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 52 indications[4].[1]

Zoloft is one of 1030 small molecule programs targeting Coccidioidomycosis. It is currently in Approved.

Indications

218

Total Trials

Active Trials

1,029

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

CoccidioidomycosisActive, not recruiting

Cryptococcal MeningitisActive, not recruiting

Depressive DisorderActive, not recruiting

MelancholiaActive, not recruiting

Premenstrual TensionApproved

Mood DisorderApproved

SuicideActive, not recruiting

StrokeActive, not recruiting

Orthostatic IntoleranceActive, not recruiting

Phobic DisorderActive, not recruiting

CoccidioidomycosisPhase 2

Active, not recruiting

Cryptococcal MeningitisPhase 3

Active, not recruiting

Depressive DisorderApproved

Active, not recruiting

MelancholiaApproved

Active, not recruiting

Premenstrual TensionApproved

Approved

Mood DisorderApproved

Approved

SuicidePhase 2/Phase 3

Active, not recruiting

StrokeApproved

Active, not recruiting

Orthostatic IntolerancePhase 1/Phase 2

Active, not recruiting

Phobic DisorderPreclinical

Active, not recruiting

Showing 10 of 51 indications

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Zoloft

VViatris Specialty LLC

Idamycin

62 3

Neupogen

EEastern Cooperative Oncology Group

Phase 3

31 4

Clolar

GGenzyme, a Sanofi Company

Phase 3

21 5

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Phase 3

1 6

Diflucan

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Phase 3

1 7

Dalalone

CCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Phase 3

1 8

Lenograstim

Sanofi

Phase 3

1 9

Caspofungin Acetate

Merck & Co.

Phase 3

1 10

Experimental

Biogen

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 2Recruiting

Anxiety

NCT06081348

Post-ApprovalRecruiting

Social Anxiety Disorder

NCT04221997

Phase 3Not yet recruiting

Depression

NCT06827431

Q4 2026

Phase 2Recruiting

Major Depressive Disorder

NCT04637620

Q2 2027

N/ARecruiting

Anxiety

NCT05683223

Q3 2027

Phase 1/2Recruiting

Adolescent

NCT05814640

Clinical

Trials by Indication[1]

Depression20 trials

Riluzole Augmentation Pilot in Depression (RAPID) Trial

Terminated·—·Phase 2·NCT01703039·21 enrolled

The Research of Ammoxetine Hydrochloride Enteric-coated Tablets in Subjects With Depression

Not yet recruiting· CSPC ZhongQi Pharmaceutical Technology Co., Ltd. logo

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.·Phase 3·NCT06827431·770 enrolled

Integral Assessment in Unipolar Depression

Unknown status·UUniversity of Sao Paulo·Phase 4·NCT02268487·100 enrolled

Show 17 more trials

Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care for Depression

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT01407094·296 enrolled

Seroquel Alone Versus Seroquel With an SSRI for Depression With Psychotic Symptoms

Terminated·MMassachusetts General Hospital·Phase 4·NCT00955474·32 enrolled

Treatments for Depression: Drug Versus Psychotherapy

Completed·UUniversity of Pennsylvania·Phase 3·NCT00043550·156 enrolled

Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.

Completed·HHadassah Medical Organization·Phase 3·NCT00158990·220 enrolled

International Study to Predict Optimised Treatment - in Depression

Unknown status·BBRC Operations Pty. Ltd.·Phase 4·NCT00693849·2,688 enrolled

Depression Care Management for Depressed Elders in China Primary Care

Unknown status·ZZhejiang University·Phase 4·NCT01287494·320 enrolled

Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

Completed·—·Phase 2/3·NCT00340379·72 enrolled

Study for Evaluating Different Methods of Measuring Depression Treatment Response

Completed· Pfizer logo

Pfizer·N/A·NCT00406952·165 enrolled

Sequenced Treatment Alternatives to Relieve Depression (STAR*D)

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00021528·4,000 enrolled

ACE-D Aim 3 Clinical Cognitive Trial to Enhance Translation in Depression

Recruiting·SStanford University·Phase 2·NCT06408246·162 enrolled

Effect of Brain Lesion Severity on Treatment Response in Late-Life Depression

Completed·—·N/A·NCT00339066·131 enrolled

Bipolar II Depression: Lithium, SSRI, or the Combination

Completed·LLindner Center of HOPE·Phase 3·NCT00276965·139 enrolled

Study of the Effect of Antidepressant Drugs on Neurotrophic Factors in Patients With Depression

