sertraline
Trade name: zoloft
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
Earliest trial started Sep 1, 1992 (NCT00491478)
Timeline
1990s
- Dec 30, 1991
Pfizer — Earliest FDA Approval
- Dec 30, 1991
Viatris — Marketing Organization
- Dec 30, 1991
Pfizer — NDA Organization
- Dec 30, 1991
Upjohn — Marketing Organization
- Dec 30, 1991
Viatris — NDA Secondary Org
- Jan 1, 1992
Earliest Phase 3 Sponsor(trial)
- Jan 1, 1995
Earliest Phase 2 Sponsor(trial)
- Jan 1, 1997
Earliest Phase 1 Sponsor(trial)
2000s
- Jun 30, 2006
ACI Limited — Marketing Organization
- Jun 30, 2006
Teva — Marketing Organization
- Aug 11, 2006
Heritage Pharma — Marketing Organization
- Nov 30, 2006
Ranbaxy — Marketing Organization
- Feb 6, 2007
Viwit Pharm — Marketing Organization
- Feb 6, 2007
Actavis — Marketing Organization
- Feb 6, 2007
ANDA Repository — Marketing Organization
- Feb 6, 2007
Apotex — Marketing Organization
- Feb 6, 2007
Aurobindo Pharma — Marketing Organization
- Feb 6, 2007
Cadila Healthcare — Marketing Organization
- Feb 6, 2007
Chartwell Pharmaceuticals — Marketing Organization
- Feb 6, 2007
Fosun — Marketing Organization
- Feb 6, 2007
Invagen Pharms — Marketing Organization
- Feb 6, 2007
Lupin — Marketing Organization
- Feb 6, 2007
Mylan — Marketing Organization
- Feb 6, 2007
Pliva — Marketing Organization
- Feb 6, 2007
Sun Pharmaceuticals — Marketing Organization
- Feb 6, 2007
Torrent Pharmaceuticals Limited — Marketing Organization
- Feb 6, 2007
Zydus Discovery DMCC — Marketing Organization
- Feb 6, 2007
Appco Pharma — Marketing Organization
- Apr 30, 2007
Sciegen Pharmaceticals — Marketing Organization
- Jan 8, 2008
Granules India — Marketing Organization
- Jan 8, 2008
Wockhardt — Marketing Organization
- Mar 4, 2009
Reyoung Pharma Co Ltd — Marketing Organization
- Mar 4, 2009
Minsheng Binjiang Pharmaceuticals — Marketing Organization
- Mar 4, 2009
Austarpharma — Marketing Organization
- Aug 10, 2009
Hikma — Marketing Organization
2010s
- Jul 21, 2010
Oxford Pharmaceuticals — Marketing Organization
- Nov 7, 2014
Accord Research — Marketing Organization
2020s
- May 3, 2021
Ascent Pharmahealth — Marketing Organization
- May 3, 2021
AbbVie — Marketing Organization
- Oct 4, 2021
Alvogen — Marketing Organization
- Oct 4, 2021
Alvogen — NDA Secondary Org
Indications
Approved for
Studied for
- 22q11 Deletion Syndrome · Phase 2
- Acute Coronary Syndrome · Phase 1/Phase 2
- Acute Pain · Phase 2
- Adolescent · Phase 2
- Affect · Phase 4
- Agoraphobia · Phase 4
- AIDS-Related Opportunistic Infections · Phase 3
- Alcoholism · Phase 4
- Alzheimer Disease · Phase 4
- Angina, Unstable · Phase 3
- Antidepressive Agents · Early Phase 1
- Anxiety · Phase 4
- Anxiety Disorders · Phase 4
- Anxiety, Separation · Phase 3
- Asthma · Phase 4
- Attention Deficit and Disruptive Behavior Disorders · Phase 2
- Attention Deficit Disorder with Hyperactivity · Phase 2
- Autism Spectrum Disorder · Phase 2
- Autistic Disorder · Phase 3
- Bipolar Disorder · Phase 4
- Bone Diseases · Phase 3
- Brain Injuries, Traumatic · Phase 2/Phase 3
- Burning Mouth Syndrome · Phase 3
- Cardiovascular Diseases · Phase 3
- Chest Pain · Phase 4
- Cocaine-Related Disorders · Phase 2
- Coccidioidomycosis · Phase 2
- Cognition Disorders · Phase 4
- Compulsive Behavior · Phase 3
- Conversion Disorder · Phase 4
- Coronary Artery Disease · Phase 4
- Counseling · Phase 1/Phase 2
- Cryptococcosis · Phase 3
