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amitriptyline

Trade name: elavil

Small moleculeapproved

Approved

Apr 7, 1961

Amitriptyline is a derivative of dibenzocycloheptadiene and a tricyclic antidepressant (TCA) and is mainly used to treat symptoms of depression. It works on the central nervous system (CNS) by inhibiting the membrane pump mechanism responsible for uptake of norepinephrine and serotonin in adrenergic and serotonergic neurons. Amitriptyline has been frequently used as an active comparator in clinical trials on newer antidepressants. It is rarely used as a first-line antidepressant nowadays due to its high degree of toxicity in overdose and generally poorer tolerability than the newer antidepressants. — NCATS

Clinical trial activity

99 trials · 127 clinical orgs · 51 marketing orgs

Phase 1
9
Phase 2
43
Phase 3
28
Phase 4
19

Earliest trial started Nov 1, 1994 (NCT00000817)

Timeline

1960s

  1. Apr 7, 1961

    Earliest FDA Approval

  2. Apr 7, 1961

    AstraZeneca — NDA Secondary Org

  3. Jun 1, 1961

    Zeneca Pharmaceuticals — First NDA Organization

  4. Jun 1, 1961

    Zeneca Pharmaceuticals — NDA Organization

  5. Aug 23, 1965

    New River Pharmaceuticals — Marketing Organization

  6. Aug 23, 1965

    New River Pharmaceuticals — NDA Secondary Org

  7. Sep 17, 1969

    Schering — Marketing Organization

  8. Sep 17, 1969

    Schering — NDA Secondary Org

1970s

  1. Nov 16, 1976

    Ani Pharmaceuticals — Marketing Organization

  2. Dec 27, 1976

    Roche — Marketing Organization

  3. May 10, 1977

    Mutual Pharmaceutical — Marketing Organization

  4. Aug 2, 1977

    Teva — Marketing Organization

  5. Sep 29, 1977

    Roxane Laboratories — Marketing Organization

  6. Nov 21, 1977

    Sandoz — Marketing Organization

  7. Dec 23, 1977

    Heritage Pharma — Marketing Organization

  8. Dec 23, 1977

    Chartwell Pharmaceuticals — NDA Secondary Org

  9. Jan 23, 1978

    Boehringer Ingelheim — Marketing Organization

  10. Apr 10, 1978

    Mylan — Marketing Organization

  11. Apr 10, 1978

    Aurobindo Pharma — Marketing Organization

  12. May 11, 1978

    Watson Pharmaceuticals — Marketing Organization

  13. Oct 19, 1978

    Bristol-Myers Squibb — Marketing Organization

1980s

  1. Nov 18, 1981

    Halsey — Marketing Organization

  2. Feb 1, 1982

    Vanguard — Marketing Organization

  3. Feb 10, 1982

    Upsher-Smith Laboratories — Marketing Organization

  4. Mar 15, 1982

    Lederle — Marketing Organization

  5. Mar 15, 1982

    American Cyanamid — Marketing Organization

  6. Sep 26, 1984

    Pliva — Marketing Organization

  7. Mar 5, 1985

    West-Ward Pharmaceutical — Marketing Organization

  8. Dec 10, 1986

    Frontida BioPharm — Marketing Organization

  9. Dec 10, 1986

    ANDA Repository — Marketing Organization

  10. Dec 10, 1986

    UNITED RES LABS — Marketing Organization

  11. Jul 14, 1987

    Sun Pharmaceuticals — Marketing Organization

  12. Nov 27, 1987

    Fosun — Marketing Organization

  13. May 9, 1988

    Par Pharmaceuticals — Marketing Organization

  14. May 9, 1988

    Strides Pharma Science — Marketing Organization

1990s

  1. Oct 17, 1991

    Chartwell Pharmaceuticals — Marketing Organization

  2. Jan 1, 1997

    Earliest Phase 3 Sponsor(trial)

  3. Sep 11, 1997

    Vintage — Marketing Organization

  4. Sep 11, 1997

    Endo Pharmaceuticals — Marketing Organization

  5. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Boehringer Ingelheim — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jun 4, 2014

    Accord Research — Marketing Organization

  2. Oct 6, 2017

    Zydus Discovery DMCC — Marketing Organization

2020s

  1. Apr 7, 2020

    AiPing Pharm Inc — Marketing Organization

  2. Feb 19, 2021

    MannKind Corp — Marketing Organization

  3. Feb 19, 2021

    Mankind Pharma — Marketing Organization

  4. May 19, 2021

    Unichem — Marketing Organization

  5. Feb 2, 2022

    Micro Labs Ltd India — Marketing Organization

  6. Jun 6, 2022

    Esteve Labs — Marketing Organization

  7. Jun 6, 2022

    Leading Pharma Llc — Marketing Organization

  8. May 1, 2023

    Rubicon Research — Marketing Organization

  9. May 19, 2023

    Rising Pharmaceuticals — Marketing Organization

  10. May 19, 2023

    Graviti Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewApr 7, 1961

Chemistry & pharmacology

Loading structure…

SMILES

CN(C)CCC=C1c2ccccc2CCc2ccccc21
Mol. weight
277.41 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral, Parenteral
Availability
Prescription Only

