sertraline

Trade name: zoloft

Small moleculeapproved

Approved

Dec 30, 1991

Sertraline (trade names Zoloft and others) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. Sertraline is primarily prescribed for major depressive disorder in adult outpatients as well as obsessive-compulsive disorder, panic disorder, and social anxiety disorder, in both adults and children. The exact mechanism of action sertraline is not fully known, but the drug appears to selectively inhibit the reuptake of serotonin at the presynaptic membrane. This results in an increased synaptic concentration of serotonin in the CNS, which leads to numerous functional changes associated with enhanced serotonergic neurotransmission. It is suggested that these modifications are responsible for the antidepressant action observed during long-term administration of antidepressants. It has also been hypothesized that obsessive-compulsive disorder is caused by the dysregulation of serotonin, as it is treated by sertraline, and the drug corrects this imbalance. Compared to other SSRIs, sertraline tends to be associated with a higher rate of psychiatric side effects and diarrhea. It tends to be more activating (that is, associated with a higher rate of anxiety, agitation, insomnia, etc.) than other SSRIs, aside from fluoxetine. Over a two-week treatment of healthy volunteers, sertraline slightly improved verbal fluency but did not affect word learning, short-term memory, vigilance, flicker fusion time, choice reaction time, memory span, or psychomotor coordination. In spite of lower subjective rating, that is, feeling that they performed worse, no clinically relevant differences were observed in the objective cognitive performance in a group of people treated for depression with sertraline for 1.5 years as compared to healthy controls — NCATS

Clinical trial activity

331 trials · 303 clinical orgs · 35 marketing orgs

Phase 1
44
Phase 2
118
Phase 3
67
Phase 4
101

Earliest trial started Sep 1, 1992 (NCT00491478)

Timeline

1990s

  1. Dec 30, 1991

    Pfizer — Earliest FDA Approval

  2. Dec 30, 1991

    Viatris — Marketing Organization

  3. Dec 30, 1991

    Pfizer — NDA Organization

  4. Dec 30, 1991

    Upjohn — Marketing Organization

  5. Dec 30, 1991

    Viatris — NDA Secondary Org

  6. Jan 1, 1992

    Earliest Phase 3 Sponsor(trial)

  7. Jan 1, 1995

    Earliest Phase 2 Sponsor(trial)

  8. Jan 1, 1997

    Earliest Phase 1 Sponsor(trial)

