndrome · diarrheal disease · drug dependence · drug-induced mental disorder · dysthymic disorder · functional gastric disease · heroin dependence · hypersomnia · hypoproteinemia, hypercatabolic · irritable bowel syndrome · metastatic neoplasm · methamphetamine dependence · nutritional deficiency disease · obstructive sleep apnea syndrome · post-traumatic stress disorder · Rett syndrome · schizophrenia · substance abuse · substance withdrawal syndrome · substance-related disorder · alcohol-related disorders · Alzheimer disease · benign shuddering attacks · dyspepsia · fibromyalgia · headache disorder · sleep apnea syndrome · sleep disorder
Investigated by
National Institute of Mental Health (NIMH) · Samsung Medical Center · Actavis Inc. · Massachusetts General Hospital · Mayo Clinic · New York State Psychiatric Institute
+110 more · Teva Pharmaceuticals USA · Universiti Sains Malaysia · ASST Ospedale Santi Paolo e Carlo, Milano, Italy · Aarhus University Hospital · Air Force Military Medical University, China · Ajay Wasan, MD, Msc · Alzheimer's Society · American Association of Chairs of Departments of Psychiatry · Autism Speaks · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh · Birmingham and Solihull Mental Health NHS Foundation Trust · Bispebjerg Hospital · Boston University · Capital Medical University · Central South University · Chinese Academy of Sciences · Chonnam National University Hospital · Corning Hospital, Shenzhen City · Dartmouth-Hitchcock Medical Center · Emory University · Englewood Hospital and Medical Center · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · First Affiliated Hospital Xi'an Jiaotong University · First Affiliated Hospital of Kunming Medical University · Fudan University · Fund for Advancement of Medical Science · Guy's and St Thomas' NHS Foundation Trust · Hannover Medical School · Herlev and Gentofte Hospital · Hospices Civils de Lyon · Hvidovre University Hospital · IRCSS Gianna Gaslini, Genova, Italy · Imperial College Healthcare NHS Trust · Imperial College London · Indiana University · Janssen Research & Development, LLC · Kafrelsheikh University · King's College Hospital NHS Trust · King's College London · Kolding Sygehus · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London North West Healthcare NHS Trust · London School of Economics and Political Science · M.D. Anderson Cancer Center · Max Woerzner's Research Award · Max-Planck-Institute of Psychiatry · Medical University of Vienna · Ministry of Higher Education, Malaysia · Montefiore Medical Center · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · National Institute of Mental Health, Dhaka · National Institute of Psychiatry Ramón de la Fuente Muñiz · National Institute on Drug Abuse (NIDA) · National Institutes of Health (NIH) · New Mexico Cancer Research Alliance · Nordsjaellands Hospital · Northwestern University · Norwich Clinical Trials Unit · Odense University Hospital · Organon · Peking University · Peking University Sixth Hospital · Policlinico G . Martino, Messina Italy · Policlinico S.Maria alle Scotte, Siena, Italy · Quebec Researchnetwork on aging · Regionernes Medicinpulje · Renmin Hospital of Wuhan University · Research Foundation for Mental Hygiene, Inc. · Rigshospitalet, Denmark · Sahlgrenska University Hospital · San Francisco Department of Public Health · Second Military Medical University · Seoul National University Boramae Hospital · all 116 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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