Completed·—··NCT03126188·105 enrolled

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

Recruiting·UUniversity of Texas at Austin·Phase 4·NCT05892744·50 enrolled

Personalized Sertraline Dosing in Patients With Depression

Unknown status·UUniversity of Belgrade··NCT05210153·148 enrolled

Study of Pharmacotherapy of Psychotic Depression

Completed·WWeill Medical College of Cornell University·Phase 3·NCT00056472·259 enrolled

Preventing Depression Recurrence in Diabetes

Completed·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·Phase 4·NCT00374426·262 enrolled

Major Depressive Disorder14 trials

Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)

Completed· Otsuka logo

Otsuka·Phase 3·NCT01360866·2,944 enrolled

Algorithm Guided Treatment Strategies for Major Depressive Disorder

Unknown status·SShanghai Mental Health Center·Phase 4·NCT01764867·1,080 enrolled

Efficacy Study of Transcranial Direct Current Stimulation to Treat Major Depressive Disorder

Completed·UUniversity of Sao Paulo·Phase 2/3·NCT01033084·120 enrolled

Show 11 more trials

A New Treatment Approach for Major Depressive Disorder Based Upon Targeting Monoamine Oxidase A (MAO-A)

Completed·CCentre for Addiction and Mental Health·Phase 1·NCT02269540·10 enrolled

A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder

Completed· Biogen logo

Biogen·Phase 3·NCT04476030·440 enrolled

Multicentre Trial to Evaluate the Safety and Efficacy of CP-316,311 in Major Depressive Disorder

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00143091·200 enrolled

A Research Study to Compare the Treatments of a Combination of Elzasonan With Zoloft, to Zoloft Alone, or Placebo in People With Major Depressive Disorder (MDD)

Completed· Pfizer logo

Pfizer·Phase 2·NCT00275197·262 enrolled

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure

Recruiting·—·Phase 3·NCT05603104·1,254 enrolled

Rhodiola Rosea Therapy of Major Depressive Disorder

Completed·UUniversity of Pennsylvania·Phase 3·NCT01098318·58 enrolled

Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder

Completed·KKRL Hospital, Islamabad·Phase 3·NCT05950061·744 enrolled

NMDA Modulation in Major Depressive Disorder

Recruiting·—·Phase 2·NCT04637620·90 enrolled

Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00351910·494 enrolled

Analisis of Facors Involved in Antidepressant Treatment Response of Major Depressive Disorder

Completed·SShowa University·N/A·NCT01454635·96 enrolled

NMDA Modulation in Major Depressive Disorder in Late- Life

Completed·—·Phase 2·NCT03414931·136 enrolled

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

Combined Treatment for Alcohol-Dependent Individuals With PTSD

Completed·NNew York State Psychiatric Institute·Phase 2·NCT00262223·69 enrolled

Antidepressant Treatment for Premenstrual Syndrome and Premenstrual Dysphoric Disorder

Completed·YYale University·Phase 1/2·NCT00048854·66 enrolled

Show 5 more trials

Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial

Completed·RResearch Foundation for Mental Hygiene, Inc.·Phase 4·NCT01178671·38 enrolled

SMART Trial to Predict Anhedonia Response to Antidepressant Treatment

Completed·MMclean Hospital·Phase 4·NCT05537584·133 enrolled

The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy

Completed·CCharlotte Sonne·Phase 4·NCT01569685·207 enrolled

Cognitive Processing Therapy vs. Sertraline for the Treatment of PTSD & SUD in Egyptian Patients

Completed·—·Phase 1·NCT03469128·150 enrolled

Psychiatric Orders in Psychoanalytic Treatment of ASD

Unknown status·YYang I. Pachankis, PhD··NCT05930912·1 enrolled

Anxiety6 trials

Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Completed·SShiraz University of Medical Sciences·Phase 2/3·NCT02565316·70 enrolled

Neural Markers of Treatment Mechanisms and Prediction of Treatment Outcomes in Social Anxiety

