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mirtazapine

Trade name: remeron

Small moleculeapproved

Approved

Jun 14, 1996

Mirtazapine, originally known as ORG 3770, was first synthesized by the Department of Medicinal Chemistry of NV Organon in the Netherlands (Kaspersen et al. 1989). First approved for use in major depression in the Netherlands in 1994, mirtazapine was introduced in the United States in 1996. The antidepressant mirtazapine has a dual mode of action. It is a noradrenergic and specific serotonergic antidepressant (NaSSA) that acts by antagonizing the adrenergic alpha2-autoreceptors and alpha2-heteroreceptors as well as by blocking 5-HT2 and 5-HT3 receptors. It enhances, therefore, the release of norepinephrine and 5-HT1A-mediated serotonergic transmission. This dual mode of action may conceivably be responsible for mirtazapine's rapid onset of action. — NCATS

Clinical trial activity

111 trials · 130 clinical orgs · 21 marketing orgs

Phase 1
19
Phase 2
47
Phase 3
23
Phase 4
29

Earliest trial started Jul 1, 2001 (NCT00021528)

Timeline

1990s

  1. Jun 14, 1996

    Organon — Earliest FDA Approval

  2. Jun 14, 1996

    Organon — NDA Organization

  3. Jun 14, 1996

    Organon — Marketing Organization

2000s

  1. Jan 1, 2001

    Actavis — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  3. Jan 24, 2003

    Teva — Marketing Organization

  4. Jun 19, 2003

    Mylan — Marketing Organization

  5. Jun 19, 2003

    Roxane Laboratories — Marketing Organization

  6. Jun 19, 2003

    Upsher-Smith Laboratories — Marketing Organization

  7. Jun 19, 2003

    Watson Pharmaceuticals — Marketing Organization

  8. Jun 19, 2003

    Boehringer Ingelheim — Marketing Organization

  9. Jun 19, 2003

    Chartwell Pharmaceuticals — Marketing Organization

  10. Jun 19, 2003

    PHARMOBEDIENT — Marketing Organization

  11. Jun 20, 2003

    Actavis — Marketing Organization

  12. Jan 1, 2004

    Earliest Phase 3 Sponsor(trial)

