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 35 indications[4].[1]

Zoloft is one of 656 small molecule programs targeting Depressive Disorder. It is currently in Approved.

Indications

220

Total Trials

Active Trials

655

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Depressive DisorderActive, not recruiting

MelancholiaActive, not recruiting

Premenstrual TensionApproved

Mood DisorderTerminated

StrokeActive, not recruiting

Phobic DisorderActive, not recruiting

Chest PainActive, not recruiting

NecrosisTerminated

Sexual DysfunctionActive, not recruiting

Panic DisorderCompleted

Depressive DisorderApproved

Active, not recruiting

MelancholiaApproved

Active, not recruiting

Premenstrual TensionApproved

Approved

Mood DisorderApproved

Terminated

StrokeApproved

Active, not recruiting

Phobic DisorderPreclinical

Active, not recruiting

Chest PainApproved

Active, not recruiting

NecrosisApproved

Terminated

Sexual DysfunctionApproved

Active, not recruiting

Panic DisorderApproved

Completed

Showing 10 of 35 indications

Competition

Competitive Landscape

235 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Zoloft

VViatris Specialty LLC

Novantrone

34 3

Xospata

Astellas

Phase 3

24 4

Fludara

Sanofi

Phase 3

18 5

Mylotarg

WWyeth-Lederle Vaccines

Phase 3

38 6

Vanflyta

Daiichi Sankyo

Phase 3

16 7

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

32 8

Neupogen

EEastern Cooperative Oncology Group

Phase 3

30 9

Nexavar

Busulfex

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

Timeline

Expected Milestones

Q4 2026

Post-ApprovalRecruiting

Social Anxiety Disorder

NCT07192367

Q3 2027

Phase 1/2Recruiting

Adolescent

NCT05814640

Post-ApprovalRecruiting

Depression

NCT05892744

Q2 2028

Phase 3Recruiting

First-Line Treatment

NCT05973786

Phase 3Recruiting

Major Depressive Disorder

NCT05603104

Q1 2029

Phase 2Recruiting

Depression

NCT06408246

Clinical

Trials by Indication[1]

Depression19 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

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

Completed·—··NCT03126188·105 enrolled

Show 16 more trials

Establishing Multimodal Brain Biomarkers for Treatment Selection in Depression

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

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

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

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

Bipolar II Depression: Lithium, SSRI, or the Combination

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

Riluzole Augmentation Pilot in Depression (RAPID) Trial

Terminated·—·Phase 2·NCT01703039·21 enrolled

Integral Assessment in Unipolar Depression

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

Treatments for Depression: Drug Versus Psychotherapy

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

Major Depressive Disorder11 trials

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

Algorithm Guided Treatment Strategies for Major Depressive Disorder

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

Show 8 more trials

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

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

Rhodiola Rosea Therapy of Major Depressive Disorder

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

NMDA Modulation in Major Depressive Disorder in Late- Life

Completed·—·Phase 2·NCT03414931·136 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

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

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

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

Treatment Resistant Depression9 trials

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

Interpersonal Psychotherapy for Treatment Resistant Depression

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

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