Recruiting·—·N/A·NCT05683223·240 enrolled

Trial of Sertraline Versus Cognitive Behaviour Therapy for Generalised Anxiety

Terminated·UUniversity College, London·Phase 4·NCT02347033·5 enrolled

Show 3 more trials

Specifying and Treating Anxiety in Autism Research

Completed·UUniversity of California, Davis·Phase 2·NCT03279471·68 enrolled

Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders

Recruiting·HHolland Bloorview Kids Rehabilitation Hospital·Phase 2·NCT06081348·130 enrolled

Sequencing CBT for Child Anxiety: CBT Plus Sertraline Versus Switch to Sertraline

Terminated·YYale University·Phase 2·NCT01977729·1 enrolled

Postpartum Depression5 trials

Treatment of Postpartum Depression With Psychotherapy and Add-on Sertraline

Completed·TTel-Aviv Sourasky Medical Center·N/A·NCT01028482·42 enrolled

Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression

Terminated·TThe Cooper Health System·N/A·NCT02235064·2 enrolled

Postpartum Depression: Transdermal Estradiol Versus Sertraline

Terminated·NNorthwestern University·Phase 4·NCT00744328·85 enrolled

Show 2 more trials

Sertraline for the Prevention of Recurrent Postpartum Depression

Completed·UUniversity of Pittsburgh·Phase 3·NCT00276900·300 enrolled

Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression

Completed·WWomen and Infants Hospital of Rhode Island·Phase 2·NCT00602355·162 enrolled

95 more indications

Post-Traumatic Stress Disorder5 trials

Serotonin Selective Reuptake Inhibitor Treatment of Dual Diagnosis Post-traumatic Stress Disorder and Alcohol Problems

Completed·TThe University of Texas Health Science Center at San Antonio·Phase 4·NCT02504931·49 enrolled

Comparison of Two Treatments for Post-Traumatic Stress Disorder

Completed·—·Phase 3·NCT00127673·200 enrolled

A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder (PTSD)

Completed· Otsuka logo

Otsuka·Phase 2·NCT03033069·336 enrolled

Show 2 more trials

Brexpiprazole as Combination Therapy With Sertraline in the Treatment of Adults With Post-traumatic Stress Disorder

Completed· Otsuka logo

Otsuka·Phase 3·NCT04174170·591 enrolled

Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder

Terminated·NNYU Langone Health·Phase 4·NCT00391430·39 enrolled

Major Depression5 trials

Treatment of Major Depression With St. John's Wort (Hypericum)

Completed·NNational Institute of Mental Health (NIMH)·N/A·NCT00005013

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

Cost- Effectiveness and Quality of Life Assessment in Major Depression Disorder

Completed·FFederal University of Rio Grande do Sul·Phase 4·NCT02901249·68 enrolled

Show 2 more trials

fMRI Study of Treatment Changes in Major Depression

Completed·WWashington University School of Medicine·N/A·NCT01027559·97 enrolled

Thyroid Medication and Antidepressants for Treating Major Depression

Completed·EEmory University·Phase 4·NCT00208702·153 enrolled

Social Anxiety Disorder5 trials

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

Geodon for the Treatment of Refractory Social Anxiety Disorder

Completed·—·Phase 2·NCT00215150·51 enrolled

Trial With the Treatment of Sertraline in Youth With Generalized, Separation and/or Social Anxiety Disorders.

Recruiting·UUniversity of Cincinnati·Phase 4·NCT04221997·150 enrolled

Show 2 more trials

Improving Treatment Outcomes in Pharmacotherapy of Generalized Social Anxiety Disorder

Completed·MMassachusetts General Hospital·Phase 4·NCT00282828·397 enrolled

Identifying Brain and Genetic Markers of Sertraline Treatment Response in People With Social Anxiety Disorder

Completed·UUniversity of Michigan··NCT00872131·200 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

Effects of Sertraline on Brain Connectivity in Adolescents With OCD

Completed·UUniversity of Minnesota·Phase 1/2·NCT02797808·41 enrolled

Maintenance Study for Adolescent Depression

Completed·SSunnybrook Health Sciences Centre·Phase 4·NCT00508859·93 enrolled

Show 1 more trial

Switching Medication and Augmentation Strategies for SSRI-Resistant Adolescent Depression（SMART-I)

Not yet recruiting·XXinyu Zhou·Phase 4·NCT07011693·400 enrolled

Treatment Resistant Depression4 trials

Interpersonal Psychotherapy for Treatment Resistant Depression

Unknown status·HHospital de Clinicas de Porto Alegre·N/A·NCT01896349·74 enrolled

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Withdrawn· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03852160

A Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03434041·252 enrolled

Show 1 more trial

A Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02497287·802 enrolled

Dementia3 trials

CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia

Completed·CCentre for Addiction and Mental Health·N/A·NCT02955719·145 enrolled

Dementia Antipsychotics And Antidepressants Discontinuation Study

Completed·SSykehuset Innlandet HF·Phase 4·NCT00594269·149 enrolled

Sertraline for the Treatment of Patients With Frontal Lobe Dementia (FLD)

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT00001777·30 enrolled

Mood Disorder3 trials

Sertraline in Generalized Social Phobia With Co-Occurring Anxiety and Mood Disorders

Terminated·HHamilton Health Sciences Corporation·Phase 4·NCT00182533·170 enrolled

Dynamic Measures of Neurochemistry in Mood Disorders

Completed·VVanderbilt University Medical Center·Phase 4·NCT00178828·42 enrolled

Treatment Strategy to Prevent Mood Disorders Following Traumatic Brain Injury

Completed·—·Phase 2/3·NCT00704379·94 enrolled

Combination Therapy3 trials

Combination Therapy in Patients With Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00485862·214 enrolled

Brexpiprazole as Combination Therapy With Sertraline in Treatment of Adults With PTSD

Completed· Otsuka logo

Otsuka·Phase 3·NCT04124614·450 enrolled

A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 2·NCT00636246·510 enrolled

Antidepressants3 trials

The Outcome of Treatment of Traumatised Refugees With Psychotherapy and/or Antidepressants

Completed·CCaecilie Buhmann·Phase 4·NCT00917397·280 enrolled

Antidepressants and Bone Mineral Density

Completed·GGuiyang Medical University·Phase 3·NCT02179268·203 enrolled

Strategic Use of New Generation Antidepressants for Depression

Completed·KKyoto University·Phase 4·NCT01109693·2,011 enrolled

Fasting Conditions3 trials

Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg Under Fasting Conditions

Completed·—·Phase 1·NCT01267396·32 enrolled

Bioequivalence Study of Sertraline 100 mg Tablet and ZOLOFT Following a 100 mg Dose in Healthy Subjects Under Fasting Conditions

Completed·TTorrent Pharmaceuticals Limited·Phase 1·NCT00944242

Bioequivalency Study of Sertraline Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00602849·38 enrolled

Obsessive-Compulsive Disorder3 trials

Treatment of Obsessive-Compulsive Disorder (OCD) in Children

Completed·UUniversity of Pennsylvania·Phase 3·NCT00000384

Sertraline Combined With Fluvoxamine in the Treatment of Refractory Obsessive-compulsive Disorder

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 4·NCT04963257·400 enrolled

Augmentation Study of Levetiracetam in Obsessive Compulsive Disorder

Terminated·—·Phase 2/3·NCT00299611·12 enrolled

Anxiety Disorder3 trials

Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents

Completed·UUniversity of Michigan··NCT01160588·156 enrolled

Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep

Terminated·NNew York State Psychiatric Institute·N/A·NCT02189213·14 enrolled

Child and Adolescent Anxiety Disorders (CAMS)

Completed·JJohns Hopkins University·Phase 3·NCT00052078·488 enrolled

Heart Failure2 trials

Antidepressant Medication Treatment for Depression in Individuals With Chronic Heart Failure

Completed·—·Phase 2/3·NCT00078286·469 enrolled

Vascular Effects of Sertraline in Heart Failure

Terminated·YYale University··NCT00585455·4 enrolled

Stress2 trials

Stress & Premenstrual Symptoms Study

Completed·JJohns Hopkins University·Phase 4·NCT02777372·84 enrolled

Evaluation of Stress Disorders

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00050804·80 enrolled

Prevention2 trials

Efficacy of Exposure and Response Prevention(ERP) and SSRIs in Chinese OCD Patients

Completed·SShanghai Mental Health Center·Phase 4·NCT02022709·78 enrolled

PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims

Terminated·UUniversity of Utah·Phase 4·NCT02520726·5 enrolled

Insomnia2 trials

Study Of Indiplon/Placebo With Sertraline In Insomnia Co-Existing With Depression

Terminated· Neurocrine Biosciences logo

Neurocrine Biosciences·Phase 3·NCT00232167·380 enrolled

An 8-week, Open-label Study to Evaluate the Effect of Sertraline on Polysomnogram in Depressive Patients With Insomnia