- Cryptococcus · Phase 3
- Dementia · Phase 4
- Deprescriptions · Early Phase 1
- Depression · Phase 4
- Depression, Postpartum · Phase 4
- Depressive Disorder, Treatment-Resistant · Phase 3
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 2 · Phase 4
- Disruptive, Impulse Control, and Conduct Disorders · Phase 4
- Dissociative Disorders · Phase 4
- Dizziness · Phase 1
- Dysthymic Disorder · Phase 4
- Epilepsy · Phase 4
- Fragile X Syndrome · Phase 2
- Gambling · Phase 2
- General Surgery · Phase 3
- Glioblastoma · Phase 1
- Healthy Volunteers · Phase 4
- Heart Diseases · Phase 3
- Heart Failure · Phase 4
- Hepatitis C · Phase 2
- Hepatitis C, Chronic · Phase 1
- HIV Infections · Phase 4
- Huntington Disease · Phase 1
- Hypertension · Phase 4
- Intellectual Disability · Phase 3
- Kidney Failure, Chronic · Phase 3
- Leukemia, Myeloid, Acute · Phase 1
- Liver Cirrhosis, Biliary · Phase 2
- Major Depressive Disorder · Phase 4
- Meningitis, Cryptococcal · Phase 3
- Meningitis, Fungal · Phase 3
- Mental Disorders · Phase 4
- Migraine Disorders · Phase 1
- Mood Disorders · Phase 2/Phase 3
- Mutation · Phase 2
- Myelodysplastic Syndromes · Phase 1
- Myocardial Infarction · Phase 3
- Neoplasms · Phase 3
- Neurodevelopmental Disorders · Phase 2
- Neuroticism · Phase 4
- Obesity · Phase 1
- Obsessive Behavior · Phase 4
- Obsessive-Compulsive Disorder · Phase 4
- Orthostatic Intolerance · Phase 1/Phase 2
- Pain · Phase 4
- Panic Disorder · Phase 4
- Parkinson Disease · Phase 1/Phase 2
- Pediatrics · Phase 2
- Phobia, Social · Phase 4
- Pregnancy · Phase 4
- Premenstrual Dysphoric Disorder · Phase 4
- Premenstrual Syndrome · Phase 4
- Prostatic Neoplasms · Phase 2/Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Pruritus · Phase 2
- Psychological Distress · Phase 4
- Psychophysiologic Disorders · Phase 3
- Schizophrenia · Phase 4
- Seizures · Phase 4
- Self-Injurious Behavior · Phase 3
- Sexual Dysfunction, Physiological · Phase 4
- Sleep Initiation and Maintenance Disorders · Phase 3
- Stereotyped Behavior · Phase 3
- Streptococcus · Phase 2
- Stress Disorders, Post-Traumatic · Phase 4
- Stress Disorders, Traumatic, Acute · Phase 4
- Stroke · Phase 4
- Substance-Related Disorders · Phase 2
- Suicide, Attempted · Phase 2/Phase 3
- Tachycardia · Phase 1/Phase 2
- Tic Disorders · Phase 2
- Tourette Syndrome · Phase 2
- Tuberculosis · Phase 4
- Tuberous Sclerosis · Phase 2
Mechanism of action
- Serotonin transporterINHIBITOR
SLC6A4 inhibitor
reuptake inhibitor
Approval history
- approvedDec 30, 1991
Chemistry & pharmacology
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
Sources
- ChEMBLCHEMBL809 ↗
- WikipediaSertraline ↗
- NCATSQUC7NX6WMB ↗
- ChEMBLCHEMBL1709 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06408246 | Phase 2 | Feb 1, 2026 | Stanford University |
| NCT07139834 | Phase 1 | Jan 31, 2026 | Columbia University |
| NCT07011693 | Phase 4 | Jun 20, 2025 | Chongqing Medical University |
| NCT06957223 | N/A | May 6, 2025 | CMH Nowshera, Pakistan Army |
| NCT06957210 | N/A | May 6, 2025 | CMH Nowshera, Pakistan Army |
| NCT06796946 | Early Phase 1 (Phase 1) | Apr 30, 2025 | University of Huelva |
| NCT07025590 | N/A | Apr 22, 2025 | Shantou University |
| NCT06965569 | Phase 1 | Apr 21, 2025 | Alar Pharmaceuticals Inc. |
| NCT06827431 | Phase 3 | Feb 14, 2025 | Shijiazhuang Pharma Group (CSPC) |