Oral

Yes

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 10,11-dihydro-5-(gamma-dimethylaminopropylidene)-5h-dibenzo(a,d)cycloheptene
  • 10,11-dihydro-5-(gamma-dimethylaminopropylidene)-5h-dibenzo(a,d)cycloheptene
  • 10,11-dihydro-n,n-dimethyl-5h-dibenzo(a,d)heptalene-delta(5),gamma-propylamine
  • 10,11-dihydro-n,n-dimethyl-5h-dibenzo(a,d)heptalene-delta(5),gamma-propylamine
  • 3-(10,11-dihydro-5h-dibenzo(a,d)cyclohepten-5-ylidene)-n,n-dimethyl-1-propanamine
  • 3-(10,11-dihydro-5h-dibenzo(a,d)cyclohepten-5-ylidene)-n,n-dimethyl-1-propanamine
  • 3-(10,11-dihydro-5h-dibenzo[a,d]cyclohepten-5-ylidene)-n,n-dimethylpropan-1-amine
  • 3-(10,11-dihydro-5h-dibenzo[a,d]cyclohepten-5-ylidene)-n,n-dimethylpropan-1-amine
  • 5-(3-dimethylaminopropylidene)-10,11-dihydro-5h-dibenzo(a,d)cycloheptatriene
  • 5-(3-dimethylaminopropylidene)-10,11-dihydro-5h-dibenzo(a,d)cycloheptatriene
  • 5-(3-dimethylaminopropylidene)-10,11-dihydro-5h-dibenzo(a,d)cycloheptene
  • 5-(3-dimethylaminopropylidene)-10,11-dihydro-5h-dibenzo(a,d)cycloheptene
  • 5-(gamma-dimethylaminopropylidene)-5h-dibenzo[a,d][1,4]cycloheptadiene
  • 5-(gamma-dimethylaminopropylidene)-5h-dibenzo[a,d][1,4]cycloheptadiene
  • amitid
  • amitid
  • amitril
  • amitril
  • amitriprolidine
  • amitriptilina
  • amitriptilina
  • amitriptylin
  • amitriptylin
  • amitriptylin
  • amitriptylin
  • amitriptyline
  • amitriptyline
  • amitriptyline
  • amitriptyline
  • amitriptyline
  • amitriptyline
  • amitriptyline
  • amitriptyline
  • amitriptyline
  • amitriptyline
  • amitriptyline - chlordiazepoxide
  • amitriptyline, chlordiazepoxide drug combination
  • amitriptyline hcl
  • amitriptyline hcl
  • amitriptyline hcl
  • amitriptyline hydrochloride
  • amitriptyline hydrochloride
  • amitriptyline hydrochloride
  • amitriptyline hydrochloride
  • amitriptyline hydrochloride
  • amitriptyline hydrochloride, chlordiazepoxide drug combination
  • amitriptylinum
  • amitriptylinum
  • amitryptaline
  • amitryptiline
  • amitryptiline
  • amitryptiline
  • amitryptiline hcl
  • amitryptiline hydrochloride
  • cytriptyline
  • damitriptyline
  • domical
  • domical
  • elavil
  • elavil
  • elavil
  • endep
  • endep
  • etrafon-a
  • etrafon-forte
  • lentizol
  • lentizol
  • limbitrol
  • limbitrol
  • limbitrol
  • limbitrol 5
  • limbritol
  • rellidep
  • saroten
  • saroten
  • saroten retard
  • saroten retard
  • triptafen
  • triptafen
  • triptafen-m
  • tryptizol
  • tryptizol
  • tryptizol-75

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07008235Phase 2/Phase 3 (Phase 3)Jul 1, 2025Dhaka Medical College
NCT06499116Phase 4Oct 31, 2024Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Institut Català de la Salut, University of Barcelona
NCT06245564N/AAug 20, 2024Aalborg University
NCT06417684Early Phase 1 (Phase 1)Jun 19, 2024Vanderbilt University
NCT06301061N/AApr 1, 2024University of Naples Frederico II
NCT06312813Phase 2Feb 27, 2024Wright State University
NCT06162819N/AJan 1, 2024Shalamar Institute of Health Sciences
NCT06091553Phase 2Oct 20, 2023Beni Suef University
NCT05889624N/AAug 22, 2023Patient-Centered Outcomes Research Institute, University of Cincinnati
NCT06158230Phase 2Mar 19, 2023Bangladesh Medical University
NCT05593614Phase 2Dec 31, 2022AlgoTherapeutix
NCT05646693Phase 2Dec 1, 2022University of Guadalajara
NCT05759845Phase 4Aug 22, 2022Dhaka Medical College
NCT05279963N/AMar 16, 2022Zhejiang University
NCT05120934Phase 2Nov 1, 2021Mayo Clinic
NCT05110144Phase 2Nov 1, 2021Mayo Clinic
NCT04725383Phase 3Jun 1, 2021University of Missouri, Kansas City
NCT04704453Phase 2Apr 28, 2021University of Toulouse
NCT04750967N/AApr 3, 2021Dr. Lutfi Kirdar Kartal Training and Research Hospital
NCT04777838Phase 2/Phase 3 (Phase 3)Mar 31, 2021University of Coimbra, University of Salamanca
Showing 20 of 99 trials
Page 1 / 5