Completed·GGuang Dong Provincial Mental Health Institute·N/A·NCT01032434·31 enrolled

Brain Injury2 trials

Treatment of Post-Traumatic Brain Injury (TBI) Depression

Completed·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT00233103·52 enrolled

Sertraline vs. Placebo for Symptoms Following Traumatic Brain Injury

Unknown status·WWalter Reed Army Medical Center·N/A·NCT00208585·100 enrolled

Fed2 trials

Bioequivalency Study of Sertraline Under Fed Conditions

Completed·RRoxane Laboratories·N/A·NCT00601588·43 enrolled

Bioequivalence Study of Sertraline Hydrochloride Tablets 100 mg in Fed Conditions

Completed·—·Phase 1·NCT01267383·32 enrolled

Bipolar Disorder2 trials

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Cost- Effectiveness and Quality of Life Assessment in Bipolar Disorder Depressive Episode

Completed·FFederal University of Rio Grande do Sul·Phase 4·NCT02918097·78 enrolled

Tics2 trials

Study of Drug Combination on Pharmacokinetics in Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT02175602·41 enrolled

Pharmacokinetics and Pharmacodynamics of Sertraline After Low Dose Administration

Completed·SSeoul National University Hospital·Phase 4·NCT00969852·10 enrolled

Alcohol Dependence2 trials

Effectiveness of Sertraline in Treating Pathological Gamblers With a Diagnosis of Alcohol Dependence - 1

Terminated·NNew York State Psychiatric Institute·Phase 2·NCT00249431·9 enrolled

Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)

Completed·YYale University·Phase 2·NCT00000451·198 enrolled

Epilepsy2 trials

Depression and Health Outcomes in Refractory Epilepsy

Completed·—·Phase 3·NCT00026637·140 enrolled

Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline

Withdrawn·RRush University Medical Center·Phase 4·NCT01309074

Panic Disorder2 trials

A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00677352·321 enrolled

Therapies for Treatment-Resistant Panic Disorder Symptoms

Completed·MMassachusetts General Hospital·Phase 2/3·NCT00118417·46 enrolled

Hypoperfusion2 trials

Frontal Hypoperfusion Effects on Antidepressant Outcomes in Late-Life Depression

Completed·VVanderbilt University·Phase 4·NCT01896934·31 enrolled

Effects of Cerebral Hypoperfusion and Its Reversal on Late-Life Depression

Terminated·VVanderbilt University·Phase 4·NCT01794455·1 enrolled

Seizure2 trials

Treatment Trial for Psychogenic Nonepileptic Seizures

Completed·RRhode Island Hospital·Phase 4·NCT00835627·38 enrolled

Treatments for Psychogenic Nonepileptic Seizures (NES)

Completed·RRhode Island Hospital·Phase 4·NCT00159965·38 enrolled

Medication2 trials

Brain Activity Changes and Treatment Response in Depressed People Who Are Receiving Antidepressant Medication

Completed·NNational Institute of Mental Health (NIMH)·Phase 4·NCT00375843·118 enrolled

Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene

Unknown status·HHolsboerMaschmeyer NeuroChemie GmbH·Phase 4·NCT02237937·80 enrolled

Cerebral Perfusion2 trials

Late-life Depression and Cerebral Perfusion

Withdrawn·VVanderbilt University·N/A·NCT01751828

The Effect of Problem Solving Therapy and Antidepressant Therapy on Cerebral Perfusion and Brain Derived Neurotropic Factor (BDNF) in Depressed Elders

Completed·UUniversity of California, San Francisco·N/A·NCT01305889·19 enrolled

Effectiveness2 trials

Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder

Completed·YYale University·Phase 4·NCT00536198·252 enrolled

Acute Effectiveness of Additional Drugs to the Standard Treatment of Depression

Completed·NNational Institute of Mental Health (NIMH)·Phase 2·NCT00001483·75 enrolled

ALS1 trial

Modulation of Visually Evoked Potentials by an Antidepressant

Completed·UUniversity Hospital Freiburg·N/A·NCT00263133·12 enrolled

Pediatric1 trial

Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.··NCT01302080·941 enrolled

First-line Treatment1 trial

The Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Recruiting·—·Phase 3·NCT05973786·418 enrolled

Elective1 trial

Vortioxetine in the Elderly vs. Selective Serotonin Reuptake Inhibitors (SSRIs): a Pragmatic Assessment