2000s

  1. Jun 30, 2006

    ACI Limited — Marketing Organization

  2. Jun 30, 2006

    Teva — Marketing Organization

  3. Aug 11, 2006

    Heritage Pharma — Marketing Organization

  4. Nov 30, 2006

    Ranbaxy — Marketing Organization

  5. Feb 6, 2007

    Viwit Pharm — Marketing Organization

  6. Feb 6, 2007

    Actavis — Marketing Organization

  7. Feb 6, 2007

    ANDA Repository — Marketing Organization

  8. Feb 6, 2007

    Apotex — Marketing Organization

  9. Feb 6, 2007

    Aurobindo Pharma — Marketing Organization

  10. Feb 6, 2007

    Cadila Healthcare — Marketing Organization

  11. Feb 6, 2007

    Chartwell Pharmaceuticals — Marketing Organization

  12. Feb 6, 2007

    Fosun — Marketing Organization

  13. Feb 6, 2007

    Invagen Pharms — Marketing Organization

  14. Feb 6, 2007

    Lupin — Marketing Organization

  15. Feb 6, 2007

    Mylan — Marketing Organization

  16. Feb 6, 2007

    Pliva — Marketing Organization

  17. Feb 6, 2007

    Sun Pharmaceuticals — Marketing Organization

  18. Feb 6, 2007

    Torrent Pharmaceuticals Limited — Marketing Organization

  19. Feb 6, 2007

    Zydus Discovery DMCC — Marketing Organization

  20. Feb 6, 2007

    Appco Pharma — Marketing Organization

  21. Apr 30, 2007

    Sciegen Pharmaceticals — Marketing Organization

  22. Jan 8, 2008

    Granules India — Marketing Organization

  23. Jan 8, 2008

    Wockhardt — Marketing Organization

  24. Mar 4, 2009

    Reyoung Pharma Co Ltd — Marketing Organization

  25. Mar 4, 2009

    Minsheng Binjiang Pharmaceuticals — Marketing Organization

  26. Mar 4, 2009

    Austarpharma — Marketing Organization

  27. Aug 10, 2009

    Hikma — Marketing Organization

2010s

  1. Jul 21, 2010

    Oxford Pharmaceuticals — Marketing Organization

  2. Nov 7, 2014

    Accord Research — Marketing Organization

2020s

  1. May 3, 2021

    Ascent Pharmahealth — Marketing Organization

  2. May 3, 2021

    AbbVie — Marketing Organization

  3. Oct 4, 2021

    Alvogen — Marketing Organization

  4. Oct 4, 2021

    Alvogen — NDA Secondary Org

Indications

Studied for

Mechanism of action

Approval history

  • approvedDec 30, 1991

Chemistry & pharmacology

Loading structure…

SMILES

CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Mol. weight
306.24 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • (1s,4s)-sertraline
  • (1s,4s)-sertraline
  • (1s-cis)-1,2,3,4-tetrahydro-4-(3,4-dichlorophenyl)-n-methyl-1-naphthalenamine
  • (1s-cis)-1,2,3,4-tetrahydro-4-(3,4-dichlorophenyl)-n-methyl-1-naphthalenamine
  • aremis
  • aremis
  • besitron
  • cis-(+)-sertraline
  • cis-(+)-sertraline
  • cp-519741
  • cp-519741
  • cp-51974-1
  • cp-51974-1
  • lustral
  • lustral
  • sertralina
  • sertralina
  • sertraline
  • sertraline
  • sertraline
  • sertraline
  • sertraline
  • sertraline
  • sertraline
  • sertraline
  • sertraline
  • sertraline
  • (+)-sertraline
  • (+)-sertraline
  • sertraline hcl
  • sertraline hcl
  • sertraline hcl
  • sertraline hydrochloride
  • sertraline hydrochloride
  • sertraline hydrochloride
  • sertraline hydrochloride
  • sertralinum
  • sertralinum
  • zoloft
  • zoloft
  • zoloft
  • zoloft

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06408246Phase 2Feb 1, 2026Stanford University
NCT07139834Phase 1Jan 31, 2026Columbia University
NCT07011693Phase 4Jun 20, 2025Chongqing Medical University
NCT06957223N/AMay 6, 2025CMH Nowshera, Pakistan Army
NCT06957210N/AMay 6, 2025CMH Nowshera, Pakistan Army
NCT06796946Early Phase 1 (Phase 1)Apr 30, 2025University of Huelva
NCT07025590N/AApr 22, 2025Shantou University
NCT06965569Phase 1Apr 21, 2025Alar Pharmaceuticals Inc.
NCT06827431Phase 3Feb 14, 2025Shijiazhuang Pharma Group (CSPC)
NCT06704594Phase 4Dec 1, 2024Johns Hopkins University, National Institute of Mental Health (NIMH)
NCT07192367Phase 4Nov 15, 2024Kocaeli University
NCT06840379N/AOct 15, 2024Nishtar Medical University, Post-Graduate Medical Institute, Lahore
NCT06778824N/AApr 2, 2024Hualien Tzu Chi General Hospital
NCT05973786Phase 4Nov 1, 2023University of Munster, Utrecht University
NCT06081348Phase 2Oct 31, 2023Canadian Institutes of Health Research (CIHR), Dalhousie University, McMaster University, Ontario Brain Institute, Queen's University, Belfast, St. Justine's Hospital, Unity Health Toronto, University of Alberta, University of Calgary, University of Toronto, University of Western Ontario
NCT05892744Phase 4Sep 30, 2023Lehigh University, University of Texas, Austin
NCT05603104Phase 4Aug 1, 2023University of Munster, Utrecht University
NCT05683223N/AJun 1, 2023Boston University, Massachusetts Institute of Technology, Mclean Hospital, National Institute of Mental Health (NIMH)
NCT06358014N/AMay 12, 2023Capital Medical University
NCT05814640Phase 1/Phase 2 (Phase 2)Feb 20, 2023Central South University, Chongqing Medical University, People's Liberation Army of China
Showing 20 of 331 trials
Page 1 / 17