| NCT06704594 | Phase 4 | Dec 1, 2024 | Johns Hopkins University, National Institute of Mental Health (NIMH) |
| NCT07192367 | Phase 4 | Nov 15, 2024 | Kocaeli University |
| NCT06840379 | N/A | Oct 15, 2024 | Nishtar Medical University, Post-Graduate Medical Institute, Lahore |
| NCT06778824 | N/A | Apr 2, 2024 | Hualien Tzu Chi General Hospital |
| NCT05973786 | Phase 4 | Nov 1, 2023 | University of Munster, Utrecht University |
| NCT06081348 | Phase 2 | Oct 31, 2023 | Canadian 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 |
| NCT05892744 | Phase 4 | Sep 30, 2023 | Lehigh University, University of Texas, Austin |
| NCT05603104 | Phase 4 | Aug 1, 2023 | University of Munster, Utrecht University |
| NCT05683223 | N/A | Jun 1, 2023 | Boston University, Massachusetts Institute of Technology, Mclean Hospital, National Institute of Mental Health (NIMH) |
| NCT06358014 | N/A | May 12, 2023 | Capital Medical University |
| NCT05814640 | Phase 1/Phase 2 (Phase 2) | Feb 20, 2023 | Central South University, Chongqing Medical University, People's Liberation Army of China |
Organizations
Research & Development (303)
Marketing (44)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACI Limited | For profit | MKTG | Jun 30, 2006 |
| ACI Limited | For profit | MKTG | Jun 30, 2006 |
| ANDA Repository | For profit | MKTG | Feb 6, 2007 |
| AbbVie | For profit | MKTG | May 3, 2021 |
| Accord Research | For profit | MKTG | Nov 7, 2014 |
| Actavis | For profit | MKTG | Feb 6, 2007 |
| Alvogen | For profit | MKTG | Oct 4, 2021 |
| Alvogen | For profit | NDA2 | Oct 4, 2021 |
| Apotex | For profit | MKTG | Feb 6, 2007 |
| Appco Pharma | For profit | MKTG | Feb 6, 2007 |
| Ascent Pharmahealth | For profit | MKTG | May 3, 2021 |
| Aurobindo Pharma | For profit | MKTG | Feb 6, 2007 |
| Austarpharma | For profit | MKTG | Mar 4, 2009 |
| Cadila Healthcare | For profit | MKTG | Feb 6, 2007 |
| Chartwell Pharmaceuticals | For profit | MKTG | Feb 6, 2007 |
| Fosun | For profit | MKTG | Feb 6, 2007 |
| Granules India | For profit | MKTG | Jan 8, 2008 |
| Heritage Pharma | For profit | SYN | Aug 11, 2006 |
| Heritage Pharma | For profit | MKTG | Aug 11, 2006 |
| Hikma | For profit | MKTG | Aug 10, 2009 |
| Invagen Pharms | For profit | MKTG | Feb 6, 2007 |
| Lupin | For profit | MKTG | Feb 6, 2007 |
| Minsheng Binjiang Pharmaceuticals | For profit | MKTG | Mar 4, 2009 |
| Mylan | For profit | MKTG | Feb 6, 2007 |
| Mylan | For profit | SYN | Jul 15, 2004 |
| Oxford Pharmaceuticals | For profit | MKTG | Jul 21, 2010 |
| Pfizer | For profit | NDA | Dec 30, 1991 |
| Pfizer | For profit | IND | — |
| Pliva | For profit | MKTG | Feb 6, 2007 |
| Ranbaxy | For profit | MKTG | Nov 30, 2006 |
| Reyoung Pharma Co Ltd | For profit | MKTG | Mar 4, 2009 |
| Sciegen Pharmaceticals | For profit | MKTG | Apr 30, 2007 |
| Sun Pharmaceuticals | For profit | MKTG | Feb 6, 2007 |
| Sun Pharmaceuticals | For profit | SYN | Feb 6, 2007 |
| Teva | For profit | MKTG | Jun 30, 2006 |
| Teva | For profit | SYN | Aug 11, 2006 |
| Teva | For profit | SYN | Feb 6, 2007 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Feb 6, 2007 |
| Upjohn | For profit | MKTG | Dec 30, 1991 |
| Viatris | For profit | MKTG | Dec 30, 1991 |
| Viatris | For profit | NDA2 | Dec 30, 1991 |
| Viwit Pharm | For profit | MKTG | Feb 6, 2007 |
| Wockhardt | For profit | MKTG | Jan 8, 2008 |
| Zydus Discovery DMCC | For profit | MKTG | Feb 6, 2007 |