Completed·AAzienda Ospedaliera Universitaria Integrata Verona·Phase 4·NCT03779789·362 enrolled

Heart Disease1 trial

Exercise to Treat Depression in Individuals With Coronary Heart Disease

Completed·—·Phase 3·NCT00302068·101 enrolled

Chronic Kidney Disease1 trial

Chronic Kidney Disease Antidepressant Sertraline Trial

Completed·VVA Office of Research and Development·Phase 3·NCT00946998·201 enrolled

Aging1 trial

Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram

Withdrawn·AAlto Neuroscience·Phase 4·NCT04388202

Volume1 trial

Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients

Unknown status·HHospital Universitario Dr. Jose E. Gonzalez·N/A·NCT04430556·30 enrolled

MPR1 trial

Improving Retention of Hispanics Receiving Antidepressant Therapy

Completed·NNew York State Psychiatric Institute·N/A·NCT00057642·50 enrolled

Fragile X Syndrome1 trial

Trial of Sertraline to Treat Children With Fragile X Syndrome

Completed·RRandi J. Hagerman, MD·Phase 2·NCT01474746·57 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Safety of Anti-Depressant for Chronic Obstructive Pulmonary Disease (SAD-COPD)

Terminated·—·N/A·NCT02813447·13 enrolled

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

Parkinson's Disease1 trial

The Effects of Sertraline on Depression in Parkinson's Disease

Completed·ZZhejiang University·N/A·NCT01437189·35 enrolled

Refractory AML1 trial

Sertraline and Cytosine Arabinoside in Adults With Relapsed and Refractory AML

Completed·—·Phase 1·NCT02891278·6 enrolled

Bipolar Depression1 trial

Quetiapine XR Versus Sertraline in Acute Bipolar Depression as add-on Therapy

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT00857584·27 enrolled

Trial1 trial

Flushes and Sertraline Trial

Completed·UUniversity of California, San Francisco·N/A·NCT00283192·100 enrolled

Cryptococcal Meningitis1 trial

Adjunctive Sertraline for the Treatment of HIV-Associated Cryptococcal Meningitis

Completed·UUniversity of Minnesota·Phase 3·NCT01802385·460 enrolled

Autism1 trial

Fluvoxamine and Sertraline in Childhood Autism - Does SSRI Therapy Improve Behaviour and/or Mood?

Completed·TThe Hospital for Sick Children·Phase 3·NCT00655174·108 enrolled

Severe Depression1 trial

A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00666757·750 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

Melancholia1 trial

Antidepressant Treatment of Melancholia in Late Life

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00000378·110 enrolled

PTSD1 trial

A Study of Sertraline to Prevent PTSD

Completed·MMassachusetts General Hospital·Phase 4·NCT00182078·26 enrolled

Necrosis1 trial

Acute Myocardial Necrosis and Depression: Antiplatelet Effect of Reuptake Inhibition of Serotonin

Terminated·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT02463110·2 enrolled

Quality of Life1 trial

Treatment of Diabetes and Depression in Hispanics and African Americans and Its Effect on A1c and Quality of Life.

Completed·—·Phase 4·NCT00624013·89 enrolled

Stroke1 trial

Sertraline for Preventing Post-stroke Depression and Improving Rehabilitation Outcomes

Terminated·UUniversity of Pittsburgh·Phase 4·NCT00177424·154 enrolled

Completed·UUniversity of Washington·N/A·NCT02655354·635 enrolled

Adverse Effect1 trial

Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.

Completed·HHadassah Medical Organization·N/A·NCT00421369·35 enrolled

Migraine1 trial

Verapamil vs. Sertraline for Vestibular Migraine & Chronic Subjective Dizziness

Completed·MMayo Clinic·Phase 1·NCT01669304·32 enrolled

Autism Spectrum Disorder1 trial

A Trial of Sertraline in Young Children With Autism Spectrum Disorder

Completed·RRandi J. Hagerman, MD·Phase 2·NCT02385799·58 enrolled

Treatment Outcome1 trial

Treatment Outcome of Vascular Depression

Completed·UUniversity of Pennsylvania··NCT00045773·208 enrolled

Cocaine-dependent1 trial

Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans

Completed·UUniversity of Arkansas·Phase 2·NCT00654953·102 enrolled

Substance Abuse1 trial

Treatment of Comorbid Depression and Substance Abuse in Young People

Completed·DDan Lubman·Phase 2·NCT00232284·60 enrolled

Perinatal Depression1 trial

A Pilot Trial of Perinatal Depression Treatment in HIV Infected Women

Completed·UUniversity of North Carolina, Chapel Hill·Phase 4·NCT04094870·80 enrolled