Organizations

Research & Development (303)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Mental Health (NIMH)Government52551995
PfizerFor profit251252000
Columbia UniversityAcademic/Hospital171451997
Duke UniversityAcademic/Hospital131241998
OtsukaFor profit131132004
Harvard UniversityAcademic/Hospital11831999
University of PennsylvaniaAcademic/Hospital11541997
National Institutes of Health (NIH)Government10341992
University of TorontoAcademic/Hospital101051997
Zhejiang UniversityAcademic/Hospital101042010
The University of Texas, DallasAcademic/Hospital9242001
Johnson and JohnsonFor profit7712015
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Government7331999
Vanderbilt UniversityAcademic/Hospital7641997
Department of Veteran AffairsGovernment6422000
Jiao Tong UniversityAcademic/Hospital6632012
University of Sao PauloAcademic/Hospital6632006
Washington University in St. LouisAcademic/Hospital6441998
Nanjing Medical UniversityAcademic/Hospital5432011
National Institute of Neurological Disorders and Stroke (NINDS)Government5131997
303 organizations
Page 1 / 16

Marketing (44)

OrganizationOrg typeRelationshipDate
ACI LimitedFor profitMKTGJun 30, 2006
ACI LimitedFor profitMKTGJun 30, 2006
ANDA RepositoryFor profitMKTGFeb 6, 2007
AbbVieFor profitMKTGMay 3, 2021
Accord ResearchFor profitMKTGNov 7, 2014
ActavisFor profitMKTGFeb 6, 2007
AlvogenFor profitMKTGOct 4, 2021
AlvogenFor profitNDA2Oct 4, 2021
ApotexFor profitMKTGFeb 6, 2007
Appco PharmaFor profitMKTGFeb 6, 2007
Ascent PharmahealthFor profitMKTGMay 3, 2021
Aurobindo PharmaFor profitMKTGFeb 6, 2007
AustarpharmaFor profitMKTGMar 4, 2009
Cadila HealthcareFor profitMKTGFeb 6, 2007
Chartwell PharmaceuticalsFor profitMKTGFeb 6, 2007
FosunFor profitMKTGFeb 6, 2007
Granules IndiaFor profitMKTGJan 8, 2008
Heritage PharmaFor profitSYNAug 11, 2006
Heritage PharmaFor profitMKTGAug 11, 2006
HikmaFor profitMKTGAug 10, 2009
Invagen PharmsFor profitMKTGFeb 6, 2007
LupinFor profitMKTGFeb 6, 2007
Minsheng Binjiang PharmaceuticalsFor profitMKTGMar 4, 2009
MylanFor profitMKTGFeb 6, 2007
MylanFor profitSYNJul 15, 2004
Oxford PharmaceuticalsFor profitMKTGJul 21, 2010
PfizerFor profitNDADec 30, 1991
PfizerFor profitIND
PlivaFor profitMKTGFeb 6, 2007
RanbaxyFor profitMKTGNov 30, 2006
Reyoung Pharma Co LtdFor profitMKTGMar 4, 2009
Sciegen PharmaceticalsFor profitMKTGApr 30, 2007
Sun PharmaceuticalsFor profitMKTGFeb 6, 2007
Sun PharmaceuticalsFor profitSYNFeb 6, 2007
TevaFor profitMKTGJun 30, 2006
TevaFor profitSYNAug 11, 2006
TevaFor profitSYNFeb 6, 2007
Torrent Pharmaceuticals LimitedFor profitMKTGFeb 6, 2007
UpjohnFor profitMKTGDec 30, 1991
ViatrisFor profitMKTGDec 30, 1991
ViatrisFor profitNDA2Dec 30, 1991
Viwit PharmFor profitMKTGFeb 6, 2007
WockhardtFor profitMKTGJan 8, 2008
Zydus Discovery DMCCFor profitMKTGFeb 6, 2007