Zoloft
(Sertraline)ApprovedSmall molecule
Sertraline is used to treat depression, anxiety disorders, obsessive-compulsive disorder, and panic disorder by helping to balance chemicals in the brain that affect mood and emotions.[2] Zoloft is currently approved and in use across 36 indications[4].[1]
Zoloft is one of 670 small molecule programs targeting Major Depressive Disorder. It is currently in Approved.
36
Indications
219
Total Trials
13
Active Trials
669
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 36 indications
Competition
Competitive Landscape
255 competitors in Acute Myeloid Leukemia
#DrugCompanyPhaseTrials
1Zoloft
VViatris Specialty LLC
Approved
Idamycin
PfizerPhase 3
Novantrone
PfizerPhase 3
Xospata
AstellasPhase 3
Fludara
SanofiPhase 3
Vanflyta
Daiichi SankyoPhase 3
Neupogen
EEastern Cooperative Oncology Group
Phase 3
Nexavar
BayerPhase 3
Cellcept
RochePhase 3
Busulfex
Akero TherapeuticsPhase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Depression18 trials
Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression
Completed·—·Phase 2/3·NCT00340379·72 enrolled
Effect of Brain Lesion Severity on Treatment Response in Late-Life Depression
Completed·—·N/A·NCT00339066·131 enrolled
Show 15 more trials
Preventing Depression Recurrence in Diabetes
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 4·NCT00374426·262 enrolled
The Research of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression
Not yet recruiting·
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 3·NCT06827431·770 enrolled
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 3·NCT06827431·770 enrolledRiluzole Augmentation Pilot in Depression (RAPID) Trial
Terminated·—·Phase 2·NCT01703039·21 enrolled
Study of the Effect of Antidepressant Drugs on Neurotrophic Factors in Patients With Depression
Completed·—··NCT03126188·105 enrolled
Major Depressive Disorder13 trials
Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure
Recruiting·—·Phase 3·NCT05603104·1,254 enrolled
Show 10 more trials
NMDA Modulation in Major Depressive Disorder
Recruiting·—·Phase 2·NCT04637620·90 enrolled
NMDA Modulation in Major Depressive Disorder in Late- Life
Completed·—·Phase 2·NCT03414931·136 enrolled
Treatment Resistant Depression9 trials
Treatment8 trials
Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)
Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 4·NCT00318773·174 enrolled
Show 5 more trials
Cognitive Processing Therapy vs. Sertraline for the Treatment of PTSD & SUD in Egyptian Patients
Completed·—·Phase 1·NCT03469128·150 enrolled
Post-Traumatic Stress Disorder6 trials
Show 3 more trials
Comparison of Two Treatments for Post-Traumatic Stress Disorder
Completed·—·Phase 3·NCT00127673·200 enrolled
90 more indications
Major Depression6 trials
Show 3 more trials
A Comparison of Sertraline Versus Venlafaxine XR in the Treatment of Major Depression
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00644982·163 enrolled
Social Anxiety Disorder6 trials
Show 3 more trials
Geodon for the Treatment of Refractory Social Anxiety Disorder
Completed·—·Phase 2·NCT00215150·51 enrolled
Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder
Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·N/A·NCT04977544·200 enrolled
Postpartum Depression5 trials
Alcohol Dependence4 trials
Sertraline and Naltrexone for Alcohol Dependence
Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00000440·124 enrolled
Adolescent4 trials
Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
Recruiting·FFirst Affiliated Hospital of Chongqing Medical University·Phase 1/2·NCT05814640·520 enrolled
Show 1 more trial
Anxiety4 trials
Show 1 more trial
Anxiety Disorder3 trials
Fed3 trials
Fasting Conditions3 trials
Combination Therapy3 trials
Mood Disorder3 trials
Antidepressants3 trials
Effectiveness2 trials
Elective2 trials
Heart Disease2 trials
Exercise to Treat Depression in Individuals With Coronary Heart Disease
Completed·—·Phase 3·NCT00302068·101 enrolled
Alzheimer's Disease2 trials
Tics2 trials
Brain Injury2 trials
Bipolar Disorder2 trials
Hypoperfusion2 trials
Obsessive-Compulsive Disorder2 trials
Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder
Terminated·—·Phase 2/3·NCT00299611·12 enrolled
Medication2 trials
Prevention2 trials
Dementia2 trials
Seizure2 trials
Heart Failure2 trials
Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure
Completed·—·Phase 2/3·NCT00078286·469 enrolled
Exercise Training1 trial
Exercise Training Versus Drug Therapy for Treating Depression in Older Adults
Completed·—·Phase 3·NCT00331305·457 enrolled
Generalized Anxiety Disorder1 trial
Burning Mouth Syndrome1 trial
Randomized Controlled Trial1 trial
Necrosis1 trial
Depressed1 trial
Sertraline and Cognitive Therapy in Depressed Alcoholics
Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00000458·100 enrolled
PET1 trial
Oxidative Stress1 trial
Cardiac Repolarization1 trial
Study to Evaluate The Effect Of Sertraline on the Cardiac Repolarization in Healthy Subjects
Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 1·NCT02651623·54 enrolled
Refractory AML1 trial
Sertraline and Cytosine Arabinoside in Adults With Relapsed and Refractory AML
Completed·—·Phase 1·NCT02891278·6 enrolled
Pruritus1 trial
Treatment of Cholestatic Pruritus With Sertraline
Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 2·NCT00058903·40 enrolled
First-line Treatment1 trial
Bipolar Depression1 trial
Cryptococcal Meningitis1 trial
Autism1 trial
Severe Depression1 trial
Lactobacillus Plantarum1 trial
Cohort Study1 trial
Efficacy and Safety1 trial
Efficacy and Safety of Sertraline in the Treatment of Maintenance Hemodialysis Patients With Depression
Completed·FFirst Affiliated Hospital of Chongqing Medical University·Phase 4·NCT06124417·125 enrolled
Glioblastoma1 trial
Gastric Bypass Surgery1 trial
Transcranial Direct Current Stimulation1 trial
Cocaine Dependence1 trial
Volume1 trial
Chronic Obstructive Pulmonary Disease1 trial
Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)
Terminated·—·N/A·NCT02813447·13 enrolled
Overweight1 trial
Metabolism1 trial
Autism Spectrum Disorder1 trial
Cocaine-dependent1 trial
Postnatal Depression1 trial
Trichotillomania1 trial
Coccidioidomycosis1 trial
Adverse Effect1 trial
Unspecified5 trials
Vortioxetine vs Sertraline in Mexicans
Completed·—·Phase 4·NCT03978286·21 enrolled
Show 2 more trials
Sertraline Effect in Uremic Pruritis
Completed·—·Phase 2·NCT05341843·60 enrolled
Regulatory
FDA Approval Timeline[5]
Mar 6, 1996
ZOLOFT
NDA NDA019839
Dec 7, 1999
ZOLOFT
NDA NDA020990
Oct 4, 2021
SERTRALINE HYDROCHLORIDE
NDA NDA215133
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Zoloft drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Sertraline. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Serotonin Transporter Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- VViatris Specialty LLC