today
US approved 1996
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06684470 Dec 2024 → Dec 2026 expected diarrheal disease, irritable bowel syndrome Mayo Clinic Recruiting No outcome recorded
Phase 110 trials · 3 met primary
Phase 1 NCT05247697 Oct 2022 → Jul 2024 insomnia University of Montreal Hospital Centre (CHUM) Completed Met primary
Phase 1 NCT06213948 Aug 2021 → Dec 2024 functional gastric disease Universiti Sains Malaysia Unknown No outcome recorded
Phase 1 NCT04614584 May 2021 → May 2024 methamphetamine dependence San Francisco Department of Public Health Completed No outcome recorded
Phase 1 NCT02228239 Sep → Dec 2014 — Janssen Research & Development, LLC Completed No outcome recorded
Phase 1 NCT00878540 Sep 2008 → Jul 2010 — Max-Planck-Institute of Psychiatry Completed No outcome recorded
Phase 1 NCT00108498 Oct 2003 → Mar 2007 obstructive sleep apnea syndrome US Department of Veterans Affairs Completed No outcome recorded
Phase 1 NCT00835575 Jul → Aug 2003 — Teva Pharmaceuticals USA Completed Met primary
Phase 1 NCT00834197 Jul → Aug 2003 — Teva Pharmaceuticals USA Completed Met primary
Phase 1 NCT00865384 Sep 2001 — Actavis Inc. Completed No outcome recorded
Phase 1 NCT00865696 Sep 2001 — Actavis Inc. Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT05452174 Jun 2022 → Oct 2023 hyperemesis gravidarum Northwestern University Withdrawn No outcome recorded
Phase 1/2 NCT03921151 May 2014 → Jan 2019 cocaine dependence Virginia Commonwealth University Completed No outcome recorded
Phase 220 trials · 2 missed
Phase 2 NCT07430046 Jul 2025 → Jun 2026 overdue Rett syndrome University of Trieste Recruiting No outcome recorded
Phase 2 NCT06323837 Jun 2024 → Dec 2026 expected substance-related disorder Washington State University Recruiting No outcome recorded
Phase 2 NCT06309472 May 2024 → Apr 2026 overdue inflammatory bowel disease, major depressive disorder King's College London Recruiting No outcome recorded
Phase 2 NCT05380479 Jun 2022 → Jan 2023 eating disorder Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh Unknown No outcome recorded
Phase 2 NCT06530290 Jun 2022 → Dec 2025 overdue Parkinson disease, anxiety Shahid Beheshti University of Medical Sciences Recruiting No outcome recorded
Phase 2 NCT05170919 Jan 2022 → Dec 2026 expected anorexia nervosa Englewood Hospital and Medical Center Enrolling by invitation No outcome recorded
Phase 2 NCT03283488 Mar 2019 → Feb 2022 eating disorder, hypoproteinemia, hypercatabolic University of Sao Paulo Completed No outcome recorded
Phase 2 NCT03785691 Mar 2019 → Jul 2022 hyperemesis gravidarum Nordsjaellands Hospital Terminated Mixed Stop: Enrollment
Phase 2 NCT03935685 Feb 2019 → Dec 2030 expected brain glioma University of California, Irvine Active not recruiting No outcome recorded
Phase 2 NCT02650544 Dec 2015 → Jun 2018 depressive disorder, non-small cell lung carcinoma Sun Yat-sen University Unknown No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT04747314 Mar 2021 → Nov 2024 anxiety, chronic pain syndrome Ajay Wasan, MD, Msc Completed No outcome recorded
Phase 2/3 NCT01598584 Jun 2012 → Dec 2015 malignant pancreatic neoplasm Tianjin Medical University Cancer Institute and Hospital Withdrawn No outcome recorded
Phase 2/3 NCT00080158 Mar 2004 → Jun 2007 depressive disorder New York State Psychiatric Institute Completed No outcome recorded
Phase 36 trials · 1 met primary · 2 missed
Phase 3 NCT04763135 Dec 2021 cancer, metastatic neoplasm Hospices Civils de Lyon Terminated No outcome recorded Stop: Enrollment
Phase 3 NCT03031184 Jan 2017 → Jun 2020 dementia University of Sussex Completed Missed primary
Phase 3 NCT02374567 Jan 2015 → Jun 2017 anxiety disorder, dementia, depressive disorder, schizophrenia +1 Hannover Medical School Terminated No outcome recorded
Phase 3 NCT02336750 Dec 2014 → Dec 2021 breast cancer Fudan University Completed Met primary
Phase 3 NCT02541526 May 2013 → Jan 2017 amphetamine abuse, heroin dependence Universiti Sains Malaysia Unknown No outcome recorded
Phase 3 NCT01302964 Aug 2010 → Oct 2017 autism spectrum disorder Massachusetts General Hospital Completed Missed primary
Phase 412 trials · 2 missed
Phase 4 NCT05978219 May → Dec 2023 major depressive disorder National Institute of Mental Health, Dhaka Completed No outcome recorded
Phase 4 NCT04155008 Mar → Apr 2021 cancer-related condition, head and neck cancer, lung cancer, malignant pancreatic neoplasm +1 Montefiore Medical Center Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT03219008 Aug 2017 → Dec 2019 major depressive disorder Shanghai Mental Health Center Unknown Missed primary
Phase 4 NCT02711215 May 2015 → Jan 2020 major depressive disorder Medical University of Vienna Unknown No outcome recorded
Phase 4 NCT01916824 Aug 2013 → Dec 2015 major depressive disorder Emory University Completed No outcome recorded
Phase 4 NCT01601002 Jun 2012 → Oct 2015 major depressive disorder London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Completed No outcome recorded
Phase 4 NCT01465919 Aug 2011 → Dec 2017 depressive disorder Seoul National University Boramae Hospital Terminated No outcome recorded
Phase 4 NCT02191124 Jun 2011 → Nov 2012 major depressive disorder Capital Medical University Completed No outcome recorded
Phase 4 NCT01178671 Jul 2010 → May 2014 post-traumatic stress disorder Research Foundation for Mental Hygiene, Inc. Completed Missed primary
Phase 4 NCT00288782 Feb 2006 → Apr 2007 depressive disorder University of Aarhus Completed No outcome recorded
Phase not applicable8 trials
— NCT04728581 Jan 2024 → May 2026 overdue insomnia, osteoarthritis, knee St. Anna Ziekenhuis, Geldrop, Netherlands Not yet recruiting No outcome recorded
— NCT06681805 Jan 2023 → Sep 2024 — Kafrelsheikh University Completed No outcome recorded
— NCT06054321 Aug 2022 → Dec 2028 expected major depressive disorder Chonnam National University Hospital Recruiting No outcome recorded
— NCT03148522 Jun 2017 → Dec 2021 — Peking University Unknown No outcome recorded
— NCT00600145 Sep 2007 → Dec 2009 drug dependence University of Virginia Withdrawn No outcome recorded
— NCT01039740 Feb 2003 → Dec 2017 depressive disorder Samsung Medical Center Unknown No outcome recorded
— NCT01352572 Jan 2002 → Dec 2018 depressive disorder Samsung Medical Center Unknown No outcome recorded
— NCT01352559 Nov 2001 → Mar 2007 depressive disorder Samsung Medical Center Unknown No outcome recorded
Comparator or background therapy43 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 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