  13. Apr 22, 2004

    Sun Pharmaceuticals — Marketing Organization

  14. Oct 22, 2004

    Aurobindo Pharma — Marketing Organization

  15. Jun 28, 2005

    Impax Laboratories — Marketing Organization

  16. Aug 22, 2007

    Apotex — Marketing Organization

2010s

  1. Jun 1, 2017

    Square Pharmaceuticals — Marketing Organization

  2. Jun 1, 2017

    Zydus Discovery DMCC — Marketing Organization

  3. Jun 1, 2017

    ACME Laboratories — Marketing Organization

2020s

  1. Jan 18, 2023

    Prasco LLC — Marketing Organization

  2. Oct 2, 2025

    Annora Pharma — Marketing Organization

  3. Feb 2, 2026

    Novitium Pharma — Marketing Organization

  4. May 19, 2026

    Micro Labs Ltd India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedJun 14, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CN1CCN2c3ncccc3Cc3ccccc3[C@H]2C1
Mol. weight
265.36 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 1,2,3,4,10,14b-hexahydro-2-methylpyrazino(2,1-a)pyrido(2,3-c)benzazepine
  • 1,2,3,4,10,14b-hexahydro-2-methylpyrazino(2,1-a)pyrido(2,3-c)benzazepine
  • 6-azamianserin
  • 6-azamianserin
  • 6-azamianserin
  • celltech brand of mirtazapine
  • esmirtazapine
  • esmirtazapine
  • esmirtazapine
  • esmirtazapine
  • esmirtazapine
  • esmirtazapine maleate
  • esmirtazapine maleate
  • mepirzapin
  • mepirzapine
  • mepirzapine
  • mepirzepine
  • mirtabene
  • mirtazapin
  • mirtazapin
  • mirtazapina
  • mirtazapina
  • mirtazapine
  • mirtazapine
  • mirtazapine
  • mirtazapine
  • mirtazapine
  • mirtazapine
  • mirtazapine
  • mirtazapine
  • mirtazapine
  • mirtazapine
  • mirtazapine
  • mirtazapinum
  • mirtazapinum
  • mirtazepine
  • mirtazepine
  • mirtazepine
  • mirtazipine
  • mirtrazapine
  • mundogen brand of mirtazapine
  • (n-methyl-11c)mirtazapine
  • norset
  • ntc-510
  • org 3770
  • org-3770
  • org-3770
  • org-3770
  • org 50081
  • org 50081
  • org 50081
  • org-50081
  • org-50081
  • organon brand of mirtazapine
  • pyrazino(2,1-a)pyrido(2,3-c)(2)benzazepine, 1,2,3,4,10,14b-hexahydro-2-methyl-
  • remergil
  • remeron
  • remeron
  • remeron
  • remeron
  • remeron
  • remeron soltab
  • remeron soltab
  • rexer
  • (s)-1,2,3,4,10,14b-hexahydro-2-methylpyrazino(2,1-a)pyrido(2,3-c)(2)benzazepine
  • (s)-1,2,3,4,10,14b-hexahydro-2-methylpyrazino(2,1-a)pyrido(2,3-c)(2)benzazepine
  • zispin
  • zispin
  • zispin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06684470Early Phase 1 (Phase 1)Nov 30, 2024Mayo Clinic
NCT06499090Early Phase 1 (Phase 1)Jul 31, 2024Assiut University
NCT06323837Phase 2Jun 17, 2024Washington State University
NCT06309472Phase 2May 1, 2024Imperial College London, University of London
NCT06321991Phase 2Feb 15, 2024Katholieke Universiteit Leuven
NCT05978219Phase 4May 25, 2023Government of Bangladesh, Sun Pharmaceuticals
NCT05923905Phase 4Jan 18, 2023Peking University
NCT06681805N/AJan 1, 2023Kafrelsheikh University
NCT05247697Phase 1Sep 1, 2022University of Montreal
NCT05452174Phase 1/Phase 2 (Phase 2)Jun 13, 2022National Institutes of Health (NIH), Northwestern University
NCT06530290Phase 2Jun 1, 2022Shahid Beheshti University of Medical Sciences
NCT05380479Phase 2Jun 1, 2022Bangladesh Medical University
NCT05170919Phase 2Jan 20, 2022Englewood Hospital and Medical Center
NCT05108688Phase 4Nov 15, 2021Ain Shams University
NCT06213948Phase 1Aug 1, 2021Univerisiti Sains Malaysia
NCT04908605Phase 4Jun 15, 2021Ain Shams University
NCT04728581N/AMay 1, 2021St. Anna Ziekenhuis, Geldrop, Netherlands
NCT04763135Phase 3Mar 8, 2021University of Lyon
NCT04614584Phase 1Jan 1, 2021City of San Francisco, University of California, Los Angeles
NCT04547842Early Phase 1 (Phase 1)Sep 1, 2020Ain Shams University
Showing 20 of 111 trials
Page 1 / 6

Organizations

Research & Development (130)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
MerckFor profit101022004
National Institute of Mental Health (NIMH)Government7242001
Ain Shams UniversityAcademic/Hospital6622018
Columbia UniversityAcademic/Hospital5442004
Sungkyunkwan UniversityAcademic/Hospital5512002
University of PittsburghAcademic/Hospital5432001
National Institute on Drug Abuse (NIDA)Government4012006
PRACSFor profit4012001
The University of Texas, DallasAcademic/Hospital4122001
Capital Medical UniversityAcademic/Hospital3312010
City of San FranciscoGovernment3322007
Department of Veteran AffairsGovernment3332003
National Institutes of Health (NIH)Government3022006
Peking UniversityAcademic/Hospital3212017
ActavisFor profit2212001
Jiao Tong UniversityAcademic/Hospital2212012
Johnson and JohnsonFor profit2222014
Katholieke Universiteit LeuvenAcademic/Hospital2222006
TevaFor profit2212003
University of LondonAcademic/Hospital2122017
130 organizations
Page 1 / 7

Marketing (30)

OrganizationOrg typeRelationshipDate
ACME LaboratoriesFor profitMKTGJun 1, 2017
ActavisFor profitMKTGJun 20, 2003
ActavisFor profitSYNJun 20, 2003
Annora PharmaFor profitMKTGOct 2, 2025
ApotexFor profitMKTGAug 22, 2007
ApotexFor profitSYNAug 22, 2007
Aurobindo PharmaFor profitMKTGOct 22, 2004
Aurobindo PharmaFor profitSYNDec 8, 2005
Aurobindo PharmaFor profitSYNDec 8, 2005
Boehringer IngelheimFor profitMKTGJun 19, 2003
Chartwell PharmaceuticalsFor profitMKTGJun 19, 2003
Impax LaboratoriesFor profitMKTGJun 28, 2005
Micro Labs Ltd IndiaFor profitMKTGMay 19, 2026
MylanFor profitMKTGJun 19, 2003
MylanFor profitSYNJun 19, 2003
Novitium PharmaFor profitMKTGFeb 2, 2026
OrganonFor profitNDAJun 14, 1996
OrganonFor profitMKTGJun 14, 1996
OrganonFor profitSYNJan 12, 2001
PHARMOBEDIENTFor profitMKTGJun 19, 2003
Prasco LLCFor profitMKTGJan 18, 2023
Roxane LaboratoriesFor profitMKTGJun 19, 2003
Square PharmaceuticalsFor profitMKTGJun 1, 2017
Square PharmaceuticalsFor profitSYNJun 1, 2017
Sun PharmaceuticalsFor profitMKTGApr 22, 2004
TevaFor profitSYNDec 22, 2003
TevaFor profitMKTGJan 24, 2003
Upsher-Smith LaboratoriesFor profitMKTGJun 19, 2003
Watson PharmaceuticalsFor profitMKTGJun 19, 2003
Zydus Discovery DMCCFor profitMKTGJun 1, 2017