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

Postnatal Depression1 trial

A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression

Completed·UUniversity of Melbourne·Phase 3·NCT02122393·45 enrolled

Cocaine Dependence1 trial

Tiagabine, Sertraline, or Donepezil for the Treatment of Cocaine Dependence - 9

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00015132

Efficacy1 trial

Predicting SSRI Efficacy in Veterans With PTSD

Terminated·VVA Office of Research and Development·Phase 4·NCT04183205·26 enrolled

Alcoholism1 trial

Sertraline Pharmacotherapy for Alcoholism Subtypes

Completed·UUConn Health·Phase 4·NCT00368550·134 enrolled

Sexual Dysfunction1 trial

Does Vilazodone Help With Antidepressant-associated Sexual Dysfunction?

Terminated·TThomas Jefferson University·Phase 4·NCT01856127·4 enrolled

Magnetic Resonance Imaging1 trial

Magnetic Resonance Imaging Study of Geriatric Depression

Completed·MMclean Hospital·N/A·NCT00245557·43 enrolled

Prolonged1 trial

PROlonGed ExpoSure Sertraline

Completed·VVA Ann Arbor Healthcare System·Phase 4·NCT01524133·223 enrolled

Transcranial Direct Current Stimulation1 trial

The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease

Terminated·NNational Cheng-Kung University Hospital·Phase 1/2·NCT02917122·15 enrolled

Orthostatic Intolerance1 trial

Treatment of Orthostatic Intolerance

Active, not recruiting·SSatish R. Raj·Phase 1/2·NCT00262470·150 enrolled

Coccidioidomycosis1 trial

Sertraline in Addition to Standard of Care Treatment for Coccidioidomycosis

Withdrawn·UUniversity of California, San Francisco·Phase 2·NCT02908334

Suicide1 trial

Treatment of Adolescent Suicide Attempters (TASA)

Completed·NNew York State Psychiatric Institute·Phase 2/3·NCT00080158·120 enrolled

Oxidative Stress1 trial

Effect of Combined Antioxidant Therapy on Oxidative Stress Markers and Inflammatory Cytokines in Patients With Tinnitus

Unknown status·UUniversity of Guadalajara·Phase 2·NCT05646693·58 enrolled

Chest pain1 trial

The Effects of Treatment With Sertraline for Noncardiac Chest Pain

Completed·MMaastricht University Medical Center·Phase 4·NCT01114100·210 enrolled

Overweight1 trial

Adding an Insulin-Sensitizing Medication to Depression Treatment for People Who Are Depressed and Overweight

Completed·WWashington University School of Medicine·Phase 4·NCT00834652·206 enrolled

Screening1 trial

Cryptococcal Antigen Screening Plus Sertraline

Terminated·UUniversity of Minnesota·Phase 3·NCT03002012·22 enrolled

Lactobacillus Plantarum1 trial

Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment

Completed·MMedical University of Bialystok·Phase 2·NCT02469545·60 enrolled

Myelodysplastic Syndrome1 trial

Sertraline in Treatment of Low-Risk Myelodysplastic Syndrome

Terminated·GGustavo Rivero·Phase 1·NCT02452983·14 enrolled

Metabolism1 trial

The Effect of a Selective Serotonin Reuptake Inhibitor on Gait, Balance, and Bone Metabolism in Older Adults

Completed·UUniversity Health Network, Toronto·Phase 4·NCT02228005·25 enrolled

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 enrolled

Cohort Study1 trial

Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea

Completed· Pfizer logo

Pfizer··NCT04446039·370,212 enrolled

Glioblastoma1 trial

A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma

Completed·UUniversity of Ulm·Phase 1/2·NCT02770378·10 enrolled

Hypertension1 trial

A Randomized Controlled Trial of Sertraline in Paroxysmal Arterial Hypertension

Unknown status·UUniversity Hospital Olomouc·Phase 4·NCT02641652·136 enrolled

Gastric Bypass Surgery1 trial

Pharmacokinetic Properties of Sertraline Before and After Gastric Bypass Surgery

Completed·NNorth Dakota State University·Phase 3·NCT01214382·31 enrolled

Trichotillomania1 trial

Sertraline and Habit Reversal in the Treatment of Patients With Trichotillomania

Completed·MMassachusetts General Hospital·Phase 4·NCT00118014·75 enrolled

Exercise Training1 trial

Exercise Training Versus Drug Therapy for Treating Depression in Older Adults

Completed·—·Phase 3·NCT00331305·457 enrolled

Burning Mouth Syndrome1 trial

Comparison of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Burning Mouth Syndrome