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2018-08-15 Upsher-Smith Laboratories Regulatory Sawai Pharmaceutical Receives Approvals for Six Compounds with 13 Strengths of Generic Drugs upsher-smith.com ↗
Sawai Pharmaceutical Co., Ltd. (Sawai, Head office: Osaka, Japan, President: Mitsuo Sawai) received approvals by the Ministry of Health, Labour and Welfare for six compounds with 13 strengths of generic drugs.
2005-06-30 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Final Approval Of Mirtazapine Orally Disintegrating Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S Food and Drug Administration has granted final approval for the company's ANDA for Mirtazapine Orally Disintegrating Tablets (ODT), 15 mg, 30 mg and 45 mg.
2003-06-19 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Approval of Mirtazapine Tablets, 45 mg tevapharm.com ↗
Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has approved the company's 45 mg strength of Mirtazapine Tablets.
2003-01-24 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Final Approval of Mirtazapine 15mg, 30mg 180-day Marketing Exclusivity tevapharm.com ↗
Jerusalem, Israel, January 24, 2003 - Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for the company's Mirtazapine Tablets, 15 mg and 30 mg.
2002-01-16 Teva Branded Pharmaceutical Products R&D, Inc. Regulatory Teva Announces Tentative Approval of Mirtazapine 15mg, 30mg and 45mg tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq:TEVA) announced today that the U.S. Food and Drug Administration (FDA) has awarded tentative approval for Mirtazapine tablets, 15 mg, 30 mg and 45 mg.

All press releases naming this drug 7 releases

DateIssuerRelease

Evidence & citations 24 cited values

Every value below carries the sentence it was read from. 107 sources stand behind the page.

FieldValueCited 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” NCT01352572 ↗

Show 95 more sources

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 (Remeron) “mirtazapine (Remeron)” NCT01165541 ↗
1

“Mirtazapine, Remeron” NCT01916824 ↗

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 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 2c (5-HT2c) receptor antagonist” CHEMBL654 ↗

“Serotonin 2a (5-HT2a) 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 ↗