Organizations

Research & Development (127)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of WashingtonAcademic/Hospital5121996
Mayo ClinicAcademic/Hospital4322006
National Institutes of Health (NIH)Government4221996
University of CincinnatiAcademic/Hospital4432006
University of RochesterAcademic/Hospital4222007
Aalborg UniversityAcademic/Hospital3122014
National Institute of Neurological Disorders and Stroke (NINDS)Government3022006
American Laryngological AssociationAcademic/Hospital2012013
AstraZenecaFor profit2122006
Boehringer IngelheimFor profit2121999
Boston UniversityAcademic/Hospital2212013
Dhaka Medical CollegeAcademic/Hospital2222022
EpiCept CorporationFor profit2212007
Federal University of Rio Grande do SulAcademic/Hospital2222010
Ludwig Maximilians UniversityAcademic/Hospital2012014
McMaster UniversityAcademic/Hospital2012006
National Cancer Institute (NCI)Government2112007
National Center for Complementary and Integrative Health (NCCIH)Government2122002
National Institute of Allergy and Infectious Diseases (NIAID)Government2221994
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government2112005
127 organizations
Page 1 / 7

Marketing (60)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGDec 10, 1986
Accord ResearchFor profitMKTGJun 4, 2014
AiPing Pharm IncFor profitMKTGApr 7, 2020
Am TherapFor profitMKTG—
American CyanamidFor profitMKTGMar 15, 1982
Ani PharmaceuticalsFor profitMKTGNov 16, 1976
Ani PharmaceuticalsFor profitSYNNov 16, 1976
AstraZenecaFor profitNDA2Apr 7, 1961
Aurobindo PharmaFor profitMKTGApr 10, 1978
Boehringer IngelheimFor profitMKTGJan 23, 1978
Bristol-Myers SquibbFor profitMKTGOct 19, 1978
Chartwell PharmaceuticalsFor profitNDA2Dec 23, 1977
Chartwell PharmaceuticalsFor profitMKTGOct 17, 1991
Copley PharmaceuticalsFor profitMKTG—
Endo PharmaceuticalsFor profitMKTGSep 11, 1997
Esteve LabsFor profitMKTGJun 6, 2022
FosunFor profitMKTGNov 27, 1987
Frontida BioPharmFor profitMKTGDec 10, 1986
Graviti PharmaceuticalsFor profitMKTGMay 19, 2023
HalseyFor profitMKTGNov 18, 1981
Heritage PharmaFor profitMKTGDec 23, 1977
Heritage PharmaFor profitSYNDec 16, 1988
Leading Pharma LlcFor profitMKTGJun 6, 2022
LederleFor profitMKTGMar 15, 1982
Mankind PharmaFor profitMKTGFeb 19, 2021
MannKind CorpFor profitMKTGFeb 19, 2021
Micro Labs Ltd IndiaFor profitMKTGFeb 2, 2022
Mutual PharmaceuticalFor profitMKTGMay 10, 1977
MylanFor profitMKTGApr 10, 1978
MylanFor profitSYNDec 10, 1986
New River PharmaceuticalsFor profitMKTGAug 23, 1965
New River PharmaceuticalsFor profitNDA2Aug 23, 1965
Par PharmaceuticalsFor profitMKTGMay 9, 1988
PlivaFor profitMKTGSep 26, 1984
Puracap PharmaceuticalFor profitMKTG—
Rising PharmaceuticalsFor profitMKTGMay 19, 2023
RocheFor profitMKTGDec 27, 1976
Roxane LaboratoriesFor profitMKTGSep 29, 1977
Rubicon ResearchFor profitMKTGMay 1, 2023
SandozFor profitMKTGNov 21, 1977
ScheringFor profitMKTGSep 17, 1969
ScheringFor profitNDA2Sep 17, 1969
Strides Pharma ScienceFor profitMKTGMay 9, 1988
Sun PharmaceuticalsFor profitMKTGJul 14, 1987
Sun PharmaceuticalsFor profitSYNNov 12, 1986
SuperpharmFor profitMKTG—
TevaFor profitMKTGAug 2, 1977
TevaFor profitSYNDec 16, 1988
UCBFor profitMKTG—
UNITED RES LABSFor profitMKTGDec 10, 1986
UnichemFor profitMKTGMay 19, 2021
Upsher-Smith LaboratoriesFor profitMKTGFeb 10, 1982
Upsher-Smith LaboratoriesFor profitSYNApr 7, 2020
VanguardFor profitMKTGFeb 1, 1982
VintageFor profitMKTGSep 11, 1997
Warner ChilcottFor profitMKTG—
Watson PharmaceuticalsFor profitMKTGMay 11, 1978
West-Ward PharmaceuticalFor profitMKTGMar 5, 1985
Zeneca PharmaceuticalsFor profitNDAJun 1, 1961
Zydus Discovery DMCCFor profitMKTGOct 6, 2017