Unknown status·FFederico II University·Phase 3·NCT06025474·203 enrolled

Generalized Anxiety Disorder1 trial

Pharmacological Treatment of Generalized Anxiety Disorder in the Elderly

Completed·VVA Office of Research and Development·Phase 4·NCT00701675·42 enrolled

Adverse Events1 trial

Sertraline and the Risk of Serious Adverse Events

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's··NCT07387120·6,893 enrolled

Randomized Controlled Trial1 trial

Effect of Sertraline on Inflammation in Hemodialysis Patients with Depression: a Randomized Controlled Trial

Active, not recruiting·NNishtar Medical University·N/A·NCT06840379·62 enrolled

Alzheimer's Disease1 trial

The Depression in Alzheimer's Disease Study (DIADS)

Completed·JJohns Hopkins University·Phase 4·NCT00009191

Unspecified5 trials

Sertraline vs. Venlafaxine XR

Completed·VVanderbilt University·Phase 3·NCT00179283·20 enrolled

A Pharmacokinetic Study of the Coadministration of LY2216684 With Sertraline

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01250873·20 enrolled

Sertraline Effect in Uremic Pruritis

Completed·—·Phase 2·NCT05341843·60 enrolled

Show 2 more trials

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Vortioxetine vs Sertraline in Mexicans

Completed·—·Phase 4·NCT03978286·21 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]
ClinicalTrials.gov — 218 trial records for Sertraline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Zoloft drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Sertraline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Sertraline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA215133). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Viatris Specialty LLC company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin Transporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: VViatris Specialty LLC

Zoloft

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Q2 2027

Q3 2027

Trials by Indication[1]

Depression20 trials

Major Depressive Disorder14 trials

Treatment8 trials

Anxiety6 trials

Postpartum Depression5 trials

Post-Traumatic Stress Disorder5 trials

Major Depression5 trials

Social Anxiety Disorder5 trials

Adolescent4 trials

Treatment Resistant Depression4 trials

Dementia3 trials

Mood Disorder3 trials

Combination Therapy3 trials

Antidepressants3 trials

Fasting Conditions3 trials

Obsessive-Compulsive Disorder3 trials

Anxiety Disorder3 trials

Heart Failure2 trials

Stress2 trials

Prevention2 trials

Insomnia2 trials

Brain Injury2 trials

Fed2 trials

Bipolar Disorder2 trials

Tics2 trials

Alcohol Dependence2 trials

Epilepsy2 trials

Panic Disorder2 trials

Hypoperfusion2 trials

Seizure2 trials

Medication2 trials

Cerebral Perfusion2 trials

Effectiveness2 trials

ALS1 trial

Pediatric1 trial

First-line Treatment1 trial

Elective1 trial

Heart Disease1 trial

Chronic Kidney Disease1 trial

Aging1 trial

Volume1 trial

MPR1 trial

Fragile X Syndrome1 trial

Chronic Obstructive Pulmonary Disease1 trial

Cardiac Repolarization1 trial

Parkinson's Disease1 trial

Refractory AML1 trial

Bipolar Depression1 trial

Trial1 trial

Cryptococcal Meningitis1 trial

Autism1 trial

Severe Depression1 trial

Pruritus1 trial

Melancholia1 trial

PTSD1 trial

Necrosis1 trial

Quality of Life1 trial

Stroke1 trial

PET1 trial

Acute Kidney Injury1 trial

Morbidity1 trial

Adverse Effect1 trial

Migraine1 trial

Autism Spectrum Disorder1 trial

Treatment Outcome1 trial

Cocaine-dependent1 trial

Substance Abuse1 trial

Perinatal Depression1 trial

Efficacy and Safety1 trial

Postnatal Depression1 trial

Cocaine Dependence1 trial